AZURETTE- desogestrel/ethinyl estradiol and ethinyl estradiol
Watson Pharma, Inc.
Azurette?
(Desogestrel/Ethinyl Estradiol and
Ethinyl Estradiol Tablets)
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.
DESCRIPTION
Azurette? (desogestrel/ethinyl estradiol and ethinyl estradiol) tablets provide an oral contraceptive regimen of 21 active white tablets, each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol), 0.02 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), followed by inactive green tablets, then followed by active blue tablets. The active blue tablets contain 0.01 mg ethinyl estradiol. The molecular weights for desogestrel and ethinyl estradiol are 310.48 and 296.40 respectively
The 21 active white tablets and active blue tablets contain the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, corn starch, povidone, stearic acid and vitamin E. The active blue tablets also contain FD&C Blue No. 1. The inactive green tablets contain the following inactive ingredients: anhydrous lactose, D&C Yellow No. 10, FD&C Blue No. 2, magnesium stearate and microcrystalline cellulose.
Meets USP Dissolution test 2.
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).
Receptor binding studies, as well as studies in animals, have shown that etonogestrel, the biologically active metabolite of desogestrel, combines high progestational activity with minimal intrinsic androgenicity (91,92). The relevance of this latter finding in humans is unknown.
INDICATIONS AND USAGE
Azurette (desogestrel/ethinyl estradiol and ethinyl estradiol) tablets are indicated for the prevention of pregnancy in women who elect to use this product as method of contraception.
Oral contraceptives are highly effective. Table II 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 these methods can result in lower failure rates.
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
Cerebral vascular or coronary artery disease
Known or susected carcinoma of the breast
Carcinoma of the endometrium or other known or sected 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
The use of oral contraceptives is associated with increased risks 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.
