Estradiol Hemihydrate, Vaginal

What are other names for this medicine?

Type of medicine: hormone

Generic and brand names: estradiol hemihydrate, vaginal; Vagifem

What is this medicine used for?

This medicine is inserted in the vagina to treat dryness, itching, and burning, in and around the vagina due to menopause (when a woman no longer has regular monthly periods).

What should my healthcare provider know before I take this medicine?

Tell your healthcare provider if you have ever had:

• an allergic reaction to any hormones or medicines
• a heart attack or stroke
• a hysterectomy (removal of the uterus)
• asthma
• blood clots in your legs, lungs, brain, or eyes
• cancer of the breast, uterus, cervix, or vagina
• depression
• diabetes
• endometriosis
• heart, liver, gallbladder or kidney disease
• high blood pressure
• high cholesterol
• lupus
• migraines or headaches along with vomiting, double vision, unsteadiness, weakness, or personality changes
• porphyria (nerve pain or sensitivity to sunlight)
• problems with calcium levels in the blood
• seizures
• unexplained vaginal bleeding
• yellowing of the eyes or skin (jaundice) during pregnancy or during past use of birth control pills.

Tell your healthcare provider if you have recently had a long period of bed rest after major surgery or a broken bone in a cast.

Tell your provider if you have a family history of heart disease, heart attack, blood clots, strokes, breast cancer, or other conditions.

Tell your healthcare provider if you smoke. Smoking while you are using this medicine increases the risk of serious side effects such as heart attack, stroke, and blood clots. The risk increases with age and the number of cigarettes smoked a day. Talk to your healthcare provider about ways to quit smoking.

Females of childbearing age: Do not take this medicine during pregnancy because it may harm the baby. Tell your healthcare provider if think you are pregnant or plan to become pregnant while taking this medicine. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Do not swallow these tablets. Use this medicine exactly as your healthcare provider prescribes. Insert the tablet at the same time each day (such as at bedtime) to help you remember.

Wash your hands before and after using this medicine. Use the applicator to put the tablet into your vagina. Lie on your back with your knees bent. Put the applicator into your vagina (like you would a tampon) as far as you can. Slowly press the plunger until you hear a click. Withdraw the applicator. The medicine will be left behind in the vagina.

Wash the applicator with soap and water after every use, rinsing and drying it well.

While using this medicine, wear a sanitary napkin to protect your clothing.

Read the information sheet that comes in the medicine package. Follow these directions carefully. If you do not understand how to use this medicine, ask your healthcare provider or pharmacist to explain.

If you are not sure of what to do if you miss a dose, contact your healthcare provider.

What should I watch out for?

Hormone therapy, also known as hormone replacement therapy (HRT) offers both benefits and risks. Estrogen has previously been prescribed to help prevent bone loss (osteoporosis). This is no longer advised because it may be harmful. Estrogen also increases the risk of stroke, blood clots in the lungs and legs, heart disease, breast cancer, and possibly dementia. Also, estrogen taken without progestin increases the risk of uterine cancer if you still have your uterus.

Most experts now recommend short-term use (up to 3 or 4 years) if hormone therapy is needed to relieve menopausal symptoms and prevent bone loss. You should take hormones only when you need them, at the lowest effective dosage, and only for as long as you need them. The risk of medical problems such as stroke or cancer increases further with higher doses and longer treatments. Discuss this with your healthcare provider.

If you are scheduled to have surgery or will be on bedrest, talk to your healthcare provider. You may need to stop taking hormones at least 4 to 6 weeks before the surgery and bedrest.

You need to see your provider regularly (every 6 months) for checkups to find out if this medicine is still needed and if you are having any side effects. Keep all your appointments. Do not take this medicine for longer than 1 year without a complete physical exam.

Sometimes this medicine causes dark spots to develop on your skin, especially with long exposure to the sun. The spots usually go away when you stop using this medicine. While you are taking this medicine, avoid long exposure to the sun. Wear protective clothing, a hat, and sunscreen lotion when you need to be outdoors. Do not use a sunlamp.

This medicine may weaken condoms, diaphragms, and cervical caps. Talk with your healthcare provider about this.

If you wear contact lenses and notice a change in your vision or it becomes difficult to wear your lenses, contact your healthcare provider.

