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PROMETRIUM
PROGESTERONE - 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.

PROGESTERONE - ORAL

(pro-JESS-ter-own)

Uses

Progesterone is a naturally occurring female hormone. This drug is used to treat menstrual problems.

OTHER

Uses

This drug may also be used after menopause (change of life) as part of combination hormone replacement therapy (HRT) with an estrogen. Progesterone lowers the risk of estrogen-related cancer of the uterus. Combination HRT should not be used to prevent heart disease.

How To Use

This medication is taken by mouth. The dosing depends on your medical condition and response to therapy. Follow your doctor's orders carefully. If taking twice daily, the morning dose should be taken 2 hours after breakfast.

Side Effects

Stomach upset, cramps, breast tenderness, drowsiness or dizziness may occur. If these effects persist or worsen, notify your doctor promptly. Report promptly: abnormal vaginal bleeding. Unlikely but report promptly: yellowing of the eyes or skin, itching, rash, mental/mood changes (e.g., depression, memory loss), pain/swelling in the legs, chest pain, vision problems, breathing problems. Very unlikely but report promptly: a migraine-type headache. Darkened patches of skin occasionally occur. Use a sunscreen and protective clothing to minimize this effect if it occurs. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

Tell your doctor your medical history (and family history), especially of: allergies (especially to drugs or peanuts), heart disease, kidney disease, liver disease, abnormal vaginal bleeding, cancer, blood clots/blood vessel problems, strokes, missed abortion, any conditions you had that worsened because of pregnancy or sex steroid use (e.g., norethindrone, progesterone). Two-drug combination hormone replacement therapy (estrogen and progestin menopause HRT) can infrequently cause cancer of the breast, heart disease (e.g., heart attack), stroke, dementia, and blood clots in the lung (pulmonary embolism) or leg. Estrogens may also increase the risk of cancer of the ovary. These risks appear to depend on the length of time this combination is used and the amount of estrogen per dose. Therefore, two-drug HRT should be used for the shortest possible length of time at the lowest effective dose, so you obtain the benefits and minimize the chance of serious side effects from long-term treatment. Discuss the risks and benefits with your doctor. If you use this drug for an extended period, you should be evaluated at least once a year. See Notes section. Blood clots may be more likely to form during very long periods of sitting or if you are bedridden, as well as with certain types of surgery. If this applies to you, ask your doctor whether you should temporarily stop your medication. Limit alcohol consumption as it may increase the side effects of this drug. Because this medication may cause drowsiness, use caution performing tasks requiring alertness (e.g., driving). This drug should not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Tell your doctor of all nonprescription and prescription medication you may use, especially of drugs that can cause drowsiness such as: sedatives, drugs for sleep, anti- anxiety drugs, anti-seizure medicines, narcotic pain relievers (e.g., codeine), psychiatric medications, muscle relaxants, certain antihistamines (e.g., diphenhydramine). Certain laboratory tests may be altered by this drug, such as gonadotropin, progesterone and pregnanediol. 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, vomiting, sleepiness, and dizziness.

Notes

Do not share this medication with others. Laboratory and/or medical tests (e.g., monthly breast self-exams, and yearly breast exams) should be performed to monitor for serious side effects.

Missed Dose

If using 2 capsules daily (200mg) at bedtime and a dose is missed, use an extra dose of 1 capsule (100mg) the following morning then continue with the normal schedule. If using 3 capsules (300mg) daily and a dose is missed, skip the missed dose and resume the normal schedule.

Storage

Store at room temperature between 59 and 86 degrees F (15-30 degrees C) away from light and moisture.