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SYNTEST D.S.
METHYLTESTOSTERONE W/ESTROGEN - ORAL

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

METHYLTESTOSTERONE W/ESTROGEN - ORAL

(METH-ill-tess-TOSS-ter-own WITH ESS-trow-jen)

COMMON BRAND NAME(S): Estratest, Menogen, Premarin w/Methyltestosterone

WARNING: This drug has been reported to increase the chance of womb (endometrial) cancer in women who have been through menopause. It also may increase the risk of cancer of the ovary or breast. Therefore, use of estrogen-only hormone therapy (e.g., in women without a uterus) must be cautious. These risks of treatment appear to depend on the length of time this drug is used and the amount of estrogen per dose. Consult your doctor or pharmacist for details. If you use this drug for an extended period, you should be evaluated at least every year. If you experience abnormal vaginal bleeding or lumps in the breast, notify your doctor promptly. This medication is not effective in preventing or treating a tendency toward miscarriages (natural habitual abortion) nor the threat of miscarriage. This drug must not be used during pregnancy because its use may result in birth defects or cancer later in the child's life. If you become pregnant or think you may be pregnant, consult your doctor immediately to discuss the risk to the fetus.

Uses

This medication is a combination of hormones used to treat symptoms of menopause when estrogens alone are not effective. Estrogen-containing products should not be used to prevent heart disease.

How To Use

This medication is taken by mouth usually once a day for 21 days, followed by no medication for 7 days, or take as directed by your doctor. Follow the dosing schedule carefully. This drug should be used for the shortest possible length of time. Consult your doctor or pharmacist if you have any questions. Do not increase your dose, take this more often than directed or stop taking this medication without first consulting your doctor.

Side Effects

Headache, irritability, restlessness, mood changes, fatigue, upset stomach, bloating, acne, change in sex drive or breast tenderness may occur. If these symptoms persist or worsen, inform your doctor. Notify your doctor immediately if you experience: swelling of the legs or feet, leg pain, chest pain, severe headache, one-sided weakness, lumps in the breast, slurred speech, vision problems, mental/mood changes (e.g., depression, memory loss), breathing difficulty. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: undiagnosed abnormal vaginal bleeding, cancer (e.g., breast or ovary), blood clots, active/recent stroke or heart attack, liver disease. Tell your doctor your medical (and family) history, especially of: heart disease, kidney disease, asthma, migraine headaches, diabetes, seizure disorder, any allergies. Depending on strength, this drug may cause a patchy, darkening of the skin on the face (melasma). Higher strengths are more likely to cause melasma. Sunlight may intensify this darkening and you may need to avoid prolonged sun exposure and sunlamps. Consult your doctor regarding use of sunscreens and protective clothing. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform you doctor immediately. It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Tell your doctor of any over-the-counter or prescription medication you may take, especially: blood thinners, steroids, thyroid, diabetes medications. This product can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include nausea.

Notes

Laboratory and/or medical tests (e.g., yearly breast exams and monthly breast self-exams) should be performed to monitor your progress and check for side effects. Do not share this medication with others. Keep out of the reach of children and pets.

Missed Dose

It is important to take each dose at the scheduled time. If you miss a dose, take it as soon as you remember unless it is near the time for the next dose. Instead, skip the missed dose and resume your dosing schedule. Do not "double-up" the dose to catch up. If more than one dose is missed, contact your doctor who will help establish a new dosing schedule.

Storage

Store at room temperature between 59 and 86 degrees F (15 to 30 degrees C) as directed away from heat and light. Do not store in the bathroom.