Generic Name: ribavirin (oral) (rye ba VYE rin)
Brand Names: Copegus, Rebetol, RibaPak, Ribasphere, RibaTab

What is ribavirin?

Ribavirin is an antiviral medication.

Ribavirin must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C.

Ribavirin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about ribavirin?

Ribavirin is not effective when used alone to treat hepatitis C. Ribavirin must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C. This medication can cause birth defects or death in an unborn baby.

• If you are a woman, do not take ribavirin if you are pregnant.

• If you are a man, do not take ribavirin if your female sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.

• Use at least two effective forms of birth control while either sexual partner is taking ribavirin, and for at least 6 months after treatment ends.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking ribavirin.

Ribavirin may decrease the number of red blood cells in your body. This is called anemia and it can be life-threatening in people who have heart disease or circulation problems. To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Call your doctor at once if you have pale or yellowed skin, dark colored urine, fever, confusion, chest pain, shortness of breath, or weakness. These may be signs of serious anemia.

What should I discuss with my healthcare provider before taking ribavirin?

You should not take this medication if you are allergic to ribavirin, or if you have:

• severe liver disease;

• autoimmune hepatitis;

• a hemoglobin disorder such as anemia, thalassemia (Mediterranean anemia), or sickle-cell anemia; or

• if you are pregnant woman, or a man whose female sexual partner is pregnant.

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before using ribavirin, tell your doctor if you have:

• kidney or liver disease;

• hepatitis B infection;

• a blood cell disorder;

• cancer;

• psoriasis;

• diabetes;

• sarcoidosis;

• a thyroid disorder;

• hepatitis B virus or human immunodeficiency virus (HIV or AIDS);

• a history of heart disease, high blood pressure, or a heart attack;

• a history of depression or suicide attempt;

• a history of drug or alcohol addiction; or

• a history of a liver or other organ transplant.

• Tell your doctor if you have been treated with interferon in the past and it did not work well in treating your hepatitis C.

This medication can cause birth defects or death in an unborn baby.

• If you are a woman, do not take ribavirin if you are pregnant. You will need frequent pregnancy tests to make sure you are not pregnant while taking ribavirin.

• If you are a man, do not take ribavirin if your female sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin. Your sexual partner will need frequent pregnancy tests to make sure she is not pregnant while you are taking ribavirin.

• Use at least two effective forms of birth control while either sexual partner is taking ribavirin, and for at least 6 months after treatment ends.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking ribavirin.

Your name may need to be listed on a ribavirin pregnancy registry if you become pregnant while you or your male sexual partner are taking this medication or during the 6 months after treatment ends. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether ribavirin had any effect on the baby.

It is not known whether ribavirin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take ribavirin?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Ribavirin is not effective when used alone to treat hepatitis C. It must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C. Take this medicine with food.

Measure the liquid form of ribavirin with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Ribavirin may decrease the number of red blood cells in your body. This is called anemia and it can be life-threatening in people who have heart disease or circulation problems. To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your liver and thyroid function may also need to be checked. Do not miss any scheduled visits to your doctor.

Call your doctor at once if you have pale or yellowed skin, dark colored urine, fever, confusion, chest pain, shortness of breath, or weakness. These may be signs of serious anemia.

It is important to use ribavirin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You may need to take this medication for many months.

Drink extra fluids while you are taking ribavirin to keep from getting dehydrated, especially during exercise or in hot weather.

Ribavirin can cause dry mouth, which could lead to tooth decay or gum disease. If you vomit while taking ribavirin, rinse your mouth out with water to prevent damage to your teeth or gums. Be sure to have regular dental exams while you are taking this medication.

Store ribavirin tablets and capsules at room temperature away from moisture, heat, and light. Store ribavirin liquid (oral solution) in the refrigerator. Do not allow it to freeze.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. If you have not taken the medication for longer than 24 hours, call your doctor for instructions. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include easy bruising or bleeding, urinating less than usual or not at all, chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, or a general ill feeling.

What should I avoid while taking ribavirin?

Treatment with ribavirin does not prevent spread of the hepatitis C virus to other people. Follow your doctor’s instructions about how to prevent passing the disease to another person.

Do not drink alcohol while taking ribavirin. Alcohol can increase the risk of damage to your liver. Ribavirin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Ribavirin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using ribavirin and call your doctor at once if you have any of these serious side effects:

• pale or yellowed skin, dark colored urine, easy bruising or bleeding, confusion, or unusual weakness;

• severe depression, hallucinations, thoughts of suicide or hurting yourself;

• fever, chills, body aches, flu symptoms, trouble breathing;

• severe blistering, peeling, and red skin rash;

• blood diarrhea, or black tarry stools;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.

Less serious side effects may include:

• feeling tired or irritable;

• dry mouth, cough;

• headache, dizziness;

• hearing or vision problems;

• hair loss, dry skin, rash, itching;

• joint or muscle pain; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ribavirin?

Before taking ribavirin, tell your doctor if you are using any of the following drugs:

• abacavir (Ziagen);

• didanosine (Videx);

• lamivudine (Combivir, Epivir, Epzicom, Trizivir);

• stavudine (Zerit);

• tenofovir (Viread);

• zalcitabine (Hivid); or

• zidovudine (Retrovir, AZT).

This list is not complete and there may be other drugs that can interact with ribavirin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about ribavirin.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with other, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 4.03. Revision Date: 07/01/2009 8:15:15 PM.

Generic Name: ribavirin (oral) (rye ba VYE rin)
Brand Names: Copegus, Rebetol, RibaPak, Ribasphere, RibaTab

What is ribavirin?

Ribavirin is an antiviral medication.

Ribavirin must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C.

Ribavirin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about ribavirin?

Ribavirin is not effective when used alone to treat hepatitis C. Ribavirin must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C. This medication can cause birth defects or death in an unborn baby.

• If you are a woman, do not take ribavirin if you are pregnant.

• If you are a man, do not take ribavirin if your female sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin.

• Use at least two effective forms of birth control while either sexual partner is taking ribavirin, and for at least 6 months after treatment ends.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking ribavirin.

Ribavirin may decrease the number of red blood cells in your body. This is called anemia and it can be life-threatening in people who have heart disease or circulation problems. To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Call your doctor at once if you have pale or yellowed skin, dark colored urine, fever, confusion, chest pain, shortness of breath, or weakness. These may be signs of serious anemia.

What should I discuss with my healthcare provider before taking ribavirin?

You should not take this medication if you are allergic to ribavirin, or if you have:

• severe liver disease;

• autoimmune hepatitis;

• a hemoglobin disorder such as anemia, thalassemia (Mediterranean anemia), or sickle-cell anemia; or

• if you are pregnant woman, or a man whose female sexual partner is pregnant.

If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before using ribavirin, tell your doctor if you have:

• kidney or liver disease;

• hepatitis B infection;

• a blood cell disorder;

• cancer;

• psoriasis;

• diabetes;

• sarcoidosis;

• a thyroid disorder;

• hepatitis B virus or human immunodeficiency virus (HIV or AIDS);

• a history of heart disease, high blood pressure, or a heart attack;

• a history of depression or suicide attempt;

• a history of drug or alcohol addiction; or

• a history of a liver or other organ transplant.

• Tell your doctor if you have been treated with interferon in the past and it did not work well in treating your hepatitis C.

This medication can cause birth defects or death in an unborn baby.

• If you are a woman, do not take ribavirin if you are pregnant. You will need frequent pregnancy tests to make sure you are not pregnant while taking ribavirin.

• If you are a man, do not take ribavirin if your female sexual partner is pregnant. An unborn baby could also be harmed if a man fathers the child while he is taking ribavirin. Your sexual partner will need frequent pregnancy tests to make sure she is not pregnant while you are taking ribavirin.

• Use at least two effective forms of birth control while either sexual partner is taking ribavirin, and for at least 6 months after treatment ends.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking ribavirin.

Your name may need to be listed on a ribavirin pregnancy registry if you become pregnant while you or your male sexual partner are taking this medication or during the 6 months after treatment ends. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether ribavirin had any effect on the baby.

It is not known whether ribavirin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take ribavirin?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Ribavirin is not effective when used alone to treat hepatitis C. It must be used together with an interferon alfa product (such as Peg-Intron or Intron A) to treat chronic hepatitis C. Take this medicine with food.

Measure the liquid form of ribavirin with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Ribavirin may decrease the number of red blood cells in your body. This is called anemia and it can be life-threatening in people who have heart disease or circulation problems. To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your liver and thyroid function may also need to be checked. Do not miss any scheduled visits to your doctor.

Call your doctor at once if you have pale or yellowed skin, dark colored urine, fever, confusion, chest pain, shortness of breath, or weakness. These may be signs of serious anemia.

It is important to use ribavirin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You may need to take this medication for many months.

Drink extra fluids while you are taking ribavirin to keep from getting dehydrated, especially during exercise or in hot weather.

Ribavirin can cause dry mouth, which could lead to tooth decay or gum disease. If you vomit while taking ribavirin, rinse your mouth out with water to prevent damage to your teeth or gums. Be sure to have regular dental exams while you are taking this medication.

Store ribavirin tablets and capsules at room temperature away from moisture, heat, and light. Store ribavirin liquid (oral solution) in the refrigerator. Do not allow it to freeze.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. If you have not taken the medication for longer than 24 hours, call your doctor for instructions. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include easy bruising or bleeding, urinating less than usual or not at all, chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, or a general ill feeling.

What should I avoid while taking ribavirin?

Treatment with ribavirin does not prevent spread of the hepatitis C virus to other people. Follow your doctor’s instructions about how to prevent passing the disease to another person.

