Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Mayne Pharma Inc.
LEVONORGESTREL
LEVONORGESTREL 0.15 mg
PRESCRIPTION DRUG
Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is indicated for use by females of reproductive age to prevent pregnancy. Do not prescribe levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets 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 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 h
Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are available as round, film-coated, unscored, biconvex tablets debossed with TV on one side, packaged in an Extended-Cycle Tablet Dispenser, each containing a 13-week supply of the tablets in the following order: Box of 1 Extended-Cycle Tablet Dispenser NDC 51862-489-65 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
New Drug Application Authorized Generic
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL- LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL MAYNE PHARMA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND ETHINYL ESTRADIOL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND ETHINYL ESTRADIOL TABLETS. LEVONORGESTREL AND 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 OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND ETHINYL ESTRADIOL TABLETS. (4) CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS FROM COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4) RECENT MAJOR CHANGES Contraindications (4) 8/2017 Warnings and Precautions (5.4) 8/2017 INDICATIONS AND USAGE Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets 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) Take tablets in the order directed on the Extended-Cycle Tablet Dispenser (2) DOSAGE FORMS AND STRENGTHS Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets consists of 91 tablets in the following order (3): 42 light pink tablets containing 0.15 mg levonorgestrel and 0.02 mg ethinyl estradiol, 21 pink tablets containing 0.15 mg of levonorgestrel and 0.025 mg ethinyl estradiol, and 21 purple tablets containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol, and 7 yellow tablets containing 0.01 mg of ethinyl estradiol. (3) CONTRAINDICATIONS A high risk of arterial or venous thrombotic diseases (4) Undiagnosed abnormal uterine bleeding (4) Breast cancer or other estrogen- or progestin-sens Lugege kogu dokumenti