AVIANE 28 DAY- levonorgestrel and ethinyl estradiol
Barr Laboratories Inc.
WARNINGS
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with the extent of smoking (in epidemiologic studies, 15 or more cigarettes per day was associated with significantly increased risk) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
DESCRIPTION
21 orange active tablets each containing 0.10 mg of levonorgestrel, d(-)-13?-ethyl-17?-ethinyl-17?-hydroxygon-4-en-3-one, totally synthetic progestogen, and 0.02 mg of ethinyl estradiol, 17?-ethinyl-1,3,5(10)-estratriene-3,17?-diol. The inactive ingredients present are: FD&C Yellow No. Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate and titanium dioxide.
7 Light-green, inert tablets each contain: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. Aluminum Lake, FD&C Yellow No. Aluminum Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose and pregelatinized starch.
Levonorgestrel Ethinyl Estradiol Molecular Weight: 312.45 C21 H28 O2 Molecular Weight: 296.40 C20 H24 O2
Mode of Action
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
Aviane is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as method of contraception.
CONTRAINDICATIONS
Combination oral contraceptives should not be used in women with any of the following conditions:
Thrombophlebitis or thromboembolic disorders
A history of deep-vein thrombophlebitis or thromboembolic disorders
Cerebrovascular or coronary artery disease (current or past history)
Valvular heart disease with thrombogenic complications
Thrombogenic rhythm disorders
Hereditary or acquired thrombophilias
Major surgery with prolonged immobilization
Diabetes with vascular involvement
Headaches with focal neurological symptoms
Uncontrolled hypertension
Known or suspected carcinoma of the breast or personal history of breast cancer
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, or active liver disease
Known or suspected pregnancy
Hypersensitivity to any of the components of Aviane
Pregnancy
Pregnancy Category X.
DOSAGE AND ADMINISTRATION
To achieve maximum contraceptive effectiveness, Aviane (levonorgestrel and ethinyl estradiol tablets, USP 0.10 mg/0.02 mg) must be taken exactly as directed and at intervals not exceeding 24 hours. The dosage of Aviane 28 is one orange tablet daily for 21 consecutive days, followed by one light-green inert tablet daily for consecutive days, according to the prescribed schedule. It is recommended that Aviane 28 tablets be taken at the same time each day.
The dispenser should be kept in the wallet supplied to avoid possible fading of the pills. If the pills fade, patients should continue to take them as directed.
HOW SUPPLIED
Aviane? 28 tablets (0.10 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets, USP) are packaged in blister cards, each containing 21 orange active tablets and light-green inert tablets. Each orange tablet is round, coated and debossed with dp on one side and 016 on the other side. Each light-green tablet is round and debossed with dp on one side and 519 on the other side.
Available in cartons of six blister cards
NDC 0555-9045-58
Store at 20? to 25?C (68? to 77?F) [See USP Controlled Room Temperature].