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Voltaren

30/06/10

Generic name: Diclofenac sodium
Brand names: Cataflam, Voltaren

Why is Voltaren prescribed?

Voltaren and Cataflam are nonsteroidal anti-inflammatory drugs used to relieve the inflammation, swelling, stiffness, and joint pain associated with rheumatoid arthritis, osteoarthritis (the most common form of arthritis), and ankylosing spondylitis (arthritis and stiffness of the spine). Voltaren-XR, the extended-release form of Voltaren, is used only for long-term treatment. Cataflam is also prescribed for immediate relief of pain and menstrual discomfort.

Most important fact about Voltaren

You should have frequent checkups with your doctor if you take Voltaren regularly. Ulcers or internal bleeding can occur without warning.

How should you take Voltaren?

To minimize stomach upset and related side effects, your doctor may recommend taking this medicine with food, milk, or an antacid. However, this may delay onset of relief.

Take Voltaren with a full glass of water. Also, do not lie down for about 20 minutes after taking it. This will help to prevent irritation in your upper digestive tract.

Take Voltaren exactly as prescribed.

If you miss a dose…
If you take this medicine on a regular schedule, 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. Keep the container tightly closed and protect from moisture.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Voltaren.

Side effects may include:
Abdominal bleeding, abdominal pain or cramps, abdominal swelling, anemia, blood clotting problems, constipation, diarrhea, dizziness, fluid retention, gas, headache, heartburn, indigestion, itching, nausea, peptic ulcers, rash, ringing in the ears, vomiting

This side effects list is not complete. If you have any questions about side effects you should consult your doctor. Report any new or continuing symptoms to your doctor right away.

Why should Voltaren not be prescribed?

If you have an allergic reaction to Voltaren or Cataflam, or if you have had asthma attacks, hives, or other allergic reactions caused by aspirin or other nonsteroidal anti-inflammatory drugs, you should not take Voltaren. Make sure your doctor is aware of any drug reactions you have experienced.

Special warnings about Voltaren

Remember that Voltaren has been known to cause peptic ulcers and bleeding. Contact your doctor immediately if you suspect a problem.

Use Voltaren cautiously if you have kidney problems, heart disease, or high blood pressure. It can cause fluid retention.

This medication can also cause liver problems. If you develop signs of liver disease such as nausea, fatigue, lethargy, itching, yellowish eyes and skin, tenderness in the upper right area of your abdomen, or flu-like symptoms, notify your doctor at once.

Rare cases of meningitis (inflammation of the membrane enclosing the brain) have been linked to Voltaren. If symptoms such as fever and coma develop, alert the doctor immediately.

In rare instances, Voltaren may also affect your vision. If you notice any problems, stop taking the drug and check with your doctor.

Possible food and drug interactions when taking Voltaren

If Voltaren or Cataflam 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 Voltaren with the following:

Aspirin
Blood thinners such as Coumadin
Cyclosporine (Sandimmune)
Digitalis drugs such as Lanoxin
Diuretics such as Dyazide, Midamor, and Lasix
Insulin or oral antidiabetes medications such as Micronase
Lithium (Eskalith, Lithobid)
Methotrexate
Phenobarbital

Special information if you are pregnant or breastfeeding

Do not take Voltaren late in your pregnancy; it could harm the baby. Check with your doctor before taking the drug early in pregnancy; it should be used only if necessary. The drug does appear in breast milk and could affect a nursing infant. If Voltaren is essential to your health, your doctor may advise you to discontinue breastfeeding until your treatment with Voltaren is finished.

Recommended dosage for Voltaren

ADULTS

Osteoarthritis

The usual dose is 100 to 150 milligrams a day, divided into smaller doses of 50 milligrams 2 or 3 times a day (for Voltaren or Cataflam) or 75 milligrams twice a day (for Voltaren). The usual dose of Voltaren-XR (extended-release) is 100 milligrams taken once a day.

Rheumatoid Arthritis

The usual dose is 100 to 200 milligrams a day, divided into smaller doses of 50 milligrams 3 to 4 times a day (for Voltaren or Cataflam), 75 milligrams twice a day (for Voltaren), or 100 milligrams once or twice a day (for Voltaren-XR).

People with rheumatoid arthritis should not take more than 225 milligrams a day.

Ankylosing Spondylitis

The usual dose is 100 to 125 milligrams of Voltaren a day, divided into smaller doses of 25 milligrams 4 times a day, with another 25 milligrams at bedtime if necessary.

Pain and menstrual discomfort

The usual starting dose of Cataflam is 50 milligrams every 8 hours as needed, although to provide better relief on the first day doctors sometimes prescribe a starting dose of 100 milligrams followed by two 50-milligram doses. After the first day, you should not take more than 150 milligrams in a day.

CHILDREN

The safety and effectiveness of Voltaren have not been established in children.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek medical attention immediately.

The symptoms of Voltaren overdose may include:
Acute kidney failure, drowsiness, loss of consciousness, lung inflammation, nausea, vomiting

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Vivotif Berna

30/06/10

Generic Name: typhoid vaccine (live), oral (TYE foid vax EEN)
Brand Names: Vivotif Berna

What is typhoid vaccine?

Typhoid (also called “typhoid fever”) is a serious disease caused by Salmonella typhi bacteria. Typhoid can be fatal if left untreated.

Typhoid can cause high fever, muscle aches, severe headache, weakness, confusion or agitation, loss of appetite, stomach pain, diarrhea or constipation, and rose-colored spots on the skin.

Untreated typhoid infection may lead to kidney failure, or intestinal bleeding caused by perforation (forming of a hole), which can be fatal. If the infection spreads to the gallbladder, the infected person may become a chronic carrier of the bacteria that causes typhoid. A carrier may have no symptoms but is capable of spreading the infection to others.

