OVCON 50

OVCON 50- norethindrone and ethinyl estradiol
Warner Chilcott (US), LLC

28-Day Regimen

Rx only

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

Description

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:

Norethindrone and Ethinyl Estradiol structural formulas
(click image for full-size original)

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.

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).

INDICATIONS AND USAGE

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.

TABLE 1 LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD % of Women Experiencing an Accidental Pregnancy in the First Year of Continuous Use
*
The authors’ best guess of the percentage of women expected to experience an accidental pregnancy among couples who initiate a method (not necessarily for the first time) and who use it consistently and correctly during the first year if they do not stop for any reason other than pregnancy.
This term represents “typical” couples who initiate use of a method (not necessarily for the first time), who experience an accidental pregnancy during the first year if they do not stop use for any reason other than pregnancy.
Combined typical rate for both combined and progestin only.
§
Combined typical rate for both medicated and nonmedicated IUD.
Method Lowest Expected * Typical
(No contraception) (85) (85)
Oral contraceptives
combined 0.1 3
progestin only 0.5 3
Diaphragm with spermicidal 6 18
cream or jelly
Spermicides alone (foam, creams, 3 21
jellies and vaginal suppositories)
Vaginal sponge
nulliparous 6 18
multiparous 9 28
IUD 0.8-2.0 3§
Condom without spermicides 2 12
Periodic abstinence 1-9 20
(all methods)
Injectable progestogen 0.3-0.4 0.3-0.4
Implants
6 capsules 0.04 0.04
2 rods 0.03 0.03
Female sterilization 0.2 0.4
Male sterilization 0.1 0.15
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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