Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Physicians Total Care, Inc.
LEVONORGESTREL
LEVONORGESTREL 0.15 mg
PRESCRIPTION DRUG
Seasonique® (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) is indicated for use by women to prevent pregnancy. Do not prescribe Seasonique to women who are known to have the following: - A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]. Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)] Have cerebrovascular disease [see Warnings and Precautions (5.1)] Have coronary artery disease [see Warnings and Precautions (5.1)] Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)] Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)] Have uncontrolled hypertension [see Warnings and Precautions (5.4)] . Have diabetes with vascular
Seasonique tablets (levonorgestrel/ethinyl estradiol tablets and ethinyl estradiol tablets) are available in Extended-Cycle Tablet Dispensers (NDC 54868-6276-0), each containing a 13-week supply of tablets: 84 light blue-green tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 yellow tablets each containing 0.01 mg of ethinyl estradiol. The light blue-green tablets are round, film-coated, biconvex, unscored tablets debossed with stylized b on one side and 555 on the other side. The yellow tablets are round, biconvex, film-coated, unscored tablets debossed with stylized b on one side and 556 on the other side. Box of 1 Extended-Cycle Tablet Dispensers NDC 54868-6276-0 Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].
New Drug Application
SEASONIQUE - LEVONORGESTREL / ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL PHYSICIANS TOTAL CARE, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SEASONIQUE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SEASONIQUE. SEASONIQUE (LEVONORGESTREL/ETHINYL ESTRADIOL TABLETS AND ETHINYL ESTRADIOL TABLETS) FOR ORAL USE INITIAL U.S. APPROVAL: 1982 WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_. WOMEN WHO ARE OVER 35 YEARS OLD AND SMOKE SHOULD NOT USE SEASONIQUE. CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS FROM COMBINATION ORAL CONTRACEPTIVE (COC) USE. INDICATIONS AND USAGE Seasonique is an estrogen/progestin COC indicated for use by women to prevent pregnancy. (1) DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day for 91 days. (2) DOSAGE FORMS AND STRENGTHS Seasonique consists of 84 light blue-green tablets containing 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol, and 7 yellow tablets containing 0.01 mg ethinyl estradiol. (3) CONTRAINDICATIONS A high risk of arterial or venous thrombotic diseases (4) Undiagnosed abnormal genital bleeding (4) Breast cancer or other estrogen- or progestin-sensitive cancer (4) Liver tumors or liver disease (4) Pregnancy (4) WARNINGS AND PRECAUTIONS Vascular risks: Stop Seasonique if a thrombotic event occurs. Stop Seasonique at least 4 weeks before and through 2 weeks after major surgery. Start Seasonique no earlier than 4 weeks after delivery, in women who are not breastfeeding. (5.1) Liver disease: Discontinue Seasonique if jaundice occurs. (5.3) High blood pressure: Do not prescribe Seasonique for women with uncontrolled hypertension or hypertension with vascular disease. (5.4) Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking Seasonique. Consider an alternate contraceptive method for women with uncontrolled dyslipidemias. (5.6) Hea Lestu allt skjalið