Generic Name: cytarabine (sye TAR a been)
Brand names: Cytosar-U, Tarabine PFS, Cytosar

What is cytarabine?

Cytarabine is a cancer medication. Cytarabine interferes with the growth of cancer cells and slows their growth and spread in the body.

Cytarabine is used to treat certain types of leukemia (blood cancers). Cytarabine is also used to treat leukemia associated with meningitis.

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

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

Do not receive this medication without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before receiving cytarabine, tell your doctor if you are allergic to any drugs, or if you have a breathing disorder such as asthma, or a history of stomach ulcer or bleeding.

Cytarabine can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a “live” vaccine while you are being treated with cytarabine. The live vaccine may not work as well during this time, and may not fully protect you from disease.

What should I discuss with my healthcare provider before receiving cytarabine?

You should not use this medication if you are allergic to cytarabine.

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

• asthma or other breathing disorder; or

• a history of stomach ulcer or bleeding.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not receive cytarabine without telling your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. It is not known whether cytarabine 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 is cytarabine given?

Cytarabine is given as an injection through a needle placed into a vein, under the skin, or into the space around the spinal cord. You will receive this injection in a clinic or hospital setting.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when the medicine is injected.

Cytarabine can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

What happens if I miss a dose?

Contact your doctor for instructions if you miss an appointment for your cytarabine injection.

What happens if I overdose?

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

Overdose symptoms may include extreme drowsiness, or changes in personality or behavior.

What should I avoid while receiving cytarabine?

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a “live” vaccine while you are being treated with cytarabine. The live vaccine may not work as well during this time, and may not fully protect you from disease.

Cytarabine 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. Call your doctor at once if you have a serious side effect such as:

• easy bruising or bleeding, unusual weakness;

• eye pain or redness, problems with your vision;

• sudden shortness of breath, dry cough;

• unusual thoughts or behavior;

• problems with urination;

• black, bloody, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• fever, chest pain, muscle or bone pain, skin rash, tired feeling, and redness of the eyes (may occur 6 to 12 hours after your injection).

Less serious side effects may include:

• nausea, vomiting, diarrhea, stomach pain;

• mouth sores;

• drowsiness, dizziness;

• loss of appetite;

• sores or swelling around your mouth or rectum;

• sore throat;

• hair loss; or

• headache.

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.

Cytarabine Dosing Information

Usual Adult Dose for Acute Nonlymphocytic Leukemia:

As a part of a combination chemotherapy:
100 mg/m2/day by continuous IV infusion (days 1 to 7) or 100 mg/m2 IV every 12 hours (days 1 to 7) with an anthracycline.

Usual Adult Dose for non-Hodgkin’s Lymphoma:

Acute Leukemia Induction:
100 to 200 mg/m2/day or 2 to 6 mg/kg/day as a continuous IV infusion over 24 hours or in divided doses by rapid injection for 5 to 10 days. This course may be repeated approximately every 2 weeks.

For refractory non-Hodgkin’s lymphomas and acute myeloid leukemia:
2 to 3 g/m2 IV every twelve hours for up to 12 doses The IV infusion generally takes place over 1 to 3 hours. The dose of cytarabine should be suspended or modified if the ANC is below 1000/mm3 or the platelet count is below 50,000/mm3.

For chronic granulocytic leukemia / chronic myelogenous leukemia:
20 mg/m2 subcutaneously for 10 days per month for 6 months with interferon alfa.

Usual Adult Dose for Chronic Myelogenous Leukemia:

Acute Leukemia Induction:
100 to 200 mg/m2/day or 2 to 6 mg/kg/day as a continuous IV infusion over 24 hours or in divided doses by rapid injection for 5 to 10 days. This course may be repeated approximately every 2 weeks.

For refractory non-Hodgkin’s lymphomas and acute myeloid leukemia:
2 to 3 g/m2 IV every twelve hours for up to 12 doses The IV infusion generally takes place over 1 to 3 hours. The dose of cytarabine should be suspended or modified if the ANC is below 1000/mm3 or the platelet count is below 50,000/mm3.

For chronic granulocytic leukemia / chronic myelogenous leukemia:
20 mg/m2 subcutaneously for 10 days per month for 6 months with interferon alfa.