Do not drink alcohol while taking ribavirin. Alcohol can increase the risk of damage to your liver. Ribavirin can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Ribavirin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using ribavirin and call your doctor at once if you have any of these serious side effects:

• pale or yellowed skin, dark colored urine, easy bruising or bleeding, confusion, or unusual weakness;

• severe depression, hallucinations, thoughts of suicide or hurting yourself;

• fever, chills, body aches, flu symptoms, trouble breathing;

• severe blistering, peeling, and red skin rash;

• blood diarrhea, or black tarry stools;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate.

Less serious side effects may include:

• feeling tired or irritable;

• dry mouth, cough;

• headache, dizziness;

• hearing or vision problems;

• hair loss, dry skin, rash, itching;

• joint or muscle pain; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ribavirin?

Before taking ribavirin, tell your doctor if you are using any of the following drugs:

• abacavir (Ziagen);

• didanosine (Videx);

• lamivudine (Combivir, Epivir, Epzicom, Trizivir);

• stavudine (Zerit);

• tenofovir (Viread);

• zalcitabine (Hivid); or

• zidovudine (Retrovir, AZT).

This list is not complete and there may be other drugs that can interact with ribavirin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about ribavirin.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with other, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 4.03. Revision Date: 07/01/2009 8:15:15 PM.

Generic Name: Ribavirin (RYE-ba-VIR-in)
Brand Name: Examples include Rebetol and Ribasphere

Ribasphere Capsules is used for:

Treating chronic hepatitis C infection in certain patients when used in combination with interferon. It may also be used for other conditions as determined by your doctor.

Ribasphere Capsules is an antiviral medicine. Exactly how Ribasphere Capsules works to treat hepatitis C is not known.

Do NOT use Ribasphere Capsules if:

• you are allergic to any ingredient in Ribasphere Capsules or have had a severe allergic reaction (eg, red, swollen, blistered, or peeling skin) to ribavirin or any other ingredient in Ribasphere Capsules
• you are pregnant
• your female sexual partner is pregnant or could become pregnant within the next 6 months
• you have certain blood disorders (eg, hemolytic anemia, sickle-cell anemia, thalassemia major), a history of serious heart problems, severe kidney problems, or inflammation of the pancreas (acute pancreatitis)
• you have autoimmune hepatitis (liver problems caused by your body instead of a virus)
• you are taking didanosine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ribasphere Capsules:

Some medical conditions may interact with Ribasphere Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have female sexual partner who is of childbearing age
• if you have a history of cancer, heart problems or heart attack, high blood pressure, kidney problems, diabetes, pancreas problems, lung or breathing problems, sarcoidosis, blood problems (eg, anemia), thyroid problems, HIV infection, or eye or vision problems
• if you have liver problems (other than hepatitis C infection) such as hepatitis B infection, cirrhosis of the liver, or decreased liver function
• if you have a history of anxiety or other mood or mental disorders (eg, depression), thoughts of suicide, or suicidal behavior
• if you have used interferon before to treat hepatitis C and it did not work
• if you had an organ transplant and you are taking medicine that keeps your body from rejecting the transplant
• if you have a history of drug or alcohol abuse

Some MEDICINES MAY INTERACT with Ribasphere Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Other antiretroviral medicines for HIV infection, didanosine, other nucleoside reverse transcriptase inhibitors (NRTIs) (eg, lamivudine), or thiopurines (eg, azathioprine) because the risk of serious side effects, including risk of infection, nerve problems (peripheral neuropathy), pancreas problems, bone marrow suppression, lactic acidosis, and severe or fatal liver failure, may be increased by Ribasphere Capsules
• Anticoagulants (eg, warfarin) and certain NRTIs (eg, lamivudine, stavudine, zidovudine) because their effectiveness may be decreased by Ribasphere Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ribasphere Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ribasphere Capsules:

Use Ribasphere Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Ribasphere Capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ribasphere Capsules refilled.
• Take Ribasphere Capsules by mouth with food.
• Swallow Ribasphere Capsules whole. Do not break, crush, or chew before swallowing.
• Drinking extra fluids while you are taking Ribasphere Capsules is recommended. Check with your doctor for instructions.
• Taking Ribasphere Capsules at the same time each day will help you remember to take it.
• Take Ribasphere Capsules on a regular schedule to get the most benefit from it.
• Continue to use Ribasphere Capsules even if you feel well. Do not miss any doses.
• If you miss a dose of Ribasphere Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ribasphere Capsules.

Important safety information:

• Ribasphere Capsules may cause dizziness or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Ribasphere Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Avoid drinking alcohol, including beer, wine, and liquor, because it could worsen liver disease.
• At least 2 reliable forms of effective birth control must be used during treatment with Ribasphere Capsules and for 6 months after treatment with Ribasphere Capsules is stopped.
• Women of childbearing potential who either take Ribasphere Capsules or are sexual partners of men who take Ribasphere Capsules must have a pregnancy test before therapy with Ribasphere Capsules is started, monthly during therapy, and monthly for 6 months after Ribasphere Capsules is stopped.
• Children and teenagers who take Ribasphere Capsules may be at increased risk for suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Ribasphere Capsules closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood, aggression, anger, anxiety, nervousness, irritable behavior, or any unusual changes in mood or behavior occur. Contact the doctor right away if any signs or suicidal thoughts or actions occur.
• Ribasphere Capsules may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• Ribasphere Capsules may cause dry mouth and increase the risk of teeth and gum problems. Proper dental care is important while you are taking Ribasphere Capsules. Brush and floss your teeth carefully at least twice a day and visit the dentist regularly.
• If vomiting occurs while you are taking Ribasphere Capsules, be sure to rinse your mouth and clean your teeth afterwards.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Diabetes patients – Ribasphere Capsules may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including pregnancy tests; complete blood cell counts; hemoglobin levels; and heart, liver, kidney, thyroid, lung function tests, and eye exams, may be performed while you use Ribasphere Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Ribasphere Capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially anemia.
• Ribasphere Capsules may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they take Ribasphere Capsules.
• Ribasphere Capsules should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Ribasphere Capsules if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Ribasphere Capsules is found in breast milk. Do not breast-feed while taking Ribasphere Capsules.

Possible side effects of Ribasphere Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; cough; diarrhea; dizziness; dry mouth; dry skin; loss of appetite; mild headache, nausea, or vomiting; mild pain, redness, or swelling at the injection site; sinus problems; tiredness; upset stomach; weakness or fatigue.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; itching; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in hearing, taste, or vision; chest pain; dark, tarry, or bloody stools; dark urine; decrease in the amount of urine; fever, chills, or sore throat; hair loss; joint pain; menstrual problems; mood or mental problems (eg, agitation, aggression, anger, anxiety, decreased concentration, depression, irritability, nervousness); muscle pain or weakness; prolonged nausea and vomiting; rapid breathing; severe headache; severe or persistent pain, redness, or swelling at the injection site; severe stomach or back pain; shortness of breath; suicidal thoughts or actions; trouble sleeping; unusual bruising or bleeding; unusual or severe tiredness and fatigue; weight loss; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Ribasphere Capsules:

Store Ribasphere Capsules at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ribasphere Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Ribasphere Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Ribasphere Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Ribasphere Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: estrogen (Oral route, Parenteral route, Topical application route, Transdermal route)

Commonly used brand name(s):

In the U.S.

• Alora
• Cenestin
• Climara
• Divigel
• Elestrin
• Emcyt
• Enjuvia
• Esclim
• Estinyl
• EstroGel
• Evamist
• Femtrace
• Gynodiol
• Menest
• Menostar
• Ogen .625
• Ogen 1.25
• Ogen 2.5
• Premarin
• Vivelle
• Vivelle-Dot

In Canada

• Estraderm
• Estradot Transdermal
• Estradot Transdermal Therapeutic System
• Estradot Transdermal Therapeutic System
• Estrogel
• Oesclim
• Rhoxal-Estradiol Derm 50
• Rhoxal-Estradiol Derm 75
• Roxal-Estradiol Derm 100
• Vivelle 100 Mcg
• Vivelle 25 Mcg

Available Dosage Forms:

• Tablet
• Tablet, Enteric Coated
• Capsule
• Patch, Extended Release
• Gel/Jelly
• Spray
• Emulsion

Uses For Rhoxal-Estradiol Derm 50

Estrogens are female hormones. They are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years.

The ovaries begin to produce less estrogen after menopause (the change of life). This medicine is prescribed to make up for the lower amount of estrogen. Estrogens help relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness.

Estrogens are prescribed for several reasons:

• To provide additional hormone when the body does not produce enough of its own, such as during menopause or when female puberty (development of female sexual organs) does not occur on time. Other conditions include a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or ovary problems (female hypogonadism or failure or removal of both ovaries).
• To help prevent weakening of bones (osteoporosis) in women past menopause.
• In the treatment of selected cases of breast cancer in men and women.
• In the treatment of cancer of the prostate in men.

Estrogens may also be used for other conditions as determined by your doctor.

There is no medical evidence to support the belief that the use of estrogens will keep the patient feeling young, keep the skin soft, or delay the appearance of wrinkles. Nor has it been proven that the use of estrogens during menopause will relieve emotional and nervous symptoms, unless these symptoms are caused by other menopausal symptoms, such as hot flashes or hot flushes.

Estrogens are available only with your doctor’s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, estrogen is used in certain patients with the following medical conditions:

• Gender identity disorder, male-to-female transsexualism (person who is born as a man but adapts to a woman’s lifestyle, sees himself as a woman, and feels like a woman instead of a man
• Osteoporosis caused by lack of estrogen before menopause
• Turner’s syndrome (a genetic disorder)

Before Using Rhoxal-Estradiol Derm 50

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of this medicine before puberty is not recommended. Growth of bones can be stopped early. Girls and boys may develop growth of breasts. Girls may have vaginal changes, including vaginal bleeding.

