Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)
Trigen Laboratories, LLC
AMLODIPINE BESYLATE
AMLODIPINE 5 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
AMLODIPINE AND VALSARTAN - AMLODIPINE AND VALSARTAN TABLET, FILM COATED TRIGEN LABORATORIES, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION AMLODIPINE AND VALSARTAN TABLETS THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMLODIPINE AND VALSARTAN TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMLODIPINE AND VALSARTAN TABLETS. AMLODIPINE AND VALSARTAN TABLETS, FOR ORAL USE. INITIAL U.S. APPROVAL: 2007 WARNING: FETAL TOXICITY_ SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ When pregnancy is detected, discontinue amlodipine and valsartan tablets as soon as possible. (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (5.1) INDICATIONS AND USAGE Amlodipine and valsartan tablets are the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Amlodipine and valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure: (1) In patients not adequately controlled on monotherapy (1) As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals (1). Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1) DOSAGE AND ADMINISTRATION GENERAL CONSIDERATIONS: (2) Majority of effect attained within 2 weeks (2.1) May be administered with other antihypertensive agents (2.1) HYPERTENSION (2) May be used as add-on therapy for patients not controlled on monotherapy (2.2) Patients who experience dose-limiting adverse reactions on monotherapy may be switched to amlodipine and valsartan tablets containing a lower dose of that component (2.2) May be substituted for titrated components (2.3) When used as initial therapy: Initiate with 5/160 mg, then titrate upwards as necessary to a maximum of 10/320 mg once daily (2.4) DOSAGE FORMS AND STRENGTHS Tablets (amlodipine/valsartan mg): 5/160, 10/ Perskaitykite visą dokumentą