Usual Adult Dose for Acute Myeloid Leukemia:

Acute Leukemia Induction:
100 to 200 mg/m2/day or 2 to 6 mg/kg/day as a continuous IV infusion over 24 hours or in divided doses by rapid injection for 5 to 10 days. This course may be repeated approximately every 2 weeks.

For refractory non-Hodgkin’s lymphomas and acute myeloid leukemia:
2 to 3 g/m2 IV every twelve hours for up to 12 doses The IV infusion generally takes place over 1 to 3 hours. The dose of cytarabine should be suspended or modified if the ANC is below 1000/mm3 or the platelet count is below 50,000/mm3.

For chronic granulocytic leukemia / chronic myelogenous leukemia:
20 mg/m2 subcutaneously for 10 days per month for 6 months with interferon alfa.

Usual Adult Dose for Leukemia:

Acute Leukemia Induction:
100 to 200 mg/m2/day or 2 to 6 mg/kg/day as a continuous IV infusion over 24 hours or in divided doses by rapid injection for 5 to 10 days. This course may be repeated approximately every 2 weeks.

For refractory non-Hodgkin’s lymphomas and acute myeloid leukemia:
2 to 3 g/m2 IV every twelve hours for up to 12 doses The IV infusion generally takes place over 1 to 3 hours. The dose of cytarabine should be suspended or modified if the ANC is below 1000/mm3 or the platelet count is below 50,000/mm3.

For chronic granulocytic leukemia / chronic myelogenous leukemia:
20 mg/m2 subcutaneously for 10 days per month for 6 months with interferon alfa.

Usual Adult Dose for Meningeal Leukemia:

The manufacturer has stated that doses ranging from 5 mg/m2 to 75 mg/m2 has been used intrathecally and the frequency of administration has varied from once a day for 4 days to once every 4 days. The manufacturer has further stated that 30 mg/m2 every 4 days until cerebrospinal fluid findings were normal, followed by one additional treatment was the therapy most frequently used.

Some clinicians today recommend 10 to 30 mg intrathecally up to 3 times a week.

Usual Pediatric Dose for Acute Nonlymphocytic Leukemia:

As a part of a combination chemotherapy:
100 mg/m2/day by continuous IV infusion (days 1 to 7) or 100 mg/m2 IV every 12 hours (days 1 to 7) with an anthracycline.

Usual Pediatric Dose for non-Hodgkin’s Lymphoma:

For refractory non-Hodgkin’s lymphomas and acute myeloid leukemia:
1 to 3 g/m2 IV every twelve hours for up to 12 doses The IV infusion generally takes place over 1 to 3 hours. The dose of cytarabine should be suspended or modified if the ANC is below 1000/mm3 or the platelet count is below 50,000/mm3.

Usual Pediatric Dose for Acute Myeloid Leukemia:

For refractory non-Hodgkin’s lymphomas and acute myeloid leukemia:
1 to 3 g/m2 IV every twelve hours for up to 12 doses The IV infusion generally takes place over 1 to 3 hours. The dose of cytarabine should be suspended or modified if the ANC is below 1000/mm3 or the platelet count is below 50,000/mm3.

Usual Pediatric Dose for Meningeal Leukemia:

The manufacturer has stated that doses ranging from 5 mg/m2 to 75 mg/m2 has been used intrathecally and the frequency of administration has varied from once a day for 4 days to once every 4 days. The manufacturer has further stated that 30 mg/m2 every 4 days until cerebrospinal fluid findings were normal, followed by one additional treatment was the therapy most frequently used.

However, some clinicians recommend the following age based dosing:
<1 year: 20 mg
1 to 2 years: 30 mg
2 to 3 years: 50 mg
>3 years: 70 to 75 mg

What other drugs will affect cytarabine?

Tell your doctor if you take digoxin (Lanoxin).

This list is not complete and there may be other drugs that can interact with cytarabine. 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 cytarabine.

• 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: 2.02. Revision Date: 06/23/2009 11:24:38 AM.

sye-TAYR-a-been

Pharmacologic Class: Antimetabolite

Uses For cytarabine

Cytarabine belongs to the group of medicines called antimetabolites. It is used to treat some kinds of cancers of the blood. It may also be used to treat other kinds of cancer, as determined by your doctor.

Cytarabine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by cytarabine, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with cytarabine, you and your doctor should talk about the good cytarabine will do as well as the risks of using it.

Cytarabine is to be administered only by or under the immediate supervision of your doctor.