This medicine may be used to start puberty in teenagers with some types of delayed puberty.

Geriatric

Elderly people are especially sensitive to the effects of estrogens. This may increase the chance of side effects during treatment, especially stroke, invasive breast cancer, and memory problems.

Pregnancy

Estrogens are not recommended for use during pregnancy or right after giving birth. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause.

Certain estrogens have been shown to cause serious birth defects in humans and animals. Some daughters of women who took diethylstilbestrol (DES) during pregnancy have developed reproductive (genital) tract problems and, rarely, cancer of the vagina or cervix (opening to the uterus) when they reached childbearing age. Some sons of women who took DES during pregnancy have developed urinary-genital tract problems.

Breast Feeding

Use of this medicine is not recommended in nursing mothers. Estrogens pass into the breast milk and their possible effect on the baby is not known.

Interactions with Medicines

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bacillus of Calmette and Guerin Vaccine, Live
• Felbamate
• Influenza Virus Vaccine, Live
• Isotretinoin
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Paclitaxel
• Paclitaxel Protein-Bound
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• St John’s Wort
• Theophylline
• Tizanidine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

For all patients

• Blood clotting problems (or history of during previous estrogen therapy)—Estrogens usually are not used until blood clotting problems stop; using estrogens is not a problem for most patients without a history of blood clotting problems due to estrogen use

• Asthma or
• Calcium, too much or too little in blood or
• Diabetes mellitus (sugar diabetes) or
• Epilepsy (seizures) or
• Heart problems or
• Kidney problems or
• Liver tumors, benign or
• Lupus erythematosus, systemic or
• Migraine headaches—Estrogens may worsen these conditions.

• Breast cancer or
• Bone cancer or
• Cancer of the uterus or
• Fibroid tumors of the uterus—Estrogens may interfere with the treatment of breast or bone cancer or worsen cancer of the uterus when these conditions are present.

• Changes in genital or vaginal bleeding of unknown causes—Use of estrogens may delay diagnosis or worsen condition. The reason for the bleeding should be determined before estrogens are used.

• Endometriosis or
• High cholesterol or triglycerides (or history of) or
• Gallbladder disease or gallstones (or history of) or
• Liver disease (or history of) or
• Pancreatitis (inflammation of pancreas) or
• Porphyria—Estrogens may worsen these conditions. Although estrogens can improve blood cholesterol, they can worsen blood triglycerides for some people.

• Hypothyroid (too little thyroid hormone)—Dose of thyroid medicine may need to be increased.

• Vision changes, sudden onset including
• Bulging eyes or
• Double vision or
• Migraine headache or
• Vision loss, partial or complete—Estrogens may cause these problems. Tell your doctor if you have had any of these problems, especially while taking estrogen or oral contraceptives (“birth control pills”).

For males treated for breast or prostate cancer

• Blood clots or
• Heart or circulation disease or
• Stroke—Males with these medical problems may be more likely to have clotting problems while taking estrogens; the high doses of estrogens used to treat male breast or prostate cancer have been shown to increase the chances of heart attack, phlebitis (inflamed veins) caused by a blood clot, or blood clots in the lungs.

Proper Use of estrogen

This section provides information on the proper use of a number of products that contain estrogen. It may not be specific to Rhoxal-Estradiol Derm 50. Please read with care.

Estrogens usually come with patient information or directions. Read them carefully before taking this medicine.

Take this medicine only as directed by your doctor. Do not take more of it and do not take or use it for a longer time than your doctor ordered. For patients taking any of the estrogens by mouth, try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

For patients taking any of the estrogens by mouth or by injection:

• Nausea may occur during the first few weeks after you start taking estrogens. This effect usually disappears with continued use. If the nausea is bothersome, it can usually be prevented or reduced by taking each dose with food or immediately after food.

For patients using the transdermal (skin patch) form of estradiol:

• Wash and dry your hands thoroughly before and after handling the patch.
• Apply the patch to a clean, dry, non-oily skin area of your lower abdomen, hips below the waist, or buttocks that has little or no hair and is free of cuts or irritation. The manufacturer of the 0.025-mg patch recommends that its patch be applied to the buttocks only. Furthermore, each new patch should be applied to a new site of application. For instance, if the old patch is taken off the left buttock, then apply the new patch to the right buttock.
• Do not apply to the breasts. Also, do not apply to the waistline or anywhere else where tight clothes may rub the patch loose.
• Press the patch firmly in place with the palm of your hand for about 10 seconds. Make sure there is good contact, especially around the edges.
• If a patch becomes loose or falls off, you may reapply it or discard it and apply a new patch.
• Each dose is best applied to a different area of skin on your lower abdomen, hips below the waist, or buttocks so that at least 1 week goes by before the same area is used again. This will help prevent skin irritation.

For patients using the topical emulsion (skin lotion) form of estradiol:

• Washing and drying hands thoroughly before each application.
• Apply while you are sitting comfortably. Apply one pouch to each leg every morning.
• Apply the entire contents of one pouch to clean, dry skin on the left thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.
• Apply entire contents of the second pouch to clean, dry skin on the right thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.
• Rub any remaining emulsion on both hands on the buttocks.
• Washing and drying hands thoroughly after application.
• To avoid transfer to other individuals, allow the application areas to dry completely before covering with clothing.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For conjugated estrogens
• For oral dosage form (tablets):
  • For treating breast cancer in women after menopause and in men:
    • Adults—10 milligrams (mg) three times a day for at least three months.
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    • Adults—0.3 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.
  • To prevent loss of bone (osteoporosis):
    • Adults—0.3 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.
  • For treating ovary problems (female hypogonadism or for starting puberty):
    • Adults and teenagers—0.3 to 0.625 mg a day. Your doctor may want you to take the medicine only on certain days of the month.
  • For treating ovary problems (failure or removal of both ovaries):
    • Adults—1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating prostate cancer:
    • Adults—1.25 to 2.5 mg three times a day.
• For injection dosage form:
  • For controlling abnormal bleeding of the uterus:
    • Adults—25 mg injected into a muscle or vein. This may be repeated in six to twelve hours if needed.

• For esterified estrogens
• For oral dosage form (tablets):
  • For treating breast cancer in women after menopause and in men:
    • Adults—10 milligrams (mg) three times a day for at least three months.
  • For treating a genital skin condition (vulvar atrophy) or inflammation of the vagina (atrophic vaginitis), or to prevent loss of bone (osteoporosis):
    • Adults—0.3 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating ovary problems (failure or removal of both ovaries):
    • Adults—1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating ovary problems (female hypogonadism):
    • Adults—2.5 to 7.5 mg a day. This dose may be divided up and taken in smaller doses. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating symptoms of menopause:
    • Adults—0.625 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating prostate cancer:
    • Adults—1.25 to 2.5 mg three times a day.

• For estradiol
• For oral dosage form:
  • For treating breast cancer in women after menopause and in men:
    • Adults—10 milligrams (mg) three times a day for at least three months .
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), ovary problems (female hypogonadism or failure or removal of both ovaries), or symptoms of menopause:
    • Adults—At first, 1 to 2 milligrams (mg) one time per day for at least three months. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may also need to change the dose based on how your body responds to the medication .
  • For treating prostate cancer:
    • Adults—1 to 2 mg three times a day .
  • To prevent loss of bone (osteoporosis):
    • Adults—0.5 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month .
• For topical emulsion dosage form (skin lotion):
  • For treating symptoms of menopause:
    • Adults—1.74 grams (one pouch) applied to the skin of each leg (thigh and calf) once a day in the morning.
• For transdermal dosage form (skin patches):
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, ovary problems (female hypogonadism or failure or removal of both ovaries), or to prevent loss of bone (osteoporosis):
    • For the Climara patches
    • Adults—0.025 to 0.1 milligram (mg) (one patch) applied to the skin and worn for one week. Then, remove that patch and apply a new one. A new patch should be applied once a week for three weeks. During the fourth week, you may or may not wear a patch. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.
    • For the Alora, Estraderm, Estradot, Vivelle, or Vivelle-Dot patches
    • Adults—0.025 to 0.1 mg (one patch) applied to the skin and worn for one half of a week. Then, remove that patch and apply and wear a new patch for the rest of the week. A new patch should be applied two times a week for three weeks. During the fourth week, you may or may not apply new patches. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.

• For estradiol cypionate
• For injection dosage form:
  • For treating ovary problems (female hypogonadism):
    • Adults—1.5 to 2 milligrams (mg) injected into a muscle once a month.
  • For treating symptoms of menopause:
    • Adults—1 to 5 mg injected into a muscle every three to four weeks.

• For estradiol valerate
• For injection dosage form:
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, or ovary problems (female hypogonadism or failure or removal of both ovaries):
    • Adults—10 to 20 milligrams (mg) injected into a muscle every four weeks as needed.
  • For treating prostate cancer:
    • Adults—30 mg injected into a muscle every one or two weeks.

• For estrone
• For injection dosage form:
  • For controlling abnormal bleeding of the uterus:
    • Adults—2 to 5 milligrams (mg) a day, injected into a muscle for several days.
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    • Adults—0.1 to 0.5 mg injected into a muscle two or three times a week. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.
  • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
    • Adults—0.1 to 1 mg a week. This is injected into a muscle as a single dose or divided into more than one dose. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.
  • For treating prostate cancer:
    • Adults—2 to 4 mg injected into a muscle two or three times a week.