Typhoid is spread through contact with the stool (bowel movements) of a person infected with the bacteria. This usually occurs by eating food or drinking water that has become contaminated with feces from an infected person. Once in the digestive tract, typhoid infection can spread to the blood and other parts of the body.

Typhoid fever is most common in non-industrialized parts of the world, especially Asia, Africa, and Central or South America. People who travel to those regions are at risk of coming into contact with the disease.

The typhoid vaccine is used to help prevent this disease in adults and children who are at least 6 years old. Although not part of a routine immunization schedule in the U.S., typhoid vaccine is recommended for people who travel to areas where the disease is common.

This vaccine works by exposing you to a small amount of the bacteria, which causes your body to develop immunity to the disease.

Typhoid vaccine will not treat an active infection that has already developed in the body, and will not prevent any disease caused by bacteria other than Salmonella typhi.

Like any vaccine, the typhoid vaccine may not provide protection from disease in every person.

What is the most important information I should know about typhoid vaccine?

You should not receive this vaccine if you have ever had an allergic reaction to typhoid vaccine in the past, or if you have fever with any type of infection or illness, or a weak immune system caused by disease or by using certain medicines such as chemotherapy. Typhoid vaccine should not be used in a person who is a typhoid carrier.

Before you receive this vaccine, tell the doctor if you have any illness with vomiting or diarrhea, if you are taking an antibiotic or sulfa drug (Azulfidine, Bactrim, Cotrim, Gantrisin, Septra, SMX-TMP, Sulfazine), or if you plan to start taking an anti-malaria medication within 10 days after receiving typhoid vaccine.

You can still receive a vaccine if you have a minor cold. In the case of a more severe illness with a fever or any type of infection, the doctor may ask you to wait until you get better before you can receive the vaccine.

The typhoid oral vaccine is given in a series of 4 capsules that are taken 1 per day on alternating days (days 1, 3, 5, and 7). On this alternating-day schedule, you will take 1 capsule every 48 hours for 7 days. You must take each capsule according to the recommended schedule for this vaccine to be effective.

You should complete all doses at least 1 week before your scheduled travel or possible exposure to typhoid.

You must keep typhoid vaccine capsules cold when not in use. Once you receive the capsules from your doctor or pharmacy, take them directly home and place them in the refrigerator. Keep each capsule in the foil blister pack in the refrigerator until you are ready to take it. Do not allow the capsules to freeze.

Like any vaccine, the typhoid vaccine may not provide protection from disease in every person.

In addition to receiving typhoid vaccine, take precautions while traveling such as avoiding raw fruits or vegetables that cannot be peeled, drinks that contain ice, flavored ices that may have been made with contaminated water, unbottled or unboiled water, or any food or beverage purchased from a street vendor.

What should I discuss with my healthcare provider before receiving typhoid vaccine?

Typhoid vaccine should not be used in a person who is a typhoid carrier. You should not receive this vaccine if you have ever had an allergic reaction to typhoid vaccine in the past, or if you have:

fever with any type of infection or illness;
a weak immune system caused by disease such as HIV/AIDS or cancer; or
a weak immune system caused by using certain medicines such as chemotherapy.

You may not be able to receive this vaccine if you have:

stomach flu or any illness with vomiting or diarrhea;
if you are taking an antibiotic, especially a sulfa drug such as sulfasalazine (Azulfidine, Sulfazine), sulfamethoxazole (Bactrim, Cotrim, Septra, SMX-TMP), or sulfisoxazole (Gantrisin); or
if you plan to start taking an anti-malaria medication within 10 days after receiving a typhoid oral vaccine.

Vaccines may be harmful to an unborn baby and generally should not be given to a pregnant woman. However, not vaccinating the mother could be more harmful to the baby if the mother becomes infected with a disease that this vaccine could prevent. Your doctor will decide whether you should receive this vaccine, especially if you have a high risk of infection with typhoid. It is not known whether typhoid vaccine passes into breast milk, or if it could harm a nursing baby. Do not receive this vaccine without telling your doctor if you are breast-feeding a baby.

How is typhoid vaccine given?

Typhoid vaccine is recommended for adults and children in the following situations:

people who travel to countries where typhoid fever is common;
people who will have long-term exposure to food or water that may be contaminated with typhoid;
people who live with someone who is a typhoid carrier; and
laboratory workers who may come into contact with Salmonella typhi in a work setting.

You should complete all doses at least 1 week before your scheduled travel or possible exposure to typhoid.

Swallow the capsule as quickly as possible after placing it in your mouth. Take with a full glass of cold or lukewarm water or other beverage. Do not use warm or hot drinks such as coffee, tea, or warm milk. The liquid you use to help swallow the typhoid vaccine capsule should not be warmer than your body temperature (98.6 degrees F).

Do not crush, chew, or break a typhoid vaccine capsule. Swallow the pill whole. The enteric-coated pill has a special coating to release the vaccine slowly into your body. Breaking the pill could damage this coating.

The complete series of 4 vaccine capsules should provide protection against typhoid for up to 5 years. Another series of 4 capsules is then recommended every 5 years during possible exposure to typhoid. Your individual booster schedule may be different from these guidelines. Follow your doctor’s instructions or the schedule recommended by the Centers for Disease Control and Prevention (CDC).

Be sure you receive all recommended doses of this vaccine. If you do not receive the full series of capsules every 5 years during continued exposure, you may not be fully protected against the disease.

Wash your hands often to help prevent typhoid when you are in an area where contamination is possible.

What happens if I miss a dose?

Contact your doctor if you forget to take a capsule on the scheduled day. You may need to start over to make sure you are fully protected against the disease.

Be sure to receive another series of 4 capsules every 5 years during continued exposure to typhoid.

What happens if I overdose?

An overdose of this vaccine is unlikely to occur when taken as directed.

What should I avoid before or after getting typhoid vaccine?

