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Prometrium (Progesterone)

Are there any known side effects associated with PROMETRIUM® Capsules?

PROMETRIUM® has been proven safe and effective for use in hormone replacement therapy and treatment of secondary amenorrhea. Patients who may be allergic to peanuts or who suffer from severe liver disease or who have known or suspected breast cancer or pregnancy should not take PROMETRIUM® Capsules.

Common side effects of PROMETRIUM® Capsules when given alone for secondary amenorrhea are dizziness, abdominal cramping, headache and breast pain.

The most frequently occurring adverse events in women taking estrogen(0.625mg/d) and cyclic Prometrium Capsules( 200mg/d for 12d/mo) are: breast tenderness, dizziness, abdominal bloating, vaginal discharge, chest pain and diarrhea.

PROMETRIUM® Capsules should be used cautiously in patients with conditions that may be aggravated by fluid retention (e.g. migraine, asthma, cardiac or renal dysfunction, epilepsy), a history of mental depression or diabetes. Transient dizziness may occur in some patients; they should use caution when driving a motor vehicle or operating machinery. A small percentage of women may experience extreme dizziness and/or drowsiness during initial therapy. For these women, bedtime dosing is advised.

Prometrium : Full Prescribing Information

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PROMETRIUM® Capsules CONTAINS PEANUT OIL AND SHOULD NEVER BE USED BY PATIENTS ALLERGIC TO PEANUTS.

Other Contraindications:

- Thrombophlebitis, thromboembolic disorder, cerebral apoplexy or patients with a past history of these conditions.
- Severe liver dysfunction or disease.
- Known or suspected malignancy of breast or reproductive organs.
- Undiagnosed vaginal bleeding.
- Missed abortion.
- As a diagnostic test for pregnancy.
- Known sensitivity to PROMETRIUM® Capsules or its ingredients.
- Known or suspected pregnancy.

Peanut oil is commonly used as a suspending agent in capsule formulations, including PROMETRIUM® Capsules. Physicians and pharmacists should be aware of patients who may be allergic to peanuts. Patients who are allergic to peanuts should not take PROMETRIUM® Capsules.

Secondary amenorrhea refers to the abnormal cessation of menses in women who would otherwise be menstruating. Amenorrhea is a general term indicating absence of menses.

What is "micronization"?

Micronization is the reduction in particle size that allows for the progesterone to be easily absorbed, enabling oral administration.

What advantages does micronized progesterone offer?

Since progesterone was not easily absorbed when taken in pill form, progesterone products have traditionally been available in various other forms including suppositories and topical creams. PROMETRIUM® Capsules is an oral formulation of micronized progesterone. Micronization increases the absorption of progesterone. PROMETRIUM® Capsules is the only oral dosage form of micronized progesterone approved by the FDA in the U.S. Until the introduction of PROMETRIUM® Capsules, oral micronized progesterone was available only from specialized "compounding" pharmacies, where consistency and strength could vary from batch to batch.

PROMETRIUM®

- PROMETRIUM® Capsules is structurally identical to the progesterone naturally produced in a woman's body.
- The progesterone in PROMETRIUM® Capsules is synthesized from yams.
History
- Oral micronized progesterone was first available in France in 1980.
- In April 2000, PROMETRIUM® Capsules became the most prescribed, branded, single-entity progestogen on the market.
Recommended Dose
- The suggested dose for PROMETRIUM® Capsules for use in hormone replacement therapy is 200 mg capsules taken orally once a day, in the evening, for 12 sequential days per 28 day cycle.
- The suggested dose for PROMETRIUM® Capsules for treatment of secondary amenorrhea is 400 mg capsules taken orally once a day, in the evening, for 10 days.

Safety/Contraindications and Side Effects

- PATIENTS WHO MAY BE ALLERGIC TO OR HAVE KNOWN SENSITIVITIES TO PEANUTS SHOULD NOT TAKE PROMETRIUM® Capsules.
- Transient dizziness may occur in some patients; they should use caution when driving a motor vehicle or operating machinery. A small percentage of women may experience extreme dizziness and/or drowsiness during initial therapy. For these women, bedtime dosing is advised.
- Common side effects of PROMETRIUM® Capsules when given alone for secondary amenorrhea are dizziness, abdominal cramping, headache and breast pain.
The most frequently occurring adverse events in women taking estrogen(0.625mg/d) and cyclic Prometrium Capsules( 200mg/d for 12d/mo) are: breast tenderness, dizziness, abdominal bloating, vaginal discharge, chest pain and diarrhea.
- PROMETRIUM® Capsules is not recommended for patients with known or suspected pregnancy, current or past history of thrombotic disorders, severe liver dysfunction or disease, known or suspected malignancy of breast or reproductive organs, undiagnosed vaginal bleeding, missed abortion, or as a diagnostic test for pregnancy.
- PROMETRIUM® Capsules is rated Pregnancy Category B.


Prometrium : Full Prescribing Information

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