estradiol vaginal (local)

Some estradiol products placed directly into the vagina are used for "local" treatment of vaginal menopause symtoms 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.

Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, 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 vaginal.

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.

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

Estradiol vaginal (local) is used to treat certain symptoms of menopause such as dryness, burning, and itching of the vaginal area. Estradiol vaginal also reduces urgency or irritation of urination.

Estradiol vaginal (local) may also be used for purposes other than those listed in this medication guide.

Do not use estradiol vaginal 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 vaginal, 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 not be able to use estradiol vaginal, or you may need a dosage adjustment or special tests 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 vaginal.

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 vaginal 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 may decrease breast milk flow and have other effects on milk composition. Do not use estradiol without first talking to your doctor if you are breast-feeding a baby.

Some estradiol products placed directly into the vagina are used for "local" treatment of vaginal menopause symtoms 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.

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.

To use the estradiol vaginal ring:

• Squeeze the sides of the ring together and insert it into the vagina as far as possible. You should not be able to feel the ring once it is in place. If you can feel it, use a finger to push it in farther. It is not possible for the ring to go too far in or become lost.
• Leave the ring in place for 90 days. If the ring ever falls out, rinse it with warm water and reinsert it. If it slides down into the lower part of the vagina, use a finger to push it in farther. After 90 days, remove the ring. Your doctor may want you to replace it with a new ring.
• The ring does not need to be removed during sexual intercourse. Neither partner should be able to feel the ring when it is in place. If the ring is bothersome, you may remove it, rinse it with warm water, and reinsert it after intercourse.
• To remove the ring, loop a finger through the ring and gently pull it from the vagina.

To use the estradiol vaginal cream:

• Using the marked applicator provided, measure the prescribed dose of cream.
• Lie on your back with your knees drawn up, sit, or stand in a position that allows you comfortable access to the vaginal area. Gently insert the applicator deep into your vagina and press in the plunger to empty the cream from the applicator into the vagina.
• Take apart the applicator and wash it with mild soap and warm water. Allow the applicator to dry completely before using it again.

To use the estradiol vaginal tablets:

• Each vaginal tablet is supplied in a disposable applicator.
• Lie on your back with your knees drawn up, sit, or stand in a position that allows you comfortable access to the vaginal area. Gently insert the applicator deep into your vagina and press in the plunger to empty the tablet into the vagina.
• Throw the applicator away.

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

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

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

If a vaginal ring falls out, rinse it with warm water and reinsert it. If it slides down into the lower part of the vagina, use a finger to push it in farther.

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an estradiol vaginal overdose may include nausea, vomiting, and vaginal bleeding.

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

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:

• 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.

Other less serious side effects are more likely to occur, such as:

• 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.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Before using estradiol vaginal, 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);
• rifampin (Rifadin, Rifater, Rifamate, Rimactane); or
• antibiotics such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Erythrocin, Ery-Tab), ketoconazole (Nizoral), or itraconazole (Sporanox);

If you are using any of these drugs, you may not be able to use estradiol vaginal or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect estradiol vaginal. 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.

Your pharmacist has more information about estradiol vaginal (local) written for health professionals that you may read.

Different forms of estradiol vaginal (local) are available with a prescription under the brand names Estrace Vaginal Cream, Estring vaginal ring, and Vagifem vaginal tablets. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.