In addition to receiving typhoid vaccine, take precautions while traveling to further prevent coming into contact with bacteria that cause typhoid fever:

Avoid eating leafy vegetables such as spinach or lettuce, which are harder to wash properly.
Avoid eating raw fruits or vegetables that cannot be peeled, or that have been peeled by another person.
Avoid drinks that contain ice, or frozen treats and flavored ices that may have been made with contaminated water.
Avoid eating foods you have not cooked or prepared yourself. Use clean surfaces and utensils when preparing food.
Drink only bottled water (carbonated is best) or water that has been boiled for at least 1 minute.
Avoid any food or beverage purchased from a street vendor.

Typhoid vaccine side effects

You should not receive a booster dose if you had a life-threatening allergic reaction after taking a typhoid vaccine capsule.

Becoming infected with typhoid is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.

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 include:

low fever;
headache;
nausea, vomiting, diarrhea, stomach pain; or
mild skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect typhoid vaccine?

Before receiving this vaccine, tell the doctor about all other vaccines you have recently received.

You should not take an anti-malaria medication called proguanil (Malarone) for at least 10 days after you have received your last dose of typhoid vaccine. Proguanil may make typhoid vaccine less effective.

There may be other drugs that can affect this vaccine. 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 doctor or pharmacist may have information about this vaccine written for health professionals that you may read. You may also find additional information from your local health department or the Centers for Disease Control and Prevention.

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.

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Vivotif Berna Vaccine Delayed-Release Capsules

30/06/10

Generic Name: Typhoid Vaccine Live (TIE-foyd)
Brand Name: Vivotif Berna Vaccine

Vivotif Berna Vaccine Delayed-Release Capsules are used for:

Preventing typhoid fever in persons 6 years old and older who are at increased risk because they are traveling to an area where this infection is more common, have been in contact with infected individuals, or work in an environment that increases their risk (eg, lab work).

Vivotif Berna Vaccine Delayed-Release Capsules are a vaccine. It works by stimulating the body to produce antibodies against typhoid fever.

Do NOT use Vivotif Berna Vaccine Delayed-Release Capsules if:

you are allergic to any ingredient in Vivotif Berna Vaccine Delayed-Release Capsules
you have a current infection, cancer, fever, persistent vomiting or diarrhea, other stomach illness, or HIV or another condition that weakens the immune system
you are taking a sulfonamide (eg, sulfamethoxazole), another antibiotic (eg, penicillin), or a medicine that weakens the immune system (eg, cyclosporine, certain cancer medicines)

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

Before using Vivotif Berna Vaccine Delayed-Release Capsules:

Some medical conditions may interact with Vivotif Berna Vaccine Delayed-Release Capsules. 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 an infection or fever, chronic diarrhea, an illness affecting the stomach or intestines, undiagnosed rectal hemorrhage, or persistent vomiting, or you are receiving chemotherapy or radiation therapy

Some MEDICINES MAY INTERACT with Vivotif Berna Vaccine Delayed-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

Antibiotics (eg, penicillin), corticosteroids (eg, prednisone), immunosuppressants (eg, certain cancer medicines, cyclosporine), or sulfonamides (eg, sulfamethoxazole) because they may decrease Vivotif Berna Vaccine Delayed-Release Capsules’s effectiveness
Proguanil because it may decrease Vivotif Berna Vaccine Delayed-Release Capsules’s effectiveness. You should not take proguanil for at least 10 days after your last dose of Vivotif Berna Vaccine Delayed-Release Capsules. Discuss any questions with your doctor

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vivotif Berna Vaccine Delayed-Release 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 Vivotif Berna Vaccine Delayed-Release Capsules:

Use Vivotif Berna Vaccine Delayed-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Vivotif Berna Vaccine Delayed-Release Capsules with a cold or lukewarm drink 1 hour before or 2 hours after a meal.
Swallow Vivotif Berna Vaccine Delayed-Release Capsules whole. Do not break, crush, or chew before swallowing.
Do not take cracked or broken capsules.
Do not drink alcohol within 2 hours of taking Vivotif Berna Vaccine Delayed-Release Capsules.
Do not forget to skip a day between capsules. Take a capsule EVERY OTHER DAY as directed by your doctor.
For Vivotif Berna Vaccine Delayed-Release Capsules to be effective, you must complete all 4 doses at least 1 week before exposure to typhoid fever.
If you miss a dose of Vivotif Berna Vaccine Delayed-Release Capsules, take it as soon as possible. If you do not remember until the next day, take the dose as soon as possible and reschedule your doses from that day.

Ask your health care provider any questions you may have about how to use Vivotif Berna Vaccine Delayed-Release Capsules.

Important safety information:

Notify your doctor if you experience diarrhea, vomiting, or flu-like symptoms after taking Vivotif Berna Vaccine Delayed-Release Capsules.
This vaccine helps prevent typhoid fever, but does not provide 100% protection. It is important to also avoid infected people, food, and water.
It is recommended that you receive another 4 doses of Vivotif Berna Vaccine Delayed-Release Capsules every 5 years if you continue to be exposed to typhoid fever.
Vivotif Berna Vaccine Delayed-Release Capsules are not recommended for use in CHILDREN younger than 6 years of age; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vivotif Berna Vaccine Delayed-Release Capsules during pregnancy. It is not known if Vivotif Berna Vaccine Delayed-Release Capsules are found in breast milk. If you are or will be breast-feeding while you use Vivotif Berna Vaccine Delayed-Release Capsules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Vivotif Berna Vaccine Delayed-Release 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:

Diarrhea; fever; headache; muscle pain; nausea; stomach cramps or pain; vomiting.

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); difficulty swallowing; unusual hoarseness.

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 Vivotif Berna Vaccine Delayed-Release Capsules:

Store Vivotif Berna Vaccine Delayed-Release Capsules in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), at all times. Do not freeze. Keep Vivotif Berna Vaccine Delayed-Release Capsules out of the reach of children and away from pets.

