Top 300 Pharmacy Drug Cards

PROGESTERONE: Prometrium, Various

Class: Progestin Hormone

Dosage Forms. Oral Capsule: 100 mg, 200 mg

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Common FDA Label Indication, Dosing, and Titration.

1. Prevention of estrogen-induced endometrial hyperplasia: 200 mg po daily hs × 12 sequential days per 28-d cycle while conjugated estrogens are administered

2. Secondary physiologic amenorrhea: 400 mg po daily hs × 10 d

Off-Label Uses. None

MOA. Progesterone transforms proliferative endometrium into secretory endometrium. Parenterally administered progesterone inhibits gonadotropin production, which in turn prevents follicular maturation and ovulation.

Drug Characteristics: Progesterone

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Medication Safety Issues: Progesterone

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Drug Interactions: Progesterone

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Adverse Reactions: Progesterone

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Efficacy Monitoring Parameters. Resolution of clinical signs of abnormal bleeding or symptoms being managed with this product.

Toxicity Monitoring Parameters. Monitor BMD; conduct diagnostic evaluation to rule out malignancy in the event of persistent or recurring vaginal bleeding.

Key Patient Counseling Points. Advise patients that menstrual bleeding should occur 3-7 d after last dose. Patient should report if menstruation does not occur within 7 d after last dose.

Clinical Pearls. Injectable formulation of progesterone is administered every 3 mo for contraception and for pain associated with endometriosis. Topical formulation is also available for other indications. Combination of estrogens and progestins should not be used for the prevention of cardiovascular disease. Increased risk of myocardial infarction, stroke, invasive breast cancer, PE, and DVT has been shown in postmenopausal women. Evidence regarding teratogenicity is conflicting; some studies show birth defects, and other studies show no effect.