What is the most important information I should know about Estrace?

• Estrace increases the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, with Estrace lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together with the estrogen. Visit your doctor regularly and report any unusual vaginal bleeding right away.
• Treatment with Estrace long-term may increase the risk of stroke. Because of this risk, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking Estrace long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.
• The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50-79 years of age) during 5 years of treatment with oral conjugated estrogens combined with medroxyprogesterone acetate.
• The Women's Health Initiative Memory Study (WHIMS) found that postmenopausal women 65 years of age or older who were treated with oral conjugated estrogens plus medroxyprogesterone acetate had an increased risk of developing dementia. It is unknown whether this finding applies to younger postmenopausal women or to women using estrogen only therapy.
• Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking Estrace.
• Do not take Estrace if you are pregnant.

What is Estrace?

• Estrace is a form of estrogen. Estrogen is a female sex hormone necessary for many processes in the body.
• Estrace is used to treat symptoms of menopause such as hot flashes and dryness, burning, and irritation in the vaginal area; deficiency in ovary function (including underdevelopment of female sexual characteristics and some types of infertility); Turner's syndrome; some types of breast cancer in men and in postmenopausal women; degeneration of the vagina and urethra; and prostate cancer. In addition, Estrace is used to prevent osteoporosis.
• Estrace may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Estrace?

• Do not take Estrace without first talking to your doctor if you have
  • a circulation, bleeding, or blood-clotting disorder;
  • undiagnosed, abnormal vaginal bleeding; or
  • any type of breast, uterine, or hormone-dependent cancer.
• Taking Estrace may not be recommended in some cases if you have any of the conditions listed above.
• Before taking Estrace, tell your doctor if you have
  • high blood pressure, angina, or heart disease;
  • a history of stroke or heart attack;
  • high levels of cholesterol or triglycerides in the blood;
  • liver disease;
  • kidney disease;
  • asthma;
  • epilepsy;
  • migraines;
  • diabetes;
  • depression;
  • gallbladder disease;
  • uterine fibroids; or
  • had a hysterectomy (uterus removed).
• You may not be able to take Estrace, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.
• The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50-79 years of age) during 5 years of treatment with oral conjugated estrogens combined with medroxyprogesterone acetate.
• The Women's Health Initiative Memory Study (WHIMS) found that postmenopausal women 65 years of age or older who were treated with oral conjugated estrogens plus medroxyprogesterone acetate had an increased risk of developing dementia. It is unknown whether this finding applies to younger postmenopausal women or to women using estrogen only therapy.
• Treatment with Estrace long-term may increase the risk of stroke. Because of this risk, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking Estrace long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.
• Estrace is in the FDA pregnancy category X. This means that Estrace is known to cause birth defects in an unborn baby. Do not take this medication if you are pregnant or could become pregnant during treatment.
• Estrace may decrease milk flow and have other effects on milk composition. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.

How should I take Estrace?