General information:

If you have any questions about Vivotif Berna Vaccine Delayed-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
Vivotif Berna Vaccine Delayed-Release Capsules are 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 Vivotif Berna Vaccine Delayed-Release 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.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

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Volmax

30/06/10

Generic Name: albuterol (Oral route)

al-BUE-ter-ol

Commonly used brand name(s):

In the U.S.

Proventil
Proventil Repetabs
Ventolin
Volmax
VoSpire ER

In Canada

Apo-Salvent Inhaler

Available Dosage Forms:

Tablet
Syrup
Tablet, Extended Release

Therapeutic Class: Bronchodilator

Pharmacologic Class: Sympathomimetic

Uses For Volmax

Albuterol is used to treat bronchospasm or wheezing in patients with reversible obstructive airway disease, such as asthma.

Albuterol belongs to the family of medicines known as adrenergic bronchodilators. Adrenergic bronchodilators are medicines that open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

This medicine is available only with your doctor’s prescription.

Before Using Volmax

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 this medicine, the following should be considered:

Allergies

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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of albuterol in children 2 years of age and older.

Geriatric

No information is available on the relationship of age to the effects of albuterol in geriatric patients. However, elderly patients are more likely to have age-related heart problems, which may require caution and an adjustment in the dose for patients receiving albuterol.

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

Using this medicine 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.

Acebutolol
Alprenolol
Arotinolol
Atenolol
Atomoxetine
Befunolol
Betaxolol
Bevantolol
Bisoprolol
Bopindolol
Brofaromine
Bucindolol
Bupranolol
Carteolol
Carvedilol
Celiprolol
Clorgyline
Dilevalol
Esmolol
Furazolidone
Iproniazid
Isocarboxazid
Labetalol
Landiolol
Lazabemide
Levobetaxolol
Levobunolol
Linezolid
Mepindolol
Metipranolol
Metoprolol
Moclobemide
Nadolol
Nebivolol
Nialamide
Nipradilol
Oxprenolol
Pargyline
Penbutolol
Phenelzine
Pindolol
Procarbazine
Propranolol
Rasagiline
Selegiline
Sotalol
Talinolol
Tertatolol
Timolol
Toloxatone
Tranylcypromine

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.

Proper Use of albuterol

This section provides information on the proper use of a number of products that contain albuterol. It may not be specific to Volmax. Please read with care.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine or any asthma medicine without telling your doctor. To do so may increase the chance for breathing problems.

Swallow the extended-release tablet whole with water or liquids. Do not break, crush, or chew the tablet.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

The dose of this medicine 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 this medicine. 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 treatment of bronchospasm:
- For oral dosage form (syrup, tablets):
  - Adults and children older than 12 years of age—2 or 4 milligrams (mg) taken 3 or 4 times per day. Your doctor may increase your dose as needed up to a maximum of 32 mg per day, divided and given 4 times per day.
  - Children 6 to 12 years of age—2 mg taken 3 or 4 times per day. Your doctor may increase your dose as needed up to a maximum dose of 24 mg per day, divided and given 4 times per day.
  - Children 2 to 6 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.1 milligram (mg) per kilogram (kg) of body weight per dose, given 3 times per day, and each dose will not be more than 2 mg. Your doctor may increase your dose as needed up to a maximum dose of 12 mg per day, divided and given 3 times a day.
  - Children younger than 2 years of age—Use and dose must be determined by your child’s doctor.
- For oral dosage form (extended-release tablets):
  - Adults and children older than 12 years of age—8 milligrams (mg) every 12 hours. Your doctor may increase your dose as needed up to a maximum of 32 mg per day, divided and given every 12 hours.
  - Children 6 to 12 years of age—4 mg every 12 hours. Your doctor may increase your dose as needed up to a maximum dose of 24 mg per day, divided and given every 12 hours.
  - Children younger than 6 years of age—Use and dose must be determined by your child’s doctor.

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.

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 Volmax

It is very important that your doctor check your progress or your child’s progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you or your child have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

You or your child may also be taking an antiinflammatory medicine, such as a steroid, together with this medicine. Do not stop taking the antiinflammatory medicine, even if your asthma seems better, unless you are told to do so by your doctor.

Albuterol may cause allergic reactions. Stop using the medicine and check with your doctor right away if you or your child develop a skin rash, hives, itching, swelling, or any type of allergic reaction after taking this medicine.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you or your child have more than one of the following symptoms: convulsions; decreased urine; dry mouth; increased thirst; irregular heartbeat; loss of appetite; mood changes; muscle pain or cramps; nausea or vomiting; numbness or tingling in the hands, feet, or lips; shortness of breath; or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

Volmax 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:

More common

Shakiness in the legs, arms, hands, or feet
trembling or shaking of the hands or feet

Less common

Fast, irregular, pounding, or racing heartbeat or pulse

Rare

Cough
difficulty breathing
difficulty with swallowing
hives or welts
hoarseness
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
noisy breathing
redness of the skin
shortness of breath
skin rash
slow or irregular breathing
swelling of the mouth or throat
tightness in the chest
wheezing

Incidence not known

Agitation
anxiety
arm, back, or jaw pain
blurred vision
chest pain or discomfort
confusion
convulsions
extra heartbeats
fainting
hallucinations
headache
irritability
lightheadedness
mood or mental changes
muscle pain or cramps
muscle spasm or jerking of all extremities
nervousness
nightmares
pounding in the ears
restlessness
sudden loss of consciousness
sweating
total body jerking
unusual feeling of excitement
vomiting

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

Dizziness
feeling of warmth
irritability
nausea
redness of the face, neck, arms, and occasionally, upper chest
sleeplessness
trouble with holding or releasing urine
trouble sleeping
unable to sleep

Rare

Sleepiness
unusual drowsiness

Incidence not known

Bad, unusual, or unpleasant (after) taste
change in taste
feeling of constant movement of self or surroundings
gagging
rough, scratchy sound to voice
sensation of spinning
tightness in the throat

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.