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, cytarabine is used in certain patients with the following medical conditions:

• Cancer of the lymph system
• Cancer of the brain and spinal cord
• Myelodysplastic syndromes (MDS)

Before Using cytarabine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For cytarabine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to cytarabine 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

Although there is no specific information comparing use of cytarabine in children with use in other age groups, cytarabine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of cytarabine in the elderly with use in other age groups, cytarabine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

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

• Rotavirus Vaccine, Live

Using cytarabine 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
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• 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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Chickenpox (including recent exposure) or
• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Gout (history of) or
• Kidney stones (history of)—Cytarabine may increase levels of uric acid in the body, which can cause gout or kidney stones

• Infection—Cytarabine can decrease your body’s ability to fight infection

• Kidney disease or
• Liver disease—Effects of cytarabine may be increased because of slower removal from the body

Proper Use of cytarabine

cytarabine is sometimes given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to take them at the right times.

While you are receiving cytarabine, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

cytarabine often causes nausea and vomiting. However, it is very important that you continue to receive the medicine even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Dosing

The dose of cytarabine 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 cytarabine. 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.

Precautions While Using cytarabine

It is very important that your doctor check your progress at regular visits to make sure that cytarabine is working properly and to check for unwanted effects.

While you are being treated with cytarabine, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor’s approval. Cytarabine may lower your body’s resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Cytarabine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

cytarabine Side Effects

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.

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

Less common

• Black, tarry stools
• blood in urine
• cough or hoarseness
• fever or chills
• lower back or side pain
• painful or difficult urination
• pinpoint red spots on skin
• unusual bleeding or bruising

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

More common

• Sores in mouth and on lips

Less common

• Joint pain
• numbness or tingling in fingers, toes, or face
• swelling of feet or lower legs
• unusual tiredness

Rare

• Bone or muscle pain
• chest pain
• decrease in urination
• difficulty in swallowing
• fainting spells
• general feeling of discomfort or illness or weakness
• heartburn
• irregular heartbeat
• pain at place of injection
• reddened eyes
• shortness of breath
• skin rash
• weakness
• yellow eyes or skin

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

• Loss of appetite
• nausea and vomiting

Less common or rare

• Diarrhea
• dizziness
• headache
• itching of skin
• skin freckling

cytarabine may cause a temporary loss of hair in some people. After treatment with cytarabine has ended, normal hair growth should return.

After you stop using cytarabine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Black, tarry stools
• blood in urine or stools
• cough or hoarseness
• fever or chills
• lower back or side pain
• painful or difficult urination
• pinpoint red spots on skin
• unusual bleeding or bruising

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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Brand names: Periactin

Why is Cyproheptadine hydrochloride prescribed?

Periactin is an antihistamine given to help relieve cold- and allergy-related symptoms such as hay fever, nasal inflammation, stuffy nose, red and inflamed eyes, hives, and swelling. Periactin may also be given after epinephrine to help treat anaphylaxis, a life-threatening allergic reaction.

Some doctors prescribe Periactin to treat cluster headache and to stimulate appetite in underweight people.

Most important fact about Cyproheptadine hydrochloride

Like other antihistamines, Periactin may make you feel sleepy and sluggish. However, some people, particularly children, may have the opposite reaction and become excited.

How should you take Cyproheptadine hydrochloride?

Take Periactin exactly as prescribed by your doctor.

• If you miss a dose…
  Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Do not take 2 doses at once.

• Storage instructions…
  Store at room temperature in a tightly closed container.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor immediately. Only your doctor can determine whether it is safe for you to continue taking Periactin.

• Side effects may include:
  Anaphylaxis (life-threatening allergic reaction), anemia, appetite loss, chest congestion or tightness, chills, confusion, constipation, convulsions, diarrhea, difficulty urinating, dizziness, dry mouth, nose, or throat, earlier-than-expected menstrual period, exaggerated feeling of well-being, excessive perspiration, excitement, faintness, fatigue, fluttery or throbbing heartbeat, frequent urination, hallucinations, headache, hives, hysteria, inability to urinate, increased appetite and weight gain, insomnia, irritability, lack of coordination, light sensitivity, liver problems, low blood pressure, nausea, nervousness, rapid heartbeat, rash and swelling, restlessness, ringing in the ears, sleepiness, stomach pain, stuffy nose, tingling or pins and needles, tremor, vertigo, vision problems (double vision, blurred vision), vomiting, weight gain, wheezing, yellow eyes and skin

Older people, in particular, are likely to become dizzy or drowsy, or develop low blood pressure in response to Periactin.