• For estropipate
• For oral dosage form (tablets):
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    • Adults—0.75 to 6 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
    • Adults—1.5 to 9 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • To prevent loss of bone (osteoporosis):
    • Adults—0.75 mg a day. Your doctor may want you to take the medicine each day for twenty-five days of a thirty-one–day cycle.

• For ethinyl estradiol
• For oral dosage form (tablets):
  • For treating breast cancer in women after menopause and in men:
    • Adults—1 milligram (mg) three times a day.
  • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
    • Adults—0.05 mg one to three times a day for three to six months. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating prostate cancer:
    • Adults—0.15 to 3 mg a day.
  • For treating symptoms of menopause:
    • Adults—0.02 to 0.05 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.

• For ethinyl estradiol and norethindrone
• For oral dosage form (tablets):
  • For treating symptoms of menopause:
    • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.
  • To prevent loss of bone (osteoporosis):
    • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Rhoxal-Estradiol Derm 50

It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every year, but some doctors require them more often.

In some patients using estrogens, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast, ovaries, or uterus (womb).. Therefore, it is very important that you regularly check your breasts for any unusual lumps or discharge. Report any problems to your doctor. You should also have a mammogram (x-ray pictures of the breasts) done if your doctor recommends it. Because breast cancer has occurred in men taking estrogens, regular breast self-exams and exams by your doctor for any unusual lumps or discharge should be done.

If your menstrual periods have stopped, they may start again. This effect will continue for as long as the medicine is taken. However, if taking the continuous treatment (0.625 mg conjugated estrogens and 2.5 mg medroxyprogesterone once a day), monthly bleeding usually stops within 10 months.

Also, vaginal bleeding between your regular menstrual periods may occur during the first 3 months of use. Do not stop taking your medicine. Check with your doctor if bleeding continues for an unusually long time, if your period has not started within 45 days of your last period, or if you think you are pregnant.

Tell the doctor in charge that you are taking this medicine before having any laboratory test because some results may be affected.

Rhoxal-Estradiol Derm 50 Side Effects

Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:

The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer.

Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast. Breast cancer has been reported in men taking estrogens.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

The following side effects may be caused by blood clots, which could lead to stroke, heart attack, or death. These side effects occur rarely, and, when they do occur, they occur in men treated for cancer using high doses of estrogens.

Check with your doctor immediately if any of the following side effects occur:

Rare – for males being treated for breast or prostate cancer only

• Headache (sudden or severe)
• loss of coordination (sudden)
• loss of vision or change of vision (sudden)
• pains in chest, groin, or leg, especially in calf of leg
• shortness of breath (sudden and unexplained)
• slurring of speech (sudden)
• weakness or numbness in arm or leg

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Breast pain (in females and males)
• fast heartbeat
• fever
• hives
• hoarseness
• increased breast size (in females and males)
• irritation of skin
• itching of skin
• joint pain, stiffness or swelling
• rash
• redness of skin
• shortness of breath
• swelling of eyelids, face, lips, hands, or feet
• swelling of feet and lower legs
• tightness in chest
• troubled breathing or swallowing
• weight gain (rapid)
• wheezing

Less common or rare

• Changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of bleeding)
• chest pain
• chills
• cough
• heavy non-menstrual vaginal bleeding
• lumps in, or discharge from, breast (in females and males)
• pains in stomach, side, or abdomen
• yellow eyes or skin

Frequency not determined

• Abdominal bloating
• abdominal cramps
• acid or sour stomach
• anxiety
• backache
• belching
• blindness
• blistering, peeling, loosening of skin
• blue-yellow color blindness
• blurred vision
• change in vaginal discharge
• changes in vision
• changes in skin color
• chest discomfort
• clay-colored stools
• clear or bloody discharge from nipple
• confusion
• constipation
• convulsions
• dark urine
• decrease in amount of urine
• decreased vision
• depression
• diarrhea
• difficulty breathing
• difficulty in speaking
• dimpling of breast skin
• dizziness
• double vision
• dry mouth
• eye pain
• fainting
• fluid-filled skin blisters
• full feeling in upper abdomen
• full or bloated feeling or pressure in the stomach
• headache
• heartburn
• inability to move arms, legs, or facial muscles
• inability to speak
• incoherent speech
• increased urination
• indigestion
• inverted nipple
• irregular heartbeats
• light-colored stools
• lightheadedness
• loss of appetite
• loss of bladder control
• lump under the arm
• metallic taste
• migraine headache
• mood or mental changes
• muscle cramps in hands, arms, feet, legs, or face
• muscle pain
• muscle spasm or jerking of all extremities
• muscle weakness
• nausea
• noisy breathing
• numbness or tingling of hands, feet, or face
• pain in ankles or knees
• pains in chest, groin, or legs, especially calves of legs
• pain or discomfort in arms, jaw, back or neck
• pain or feeling of pressure in pelvis
• painful or tender cysts in the breasts
• painful, red lumps under the skin, mostly on the legs
• pain; tenderness; swelling of foot or leg
• partial or complete loss of vision in eye
• pelvic pain
• persistent crusting or scaling of nipple
• pinpoint red or purple spots on skin
• prominent superficial veins over affected area
• red, irritated eyes
• redness or swelling of breast
• sensitivity to the sun
• severe headaches of sudden onset
• skin thinness
• skin warmth
• slow speech
• sore on the skin of the breast that does not heal
• sore throat
• sores, ulcers, or white spots in mouth or on lips
• stomach discomfort, upset or pain
• sudden loss of consciousness
• sudden loss of coordination
• sudden onset of shortness of breath for no apparent reason
• sudden onset of slurred speech
• sudden vision changes
• swelling of abdominal or stomach area
• swelling of fingers or hands
• thirst
• tremor
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting
• vomiting of blood
• weight loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abnormal growth filled with fluid or semisolid material
• accidental injury
• bladder pain
• bloated full feeling
• bloody or cloudy urine
• body aches or pain
• coating or white patches on tongue
• congestion
• cough producing mucus
• decrease in amount of urine
• difficult, burning, or painful urination
• discouragement
• dryness of throat
• ear congestion or pain
• excess air or gas in stomach or intestines
• fear
• feeling of warmth
• feeling sad or empty
• frequent urge to urinate
• general feeling of discomfort or illness
• headache, severe and throbbing
• increased clear or white vaginal discharge
• irritability
• itching of the vaginal, rectal or genital areas
• lack of appetite
• lack or loss of strength
• loss of interest or pleasure
• mild dizziness
• neck pain
• nervousness
• pain
• pain during sexual intercourse
• painful or difficult urination
• pain or tenderness around eyes and cheekbones
• passing gas
• redness of the face, neck, arms and occasionally, upper chest
• runny nose
• skin irritation or redness where skin patch was worn
• shivering
• sleeplessness
• sneezing
• sore mouth or tongue
• stuffy nose
• sudden sweating
• tender, swollen glands in neck
• thick, white vaginal discharge with no odor or with a mild odor
• tiredness
• trouble concentrating
• trouble sleeping
• unable to sleep
• voice changes

Less common

• Blemishes on the skin
• burning, crawling, itching, numbness, prickling, “pins and needles” , or tingling feelings
• burning or stinging of skin
• diarrhea (mild)
• difficulty in moving
• dizziness (mild)
• increased hair growth, especially on the face
• lower abdominal pain or pressure
• mood or mental changes
• muscle stiffness
• painful cold sores or blisters on lips, nose, eyes, or genitals
• pimples
• pounding in the ears
• problems in wearing contact lenses
• slow heartbeat
• tooth or gum pain
• unusual decrease in sexual desire (in males)
• unusual increase in sexual desire (in females)
• white or brownish vaginal discharge

Frequency not determined

• Abdominal pain
• abnormal turning out of cervix
• changes in appetite
• dull ache or feeling of pressure or heaviness in legs
• fatigue
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• irritability
• large amount of triglyceride in the blood
• leg cramps
• patchy brown or dark brown discoloration of skin
• poor insight and judgment
• problems with memory or speech
• trouble recognizing objects
• trouble thinking and planning
• trouble walking
• twitching, uncontrolled movements of tongue, lips, face, arms, or legs
• unexpected or excess milk flow from breasts

Also, many women who are taking estrogens with a progestin (another female hormone) will start having monthly vaginal bleeding, similar to menstrual periods, again. This effect will continue for as long as the medicine is taken. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (total hysterectomy).

This medicine may cause loss or thinning of scalp hair in some people.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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Generic Name: estrogen (Oral route, Parenteral route, Topical application route, Transdermal route)

Commonly used brand name(s):

In the U.S.

• Alora
• Cenestin
• Climara
• Divigel
• Elestrin
• Emcyt
• Enjuvia
• Esclim
• Estinyl
• EstroGel
• Evamist
• Femtrace
• Gynodiol
• Menest
• Menostar
• Ogen .625
• Ogen 1.25
• Ogen 2.5
• Premarin
• Vivelle
• Vivelle-Dot

In Canada

• Estraderm
• Estradot Transdermal
• Estradot Transdermal Therapeutic System
• Estradot Transdermal Therapeutic System
• Estrogel
• Oesclim
• Rhoxal-Estradiol Derm 50
• Rhoxal-Estradiol Derm 75
• Roxal-Estradiol Derm 100
• Vivelle 100 Mcg
• Vivelle 25 Mcg

Available Dosage Forms:

• Tablet
• Tablet, Enteric Coated
• Capsule
• Patch, Extended Release
• Gel/Jelly
• Spray
• Emulsion

Uses For Rhoxal-Estradiol Derm 75

Estrogens are female hormones. They are produced by the body and are necessary for the normal sexual development of the female and for the regulation of the menstrual cycle during the childbearing years.