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Vivotif

30/06/10

Generic Name: typhoid vaccine, live (Oral route)

TYE-foid VAX-een, lyve

Commonly used brand name(s):

In the U.S.

Vivotif

Available Dosage Forms:

Capsule, Delayed Release
Capsule

Therapeutic Class: Vaccine

Uses For Vivotif

Typhoid fever is a serious disease that can cause death. It is caused by a germ called Salmonella typhi, and is spread most often through infected food or water. Typhoid may also be spread by close person-to-person contact with infected persons (such as occurs with persons living in the same household). Some infected persons do not appear to be sick, but they can still spread the germ to others.

Typhoid fever is very rare in the U.S. and other areas of the world that have good water and sewage (waste) systems. However, it is a problem in parts of the world that do not have such systems. If you are traveling to certain countries or remote areas, typhoid vaccine will help protect you from typhoid fever. The U.S. Centers for Disease Control (CDC) currently recommend caution in the following areas of the world:

Africa
Asia
Latin America

Typhoid vaccine taken by mouth helps prevent typhoid fever, but does not provide 100% protection. Therefore, it is very important to avoid infected persons and food and water that may be infected, even if you have taken the vaccine.

To get the best possible protection against typhoid, you should complete the vaccine dosing schedule (all 4 doses of the vaccine) at least 1 week before travel to areas where you may be exposed to typhoid.

If you will be traveling regularly to parts of the world where typhoid is a problem, you should get a booster (repeat) dose of the vaccine every 5 years.

Typhoid vaccine is available only from a health care professional.

Before Using Vivotif

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

Allergies

Pediatric

Typhoid vaccine is not recommended for infants and children up to 6 years of age. Although there is no specific information comparing use of typhoid vaccine in children 6 years of age and over with use in other age groups, this vaccine is not expected to cause different side effects or problems in these 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 typhoid vaccine in the elderly with use in other age groups, this vaccine 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	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

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Receiving this vaccine 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.

Aclarubicin
Adalimumab
Aldesleukin
Altretamine
Amonafide
Amsacrine
Asparaginase
Azacitidine
Azathioprine
Bleomycin
Broxuridine
Busulfan
Capecitabine
Carboplatin
Carmustine
Certolizumab Pegol
Chlorambucil
Cisplatin
Cladribine
Cyclophosphamide
Cytarabine
Cytarabine Liposome
Dacarbazine
Dactinomycin
Daunorubicin
Daunorubicin Citrate Liposome
Decitabine
Docetaxel
Doxifluridine
Doxorubicin Hydrochloride
Doxorubicin Hydrochloride Liposome
Edatrexate
Eflornithine
Epirubicin
Estramustine
Etanercept
Etoposide
Floxuridine
Fludarabine
Fluorouracil
Fotemustine
Gallium Nitrate
Gemcitabine
Golimumab
Hydroxyurea
Idarubicin
Ifosfamide
Irinotecan
Lomustine
Mechlorethamine
Melphalan
Mercaptopurine
Methotrexate
Mitolactol
Mitomycin
Mitotane
Mitoxantrone
Mycophenolic Acid
Oxaliplatin
Paclitaxel
Pegaspargase
Pentostatin
Pipobroman
Pirarubicin
Plicamycin
Procarbazine
Raltitrexed
Rilonacept
Rituximab
Sirolimus
Streptozocin
Tacrolimus
Teceleukin
Tegafur
Temsirolimus
Teniposide
Thioguanine
Thiotepa
Topotecan
Treosulfan
Trimetrexate
Trofosfamide
Uracil Mustard
Vinblastine
Vincristine
Vincristine Liposome
Vindesine
Vinorelbine

Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abatacept
Cytomegalovirus Immune Globulin, Human
Leflunomide
Proguanil
Vaccinia Immune Globulin, Human

Interactions with Food/Tobacco/Alcohol

Proper Use of Vivotif

It is important that all 4 doses of the vaccine be taken exactly as directed. If all the doses are not taken or if doses are not taken at the correct times, the vaccine may not work properly.

The vaccine capsules are meant to dissolve in the intestines. Therefore, they should be inspected to make sure that they are not broken or cracked when you take them. If any are broken or cracked, you will need to replace them.

Typhoid vaccine must be stored in the refrigerator at a temperature between 2 and 8 °C (35.6 and 46.4 °F) at all times. If the vaccine is left at room temperature, it will lose its effectiveness. Therefore, remember to replace unused vaccine in the refrigerator between doses.

Each dose of the vaccine should be taken approximately 1 hour before a meal. Take with a cold or lukewarm drink that has a temperature that does not exceed body temperature, e.g., 37 °C (98.6 °F).

Swallow the capsule whole. Do not chew it before swallowing. Also swallow the capsule as soon as possible after you place it in your mouth.

Dosing

Take 1 capsule by mouth every other day for a total of 4 doses.

Missed Dose

Call your doctor or pharmacist for instructions.

If you do not remember the missed dose until the next day, take the missed dose at that time and reschedule your every-other-day doses from then. It is important that this vaccine be taken exactly as directed so it can give you the most protection against typhoid fever.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Vivotif

Tell your doctor that you have taken this vaccine:

If you are to receive any other live vaccines within 1 month after taking this vaccine.

Vivotif 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:

Symptoms of allergic reaction

Difficulty in breathing or swallowing
hives
itching, especially of feet or hands
reddening of skin, especially around ears
swelling of eyes, face, or inside of nose
unusual tiredness or weakness (sudden and severe)

Less common or rare

Diarrhea
fever
hives
nausea
skin rash
stomach cramps or pain
vomiting

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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Vivitrol

30/06/10

Generic Name: naltrexone (injection) (nal TREX own)
Brand Names: Vivitrol

What is naltrexone injection?