• Take this medication exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
• Estrace may be administered by mouth, injection, or inserted into the vagina. Your healthcare provider may administer injections of Estrace or will provide you with detailed instructions on how to administer the medication at home.
• Take each oral dose with a full glass of water.
• Take oral Estrace with food or milk to lessen stomach upset. Try to take oral doses at the same time daily.
• Use injectable Estrace exactly as directed by your healthcare provider. Do not inject any Estrace product that is discolored or has particles in it. Injectable Estrace stored at cool temperatures may develop crystals in the solution, which should dissolve as the solution warms to room temperature.
• Rotate injection sites as directed.
• Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate, puncture resistant disposal container.
• The Femring vaginal ring is inserted into the vaginal by you or your healthcare provider. To use the Femring vaginal ring:
  • Wash and dry your hands. Remove Femring from the pouch.
  • Squeeze the sides of the ring together or squeeze it into a figure-eight shape. Push the folded ring into the vagina (up and towards the lower back) as far as possible (into the upper 1/ 3 of the vagina). You should not be able to feel the ring once it is in position. If you can feel it, use a finger to push it further into the vagina. It is not possible for the ring to go too far in or become lost.
  • The ring should remain in place for 3 months. It should then be removed and replaced by a new ring, if prescribed by your doctor. To remove the ring, loop a finger through the ring and gently pull it from the vagina.
  • The ring does not need to be removed during sexual intercourse. It should not be felt by either partner. If it is bothersome, it can be removed, rinsed with warm water, and reinserted following intercourse.
  • If at any time the 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 reinsert it. If the ring falls out repeatedly, talk to your doctor.
• To use the Estrogel pump:
  • Before using the pump for the first time, it must be primed. Remove the large pump cover and fully depress the pump twice. Discard the unused gel by rinsing down the sink or placing it in the household trash in a manner that avoids accidental exposure or ingestion by household members or pets.
  • Apply EstroGel at the same time each day. You should apply your daily dose of gel to clean, dry, unbroken skin.
  • To apply the dose, collect the gel into the palm of your hand by pressing the pump firmly. Apply the gel to one arm using your hand. Spread the gel as thinly as possible over the entire area on the inside and outside of your arm from wrist to shoulder. It is not necessary to massage or rub in the gel. Allow the gel to dry for up to five minutes before dressing.
  • Wash your hands with soap and water after applying the gel to reduce the chance that the medicine will spread from your hands to other people. Alcohol based gels are flammable. Avoid fire, flame or smoking until the gel has dried.
• It is important to use Estrace regularly to get the most benefit.
• Your doctor may want you to have regularly scheduled blood tests or other medical evaluations during treatment with Estrace to monitor progress and side effects.
• Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking Estrace.
• Store Estrace at room temperature away from moisture, heat, and direct light.

What happens if I miss a dose?

• Use the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and use only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

• An overdose of this medication is unlikely to threaten life. Consult an emergency room or poison control left for advice.
• Symptoms of an Estrace overdose may include nausea, vomiting, and breakthrough bleeding in women.

What should I avoid while taking Estrace?

• There are no restrictions on food, beverages, or activity while taking Estrace unless your doctor directs otherwise.

What are the possible side effects of Estrace?

• Estrace increases the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, with Estrace lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together with the estrogen. Visit your doctor regularly and report any unusual vaginal bleeding right away.
• Treatment with Estrace long-term may increase the risk of stroke. Because of this risk, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking Estrace long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.
• If you experience any of the following serious side effects, stop taking Estrace and seek emergency medical attention:
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • shortness or breath or pain in the chest;
  • a painful, red, or swollen leg;
  • abnormal vaginal bleeding;
  • pain, swelling, or tenderness in the abdomen;
  • severe headache or vomiting, dizziness, faintness or changes in vision or speech;
  • yellowing of the skin or eyes; or
  • a lump in a breast.
• Other, less serious side effects may be more likely to occur. Continue to take Estrace and talk to your doctor if you experience
  • decreased appetite, nausea, or vomiting;
  • swollen or tender breasts;
  • acne or skin color changes;
  • decreased sex drive;
  • migraine headaches or dizziness;
  • water retention (swollen hands, feet, or ankles);
  • problems with wearing contact lenses;
  • depression; or
  • changes in menstrual cycle or breakthrough 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.

What other drugs will affect Estrace?

• Before taking Estrace, tell your doctor if you are taking any of the following medicines:
  • an anticoagulant (blood thinner) such as warfarin (Coumadin);
  • a thyroid medication such as Synthroid, Levoxyl, Levothroid, and others;
  • insulin or an oral diabetes medicine such as glipizide (Glucotrol) or glyburide (Diabeta, Micronase);
  • tamoxifen (Nolvadex);
  • didanosine (Videx);
  • phenytoin (Dilantin) or ethotoin (Peganone);
  • carbamazepine (Tegretol);
  • phenobarbital (Solfoton, Luminal);
  • primidone (Mysoline); or
  • rifampin (Rifadin).
• A dosage adjustment or special monitoring may be required during treatment if you are taking any of the medicines listed above.
• Drugs other than those listed here may also interact with Estrace. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including herbal products.