The ovaries begin to produce less estrogen after menopause (the change of life). This medicine is prescribed to make up for the lower amount of estrogen. Estrogens help relieve signs of menopause, such as hot flashes and unusual sweating, chills, faintness, or dizziness.

Estrogens are prescribed for several reasons:

• To provide additional hormone when the body does not produce enough of its own, such as during menopause or when female puberty (development of female sexual organs) does not occur on time. Other conditions include a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or ovary problems (female hypogonadism or failure or removal of both ovaries).
• To help prevent weakening of bones (osteoporosis) in women past menopause.
• In the treatment of selected cases of breast cancer in men and women.
• In the treatment of cancer of the prostate in men.

Estrogens may also be used for other conditions as determined by your doctor.

There is no medical evidence to support the belief that the use of estrogens will keep the patient feeling young, keep the skin soft, or delay the appearance of wrinkles. Nor has it been proven that the use of estrogens during menopause will relieve emotional and nervous symptoms, unless these symptoms are caused by other menopausal symptoms, such as hot flashes or hot flushes.

Estrogens are available only with your doctor’s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, estrogen is used in certain patients with the following medical conditions:

• Gender identity disorder, male-to-female transsexualism (person who is born as a man but adapts to a woman’s lifestyle, sees himself as a woman, and feels like a woman instead of a man
• Osteoporosis caused by lack of estrogen before menopause
• Turner’s syndrome (a genetic disorder)

Before Using Rhoxal-Estradiol Derm 75

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of this medicine before puberty is not recommended. Growth of bones can be stopped early. Girls and boys may develop growth of breasts. Girls may have vaginal changes, including vaginal bleeding.

This medicine may be used to start puberty in teenagers with some types of delayed puberty.

Geriatric

Elderly people are especially sensitive to the effects of estrogens. This may increase the chance of side effects during treatment, especially stroke, invasive breast cancer, and memory problems.

Pregnancy

Estrogens are not recommended for use during pregnancy or right after giving birth. Becoming pregnant or maintaining a pregnancy is not likely to occur around the time of menopause.

Certain estrogens have been shown to cause serious birth defects in humans and animals. Some daughters of women who took diethylstilbestrol (DES) during pregnancy have developed reproductive (genital) tract problems and, rarely, cancer of the vagina or cervix (opening to the uterus) when they reached childbearing age. Some sons of women who took DES during pregnancy have developed urinary-genital tract problems.

Breast Feeding

Use of this medicine is not recommended in nursing mothers. Estrogens pass into the breast milk and their possible effect on the baby is not known.

Interactions with Medicines

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using medicines in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bacillus of Calmette and Guerin Vaccine, Live
• Felbamate
• Influenza Virus Vaccine, Live
• Isotretinoin
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Paclitaxel
• Paclitaxel Protein-Bound
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• St John’s Wort
• Theophylline
• Tizanidine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

For all patients

• Blood clotting problems (or history of during previous estrogen therapy)—Estrogens usually are not used until blood clotting problems stop; using estrogens is not a problem for most patients without a history of blood clotting problems due to estrogen use

• Asthma or
• Calcium, too much or too little in blood or
• Diabetes mellitus (sugar diabetes) or
• Epilepsy (seizures) or
• Heart problems or
• Kidney problems or
• Liver tumors, benign or
• Lupus erythematosus, systemic or
• Migraine headaches—Estrogens may worsen these conditions.

• Breast cancer or
• Bone cancer or
• Cancer of the uterus or
• Fibroid tumors of the uterus—Estrogens may interfere with the treatment of breast or bone cancer or worsen cancer of the uterus when these conditions are present.

• Changes in genital or vaginal bleeding of unknown causes—Use of estrogens may delay diagnosis or worsen condition. The reason for the bleeding should be determined before estrogens are used.

• Endometriosis or
• High cholesterol or triglycerides (or history of) or
• Gallbladder disease or gallstones (or history of) or
• Liver disease (or history of) or
• Pancreatitis (inflammation of pancreas) or
• Porphyria—Estrogens may worsen these conditions. Although estrogens can improve blood cholesterol, they can worsen blood triglycerides for some people.

• Hypothyroid (too little thyroid hormone)—Dose of thyroid medicine may need to be increased.

• Vision changes, sudden onset including
• Bulging eyes or
• Double vision or
• Migraine headache or
• Vision loss, partial or complete—Estrogens may cause these problems. Tell your doctor if you have had any of these problems, especially while taking estrogen or oral contraceptives (“birth control pills”).

For males treated for breast or prostate cancer

• Blood clots or
• Heart or circulation disease or
• Stroke—Males with these medical problems may be more likely to have clotting problems while taking estrogens; the high doses of estrogens used to treat male breast or prostate cancer have been shown to increase the chances of heart attack, phlebitis (inflamed veins) caused by a blood clot, or blood clots in the lungs.

Proper Use of estrogen

This section provides information on the proper use of a number of products that contain estrogen. It may not be specific to Rhoxal-Estradiol Derm 75. Please read with care.

Estrogens usually come with patient information or directions. Read them carefully before taking this medicine.

Take this medicine only as directed by your doctor. Do not take more of it and do not take or use it for a longer time than your doctor ordered. For patients taking any of the estrogens by mouth, try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better.

For patients taking any of the estrogens by mouth or by injection:

• Nausea may occur during the first few weeks after you start taking estrogens. This effect usually disappears with continued use. If the nausea is bothersome, it can usually be prevented or reduced by taking each dose with food or immediately after food.

For patients using the transdermal (skin patch) form of estradiol:

• Wash and dry your hands thoroughly before and after handling the patch.
• Apply the patch to a clean, dry, non-oily skin area of your lower abdomen, hips below the waist, or buttocks that has little or no hair and is free of cuts or irritation. The manufacturer of the 0.025-mg patch recommends that its patch be applied to the buttocks only. Furthermore, each new patch should be applied to a new site of application. For instance, if the old patch is taken off the left buttock, then apply the new patch to the right buttock.
• Do not apply to the breasts. Also, do not apply to the waistline or anywhere else where tight clothes may rub the patch loose.
• Press the patch firmly in place with the palm of your hand for about 10 seconds. Make sure there is good contact, especially around the edges.
• If a patch becomes loose or falls off, you may reapply it or discard it and apply a new patch.
• Each dose is best applied to a different area of skin on your lower abdomen, hips below the waist, or buttocks so that at least 1 week goes by before the same area is used again. This will help prevent skin irritation.

For patients using the topical emulsion (skin lotion) form of estradiol:

• Washing and drying hands thoroughly before each application.
• Apply while you are sitting comfortably. Apply one pouch to each leg every morning.
• Apply the entire contents of one pouch to clean, dry skin on the left thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.
• Apply entire contents of the second pouch to clean, dry skin on the right thigh. Rub the emulsion into the entire thigh and calf for 3 minutes until thoroughly absorbed.
• Rub any remaining emulsion on both hands on the buttocks.
• Washing and drying hands thoroughly after application.
• To avoid transfer to other individuals, allow the application areas to dry completely before covering with clothing.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For conjugated estrogens
• For oral dosage form (tablets):
  • For treating breast cancer in women after menopause and in men:
    • Adults—10 milligrams (mg) three times a day for at least three months.
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    • Adults—0.3 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.
  • To prevent loss of bone (osteoporosis):
    • Adults—0.3 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may change the dose based on how your body responds to the medication.
  • For treating ovary problems (female hypogonadism or for starting puberty):
    • Adults and teenagers—0.3 to 0.625 mg a day. Your doctor may want you to take the medicine only on certain days of the month.
  • For treating ovary problems (failure or removal of both ovaries):
    • Adults—1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating prostate cancer:
    • Adults—1.25 to 2.5 mg three times a day.
• For injection dosage form:
  • For controlling abnormal bleeding of the uterus:
    • Adults—25 mg injected into a muscle or vein. This may be repeated in six to twelve hours if needed.

• For esterified estrogens
• For oral dosage form (tablets):
  • For treating breast cancer in women after menopause and in men:
    • Adults—10 milligrams (mg) three times a day for at least three months.
  • For treating a genital skin condition (vulvar atrophy) or inflammation of the vagina (atrophic vaginitis), or to prevent loss of bone (osteoporosis):
    • Adults—0.3 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating ovary problems (failure or removal of both ovaries):
    • Adults—1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating ovary problems (female hypogonadism):
    • Adults—2.5 to 7.5 mg a day. This dose may be divided up and taken in smaller doses. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating symptoms of menopause:
    • Adults—0.625 to 1.25 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating prostate cancer:
    • Adults—1.25 to 2.5 mg three times a day.