Why should Cyproheptadine hydrochloride not be prescribed?

Do not take Periactin if you are sensitive to it, or have ever had an allergic reaction to it or to a similar antihistamine.

Do not take Periactin if you are taking an antidepressant drug known as an MAO inhibitor.

Do not take Periactin if you have the eye condition called angle-closure glaucoma, a peptic ulcer, an enlarged prostate, obstruction of the neck of the bladder, or obstruction of the outlet of the stomach.

Newborn or premature infants should not be given Cyproheptadine hydrochloride, nor should it be used by women who are breastfeeding an infant.

The elderly and those in a weakened condition should not take Cyproheptadine hydrochloride.

Special warnings about Cyproheptadine hydrochloride

Like other antihistamines, Periactin may make you drowsy or impair your coordination. Be very careful about driving, climbing, or operating machinery, or doing hazardous tasks until you know how you react to Cyproheptadine hydrochloride.

Be cautious about taking Periactin if you have bronchial asthma, the eye condition called glaucoma, an overactive thyroid gland, high blood pressure, heart disease, or circulatory problems.

Possible food and drug interactions when taking Cyproheptadine hydrochloride

Avoid alcoholic beverages while taking Periactin.

If Periactin is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Periactin with the following:

Antidepressant drugs classified as MAO inhibitors
Sedatives
Tranquilizers

Special information if you are pregnant or breastfeeding

Because of possible harm to the unborn baby, Periactin should not be used during pregnancy unless it is clearly needed. Periactin should not be taken by a woman who is breastfeeding. If you have just given birth, you will need to choose between breastfeeding and taking Periactin.

Recommended dosage for Cyproheptadine hydrochloride

ADULTS

The usual initial dose is 4 milligrams (1 tablet) 3 times daily. Dosage may range from 4 to 20 milligrams a day, but most people will take between 12 and 16 milligrams. Some may need as much as 32 milligrams a day. If you are over 65, the doctor will probably keep the dosage relatively low.

CHILDREN

Ages 2 to 6 Years

The usual dose is 2 milligrams (one-half tablet) 2 or 3 times a day; your doctor may adjust the dose if necessary. A child this age should not take more than 12 milligrams a day.

Ages 7 to 14 Years

The usual dose is 4 milligrams (1 tablet) 2 or 3 times a day; your doctor may adjust the dose if needed. A child this age should not take more than 16 milligrams a day.

Overdosage

Any drug taken in excess may have serious consequences. An overdose of Periactin can be fatal. If you suspect an overdose, seek medical attention immediately.

• Symptoms of Periactin overdose may include:
  Dilated pupils, dry mouth, extreme excitement and agitation, fever, flushing, stomach or bowel distress, stupor or coma

Overdosage in children may produce hallucinations and convulsions.

sye-PROE-ter-one

Available Dosage Forms:

• Injectable
• Tablet

Uses For cyproterone

Cyproterone is used to treat cancer of the prostate gland. The prostate gland is present only in males; therefore, females do not get prostate cancer.

cyproterone blocks the effect of the male hormone testosterone in the body. This decreases the amount of testosterone produced in the body and is one way of treating this type of cancer.

cyproterone is available only with your doctor’s prescription.

Before Using cyproterone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For cyproterone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to cyproterone 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

Studies on cyproterone have been done only in adult patients, and there is no specific information comparing use of cyproterone in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of cyproterone in the elderly with use in other age groups.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Blood clots (or history of) or
• Circulation disease (or history of) or
• Stroke (or history of)—If these conditions already are already present, cyproterone may have a greater chance of causing blood clotting problems.

• Cardiac disease—May make the condition worse.

• Depressive tendencies—May cause depression to occur.

• Type 2 diabetes mellitus—May cause a loss of control of diabetes by increasing blood and urine sugar.

• Liver disease—Effects of cyproterone may be increased because of its slower removal from the body.

Proper Use of cyproterone

At first, cyproterone often causes loss of strength and energy or tiredness. However, these effects are lessened after about the third month of treatment and it is very important that you continue to receive this medication.

This medication should not be discontinued even if improvement of the disease occurs.

