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Ovcon (Norethindrone / Ethinyl Estradiol) - Description and Clinical Pharmacology

 
 



Ovcon 35 and Ovcon 50
(Norethindrone and Ethinyl Estradiol Tablets, USP)

 21- and 28- DAY REGIMENS

Patients should be counseled that this product does not protect against HIV-infection (AIDS) and other sexually transmitted diseases.

DESCRIPTION

21-Day OVCON® 35 provides a regimen for oral contraception derived from 21 tablets composed of norethindrone and ethinyl estradiol. The chemical name for norethindrone is 17-hydroxy-19-nor-17α-pregn-4-en-20-yn-3-one and for ethinyl estradiol the chemical name is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,17-diol.

28-Day OVCON® 35 and OVCON® 50 (norethindrone and ethinyl estradiol tablets, USP) provide a continuous regimen for oral contraception derived from 21 tablets composed of norethindrone and ethinyl estradiol to be followed by 7 green tablets of inert ingredients. The structural formulas are:

The active OVCON 35 tablets contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol. The active OVCON 50 tablets contain 1 mg norethindrone and 0.05 mg ethinyl estradiol.

The green tablets contain inert ingredients.

OVCON 35, 21-Day contains the following inactive ingredients: dibasic calcium phosphate, FD&C Yellow No. 6 (aluminum lake), lactose, magnesium stearate, povidone, and sodium starch glycolate.

OVCON 35, 28-Day contains the following inactive ingredients: dibasic calcium phosphate, D&C Yellow No. 10 (aluminum lake), FD&C Blue No. 1 (aluminum lake), FD&C Yellow No. 6 (aluminum lake), lactose, magnesium stearate, povidone, and sodium starch glycolate, starch (corn), and talc.

OVCON 50, 28-Day contains the following inactive ingredients: dibasic calcium phosphate, D&C Yellow No. 10 (aluminum lake), FD&C Blue No. 1 (aluminum lake), FD&C Yellow No. 6 (aluminum lake), lactose, magnesium stearate, povidone, sodium starch glycolate, starch (corn), and talc.

CLINICAL PHARMACOLOGY

Combination oral contraceptives act by suppression of gonadotropins. Although the primary mechanism of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation).

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