• For estradiol
• For oral dosage form:
  • For treating breast cancer in women after menopause and in men:
    • Adults—10 milligrams (mg) three times a day for at least three months .
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), ovary problems (female hypogonadism or failure or removal of both ovaries), or symptoms of menopause:
    • Adults—At first, 1 to 2 milligrams (mg) one time per day for at least three months. Your doctor may want you to take the medicine each day or only on certain days of the month. Your doctor may also need to change the dose based on how your body responds to the medication .
  • For treating prostate cancer:
    • Adults—1 to 2 mg three times a day .
  • To prevent loss of bone (osteoporosis):
    • Adults—0.5 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month .
• For topical emulsion dosage form (skin lotion):
  • For treating symptoms of menopause:
    • Adults—1.74 grams (one pouch) applied to the skin of each leg (thigh and calf) once a day in the morning.
• For transdermal dosage form (skin patches):
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, ovary problems (female hypogonadism or failure or removal of both ovaries), or to prevent loss of bone (osteoporosis):
    • For the Climara patches
    • Adults—0.025 to 0.1 milligram (mg) (one patch) applied to the skin and worn for one week. Then, remove that patch and apply a new one. A new patch should be applied once a week for three weeks. During the fourth week, you may or may not wear a patch. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.
    • For the Alora, Estraderm, Estradot, Vivelle, or Vivelle-Dot patches
    • Adults—0.025 to 0.1 mg (one patch) applied to the skin and worn for one half of a week. Then, remove that patch and apply and wear a new patch for the rest of the week. A new patch should be applied two times a week for three weeks. During the fourth week, you may or may not apply new patches. Your health care professional will tell you what you should do for this fourth week. After the fourth week, you will repeat the cycle.

• For estradiol cypionate
• For injection dosage form:
  • For treating ovary problems (female hypogonadism):
    • Adults—1.5 to 2 milligrams (mg) injected into a muscle once a month.
  • For treating symptoms of menopause:
    • Adults—1 to 5 mg injected into a muscle every three to four weeks.

• For estradiol valerate
• For injection dosage form:
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), symptoms of menopause, or ovary problems (female hypogonadism or failure or removal of both ovaries):
    • Adults—10 to 20 milligrams (mg) injected into a muscle every four weeks as needed.
  • For treating prostate cancer:
    • Adults—30 mg injected into a muscle every one or two weeks.

• For estrone
• For injection dosage form:
  • For controlling abnormal bleeding of the uterus:
    • Adults—2 to 5 milligrams (mg) a day, injected into a muscle for several days.
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    • Adults—0.1 to 0.5 mg injected into a muscle two or three times a week. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.
  • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
    • Adults—0.1 to 1 mg a week. This is injected into a muscle as a single dose or divided into more than one dose. Your doctor may want you to receive the medicine each week or only during certain weeks of the month.
  • For treating prostate cancer:
    • Adults—2 to 4 mg injected into a muscle two or three times a week.

• For estropipate
• For oral dosage form (tablets):
  • For treating a genital skin condition (vulvar atrophy), inflammation of the vagina (atrophic vaginitis), or symptoms of menopause:
    • Adults—0.75 to 6 milligrams (mg) a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
    • Adults—1.5 to 9 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • To prevent loss of bone (osteoporosis):
    • Adults—0.75 mg a day. Your doctor may want you to take the medicine each day for twenty-five days of a thirty-one–day cycle.

• For ethinyl estradiol
• For oral dosage form (tablets):
  • For treating breast cancer in women after menopause and in men:
    • Adults—1 milligram (mg) three times a day.
  • For treating ovary problems (female hypogonadism or failure or removal of both ovaries):
    • Adults—0.05 mg one to three times a day for three to six months. Your doctor may want you to take the medicine each day or only on certain days of the month.
  • For treating prostate cancer:
    • Adults—0.15 to 3 mg a day.
  • For treating symptoms of menopause:
    • Adults—0.02 to 0.05 mg a day. Your doctor may want you to take the medicine each day or only on certain days of the month.

• For ethinyl estradiol and norethindrone
• For oral dosage form (tablets):
  • For treating symptoms of menopause:
    • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day.
  • To prevent loss of bone (osteoporosis):
    • Adults—1 tablet (5 mcg ethinyl estradiol and 1 mg of norethindrone) each day

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Rhoxal-Estradiol Derm 75

It is very important that your doctor check your progress at regular visits to make sure this medicine does not cause unwanted effects. These visits will usually be every year, but some doctors require them more often.

In some patients using estrogens, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums.

Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast, ovaries, or uterus (womb).. Therefore, it is very important that you regularly check your breasts for any unusual lumps or discharge. Report any problems to your doctor. You should also have a mammogram (x-ray pictures of the breasts) done if your doctor recommends it. Because breast cancer has occurred in men taking estrogens, regular breast self-exams and exams by your doctor for any unusual lumps or discharge should be done.

If your menstrual periods have stopped, they may start again. This effect will continue for as long as the medicine is taken. However, if taking the continuous treatment (0.625 mg conjugated estrogens and 2.5 mg medroxyprogesterone once a day), monthly bleeding usually stops within 10 months.

Also, vaginal bleeding between your regular menstrual periods may occur during the first 3 months of use. Do not stop taking your medicine. Check with your doctor if bleeding continues for an unusually long time, if your period has not started within 45 days of your last period, or if you think you are pregnant.

Tell the doctor in charge that you are taking this medicine before having any laboratory test because some results may be affected.

Rhoxal-Estradiol Derm 75 Side Effects

Women rarely have severe side effects from taking estrogens to replace estrogen. Discuss these possible effects with your doctor:

The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the lining of the uterus) in women after menopause. This risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than 1 year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer.

Although the incidence is low, the use of estrogens may increase you chance of getting cancer of the breast. Breast cancer has been reported in men taking estrogens.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

The following side effects may be caused by blood clots, which could lead to stroke, heart attack, or death. These side effects occur rarely, and, when they do occur, they occur in men treated for cancer using high doses of estrogens.

Check with your doctor immediately if any of the following side effects occur:

Rare – for males being treated for breast or prostate cancer only

• Headache (sudden or severe)
• loss of coordination (sudden)
• loss of vision or change of vision (sudden)
• pains in chest, groin, or leg, especially in calf of leg
• shortness of breath (sudden and unexplained)
• slurring of speech (sudden)
• weakness or numbness in arm or leg

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Breast pain (in females and males)
• fast heartbeat
• fever
• hives
• hoarseness
• increased breast size (in females and males)
• irritation of skin
• itching of skin
• joint pain, stiffness or swelling
• rash
• redness of skin
• shortness of breath
• swelling of eyelids, face, lips, hands, or feet
• swelling of feet and lower legs
• tightness in chest
• troubled breathing or swallowing
• weight gain (rapid)
• wheezing

Less common or rare

• Changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of bleeding)
• chest pain
• chills
• cough
• heavy non-menstrual vaginal bleeding
• lumps in, or discharge from, breast (in females and males)
• pains in stomach, side, or abdomen
• yellow eyes or skin

Frequency not determined

• Abdominal bloating
• abdominal cramps
• acid or sour stomach
• anxiety
• backache
• belching
• blindness
• blistering, peeling, loosening of skin
• blue-yellow color blindness
• blurred vision
• change in vaginal discharge
• changes in vision
• changes in skin color
• chest discomfort
• clay-colored stools
• clear or bloody discharge from nipple
• confusion
• constipation
• convulsions
• dark urine
• decrease in amount of urine
• decreased vision
• depression
• diarrhea
• difficulty breathing
• difficulty in speaking
• dimpling of breast skin
• dizziness
• double vision
• dry mouth
• eye pain
• fainting
• fluid-filled skin blisters
• full feeling in upper abdomen
• full or bloated feeling or pressure in the stomach
• headache
• heartburn
• inability to move arms, legs, or facial muscles
• inability to speak
• incoherent speech
• increased urination
• indigestion
• inverted nipple
• irregular heartbeats
• light-colored stools
• lightheadedness
• loss of appetite
• loss of bladder control
• lump under the arm
• metallic taste
• migraine headache
• mood or mental changes
• muscle cramps in hands, arms, feet, legs, or face
• muscle pain
• muscle spasm or jerking of all extremities
• muscle weakness
• nausea
• noisy breathing
• numbness or tingling of hands, feet, or face
• pain in ankles or knees
• pains in chest, groin, or legs, especially calves of legs
• pain or discomfort in arms, jaw, back or neck
• pain or feeling of pressure in pelvis
• painful or tender cysts in the breasts
• painful, red lumps under the skin, mostly on the legs
• pain; tenderness; swelling of foot or leg
• partial or complete loss of vision in eye
• pelvic pain
• persistent crusting or scaling of nipple
• pinpoint red or purple spots on skin
• prominent superficial veins over affected area
• red, irritated eyes
• redness or swelling of breast
• sensitivity to the sun
• severe headaches of sudden onset
• skin thinness
• skin warmth
• slow speech
• sore on the skin of the breast that does not heal
• sore throat
• sores, ulcers, or white spots in mouth or on lips
• stomach discomfort, upset or pain
• sudden loss of consciousness
• sudden loss of coordination
• sudden onset of shortness of breath for no apparent reason
• sudden onset of slurred speech
• sudden vision changes
• swelling of abdominal or stomach area
• swelling of fingers or hands
• thirst
• tremor
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting
• vomiting of blood
• weight loss

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abnormal growth filled with fluid or semisolid material
• accidental injury
• bladder pain
• bloated full feeling
• bloody or cloudy urine
• body aches or pain
• coating or white patches on tongue
• congestion
• cough producing mucus
• decrease in amount of urine
• difficult, burning, or painful urination
• discouragement
• dryness of throat
• ear congestion or pain
• excess air or gas in stomach or intestines
• fear
• feeling of warmth
• feeling sad or empty
• frequent urge to urinate
• general feeling of discomfort or illness
• headache, severe and throbbing
• increased clear or white vaginal discharge
• irritability
• itching of the vaginal, rectal or genital areas
• lack of appetite
• lack or loss of strength
• loss of interest or pleasure
• mild dizziness
• neck pain
• nervousness
• pain
• pain during sexual intercourse
• painful or difficult urination
• pain or tenderness around eyes and cheekbones
• passing gas
• redness of the face, neck, arms and occasionally, upper chest
• runny nose
• skin irritation or redness where skin patch was worn
• shivering
• sleeplessness
• sneezing
• sore mouth or tongue
• stuffy nose
• sudden sweating
• tender, swollen glands in neck
• thick, white vaginal discharge with no odor or with a mild odor
• tiredness
• trouble concentrating
• trouble sleeping
• unable to sleep
• voice changes