Naltrexone injection is a special narcotic drug that blocks the effects of other narcotic medicines and alcohol.

Naltrexone injection is used to treat narcotic drug or alcohol addiction..

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

What is the most important information I should know about naltrexone injection?

Do not use narcotic drugs or alcohol while you are being treated with naltrexone injection. Never try to overcome the effects of the medication by using large doses of narcotic drugs or alcohol. Doing so could result in dangerous effects, including coma and death. Ask your doctor before using any prescription or over-the-counter medicine to treat a cold, cough, diarrhea, or pain during your treatment with naltrexone injection. These medicines may contain narcotics or alcohol. Naltrexone injection 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.

You may notice pain, redness, bruising, swelling, or a hard lump where the medication was injected. Call your doctor if you have this type of reaction to the shot, especially if it does not clear up or gets worse within 2 weeks.

Carry an ID card or wear a medical alert bracelet stating that you are being treated with naltrexone, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are receiving this medication.

Additional forms of counseling and/or monitoring may be recommended during treatment with naltrexone injection.

What should I discuss with my health care provider before receiving naltrexone injection?

Do not receive this injection if you are allergic to naltrexone, or if you have:

an addiction to narcotics;
a history of alcohol or narcotic drug use within the past 7-10 days; or
drug or alcohol withdrawal symptoms.

Before receiving naltrexone, tell your doctor if you are allergic to any drugs, or if you have:

kidney disease;
liver disease; or
a bleeding disorder such as hemophilia.

If you have any of these conditions, you may need a dose adjustment or special tests to safely receive a naltrexone injection.

FDA pregnancy category C. It is not known whether naltrexone injection is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether naltrexone injection 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 naltrexone injection used?

Naltrexone injection (Vivitrol) is given as a shot into a muscle. This injection is usually given once a month (every 4 weeks) and can be given only by a doctor or nurse in a clinic.

It is important to receive your naltrexone injections regularly to get the most benefit.

Additional forms of counseling and/or monitoring may be recommended during treatment with naltrexone injection.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment to receive your naltrexone 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 nausea, stomach pain, dizziness, or seizure (convulsions).

What should I avoid while using naltrexone injection?

Naltrexone injection 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. Do not use narcotic drugs or alcohol while receiving naltrexone injection. Never try to overcome the effects of the medication by using large doses of narcotic drugs or alcohol. Doing so could result in dangerous effects, including coma and death. Ask your doctor before using any prescription or over-the-counter medicine to treat a cold, cough, diarrhea, or pain while you are being treated with naltrexone injection. These medicines may contain narcotics or alcohol.

Naltrexone injection 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 any of these serious side effects:

blurred vision or eye problems;
fast heartbeat;
wheezing, difficulty breathing;
mood changes, hallucinations (seeing or hearing things), confusion, thoughts of hurting yourself;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
ear pain, ringing in your ears;
feeling light-headed, fainting;
skin rash or itching; or
pain, redness, bruising, itching, swelling, oozing, skin changes, or a hard lump where the medication was injected.

Less serious side effects may include:

feeling anxious, nervous, restless, or irritable;
increased thirst;
muscle or joint aches;
weakness or tiredness;
sleep problems (insomnia); or
decreased sex drive, impotence, or difficulty having an orgasm.

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 naltrexone injection?

The pain-relieving effects of any narcotic pain medications you use will be blocked if you use them during your treatment with naltrexone injection. Harmful side effects could also occur.

Before receiving naltrexone injection, tell your doctor if you use any of the following drugs:

buprenorphine (Buprenex, Subutex);
butorphanol (Stadol);
codeine (Tylenol with codeine);
hydrocodone (Lortab, Vicodin);
hydromorphone (Dilaudid);
levorphanol (Levo-Dromoran);
meperidine (Demerol);
methadone (Dolophine, Methadose);
morphine (Kadian, MS Contin, Roxanol);
nalbuphine (Nubain);
naloxone (Narcan);
oxycodone (OxyContin, Roxicodone, Percocet);
oxymorphone (Numorphan); or
propoxyphene (Darvon, Darvocet).

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

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.

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Vivelle 25 Mcg

30/06/10

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 Vivelle 25 Mcg

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 Vivelle 25 Mcg

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.

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 Vivelle 25 Mcg. 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.

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, 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 Vivelle 25 Mcg

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.

Vivelle 25 Mcg 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

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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Vivelle-Dot

30/06/10

Generic Name: estradiol transdermal (ess tra DYE ol tranz DERM al)
Brand Names: Alora, Climara, Estraderm, Estradiol Patch, Menostar, Vivelle, Vivelle-Dot

What is Vivelle-Dot (estradiol transdermal)?

Estradiol is a form of estrogen, a female sex hormone the regulates many processes in the body.

Estradiol transdermal skin patches are used to treat certain symptoms of menopause such as dryness, burning, and itching of the vaginal area. Estradiol transdermal also reduces urgency or irritation of urination.

Estradiol skin patches are also used to treat ovarian disorders, infertility, and abnormal vaginal bleeding. Some estradiol skin patches are used to prevent postmenopausal osteoporosis. Transdermal skin patches release the drug slowly, and it is absorbed through your skin.

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

What is the most important information I should know about Vivelle-Dot (estradiol transdermal)?

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a bleeding disorder, a hormone-related cancer such as breast or uterine cancer, or abnormal vaginal bleeding. This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Estradiol increases your risk of developing endometrial hyperplasia, a condition that may lead to cancer of the uterus. Taking progestins while using estradiol may lower this risk. If your uterus has not been removed, your doctor may prescribe a progestin for you to take while you are using estradiol transdermal.

