国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
norgestimate (UNII: C291HFX4DY) (norgestimate - UNII:C291HFX4DY), ethinyl estradiol (UNII: 423D2T571U) (ethinyl estradiol - UNII:423D2T571U)
Actavis Pharma, Inc.
norgestimate
norgestimate 0.18 mg
PRESCRIPTION DRUG
TriNessa Lo Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14)] . Do not prescribe TriNessa Lo 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 and P
TriNessa Lo Tablets are available in a blister card with a VERIDATE Tablet Dispenser (unfilled): NDC 52544-087-41 Each blister card (28 tablets) contains in the following order: TriNessa Lo Tablets are packaged in a carton containing 6 blister cards and 6 unfilled VERIDATE Tablet Dispensers: NDC 52544-087-28
New Drug Application
TRINESSA LO- NORGESTIMATE AND ETHINYL ESTRADIOL ACTAVIS PHARMA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE TRINESSA LO SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TRINESSA LO. TRINESSA LO (NORGESTIMATE/ETHINYL ESTRADIOL) TABLETS FOR ORAL USE INITIAL U.S. APPROVAL: 1989 WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ TRINESSA LO IS CONTRAINDICATED IN WOMEN OVER 35 YEARS OLD WHO SMOKE. (4) CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS FROM COMBINATION ORAL CONTRACEPTIVES (COC) USE. (4) RECENT MAJOR CHANGES Contraindications (4) 08/2017 Warnings and Precautions (5.3) 08/2017 INDICATIONS AND USAGE TriNessa Lo is an estrogen/progestin COC, indicated for use by women to prevent pregnancy. (1.1) DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. (2.2) Take tablets in the order directed on the blister pack. (2.2) Do not skip or delay tablet intake. (2.2) DOSAGE FORMS AND STRENGTHS TriNessa Lo consists of 28 round, biconvex, coated tablets in the following order (3): 7 white tablets each containing 0.180 mg norgestimate and 0.025 mg ethinyl estradiol 7 light blue tablets each containing 0.215 mg norgestimate and 0.025 mg ethinyl estradiol 7 dark blue tablets each containing 0.250 mg norgestimate and 0.025 mg ethinyl estradiol 7 dark green tablets (inert) 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 Thromboembolic Disorders and Other Vascular Problems: Stop TriNessa Lo if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surge 完全なドキュメントを読む