Less common

• Blemishes on the skin
• burning, crawling, itching, numbness, prickling, “pins and needles” , or tingling feelings
• burning or stinging of skin
• diarrhea (mild)
• difficulty in moving
• dizziness (mild)
• increased hair growth, especially on the face
• lower abdominal pain or pressure
• mood or mental changes
• muscle stiffness
• painful cold sores or blisters on lips, nose, eyes, or genitals
• pimples
• pounding in the ears
• problems in wearing contact lenses
• slow heartbeat
• tooth or gum pain
• unusual decrease in sexual desire (in males)
• unusual increase in sexual desire (in females)
• white or brownish vaginal discharge

Frequency not determined

• Abdominal pain
• abnormal turning out of cervix
• changes in appetite
• dull ache or feeling of pressure or heaviness in legs
• fatigue
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• irritability
• large amount of triglyceride in the blood
• leg cramps
• patchy brown or dark brown discoloration of skin
• poor insight and judgment
• problems with memory or speech
• trouble recognizing objects
• trouble thinking and planning
• trouble walking
• twitching, uncontrolled movements of tongue, lips, face, arms, or legs
• unexpected or excess milk flow from breasts

Also, many women who are taking estrogens with a progestin (another female hormone) will start having monthly vaginal bleeding, similar to menstrual periods, again. This effect will continue for as long as the medicine is taken. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (total hysterectomy).

This medicine may cause loss or thinning of scalp hair in some people.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Generic Name: Magaldrate (MAG-al-drate)
Brand Name: Examples include Ri-Mag and Ron-Acid

Ri-Mag Suspension is used for:

Treating acid indigestion, heartburn, and sour stomach. It may also be used for other conditions as determined by your doctor.

Ri-Mag Suspension is an antacid. It works by neutralizing stomach acid and increasing the pH of the stomach.

Do NOT use Ri-Mag Suspension if:

• you are allergic to any ingredient in Ri-Mag Suspension
• you have a history of kidney problems
• you are taking citrate salts (found in some calcium supplements, antacids, and laxatives)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ri-Mag Suspension:

Some medical conditions may interact with Ri-Mag Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have appendicitis, stomach pain, nausea, vomiting, diarrhea, blockage of the bowel, rectal bleeding of unknown cause, kidney problems, or you have had bowel surgery

Some MEDICINES MAY INTERACT with Ri-Mag Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Oral blood thinners (eg, warfarin), citrate salts (found in some calcium supplements, antacids, and laxatives), or quinidine because their actions and side effects may be increased by Ri-Mag Suspension
• Bisphosphonates (eg, alendronic acid), cation exchange resins (eg, sodium polystyrene sulfonate), cephalosporins (eg, cefaclor), imidazoles (eg, fluconazole), mycophenolate, penicillamine, quinolones (eg, ciprofloxacin), tetracyclines (eg, doxycycline), or thyroid hormones because their effectiveness may be decreased by Ri-Mag Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ri-Mag Suspension may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ri-Mag Suspension:

Use Ri-Mag Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Ri-Mag Suspension may be taken with or without food.
• Shake well before using.
• If you miss a dose of Ri-Mag Suspension and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ri-Mag Suspension.

Important safety information:

• Do not exceed the recommended dose or use the maximum dose for more than 2 weeks without checking with your doctor.
• Ri-Mag Suspension contains aluminum and magnesium. Before you begin taking any new prescription or over-the-counter medicine, read the ingredients to see if it also contains aluminum or magnesium. If it does or if you are uncertain, contact your doctor or pharmacist.
• PREGNANCY and BREAST-FEEDING: It is unknown if Ri-Mag Suspension can cause harm to the fetus. If you become pregnant while taking Ri-Mag Suspension, discuss with your doctor the benefits and risks of using Ri-Mag Suspension during pregnancy. Ri-Mag Suspension is excreted in breast milk. If you are or will be breast-feeding while you are using Ri-Mag Suspension, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Ri-Mag Suspension:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; intestinal pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; loss of appetite; muscle weakness; nausea; slow reflexes; vomiting; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Ri-Mag Suspension:

Store Ri-Mag Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ri-Mag Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Ri-Mag Suspension, please talk with your doctor, pharmacist, or other health care provider.
• Ri-Mag Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Ri-Mag Suspension. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: fibrinogen (fye BRIN oh gen)
Brand Names: RiaSTAP

What is fibrinogen?

Fibrinogen is a man-made form of a protein that occurs naturally in the body and helps the blood clot.

Fibrinogen is used to treat bleeding episodes in people who have a congenital fibrinogen deficiency.

Fibrinogen may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about fibrinogen?

You should not use this medication if you have ever had an allergic reaction to it, or if you have ever had any life-threatening allergic reaction.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using fibrinogen, tell your doctor if you have a history of stroke or blood clot.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine. This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

If you are using the injections at home, be sure you understand how to properly mix and store the medication. Do not mix the medicine until you are ready to give the injection.

Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat.

Other serious side effects may include sudden numbness or weakness, chest pain, confusion, pain or swelling in your one or both legs, and problems with vision, speech, or balance.

Fibrinogen is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

What should I discuss with my health care provider before using fibrinogen?

You should not use this medication if you have ever had an allergic reaction to it, or if you have ever had any other life-threatening allergic reaction.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using fibrinogen, tell your doctor if you have a history of stroke or blood clot.

FDA pregnancy category C. It is not known whether fibrinogen is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether fibrinogen passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Fibrinogen is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How should I use fibrinogen?

Fibrinogen is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

You will need to mix fibrinogen with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication. Do not mix fibrinogen with any other medicines, or give other medicines through the same IV line.

Fibrinogen contains no preservative. Once you have pierced the rubber top of a vial with a needle, you must use that vial right away or throw it away. Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not draw your fibrinogen dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. After mixing fibrinogen with a diluent, use it right away or store the mixture at room temperature and use it within 24 hours. The mixed medicine should be clear or slightly colored. Do not use the mixed medication if it has changed colors, is cloudy, or has any particles in it.

Each single-use vial (bottle) of this medicine is for one use only. Throw away the vial after one use, even if there is still some medicine left in it after injecting your dose.

To be sure this medication is helping your condition, your blood may need to be tested often. This will help your doctor determine how long to treat you with fibrinogen. Do not miss any follow-up visits to your doctor.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Store the unmixed dry powder in a refrigerator or in a dark cool place. Keep the medicine protected from light and do not allow it to freeze. Throw away any unused vial after the expiration date on the label has passed.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a fibrinogen overdose are not known.

What should I avoid while taking fibrinogen?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using fibrinogen.

Fibrinogen side effects

Stop your IV infusion and get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing or difficult breathing; feeling like you might pass out; or swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any other serious side effect, such as:

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• sudden cough, rapid breathing, fast heart rate;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or

• pain or swelling in one or both legs.

Less serious side effects may include:

• fever

• chills;

• nausea; or

• vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect fibrinogen?

There may be other drugs that can interact with fibrinogen. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about fibrinogen.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.03. Revision Date: 04/30/2009 4:04:31 PM.

Generic Name: RHo (D) immune globulin (ROE D im MYOON GLOB yoo lin)
Brand Names: HyperRHO S/D Full Dose, HyperRHO S/D Mini Dose, MicRhoGAM, MicRhoGAM Ultra-Filtered Plus, RhoGAM, RhoGAM Ultra-Filtered Plus, Rhophylac, WinRho SDF

What is RHo (D) immune globulin?

RHo (D) immune globulin is a sterilized solution made from human blood. Rh is a substance that most people have in their blood (Rh positive) but some people don’t (Rh negative). A person who is Rh negative can be exposed to Rh positive blood through a mismatched blood transfusion or during pregnancy when the baby has the opposite blood type. When this exposure happens, the Rh negative blood will respond by making antibodies that will try to destroy the Rh positive blood cells. This can cause medical problems such as anemia (loss of red blood cells), kidney failure, or shock.

RHo (D) immune globulin is used to prevent an immune response to Rh positive blood in people with an Rh negative blood type. RHo (D) immune globulin may also be used in the treatment of immune thrombocytopenic purpura (ITP).

RHo (D) immune globulin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about RHo (D) immune globulin?

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

Before you receive this medication, tell your doctor if you have heart disease or a history of coronary artery disease, high triglycerides, a bleeding disorder, or immune globulin A (IgA) deficiency.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

Call your doctor at once if you have a serious side effect such as fever, chills, shaking, back pain, dark colored urine, rapid breathing, feeling short of breath, urinating less than usual, swelling, rapid weight gain, pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed. Do not receive a “live” vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

What should I discuss with my healthcare provider before I receive RHo (D) immune globulin?

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

If you have any of these other conditions, you may need a dose adjustment or special tests:

• heart disease or a history of coronary artery disease (hardened arteries);

• high triglycerides (a type of fat in the blood);

• a bleeding disorder (such as hemophilia); or

• immune globulin A (IgA) deficiency.

RHo (D) immune globulin is used during and after pregnancy. This medication is not known to be harmful to a baby during pregnancy or while breast-feeding.

If you are receiving this medication to treat a mismatched blood transfusion, tell your doctor if you are pregnant or if you ever plan to become pregnant.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

RHo (D) immune globulin is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although RHo (D) immune globulin is screened, tested, and treated to reduce the risk of it containing infectious agents, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is RHo (D) immune globulin given?