Long-term estradiol treatment may increase your risk of breast cancer, heart attack, or stroke. Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol transdermal.

What should I discuss with my healthcare provider before using Vivelle-Dot (estradiol transdermal)?

Do not use estradiol transdermal if you have:

a bleeding or blood-clotting disorder;
a history of stroke or circulation problems;
abnormal vaginal bleeding that a doctor has not checked; or
any type of breast, uterine, or hormone-dependent cancer.

Before using estradiol transdermal, tell your doctor if you have:

high blood pressure, angina, or heart disease;
high cholesterol or triglycerides;
liver disease;
kidney disease;
asthma;
epilepsy or other seizure disorder;
migraines;
diabetes;
depression;
gallbladder disease; or
if you have had your uterus removed (hysterectomy).

If you have any of these conditions, you may need a dose adjustment or special tests to safely use estradiol transdermal.

Long-term estradiol treatment may increase your risk of stroke. Talk with your doctor about your individual risks before using estradiol long-term. Your doctor should check your progress on a regular basis (every 3 to 6 months) to determine whether you should continue this treatment.

FDA pregnancy category X. This medication can cause birth defects. Do not use estradiol transdermal if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. Estradiol can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I use Vivelle-Dot (estradiol transdermal)?

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

Apply the skin patch to clean, dry skin on your stomach, lower back, or buttocks. Choose a different spot within these skin areas each time you apply a new patch. Avoid skin that is oily, irritated, or damaged.

Press the patch in place firmly for about 10 seconds, especially around the edges.

Do not apply a skin patch to your breasts. Do not apply a patch where it might be rubbed off by tight clothing, such as under an elastic waistband.

If a patch falls off, try putting it back on to a different skin area, pressing the patch into place for 10 seconds. If the patch will not stick you may apply a new one.

Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol transdermal.

Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply a skin patch as soon as you remember. If it is almost time to apply your next patch, skip the missed dose and apply a patch at the next regularly scheduled time. Do not use extra patches 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 nausea, vomiting, and vaginal bleeding.

What should I avoid while using Vivelle-Dot (estradiol transdermal)?

Avoid using other estrogen products without your doctor’s advice.

Vivelle-Dot (estradiol transdermal) side effects

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness or weakness, especially on one side of the body;
sudden headache, confusion, problems with vision, speech, or balance;
pain or swelling in your lower leg;
abnormal vaginal bleeding;
pain, swelling, or tenderness in your stomach;
jaundice (yellowing of the skin or eyes); or
a lump in your breast.

Less serious side effects may include:

nausea, vomiting, loss of appetite;
swollen breasts;
acne or skin color changes;
decreased sex drive, impotence, or difficulty having an orgasm;
migraine headaches or dizziness;
vaginal pain, dryness, or discomfort;
swelling of your ankles or feet;
depression; or
changes in your menstrual periods, break-through bleeding.

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 Vivelle-Dot (estradiol transdermal)?

Before using estradiol transdermal, tell your doctor if you are using any of the following drugs:

St. John’s wort;
phenobarbital (Luminal, Solfoton);
a blood thinner such as warfarin (Coumadin);
ritonavir (Norvir);
carbamazepine (Carbatrol, Tegretol);
an antibiotic such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), or rifampin (Rifadin, Rifater, Rifamate, Rimactane); or
an antifungal medication such as ketoconazole (Nizoral) or itraconazole (Sporanox).

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

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.

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Vivelle Patch

30/06/10

Generic Name: Estradiol (ESS-truh-DIE-ole)
Brand Name: Examples include Estraderm and Vivelle

Estrogens have been reported to increase the chance of uterine (womb) cancer. Estrogen-containing products should not be used to prevent heart disease or dementia. Estrogen given alone or in combination with another hormone (progestin) for replacement therapy may increase your risk for heart disease (eg, heart attacks), stroke, serious blood clots in the legs (deep vein thrombosis) or lungs (pulmonary embolism), dementia, or breast cancer. These risks appear to depend on the length of time Vivelle Patch is used and the amount of estrogen per dose. Therefore, Vivelle Patch should be used exactly as prescribed by your doctor, for the shortest possible length of time at the lowest effective dose, so that you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Consult your doctor or pharmacist for details.

Vivelle Patch is used for:

Treating conditions due to menopause (eg, hot flashes; vaginal itching, burning, or dryness), preventing osteoporosis (brittle bones) in certain women who have already gone through menopause, or replacing estrogen if the ovaries do not produce enough or are removed. It may also be used for other conditions as determined by your doctor.

Vivelle Patch is an estrogen hormone. It works by replacing natural estrogens in a woman who can no longer produce enough estrogen.

Do NOT use Vivelle Patch if:

you are allergic to any ingredient in Vivelle Patch
you are pregnant or suspect you may be pregnant
you have undiagnosed, abnormal vaginal bleeding
you have known or suspected abnormal estrogen-dependent growths, known or suspected breast cancer, or a history of breast cancer
you have or have a history of blood clots in your legs, lungs, or other blood vessels
you have had a heart attack or stroke within the past year or you have liver problems

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

Before using Vivelle Patch:

Some medical conditions may interact with Vivelle Patch. 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 breast lumps or disease, an abnormal mammogram, or a family history of breast cancer
if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, or if you have high blood pressure during pregnancy (toxemia)
if you have a vaginal infection or womb problems (eg, uterine fibroids, endometriosis, abnormal vaginal bleeding, other uterine problems)
if you have asthma, cancer (eg, breast cancer), certain blood problems (eg, porphyria), cholesterol or lipid problems, depression, diabetes, epilepsy, excessive weight gain, gallbladder disease, heart disease or other heart problems (eg, heart attack, congestive heart failure), high blood pressure, kidney or liver disease, underactive thyroid, lupus, migraine headaches, pancreas disease, seizures, yellowing of the skin or eyes (jaundice), or a history of abnormal calcium levels in the blood, or if you are very overweight
if you smoke or will be having surgery

