APRI- desogestrel and ethinyl estradiol
Barr Laboratories Inc.
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including Apri? should not be used by women who are over 35 years of age and smoke
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
DESCRIPTION
Apri? (desogestrel and ethinyl estradiol tablets USP) blister cards provide an oral contraceptive regimen of 21 rose-colored, round tablets each containing 0.15 mg desogestrel (13-ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en-20-yn-17-ol) and 0.03 mg ethinyl estradiol, USP (19-nor-17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol). Inactive ingredients include colloidal silicon dioxide, FD&C Blue No. Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl methylcellulose, lactose monohydrate, polyethylene glycol, polysorbate 80, povidone, pregelatinized corn starch, stearic acid, titanium dioxide, and vitamin E.
Apri blister cards also contain white ?inactive? tablets for oral administration, containing the following inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and pregelatinized corn starch.
CLINICAL PHARMACOLOGY
Pharmacodynamics
Combined 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 changes in the endometrium which reduce the likelihood of implantation.
INDICATIONS AND USAGE
Apri? (desogestrel and ethinyl estradiol tablets USP) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as method of contraception.
WARNINGS
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including Apri, should not be used by women who are over 35 years of age and smoke.
Thromboembolic Disorder and Other Vascular Problems
Myocardial Infarction
Cerebrovascular Diseases
Dose-Related Risk of Vascular Disease from Oral Contraceptives
Carcinoma of the Reproductive Organs and Breasts
Hepatic Neoplasia
Ocular Lesions
Gallbladder Disease
Carbohydrate and Lipid Metabolic Effects
Elevated Blood Pressure
Headache
Bleeding Irregularities
Ectopic Pregnancy
Pregnancy
Teratogenic Effects
Pregnancy Category X
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, Apri must be taken exactly as directed and at intervals not exceeding 24 hours. Apri is available in the Tablet Dispenser which is preset for Sunday Start. Day Start is also provided.
Apri? (desogestrel and ethinyl estradiol tablets USP) 28 tablets blister cards contain 21 rose-colored, round, film-coated, unscored, biconvex, tablets and round, unscored white tablets. Each rose-colored tablet (debossed with ?dp? on one side and ?575? on the other side) contains 0.15 mg desogestrel and 0.03 mg ethinyl estradiol, USP. Each white tablet (debossed with ?dp? on one side and ?570? on the other side) contains inert ingredients.