Dosing

The dose of cyproterone 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 cyproterone. 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 oral dosage form (tablets):
  • For treating prostate cancer:
    • Adults—100 to 200 milligrams (mg) per day divided into 2 to 3 doses. Take after meals.

• For injection dosage form:
  • For treating prostate cancer:
    • Adult—300 milligrams (mg) injected into a muscle once a week.

Missed Dose

If you miss a dose of cyproterone, 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.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using cyproterone

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

cyproterone may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to cyproterone before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Cyproterone may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking cyproterone:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

While you are taking cyproterone, be careful to limit the amount of alcohol you drink.

cyproterone Side Effects

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.

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

Less common

• Abdominal pain or tenderness
• agitation
• back pain
• black, tarry stools
• blisters on the skin
• bloody urine
• blurred vision
• chest pain
• chills
• clay-colored stools
• confusion
• cough
• dark urine
• decreased appetite
• decreased urine output
• difficulty swallowing
• dilated neck veins
• dizziness
• drowsiness
• dry mouth
• fainting or light-headedness when getting up from a lying or sitting position suddenly
• fast heartbeat
• fatigue
• fever
• flushed, dry skin
• fruit-like breath odor
• general feeling of discomfort or illness
• hallucinations
• headache, sudden and severe
• hives
• inability to speak
• increased blood pressure
• increased hunger
• increased thirst
• increased urination
• irregular breathing
• irregular heartbeat
• itching
• loss of consciousness
• lower back or side pain
• mood or mental changes
• nausea and vomiting
• painful or difficult urination
• pains in the chest, groin, or legs, especially the calves of legs
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• red, thickened, or scaly skin
• seizures
• shortness of breath
• skin rash
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stiff neck
• stomachache
• sudden loss of coordination
• sweating
• swelling of the feet or lower legs
• swollen and/or painful glands
• temporary blindness
• tightness in the chest
• unexplained weight loss
• unusual bleeding or bruising
• vision changes
• weakness in the arm and/or leg on one side of the body, sudden and severe
• wheezing
• yellow eyes or skin

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

• Decreased interest in sexual intercourse
• inability to have or keep an erection
• increase in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• loss in sexual ability, desire, drive, or performance
• swelling of the breasts or breast soreness in both females and males
• unexpected or excess milk flow from breasts

Less common

• Bleeding, blistering, burning, coldness, or discoloration of the skin
• change in walking and balance
• clumsiness or unsteadiness
• hair loss
• inability to move legs or arms
• increased sensitivity of skin to sunlight
• increase in bowel movements
• loose stools
• loss of strength or energy
• muscle pain or weakness
• paralysis of one side of the body
• redness or other discoloration of the skin
• severe sunburn
• soft stools
• tiredness or weakness
• unusual increase in hair growth
• weight gain

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: betaine (BET aine)
Brand Names: Cystadane

What is Cystadane (betaine)?

Betaine is a nutrient that is important for functioning of the heart and blood vessels. Betaine works in the body by preventing the build-up of an amino acid called homocysteine. This amino acid can harm blood vessels and contribute to heart disease, stroke, or circulation problems.

Betaine is a byproduct of sugar beet processing.

Betaine is used to reduce homocysteine levels in people with a genetic condition called homocystinuria, in which the amino acid builds up in the body. Betaine is not a cure for homocysteinuria.

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

What is the most important information I should know about Cystadane (betaine)?

Before taking betaine, tell your doctor about any allergies or medical conditions you have. You may not be able to take betaine, or you may need a dose adjustment or special tests during treatment.

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

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

There may be other drugs that can interact with betaine. 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.

Get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Tell your doctor about any unusual or bothersome side effects.

What should I discuss with my health care provider before taking Cystadane (betaine)?

You should not use this medication if you are allergic to betaine.

Before taking betaine, tell your doctor about any allergies or medical conditions you have. You may not be able to take betaine, or you may need a dose adjustment or special tests during treatment.

Do not take betaine without telling your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether betaine 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.

Do not give betaine to a child without the advice of a doctor.

How should I take Cystadane (betaine)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Betaine powder must be mixed with water just before you take it. Stir the mixture thoroughly and drink it right away. Do not save the mixture for later use.

Measure the powder using the dose-measuring scoop provided with your medication, not with a regular table spoon.

Do not drink the liquid if it is colored and not clear after mixing. Call your doctor for a new prescription.

Betaine is only part of a complete program of treatment that may also include other vitamin and mineral supplements and a special diet. Follow your diet and medication routines very closely.

