OVCON 35

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

norethindrone and ethinyl estradiol structural formulas
(click image for full-size original)

Norethindrone Ethinyl Estradiol

C20 H26 O2 Molecular Weight: 298.42 C20 H24 O2 Molecular Weight: 296.40

The light peach active tablets each contain 0.4 mg norethindrone and 0.035 mg ethinyl estradiol, and contain the following inactive ingredients: anhydrous lactose, dibasic calcium phosphate, FD&C yellow no. 6 aluminum lake, lactose monohydrate, magnesium stearate, povidone and sodium starch glycolate. The white tablets in the 28 Day regimen contain only inert ingredients as follows: lactose monohydrate, magnesium stearate, and pregelatinized starch.

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 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
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.
*
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 cream or jelly 6 18
Spermicides alone (foam, creams, jellies and vaginal suppositories) 3 21
Vaginal sponge
nulliparous 6 18
multiparous 9 28
IUD 0.8-2.0 3§
Condom without spermicides 2 12
Periodic abstinence (all methods) 1-9 20
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

CONTRAINDICATIONS:

Oral contraceptives should not be used in women who currently have the following conditions:

  • Thrombophlebitis or thromboembolic disorders
  • A past history of deep vein thrombophlebitis or thromboembolic disorders
  • Cerebrovascular or coronary artery disease
  • Known or suspected carcinoma of the breast
  • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
  • Undiagnosed abnormal genital bleeding
  • Cholestatic jaundice of pregnancy or jaundice with prior pill use
  • Hepatic adenomas or carcinomas
  • Known or suspected pregnancy

WARNINGS:

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.

The use of oral contraceptives is associated with increased risk of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, and gallbladder disease, although the risk of serious morbidity or mortality is very small in healthy women without underlying risk factors. The risk of morbidity and mortality increases significantly in the presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity and diabetes.

Practitioners prescribing oral contraceptives should be familiar with the following information relating to these risks.

The information contained in this package insert is principally based on studies carried out in patients who used oral contraceptives with higher formulations of estrogens and progestogens than those in common use today. The effect of long-term use of the oral contraceptives with lower formulations of both estrogens and progestogens remains to be determined.

Throughout this labeling, epidemiological studies reported are of two types: retrospective or case control studies and prospective or cohort studies. Case control studies provide a measure of the relative risk of a disease, namely, a ratio of the incidence of a disease among oral contraceptive users to that among nonusers. The relative risk does not provide information on the actual clinical occurrence of a disease. Cohort studies provide a measure of attributable risk, which is the difference in the incidence of disease between oral contraceptive users and nonusers. The attributable risk does provide information about the actual occurrence of a disease in the population*. For further information, the reader is referred to a text on epidemiological methods.

*Adapted from Stadel BB: Oral contraceptives and cardiovascular disease. N Engl J Med , 1981; 305: 612-618, 672-677; with author’s permission.

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