Vagifem

V

Pronunciation: ES-tra-DYE-ol
Generic Name: Estradiol
Brand Name: Vagifem

Vagifem should not be used to prevent heart disease, heart attacks, strokes, or dementia. Estrogens have been shown to increase the risk of heart disease (including heart attack), stroke, dementia, serious blood clots (eg, in the lungs or legs), cancer of the uterus, and breast cancer in some women. Tell your doctor right away if you have unusual vaginal bleeding while you use Vagifem. Talk with your doctor if you have questions about the benefits and risks of using Vagifem.

Vagifem should be used for the shortest possible time at the lowest effective dose to minimize the risk of these side effects. Talk with your doctor regularly about your need to use Vagifem.

Vagifem is used for:

Treating itching, burning, and dryness in or around the vaginal area in women past menopause.

Vagifem is a vaginal estrogen tablet. It works by increasing the amount of estrogen in the body in certain women who do not produce enough on their own.

Do NOT use Vagifem if: you are allergic to any ingredient in Vagifem you are pregnant or suspect you may be pregnant, have recently given birth or are breast-feeding you have unexplained, abnormal vaginal bleeding; known or suspected cancer of the breast or uterus; or estrogen-dependent tumors you have a history of breast cancer, blood clots (eg, deep vein thrombosis, pulmonary embolism), or liver problems you have had a heart attack or stroke within the last year

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

Before using Vagifem:

Some medical conditions may interact with Vagifem. 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 or a family member has a history of lumps in the breast, an abnormal mammogram, or breast cancer if you have yellowing of the whites of the eyes or skin during pregnancy or with past estrogen use, or high blood pressure during pregnancy (toxemia) if you have uterine problems (eg, uterine fibroids/endometriosis) or vaginal conditions (eg, abnormal vaginal bleeding, recurring vaginal infections, prolapse, stenosis) if you have abnormal calcium levels in the blood, asthma, cancer, a certain blood disorder (porphyria), cholesterol or lipid problems, depression, diabetes, excessive weight gain, gallbladder disease, heart disease or other heart problems, high blood pressure, kidney or liver problems, low thyroid hormone levels, lupus, migraine headaches, pancreas disease, seizures (eg, epilepsy), vision problems, or yellowing of the skin or eyes if you smoke, will be having surgery, or will be on bed rest

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

Clarithromycin, erythromycin, itraconazole, ketoconazole, or ritonavir because they may increase the risk of Vagifem's side effects Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), rifampin, or St. John's wort because they may decrease Vagifem's effectiveness Blood thinners (eg, warfarin), corticosteroids (eg, prednisone), succinylcholine, or tacrine because their actions and the risk of their side effects may be increased by Vagifem

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

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

An extra patient leaflet is available with Vagifem. Talk to your pharmacist if you have questions about this information. To use, tear off a single applicator, separate the plastic wrap, and remove the applicator from the plastic wrap. Select the position for vaginal insertion that is most comfortable for you (lying on the bed, squatting, or standing with one leg on a stool). Use the finger of one hand to press the applicator plunger. Use the other hand to gently and comfortably guide the applicator into the vagina. If the tablet falls out of the applicator before inserting the filled applicator, use a new applicator with a fresh tablet. Insert the tablet as far into the vagina as it can comfortably go without force. After inserting the filled applicator, gently press the plunger until you hear a click and the plunger is fully depressed. This will eject the tablet inside your vagina. The tablet will dissolve slowly over several hours. After depressing the plunger, gently remove the applicator and throw it away. Do not reuse the applicator. You may insert the tablet-filled applicator any time of day. You should use the applicator at the same time each day. Grapefruit and grapefruit juice may increase the risk of Vagifem's side effects. Talk to your doctor before including grapefruit or grapefruit juice in your diet while you are taking Vagifem. If you miss a dose of Vagifem, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

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

Important safety information: Vagifem may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Vagifem with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Limit alcoholic beverages while you are using Vagifem. Vagifem 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. Vagifem 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 doctor if vaginal bleeding of unknown cause occurs. This could be a sign of a serious condition requiring immediate medical attention. Contact your doctor if vaginal discomfort occurs or if you suspect you have developed an infection while taking Vagifem. 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 in these circumstances while you are taking Vagifem. Vagifem may increase the risk of breast and endometrial cancer. Your doctor may prescribe another hormone (progestin) to decrease this risk. Your doctor should reevaluate you every 3 to 6 months to determine whether you need to continue taking Vagifem. Diabetes patients - Vagifem may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine. Vagifem may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Vagifem. Lab tests, including hormone levels, physical exams, and blood pressure, may be performed while you use Vagifem. These tests may be used to monitor your condition or check for side effects. 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 Vagifem with caution in the ELDERLY; they may be more sensitive to its effects, including an increased risk of heart problems, stroke, breast or uterine cancer, and certain mental problems (eg, dementia). Vagifem should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. PREGNANCY and BREAST-FEEDING: Do not use Vagifem if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. Vagifem is found in breast milk. Do not breast-feed while taking Vagifem. Possible side effects of Vagifem:

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:

Breast pain or tenderness; diarrhea; hair loss; headache; mild nausea or vomiting; spotting or breakthrough bleeding; stomach cramps or bloating.

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); back pain; breast discharge or lump in the breast; calf or leg pain or swelling; chest pain; coughing up blood; dark urine; dizziness; fainting; fever; memory problems; mental or mood changes (eg, depression); muscle pain; one-sided weakness; painful or difficult urination; persistent or severe breast pain or tenderness; persistent or severe headache, nausea, or vomiting; severe or persistent stomach pain or swelling; slurred speech; sudden shortness of breath; sunburn-like rash; swelling of the hands, legs, or feet; unusual vaginal bleeding, discharge, itching, or odor; unusual weight changes; vision changes; vomiting; weakness or numbness of an arm or leg; yellowing of the skin or eyes.

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include excessive vaginal bleeding; severe nausea; vomiting.

Proper storage of Vagifem:

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

General information: If you have any questions about Vagifem, please talk with your doctor, pharmacist, or other health care provider. Vagifem 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. Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Vagifem. 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: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc.

Vagifem

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