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.
|
