OVCON 50- norethindrone and ethinyl estradiol
Warner Chilcott (US), LLC
Patients should be counseled that this product does not protect against HIV-infection (AIDS) and other sexually transmitted diseases.
OVCON® 50, 28-Day (norethindrone and ethinyl estradiol tablets, USP) provides 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 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. The structural formulas are:
The active OVCON 50 tablets contain 1 mg norethindrone and 0.05 mg ethinyl estradiol.
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.
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).
Oral contraceptives are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptive products such as OVCON 50, 28-Day, which contain 50 mcg of estrogen, should not be used unless medically indicated.
Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates.
|Method||Lowest Expected *||Typical †|
|Diaphragm with spermicidal||6||18|
|cream or jelly|
|Spermicides alone (foam, creams,||3||21|
|jellies and vaginal suppositories)|
|Condom without spermicides||2||12|
|Reproduced with permission of the Population Council from J. Trussell, et al: Contraceptive failure in the United States: An update. Studies in Family Planning, 21(1), January-February 1990.|
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