To be sure this medication is helping your condition, your blood will need to be tested often. Do not miss any scheduled appointments.

Store betaine at room temperature away from moisture and heat.

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, wait until then to take the medicine and skip the missed dose. 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.

Symptoms of a betaine overdose are not known.

What should I avoid while taking Cystadane (betaine)?

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

Cystadane (betaine) 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.

Less serious side effects are more likely, and you may have none at all.

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 Cystadane (betaine)?

This list is not complete and there may be other drugs that can interact with betaine. 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 doctor or pharmacist can provide more information about betaine.

• 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: 4/12/2009 4:45:10 PM.

Generic Name: Betaine (BEE-ta-een)
Brand Name: Cystadane

Cystadane Powder is used for:

Treating homocystinuria.

Cystadane Powder is a metabolic agent. It works by decreasing blood levels of homocysteine.

Do NOT use Cystadane Powder if:

• you are allergic to any ingredient in Cystadane Powder

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

Before using Cystadane Powder:

Some medical conditions may interact with Cystadane Powder. 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 cystathionine beta-synthase (CBS) deficiency or high blood methionine levels

Some MEDICINES MAY INTERACT with Cystadane Powder. However, no specific interactions with Cystadane Powder are known at this time.

Ask your health care provider if Cystadane Powder 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 Cystadane Powder:

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

• Take Cystadane Powder by mouth with or without food.
• Shake the bottle gently before removing the cap.
• Use the scoop that comes with Cystadane Powder to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Mix the prescribed amount of medicine with 4 to 6 ounces of water, juice, milk, or formula until it is completely dissolved. You may also mix Cystadane Powder with food. Swallow the mixture right away.
• Replace the cap tightly after each dose.
• If you miss a dose of Cystadane Powder, 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 Cystadane Powder.

Important safety information:

• Lab tests, including homocysteine and methionine blood levels, may be performed while you use Cystadane Powder. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• PREGNANCY and BREAST-FEEDING: It is not known if Cystadane Powder can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cystadane Powder while you are pregnant. It is not known if Cystadane Powder is found in breast milk. If you are or will be breast-feeding while you use Cystadane Powder, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Cystadane Powder:

All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Cystadane Powder. 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).

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 Cystadane Powder:

Store Cystadane Powder 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 Cystadane Powder out of the reach of children and away from pets.

General information:

• If you have any questions about Cystadane Powder, please talk with your doctor, pharmacist, or other health care provider.
• Cystadane Powder 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 Cystadane Powder. 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: cysteamine (sis TEE a meen)
Brand Names: Cystagon

What is Cystagon (cysteamine)?

Cysteamine is used to treat a condition called nephropathic cystinosis (NEF-roe-PATH-ik SIS-tin-OH-sis). It works by reducing the amount of cystine in the kidneys.

Nephropathic cystinosis is a rare genetic condition. Children with this condition develop a build-up of cystine in the kidneys, which can lead to kidney failure and other medical problems.

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

What is the most important information I should know about Cystagon (cysteamine)?

Your child should not use this medication if he or she is allergic to cysteamine or penicillamine (Cuprimine, Depen).

Before using cysteamine, tell the doctor if your child is allergic to any drugs, or if the child has skin or bone problems (including fractures), liver disease, epilepsy or other seizure disorder, a history of depression or nervous system disorder, or a history or stomach ulcer or bleeding.

There may be other medicines that can interact with cysteamine. Tell your child’s doctor about all the prescription and over-the-counter medications the child uses. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your child’s doctor. Keep a list with you of all the medicines your child uses and show this list to any doctor or other healthcare provider who treats your child.

What should I discuss with my health care provider before using Cystagon (cysteamine)?

Your child should not use this medication if he or she is allergic to cysteamine or penicillamine (Cuprimine, Depen).

Before using cysteamine, tell the doctor if your child is allergic to any drugs, or if the child has:

• skin or bone problems (including fractures);

• liver disease;

• epilepsy or other seizure disorder;

• a history of depression or nervous system disorder; or

• a history of stomach ulcer or bleeding.

If your child has any of these conditions, he or she may need a dose adjustment or special tests to safely take cysteamine.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your child’s doctor if the child is pregnant. It is not known whether cysteamine passes into breast milk or if it could harm a nursing baby.

How should I use Cystagon (cysteamine)?