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

Clarithromycin, erythromycin, azole antifungals (eg, itraconazole, ketoconazole), or ritonavir because they may increase the risk of Vivelle Patch’s side effects
Anticoagulants (eg, warfarin) because their actions and side effects may be increased by Vivelle Patch
Carbamazepine, hydantoins (eg, phenytoin), barbiturates (eg, phenobarbital), rifampin, or St. John’s wort because they may decrease Vivelle Patch’s effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vivelle Patch 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 Vivelle Patch:

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

An extra patient leaflet is available with Vivelle Patch. Talk to your pharmacist if you have questions about this information.
If you are switching from oral estrogen to Vivelle Patch, stop taking the oral estrogen and wait 1 week before using Vivelle Patch. However, if your symptoms return, you may start using Vivelle Patch sooner.
The patch is usually replaced twice a week (about every 3 to 4 days), or as directed by your doctor. Follow the dosing schedule carefully.
Do not open the sealed pouch containing the patch until ready to use. Open the pouch and remove the patch from the protective liner. Apply the patch to a clean, dry, hairless area of the body, such as the lower abdomen or the upper part of the buttock, as described in the patient information leaflet or on the package. If you have any questions about where to apply the patch, contact your doctor or pharmacist for instructions. Press the patch firmly against the skin for about 10 seconds to be sure the patch stays on. If the system lifts off of your skin, press down to reapply. Wear only 1 system at any one time.
Do not place the patch on the breast. Make sure the application site is not oily, damaged, or irritated. Avoid applying to the waistline because tight clothing may rub the patch off. Do not put the patch on an area where sitting may loosen it. Do not apply to a site that is exposed to sunlight. Contact with water while bathing, showering, or swimming will not affect the patch.
When it is time to change the patch, remove it slowly. After removing the used patch, fold it in half with the sticky sides together. Discard the patch out of the reach of children and away from pets.
Apply a new patch to a different area to prevent skin irritation. It is best to rotate the areas where the patch is applied, allowing at least 1 week in between applications to the same site. If the area around the patch becomes red, itchy, or irritated, try a new site. If the irritation continues or becomes worse, notify your doctor promptly.
Grapefruit and grapefruit juice may increase the risk of Vivelle Patch’s side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Vivelle Patch.
If you miss a dose of Vivelle Patch, use it as soon as possible. If a patch falls off, reapply it or apply a new patch and wear it for the rest of the scheduled period, then resume your usual dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Vivelle Patch.

Important safety information:

Vivelle Patch may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Vivelle Patch with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Vivelle Patch may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker, and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding the use of sunscreens and protective clothing.
Vivelle Patch may increase the risk of blood clots. The risk may be greater if you smoke (especially in women older than 35 years of age).
Contact your health care provider if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention.
Contact your health care provider if vaginal discomfort occurs or if you suspect you have developed an infection while taking Vivelle Patch.
Follow your doctor’s instructions for examining your breasts, and report any lumps immediately.
If you wear contact lenses and you develop problems with them, contact your doctor.
If you will be having surgery or will be confined to a chair or bed for a long period of time (eg, a long plane flight), notify your doctor beforehand. Special precautions may need to be taken while you are taking Vivelle Patch.
Nondrug therapy to help prevent bone loss includes a weight-bearing exercise plan, as well as adequate daily calcium and vitamin D intake. Consult your doctor or pharmacist for more details.
Vivelle Patch may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Vivelle Patch.
Diabetes patients – Vivelle Patch 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 physical exams and blood pressure, may be performed while you use Vivelle Patch. You should have breast and pelvic exams, and a Pap test at least once a year. You should also have periodic mammograms as determined by your doctor. Be sure to keep all doctor and lab appointments.
Use Vivelle Patch with caution in the ELDERLY; they may be more sensitive to its effects, especially dementia.
Vivelle Patch should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Do not use Vivelle Patch if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Vivelle Patch may be found in breast milk. If you are or will be breast-feeding while you use Vivelle Patch, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Vivelle Patch:

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:

Bone or limb pain; breakthrough bleeding; breast tenderness; dizziness or lightheadedness; neck or back pain; nausea; skin redness/irritation at the application site; upset stomach; weight change.

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); abnormal vaginal bleeding; breast lumps; breast pain; changes in vaginal bleeding (eg, spotting, breakthrough bleeding, prolonged bleeding); changes in vision or speech (eg, change in contact lens fit, loss of vision); chest pain; coughing of blood; mental/mood changes (eg, severe depression, memory loss); one-sided weakness; pain or tenderness in calves or chest; pain, swelling, or tenderness in the stomach; severe headache or vomiting; sudden, severe headache, vomiting, dizziness, or fainting; sudden shortness of breath; swelling of hands or feet; unusual vaginal discharge, itching, or odor; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

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. Symptoms may include excessive vaginal bleeding; severe nausea; vomiting.

Proper storage of Vivelle Patch:

Store Vivelle Patch at room temperature, 59 to 86 degrees F (15 to 30 degrees C). Store in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vivelle Patch out of the reach of children and away from pets.

General information:

If you have any questions about Vivelle Patch, please talk with your doctor, pharmacist, or other health care provider.
Vivelle Patch 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 Vivelle Patch. 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.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

Med-facts,V

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Vivelle 100 Mcg

30/06/10

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 Vivelle 100 Mcg

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.

Estrogens are available only with your doctor’s prescription.

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 Vivelle 100 Mcg

Allergies

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.

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

Rotavirus Vaccine, Live

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.

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 Vivelle 100 Mcg. Please read with care.

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

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

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, 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.

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 Vivelle 100 Mcg

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

Vivelle 100 Mcg Side Effects

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

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.

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

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

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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