Mircette?
(desogestrel/ethinyl estradiol and ethinyl estradiol)
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
DRUG DESCRIPTION
Mircette? (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets provide an oral contraceptive regimen of 21 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), and inactive ingredients which include vitamin E, corn starch, povidone, stearic acid, colloidal silicon dioxide, lactose, hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide, and talc, followed by 2 green tablets with the following inactive ingredients: lactose, corn starch, magnesium stearate, FD&C Blue No. 2 aluminum lake, yellow ferric oxide, hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide, and talc. Mircette? also contains 5 yellow tablets containing 0.01 mg ethinyl estradiol (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol) and inactive ingredients which include vitamin E, corn starch, povidone, stearic acid, colloidal silicon dioxide, lactose, hydroxypropyl methylcellulose, polyethylene glycol, titanium dioxide, talc, and yellow ferric oxide. The molecular weights for desogestrel and ethinyl estradiol are 310.48 and 296.40 respectively.
INDICATIONS
Mircette? (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 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 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.
SIDE EFFECTS
An increased risk of the following serious adverse reactions has been associated with the use of oral contraceptives (see WARNINGS section):
* Thrombophlebitis and venous thrombosis with or without embolism
* Arterial thromboembolism
* Pulmonary embolism
* Myocardial infarction
* Cerebral hemorrhage
* Cerebral thrombosis
* Hypertension
* Gallbladder disease
* Hepatic adenomas or benign liver tumors
There is evidence of an association between the following conditions and the use of oral contraceptives: