Estratest/Estratest H.S.

Generic name: Esterified estrogens and methyltestosterone

What is Estratest/Estratest H.S.?

Estratest/Estratest H.S. is used to ease some symptoms of menopause, such as moderate to severe hot flashes (feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating) and the burning, itching, and severe dryness in and around the vagina.

What is the most important information I should know about Estratest/Estratest H.S.?

Estrogens increase the chances of getting cancer of the uterus. Tell your doctor about any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus. Your doctor should check any unusual vaginal bleeding to find out the cause.

When estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be initiated to reduce the risk of endometrial cancer. A woman without a uterus does not need progestin. Use of estrogen, alone or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Patients should be reevaluated periodically as clinically appropriate (such as every 3 to 6-months) to determine if treatment is still necessary.

For women who have a uterus, adequate diagnostic measures, such as endometrial sampling, when indicated, should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, high blood pressure, strokes, breast cancer, and blood clots. Using estrogens with progestins may increase your risk of dementia. You and your healthcare provider should talk regularly about whether you still need treatment with Estratest/Estratest H.S.

If you have high blood pressure, high cholesterol (fat in the blood), diabetes, are overweight, or if you use tobacco, you may have a higher risk of developing heart disease. Ask your healthcare provider for ways to lower your risk for heart disease.

Do not drive or perform other possibly unsafe tasks until you know how you react to Estratest; this medication may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines.

Limit alcoholic beverages while you are taking Estratest.

Estratest may cause dark skin patches on your face (melasma). Exposure to the sun may make these patches darker; you may need to avoid prolonged exposure to the sun, sunlamps, and tanning beds. Consult your doctor regarding the use of sunscreens and protective clothing.

If you will be having surgery or will be confined to a chair or bed for a long period of time (such as a long plane flight), notify your doctor 3 to 4 weeks in advance. Special precautions may need to be taken in these circumstances while you are taking Estratest.

Have a breast exam and mammogram (breast X-ray) every year unless your healthcare provider directs you to do differently. If members of your family have had breast cancer or if you have ever had breast lumps or an abnormal mammogram (breast x-ray), you may need to have more frequent breast examinations.

You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with Estratest.

Who should not take Estratest/Estratest H.S.?

Do not start taking Estratest/Estratest H.S. if you have unusual vaginal bleeding, or if you currently have or have had certain cancers. Estrogens may increase the risk of developing certain types of cancers, including cancer of the breast or uterus. A

Do not take Estratest if you had a stroke or heart attack in the past year.

Do not take Estratest if you currently have or have had blood clots or liver problems.

Do not take Estratest if you think you may be pregnant.

Do not take this drug if you are allergic to any of its ingredients.

What should I tell my doctor before I take the first dose of Estratest/Estratest H.S.?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Estratest/Estratest H.S. Also, talk to your doctor about your complete medical history, especially if you have experienced asthma (wheezing); epilepsy (seizures); migraine; gall bladder disease; inflammation of the pancreas; diabetes; high cholesterol, lipids, or triglycerides; endometriosis; lupus; or problems with your heart, liver, thyroid, or kidneys.

If you are breastfeeding, tell your doctor before beginning treatment with this drug.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Adults: The usual dosage is 1 tablet of Estratest or 1 to 2 tablets of Estratest HS daily. Administration should be cyclic, for example, three weeks on and one week off.

How should I take Estratest/Estratest H.S.?

Take Estratest/Estratest H.S. by mouth with or without food.

This medication can be taken alone or in combination with progestin. If you do not have a uterus, there is no need to take progestin with Estratest/Estratest H.S.

Estrogens should be used at the lowest dose possible for your treatment and only as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about the dose you are taking and whether you still need treatment with Estratest/Estratest H.S.

What should I avoid while taking Estratest/Estratest H.S.?

Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or stroke.

Do not drive or perform other possibly unsafe tasks until you know how you react to Estratest; this medication may cause dizziness.

Limit alcoholic beverages while you are taking Estratest.

Avoid prolonged exposure to sun, sunlamps, and tanning beds. Estratest may cause dark skin patches on your face (melasma); exposure to the sun may make these patches darker.

What are possible food and drug interactions associated with Estratest/Estratest H.S.?

If Estratest/Estratest H.S. is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Estratest with the following: anticoagulants such as warfarin, carbamazepine, cyclosporine, hydrocortisone, insulin, macrolide, oxyphenbutazone, phenobarbital, phenytoin, rifampin, succinylcholine, tacrolimus, and tricyclic antidepressants such as amitriptyline.

What are the possible side effects of Estratest/Estratest H.S.?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: abnormal skin sensation, acne, bloating, breast enlargement, breast pain, changes in sex drive, fluid retention, hair loss, headache, irregular vaginal bleeding/spotting, stomach cramps/ nausea, deepening of voice, spotty dark patches on the face, unusual body hair growth or body movements

Serious side effects may include: breast lumps, changes in speech, changes in vision, chest pain, dizziness, leg pain, severe headaches, shortness of breath, unusual vaginal bleeding, vomiting

Can I receive Estratest/Estratest H.S. if I am pregnant or breastfeeding?

Estratest/Estratest H.S. should not be used during pregnancy. Tell your doctor immediately if you are pregnant or plan to become pregnant.

If you are or will be breastfeeding while using Estratest, check with your doctor to discuss any possible risks to your baby. (Estratest has been found in breast milk.)

What should I do if I miss a dose of Estratest/Estratest H.S.?

If you miss a dose of Estratest, take it as soon as possible that same day. If it is almost time for your next dose or it is the next day, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

How should I store Estratest/Estratest H.S.?

Store Estratest/Estratest H.S. at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Estratest out of the reach of children.