Use this medication exactly as prescribed by your child’s doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your child’s prescription label.

Your child’s doctor may occasionally change the dose to make sure and get the best results from this medication.

Do not give a whole capsule to a child who cannot swallow it easily, especially a child younger than 6 years old. Open the capsule and sprinkle the medicine into the child’s food. Ask your child’s doctor about the types of foods to mix cysteamine with for best results.

To be sure this medication is not causing harmful effects, your child’s blood will need to be tested on a regular basis. The skin and bones may also need to be checked. Do not miss any scheduled appointments.

Cystinosis is often treated with a combination of different medications, including vitamin and mineral supplements. To best treat your child’s condition, use all of his or her medications as directed by the doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your child’s doctor.

Store cysteamine at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If the next dose is less than 2 hours away, 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 your child has used too much of this medicine.

Overdose symptoms may include vomiting, dry mouth, and weakness.

What should I avoid while taking Cystagon (cysteamine)?

This medication can cause side effects that may impair thinking or reactions. Your child should be careful while driving or doing anything that requires him or her to be awake and alert.

Cystagon (cysteamine) side effects

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using cysteamine and call your child’s doctor at once if your child has any of these serious side effects (some of these may be caused by the cystinosis disorder and not by this medication):

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

• the first sign of any skin rash, no matter how mild;

• unusual bruising or streaks on the skin;

• bone or joint problems;

• weakness or fainting, black, bloody, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• extreme drowsiness, loss of balance or coordination, seizure (convulsions);

• confusion, hallucinations, bad dreams, or changes in mood or behavior;

• urinating less than usual or not at all; or

• headache, ringing in the ears, dizziness, nausea, vision problems, pain behind the eyes.

Less serious side effects may include:

• nausea, vomiting, diarrhea, stomach pain;

• loss of appetite;

• fever, chills, body aches, flu symptoms; or

• mild dizziness, nervous feeling.

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 Cystagon (cysteamine)?

There may be other medicines that can interact with cysteamine. Tell your child’s doctor about all the prescription and over-the-counter medications the child uses. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your child’s doctor. Keep a list with you of all the medicines your child uses and show this list to any doctor or other healthcare provider who treats your child.

Where can I get more information?

• Your pharmacist can provide more information about cysteamine.

• 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 your child has questions about the drugs you are taking, check with your child’s doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.05. Revision Date: 11/17/2009 3:43:46 PM.

Generic Name: cysteamine (sis TEE a meen)
Brand Names: Cystagon

What is cysteamine?

Cysteamine is used to treat a condition called nephropathic cystinosis (NEF-roe-PATH-ik SIS-tin-OH-sis). It works by reducing the amount of cystine in the kidneys.

Nephropathic cystinosis is a rare genetic condition. Children with this condition develop a build-up of cystine in the kidneys, which can lead to kidney failure and other medical problems.

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

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

Your child should not use this medication if he or she is allergic to cysteamine or penicillamine (Cuprimine, Depen).

Before using cysteamine, tell the doctor if your child is allergic to any drugs, or if the child has skin or bone problems (including fractures), liver disease, epilepsy or other seizure disorder, a history of depression or nervous system disorder, or a history or stomach ulcer or bleeding.

There may be other medicines that can interact with cysteamine. Tell your child’s doctor about all the prescription and over-the-counter medications the child uses. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your child’s doctor. Keep a list with you of all the medicines your child uses and show this list to any doctor or other healthcare provider who treats your child.

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

Your child should not use this medication if he or she is allergic to cysteamine or penicillamine (Cuprimine, Depen).

Before using cysteamine, tell the doctor if your child is allergic to any drugs, or if the child has:

• skin or bone problems (including fractures);

• liver disease;

• epilepsy or other seizure disorder;

• a history of depression or nervous system disorder; or

• a history of stomach ulcer or bleeding.

If your child has any of these conditions, he or she may need a dose adjustment or special tests to safely take cysteamine.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your child’s doctor if the child is pregnant. It is not known whether cysteamine passes into breast milk or if it could harm a nursing baby.

How should I use cysteamine?

Use this medication exactly as prescribed by your child’s doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your child’s prescription label.

Your child’s doctor may occasionally change the dose to make sure and get the best results from this medication.

Do not give a whole capsule to a child who cannot swallow it easily, especially a child younger than 6 years old. Open the capsule and sprinkle the medicine into the child’s food. Ask your child’s doctor about the types of foods to mix cysteamine with for best results.

