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Ovrette (Norgestrel) - Description and Clinical Pharmacology

 
 



DESCRIPTION

Each OVRETTE tablet contains 0.075 mg of norgestrel (dl -13-beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-one). The inactive ingredients present are cellulose, FD&C Yellow 5, lactose, magnesium stearate, and polacrilin potassium.

Each OVRETTE tablet contains 0.075 mg of a single active steroid ingredient, norgestrel, a totally synthetic progestogen. The available data suggest that the d (-) enantiomeric form of norgestrel is the biologically active portion. This form amounts to 0.0375 mg per OVRETTE tablet.

CLINICAL PHARMACOLOGY

  1. Mode of Action
    Progestin-only oral contraceptives such as OVRETTE prevent conception by suppressing ovulation in approximately half of users, thickening the cervical mucus to inhibit sperm penetration, lowering the midcycle LH and FSH peaks, slowing the movement of the ovum through the fallopian tubes, and altering the endometrium.
  2. Pharmacokinetics
    Serum progestin levels peak about two hours after oral administration, followed by rapid distribution and elimination. By 24 hours after drug ingestion, serum levels are near baseline, making efficacy dependent upon rigid adherence to the dosing schedule. There are large variations in serum levels among individual users. Progestin-only administration results in lower steady-state progestin levels and a shorter elimination half-life than concomitant administration with estrogens.

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