conjugated equine estrogens and medroxyprogesterone acetate, Prempro, Premphase

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GENERIC NAME: conjugated equine estrogens and medroxyprogesterone acetate

BRAND NAME: Prempro, Premphase

DRUG CLASS AND MECHANISM: Prempro and Premphase are combinations of conjugated estrogens (Premarin) and medroxyprogesterone (Provera). Estrogens and progestins are the two major classes of female hormones. Conjugated estrogens are a mixture of several different estrogens (estrogen salts) that are derived from natural sources and blended to approximate the composition of estrogens in the urine of pregnant horses. The main components are sodium estrone sulphate and sodium equilin sulfate. Estrogens have widespread effects on many tissues in the body. Estrogens cause growth and development of the female sexual organs and maintain female sexual characteristics such as the growth of underarm and pubic hair, body contours, and skeleton. Estrogens also increase secretions from the cervix and growth of the inner lining of the uterus (endometrium). Medroxyprogesterone is a derivative of progesterone, a naturally occurring female progestin. Progestins are responsible for changes in the mucus and inner lining of the uterus (endometrium) during the second half (secretory phase) of the menstrual cycle. Progestins prepare the endometrium for implantation of the embryo. Once an embryo implants in the endometrium, for example, and pregnancy occurs, progestins help maintain the pregnancy. At high doses, progestins can prevent ovulation (release of the egg from the ovary) and thereby prevent pregnancy. The FDA approved Prempro and Premphase in June 2003.

PRESCRIPTION: Yes

GENERIC AVAILABLE: No

PREPARATIONS:

  • Prempro: Tablets 0.3/1.5, 0.45/1.5, 0.625/2.5, and 0.625/5 (mg conjugated estrogen/mg medroxyprogesterone).
  • Premphase: Tablets, 28 day pack containing 14 tablets of 0.625 mg conjugated estrogens and 14 tablets of 0.625 mg/5 mg (conjugated estrogen/medroxyprogesterone).

STORAGE: Prempro and Premphase should be stored at room temperature between 15-30 C (59-86 F).

PRESCRIBED FOR: Prempro and Premphase are prescribed for women with a uterus who are experiencing hot flashes, vaginal dryness, vaginal atrophy, uterine bleeding and other symptoms associated with menopause. They also are approved for treating osteoporosis; however, other drugs usually are prescribed for this purpose.

DOSING: One tablet of Prempro should be taken daily. The lowest effective dose should be used. For either hot flashes or osteoporosis, patients are most often started at a dose of 0.3 mg/1.5 mg. For women with hot flashes, the dose is adjusted depending on the response of the hot flashes.

Patients should take one tablet of Premphase daily starting with the 0.625 mg conjugated estrogen tablets for 14 days (days 1 to 14) followed by one tablet daily of the 0.625/5 mg conjugated estrogen/medroxyprogesterone tablets for 14 days (days 14 to 28).

DRUG INTERACTIONS: Drugs such as St. John's Wort (Hypericum perforatum), phenobarbital, carbamazepine (Tegretol, Tegretol XR, Equetro, Carbatrol), and rifampin may increase break-down of estrogens in the liver, reducing blood levels of estrogens and possibly reducing the effect of estrogens. Erythromycin, clarithromycin (Biaxin, Biaxin XL), ketoconazole (Nizoral, Extina, Xolegel, Kuric), itraconazole (sporanox), ritonavir (Norvir) and grapefruit juice may reduce break-down of estrogens in the liver, increasing blood concentrations of estrogens and possibly increasing side effects of estrogens.




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