This medicine may increase your HDL cholesterol levels, decrease your LDL levels, and increase your blood triglyceride levels. Talk to your healthcare provider about this.

Diabetics: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Side effects are uncommon because very little estrogen is absorbed into the bloodstream. However, tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you are unable to reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash, trouble breathing, swelling of your lips, tongue and throat); sudden, severe headache; sudden, severe vomiting; sudden partial or complete loss of vision; speech problems; weakness or numbness of an arm or a leg; crushing chest pain or chest heaviness; coughing up blood; sudden shortness of breath; swelling.

Serious (report these to your healthcare provider right away): Unexplained bleeding from your vagina; dizziness, or fainting; breast lumps; redness, warmth, or swelling in your hands, ankles or feet; increased blood pressure; discomfort from contact lenses, vision changes; yellowing of the skin or eyes, especially with fever, tiredness, loss of appetite, dark urine, or light-colored bowel movements.

Other: Changes in menstruation, breast tenderness, nausea, vomiting, acne, hair loss, cramping, minor bloating, depression, anxiety, weight gain or loss, headache, sensitivity to the sun; darkening of skin on the face.

What products might interact with this medicine?

Very little estrogen is absorbed into your bloodstream so drug interactions are not likely. However, if you take the following medicines, talk with your healthcare provider to find out if using these products together might cause harmful side effects.

• alcohol
• aminoglutethimide (Cytadren)
• antibiotics such as ciprofloxacin (Cipro), erythromycin (EES, E-mycin, Ery-Ped), and clarithromycin (Biaxin)
• antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Nizoral)
• antiseizure medicines such as carbamazepine (Tegretol), primidone (Mysoline), oxcarbazepine (Trileptal), topiramate (Topamax), ethotoin (Peganone), fosphenytoin (Cerebyx), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), valproic acid (Depacon, Depakene, Depakote), tiagabine (Gabitril), and phenytoin (Dilantin)
• barbiturates such as phenobarbital, butabarbital (Butisol), pentobarbital (Nembutal), and secobarbital (Seconal)
• blood thinners such as warfarin (Coumadin)
• cholesterol-lowering medicines (statins) such as atorvastatin (Lipitor), lovastatin (Mevacor), and simvastatin (Zocor)
• corticosteroids such as cortisone (Cortone), dexamethasone (Dexameth, Dexone, Hexadrol), hydrocortisone (Hydrocortone, Cortef), methylprednisolone (Medrol), prednisolone (Pediapred, Prelone), prednisone (Liquid Pred, Prednisone Intensol), and triamcinolone (Aristocort, Kenacort)
• cyclosporine (Neoral, Sandimmune, Gengraf)
• dantrolene (Dantrium)
• diabetes medicines such as insulin, glyburide (DiaBeta, Micronase), glipizide (Glucotrol), repaglinide (Prandin), metformin (Glucophage), rosiglitazone (Avandia), and pioglitazone (Actos)
• medicines to treat HIV such as amprenavir (Agenerase), indinavir (Crixivan), nevirapine (Viramune), nelfinavir (Viracept), and ritonavir (Norvir, Kaletra)
• natural remedies such as soy, topical progesterone, black cohosh, red clover, chasteberry, evening primrose oil, dong quai, ginseng, St. John's wort, bloodroot, alfalfa, saw palmetto, and wild yam
• rifampin (Rifadin, Rimactane)
• theophylline (Theo-24, Elixophyllin, T-Phyl, Uniphyl, Quibron-T, Theolair, Theochron) and aminophylline (Truphylline)
• thyroid medicine such as levothyroxine (Levothroid, Levoxyl, Synthroid, Unithroid), liothyronine (Cytomel, Triostat), liotrix (Thyrolar), and thyroid (Armour Thyroid, Thyroid Extract, Thyroid USP)
• tricyclic antidepressants such as amitriptyline, nortriptyline (Aventyl, Pamelor), imipramine (Tofranil), and doxepin (Sinequan).

Do not eat grapefruit or drink grapefruit juice while taking this medicine. Grapefruit affects the way this medicine works and may increase the risk of side effects.

Keep a list of all your medicines (prescription, nonprescription, supplements, natural remedies, and vitamins) with you. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.