Vagifem

Generic Name: Estradiol local
Brand Names: Vagifem

What is Vagifem?

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

Some estradiol products placed directly into the vagina are used for "local" treatment of vaginal menopause symptoms involving the secretions and surrounding tissues of the vagina. Other vaginal estradiol products are used for treating menopause symptoms affecting the vagina as well as other parts of the body (such as hot flashes). This type of vaginal estradiol has "systemic" effects, meaning that it can affect parts of the body other than where the medicine is placed or applied.

The information in this leaflet is specific to estradiol vaginal products that are used for local treatment of symptoms. Estradiol vaginal (local) is used to treat vaginal symptoms of menopause such as dryness, burning, and itching. Estradiol vaginal also reduces urgency or irritation of urination.

Estradiol should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

Estradiol vaginal (local) may also be used for purposes not listed in this medication guide.

Important information about Vagifem

Estradiol can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

You should not use this medication if you have any of the following conditions: liver disease, a bleeding disorder, unusual vaginal bleeding, a history of breast or uterine cancer, or if you have ever had a heart attack, stroke, or a blood clot.

Long-term use of estradiol may increase your risk of breast cancer, uterine cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using estradiol vaginal long term.

Report any unusual vaginal bleeding right away. Have regular physical exams and self-examine your breasts for lumps on a monthly basis while using estradiol vaginal.

Estradiol vaginal should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

What should I discuss with my health care provider before taking Vagifem?

You should not use this medication if you are allergic to estradiol, if you are pregnant, or if you have:

liver disease;
a bleeding or blood-clotting disorder;
a history of heart attack, stroke, or blood clot;
unusual vaginal bleeding that a doctor has not checked; or
any type of breast, uterine, or hormone-dependent cancer.

To make sure you can safely use estradiol vaginal, tell your doctor if you have any of these other conditions:

heart disease;
risk factors for coronary artery disease (such as diabetes, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease);
hereditary angioedema (an immune system disorder);
a history of jaundice caused by pregnancy or birth control pills;
a thyroid disorder;
kidney disease;
asthma;
epilepsy or other seizure disorder;
migraines;
endometriosis or uterine fibroid tumors;
lupus;
gallbladder disease; or
high levels of calcium in your blood.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Your doctor may prescribe a progestin to take while you are using estradiol, to help lower this risk. Report any unusual vaginal bleeding right away.

Long-term use of estradiol may increase your risk of breast cancer, heart attack, stroke, or blood clot. Talk with your doctor about your individual risks before using estradiol vaginal long term.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use estradiol if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective 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 take Vagifem?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Wash your hands before and after inserting estradiol vaginal.

You should not be able to feel the vaginal ring once it is in place. Leave the vaginal ring in place for 90 days, then remove it. Your doctor may want you to replace it with a new ring.

Use the applicator provided to measure the prescribed dose of estradiol vaginal cream. Take apart the cream applicator and wash it with mild soap and warm water after each use.

Each estradiol vaginal tablet is supplied in a single-use disposable applicator. Throw the tablet applicator away after one use.

Your doctor should check your progress on a regular basis (every 3 to 6 months). Self-examine your breasts for lumps on a monthly basis while using estradiol vaginal.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using estradiol.

Store at room temperature away from moisture and heat. Keep the vaginal ring in its protective pouch until you are ready to use it.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose. Remove the vaginal ring and insert a new one as soon as you remember. Do not use an extra vaginal ring to make up the missed wearing time.

What happens if I overdose?

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

Overdose symptoms may include nausea, vomiting, and vaginal bleeding.

What should I avoid while using Vagifem?

Avoid using other vaginal products without your doctor's advice.

Grapefruit and grapefruit juice may interact with estradiol and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Vagifem 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.

Remove the vaginal ring and seek emergency medical attention if you have: fever with nausea, vomiting, diarrhea, muscle pain, dizziness, fainting, and/or sunburn-like skin rash. These may be signs of a life-threatening disease called toxic shock syndrome.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
sudden numbness or weakness, sudden severe headache, sudden vision changes, problems with speech or balance;
sudden cough, wheezing, rapid breathing, coughing up blood;
pain, swelling, warmth, or redness in one or both legs;
swelling or tenderness in your stomach;
jaundice (yellowing of the skin or eyes);
unusual vaginal bleeding;
a lump in your breast;
numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes; or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

breast swelling and tenderness, nipple discharge;
vaginal itching or discharge;
mild nausea, stomach cramps, diarrhea, bloating;
swelling of your ankles or feet;
migraine headaches or dizziness;
cold symptoms such as stuffy nose, sneezing, sore throat;
acne or skin color changes, increased facial hair, thinning scalp hair;
depressed mood; 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.

What other drugs will affect Vagifem?

Tell your doctor about all other medicines you use, especially:

St. John's wort;
an antibiotic or antifungal medication (Biaxin, Ery-Tab, Erythrocin, Ketek, Mycobutin, Nizoral, Noxafil, Rifater, Sporanox, Vfend, Zithromax, Zmax, and others); a barbiturate such as phenobarbital (Solfoton);
heart or blood pressure medication such as nicardipine (Cardene) or quinidine (Quin-G);
the hepatitis C medications boceprevir (Victrelis) or telaprevir (Incivek);
HIV/AIDS medication such as efavirenz (Sustiva, Atripla), fosamprenavir (Lexiva), indinavir (Crixivan), ritonavir (Norvir, Kaletra), and others;
seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), phenytoin (Dilantin), and others; or
thyroid replacement therapy (levothyroxine, Synthroid, Levothroid, Levoxyl, and others).

This list is not complete and there are many other drugs that can interact with estradiol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.