RHo (D) immune globulin is injected into a muscle or a vein. You will receive this injection in a clinic or hospital setting.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely for at least 8 hours after you receive immune globulin. Your urine will also need to be tested every 2 to 4 hours.

For treatment during pregnancy, this medication is usually given at regular intervals during the last half of the pregnancy, and again after the baby is born.

For treatment of a mismatched blood transfusion, the medication is given when symptoms of an immune response appear (when the body starts making Rh antibodies).

To be sure this medicine is helping your condition, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

This medication can cause false results with certain lab tests for glucose (sugar) in the blood. Tell any doctor who treats you that you are using RHo (D) immune globulin.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your RHo (D) immune globulin injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving RHo (D) immune globulin?

Do not receive a “live” vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

RHo (D) immune globulin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: rash or hives; feeling light-headed, chest tightness, difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• fever, chills, shaking, back pain, dark colored urine;

• rapid breathing, feeling short of breath.

• urinating less than usual or not at all, swelling, rapid weight gain; or

• pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed.

Less serious side effects may include:

• joint or muscle pain;

• headache, dizziness;

• feeling weak or tired;

• mild itching or skin rash;

• nausea, diarrhea, vomiting, stomach pain; or

• pain or tenderness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect RHo (D) immune globulin?

There may be other drugs that can interact with RHo (D) immune globulin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about RHo (D) immune globulin.

• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 3.01. Revision Date: 05/13/2010 11:06:17 AM.

Generic Name: RHo (D) immune globulin (ROE D im MYOON GLOB yoo lin)
Brand Names: HyperRHO S/D Full Dose, HyperRHO S/D Mini Dose, MicRhoGAM, MicRhoGAM Ultra-Filtered Plus, RhoGAM, RhoGAM Ultra-Filtered Plus, Rhophylac, WinRho SDF

What is RHo (D) immune globulin?

RHo (D) immune globulin is a sterilized solution made from human blood. Rh is a substance that most people have in their blood (Rh positive) but some people don’t (Rh negative). A person who is Rh negative can be exposed to Rh positive blood through a mismatched blood transfusion or during pregnancy when the baby has the opposite blood type. When this exposure happens, the Rh negative blood will respond by making antibodies that will try to destroy the Rh positive blood cells. This can cause medical problems such as anemia (loss of red blood cells), kidney failure, or shock.

RHo (D) immune globulin is used to prevent an immune response to Rh positive blood in people with an Rh negative blood type. RHo (D) immune globulin may also be used in the treatment of immune thrombocytopenic purpura (ITP).

RHo (D) immune globulin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about RHo (D) immune globulin?

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

Before you receive this medication, tell your doctor if you have heart disease or a history of coronary artery disease, high triglycerides, a bleeding disorder, or immune globulin A (IgA) deficiency.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

Call your doctor at once if you have a serious side effect such as fever, chills, shaking, back pain, dark colored urine, rapid breathing, feeling short of breath, urinating less than usual, swelling, rapid weight gain, pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed. Do not receive a “live” vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

What should I discuss with my healthcare provider before I receive RHo (D) immune globulin?

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

If you have any of these other conditions, you may need a dose adjustment or special tests:

• heart disease or a history of coronary artery disease (hardened arteries);

• high triglycerides (a type of fat in the blood);

• a bleeding disorder (such as hemophilia); or

• immune globulin A (IgA) deficiency.

RHo (D) immune globulin is used during and after pregnancy. This medication is not known to be harmful to a baby during pregnancy or while breast-feeding.

If you are receiving this medication to treat a mismatched blood transfusion, tell your doctor if you are pregnant or if you ever plan to become pregnant.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

RHo (D) immune globulin is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although RHo (D) immune globulin is screened, tested, and treated to reduce the risk of it containing infectious agents, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is RHo (D) immune globulin given?

RHo (D) immune globulin is injected into a muscle or a vein. You will receive this injection in a clinic or hospital setting.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely for at least 8 hours after you receive immune globulin. Your urine will also need to be tested every 2 to 4 hours.

For treatment during pregnancy, this medication is usually given at regular intervals during the last half of the pregnancy, and again after the baby is born.

For treatment of a mismatched blood transfusion, the medication is given when symptoms of an immune response appear (when the body starts making Rh antibodies).

To be sure this medicine is helping your condition, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

This medication can cause false results with certain lab tests for glucose (sugar) in the blood. Tell any doctor who treats you that you are using RHo (D) immune globulin.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your RHo (D) immune globulin injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving RHo (D) immune globulin?

Do not receive a “live” vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

RHo (D) immune globulin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: rash or hives; feeling light-headed, chest tightness, difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• fever, chills, shaking, back pain, dark colored urine;

• rapid breathing, feeling short of breath.

• urinating less than usual or not at all, swelling, rapid weight gain; or

• pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed.

Less serious side effects may include:

• joint or muscle pain;

• headache, dizziness;

• feeling weak or tired;

• mild itching or skin rash;

• nausea, diarrhea, vomiting, stomach pain; or

• pain or tenderness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect RHo (D) immune globulin?

There may be other drugs that can interact with RHo (D) immune globulin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about RHo (D) immune globulin.

• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 3.01. Revision Date: 05/13/2010 11:06:17 AM.

Generic Name: RHo (D) immune globulin (ROE D im MYOON GLOB yoo lin)
Brand Names: HyperRHO S/D Full Dose, HyperRHO S/D Mini Dose, MicRhoGAM, MicRhoGAM Ultra-Filtered Plus, RhoGAM, RhoGAM Ultra-Filtered Plus, Rhophylac, WinRho SDF

What is RHo (D) immune globulin?

RHo (D) immune globulin is a sterilized solution made from human blood. Rh is a substance that most people have in their blood (Rh positive) but some people don’t (Rh negative). A person who is Rh negative can be exposed to Rh positive blood through a mismatched blood transfusion or during pregnancy when the baby has the opposite blood type. When this exposure happens, the Rh negative blood will respond by making antibodies that will try to destroy the Rh positive blood cells. This can cause medical problems such as anemia (loss of red blood cells), kidney failure, or shock.

RHo (D) immune globulin is used to prevent an immune response to Rh positive blood in people with an Rh negative blood type. RHo (D) immune globulin may also be used in the treatment of immune thrombocytopenic purpura (ITP).

RHo (D) immune globulin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about RHo (D) immune globulin?

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

Before you receive this medication, tell your doctor if you have heart disease or a history of coronary artery disease, high triglycerides, a bleeding disorder, or immune globulin A (IgA) deficiency.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

Call your doctor at once if you have a serious side effect such as fever, chills, shaking, back pain, dark colored urine, rapid breathing, feeling short of breath, urinating less than usual, swelling, rapid weight gain, pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed. Do not receive a “live” vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

What should I discuss with my healthcare provider before I receive RHo (D) immune globulin?

You should not receive this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA. You should not receive RHo (D) immune globulin if you have hemolytic anemia (a lack of red blood cells).

If you have any of these other conditions, you may need a dose adjustment or special tests:

• heart disease or a history of coronary artery disease (hardened arteries);

• high triglycerides (a type of fat in the blood);

• a bleeding disorder (such as hemophilia); or

• immune globulin A (IgA) deficiency.

RHo (D) immune globulin is used during and after pregnancy. This medication is not known to be harmful to a baby during pregnancy or while breast-feeding.

If you are receiving this medication to treat a mismatched blood transfusion, tell your doctor if you are pregnant or if you ever plan to become pregnant.

If you are an Rh-negative woman and you become pregnant, you must tell your doctor if you have ever been exposed to Rh-positive blood in your lifetime. This includes exposure from a mismatched blood transfusion, or exposure during your first pregnancy. Your history of exposure and treatment will be extremely important to each and every one of your pregnancies.

RHo (D) immune globulin is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although RHo (D) immune globulin is screened, tested, and treated to reduce the risk of it containing infectious agents, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How is RHo (D) immune globulin given?

RHo (D) immune globulin is injected into a muscle or a vein. You will receive this injection in a clinic or hospital setting.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely for at least 8 hours after you receive immune globulin. Your urine will also need to be tested every 2 to 4 hours.

For treatment during pregnancy, this medication is usually given at regular intervals during the last half of the pregnancy, and again after the baby is born.

For treatment of a mismatched blood transfusion, the medication is given when symptoms of an immune response appear (when the body starts making Rh antibodies).

To be sure this medicine is helping your condition, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

This medication can cause false results with certain lab tests for glucose (sugar) in the blood. Tell any doctor who treats you that you are using RHo (D) immune globulin.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your RHo (D) immune globulin injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while receiving RHo (D) immune globulin?

Do not receive a “live” vaccine for at least 3 months after treatment with RHo (D) immune globulin. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

RHo (D) immune globulin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: rash or hives; feeling light-headed, chest tightness, difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• fever, chills, shaking, back pain, dark colored urine;

• rapid breathing, feeling short of breath.

• urinating less than usual or not at all, swelling, rapid weight gain; or

• pale skin, easy bruising or bleeding, rapid heart rate, trouble concentrating, feeling light-headed.

Less serious side effects may include:

• joint or muscle pain;

• headache, dizziness;

• feeling weak or tired;

• mild itching or skin rash;

• nausea, diarrhea, vomiting, stomach pain; or

• pain or tenderness where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect RHo (D) immune globulin?

There may be other drugs that can interact with RHo (D) immune globulin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about RHo (D) immune globulin.

• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 3.01. Revision Date: 05/13/2010 11:06:17 AM.