To be sure this medication is not causing harmful effects, your child’s blood will need to be tested on a regular basis. The skin and bones may also need to be checked. Do not miss any scheduled appointments.

Cystinosis is often treated with a combination of different medications, including vitamin and mineral supplements. To best treat your child’s condition, use all of his or her medications as directed by the doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your child’s doctor.

Store cysteamine at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If the next dose is less than 2 hours away, 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 your child has used too much of this medicine.

Overdose symptoms may include vomiting, dry mouth, and weakness.

What should I avoid while taking cysteamine?

This medication can cause side effects that may impair thinking or reactions. Your child should be careful while driving or doing anything that requires him or her to be awake and alert.

Cysteamine side effects

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using cysteamine and call your child’s doctor at once if your child has any of these serious side effects (some of these may be caused by the cystinosis disorder and not by this medication):

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

• the first sign of any skin rash, no matter how mild;

• unusual bruising or streaks on the skin;

• bone or joint problems;

• weakness or fainting, black, bloody, or tarry stools;

• coughing up blood or vomit that looks like coffee grounds;

• extreme drowsiness, loss of balance or coordination, seizure (convulsions);

• confusion, hallucinations, bad dreams, or changes in mood or behavior;

• urinating less than usual or not at all; or

• headache, ringing in the ears, dizziness, nausea, vision problems, pain behind the eyes.

Less serious side effects may include:

• nausea, vomiting, diarrhea, stomach pain;

• loss of appetite;

• fever, chills, body aches, flu symptoms; or

• mild dizziness, nervous feeling.

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 cysteamine?

There may be other medicines that can interact with cysteamine. Tell your child’s doctor about all the prescription and over-the-counter medications the child uses. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your child’s doctor. Keep a list with you of all the medicines your child uses and show this list to any doctor or other healthcare provider who treats your child.

Where can I get more information?

• Your pharmacist can provide more information about cysteamine.

• 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 your child has questions about the drugs you are taking, check with your child’s doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.05. Revision Date: 11/17/2009 3:43:46 PM.

sis-TEE-a-meen

Commonly used brand name(s):

In the U.S.

• Cystagon

Available Dosage Forms:

• Capsule

Therapeutic Class: Renal-Urologic Agent

Uses For cysteamine

Cysteamine is used to prevent damage that may be caused by the buildup of cystine crystals in organs such as the kidneys. cysteamine works by removing the extra cystine from the cells of the body.

Before Using cysteamine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For cysteamine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to cysteamine 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

cysteamine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of cysteamine in the elderly with use in other age groups.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Blood problems (or a history of) or
• Convulsions (seizures) or
• Liver disease—Cysteamine may make these conditions worse

Proper Use of cysteamine

If you vomit your dose of cysteamine within 20 minutes of taking it, take the dose again. However, if you vomit the dose a second time, do not repeat the dose but wait and take your next dose as scheduled. Also, if vomiting occurs more than 20 minutes after you take your dose, do not repeat the dose.

It is important that you follow any special instructions from your doctor, such as taking dietary supplements. These supplements will replace minerals lost through the kidneys.

For children under 6 years of age, the capsule may be opened and the contents of the capsule sprinkled on food or mixed in formula.

Dosing

The dose of cysteamine 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 cysteamine. 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 oral dosage form (capsules):
  • To prevent buildup of cystine crystals in the kidney:
    • Adults and teenagers—The starting dose must be determined by your doctor. Your doctor may gradually increase your dose.
    • Children—The starting dose is based on body size and must be determined by your doctor. Your doctor may gradually increase your dose.

Missed Dose

If you miss a dose of cysteamine, 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.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using cysteamine

Your doctor should check your progress at regular visits to make sure that cysteamine is working properly and does not cause unwanted effects.

cysteamine may cause some people to become dizzy or drowsy. Make sure you know how you react to cysteamine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

cysteamine Side Effects

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.

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

More common

• Abdominal pain
• diarrhea
• drowsiness
• fever
• loss of appetite
• nausea or vomiting
• skin rash

Less common

• Confusion
• dizziness
• headache
• mental depression
• sore throat
• trembling

Rare

• Convulsions (seizures)
• increased thirst
• unusual tiredness or weakness

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:

Less common

• Breath odor
• constipation

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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