SRONYX- levonorgestrel and ethinyl estradiol
Watson Pharma, Inc.
Patients should be counseled that this product does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
DESCRIPTION
Each cycle of Sronyx� (Levonorgestrel and Ethinyl Estradiol Tablets USP) consists of 21 white active tablets each containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol; and seven peach tablets − inert. The inactive ingredients are Croscarmellose Sodium NF, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose (PH 102) NF, and Povidone (K29/32) NF. Each inactive, placebo tablet contains the following inactive ingredients: FD & C Yellow #6 Lake 35-42%, Lactose Anhydrous (DT Micro) NF, Lactose Monohydrate (200M) NF, Magnesium Stearate NF and Microcrystalline Cellulose NF.
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 III 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.
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 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 risks of several serious conditions including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, gallbladder disease, and hypertension, 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.
DOSAGE AND ADMINISTRATION
Sronyx� (Levonorgestrel and Ethinyl Estradiol Tablets USP)To achieve maximum contraceptive effectiveness, Sronyx must be taken exactly as directed at intervals not exceeding 24-hours.
Sronyx is a monophasic preparation plus 7 inert tablets. The dosage of Sronyx is one tablet daily for 21 consecutive days per menstrual cycle plus 7 peach inert tablets according to the prescribed schedule. It is recommended that Sronyx be taken at the same time each day, preferably after the evening meal or at bedtime. During the first cycle of medication, the patient should be instructed to take one white Sronyx tablet daily and then 7 peach inert tablets for twenty-eight (28) consecutive days, beginning on day one (1) of her menstrual cycle. (The first day of menstruation is day one.) Withdrawal bleeding usually occurs within 3 days following the last white tablet. (If Sronyx is first taken later than the first day of the first menstrual cycle of medication or postpartum, contraceptive reliance should not be placed on Sronyx until after the first 7 consecutive days of administration. The possibility of ovulation and conception prior to initiation of medication should be considered.)
