Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Actavis Pharma, Inc.
LEVONORGESTREL
LEVONORGESTREL 0.15 mg
PRESCRIPTION DRUG
QUASENSE® (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. Do not prescribe QUASENSE to women who are known to have the following conditions: - 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 inherited or acquired hypercoagulopathies [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 uncontrolled hypertension [see Warnings
QUASENSE (levonorgestrel and ethinyl estradiol tablets) are available in Extended-Cycle Tablet Dispensers, each containing a 13-week supply of tablets: 91-Day Regimen 84 white tablets, each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 peach inert tablets. The active white tablets are round, flat faced, beveled edge, unscored tablets with debossed WATSON on one side and 966 on the other side. The inert tablets are peach, round, flat faced, beveled edge, unscored tablet debossed with WATSON on one side and P1 on the other side. Box of 3 Extended-Cycle Tablet Dispensers NDC 52544-966-91
Abbreviated New Drug Application
QUASENSE- LEVONORGESTREL AND ETHINYL ESTRADIOL ACTAVIS PHARMA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE QUASENSE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR QUASENSE. QUASENSE (LEVONORGESTREL 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. QUASENSE IS CONTRAINDICATED IN WOMEN OVER 35 YEARS OLD WHO SMOKE. (4) CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS FROM COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4) RECENT MAJOR CHANGES Contraindications (4) 08/2017 Warnings and Precautions (5.3) 08/2017 INDICATIONS AND USAGE QUASENSE 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. (2.1) Take tablets in the order directed on the Extended-Cycle Tablet Dispenser. (2.2) DOSAGE FORMS AND STRENGTHS QUASENSE consists of 84 round, white tablets containing 0.15 mg of levonorgestrel and 0.03 mg of ethinyl estradiol, and 7 round, peach inert tablets. (3) CONTRAINDICATIONS A high risk of arterial or venous thrombotic diseases (4) Liver tumors or liver disease (4) Undiagnosed abnormal uterine bleeding (4) Pregnancy (4) Breast cancer or other estrogen- or progestin-sensitive cancer (4) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (4) WARNINGS AND PRECAUTIONS Thrombotic disorders and other vascular problems: Stop QUASENSE if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. (5.1) Liver disease: Discontinue QUASENSE if jaundice occurs. (5.2) High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop Q Baca dokumen lengkapnya