Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)
Teva Pharmaceuticals USA, Inc.
AMLODIPINE BESYLATE
AMLODIPINE 5 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
AMLODIPINE, VALSARTAN, AND HYDROCHLOROTHIAZIDE- AMLODIPINE, VALSARTAN, AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED TEVA PHARMACEUTICALS USA, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMLODIPINE, VALSARTAN, AND HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMLODIPINE, VALSARTAN, AND HYDROCHLOROTHIAZIDE TABLETS. AMLODIPINE, VALSARTAN, AND HYDROCHLOROTHIAZIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2009 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • INDICATIONS AND USAGE • • DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS Tablets: (amlodipine/valsartan/hydrochlorothiazide mg) 5/160/12.5, 5/160/25, 10/160/12.5, 10/160/25, 10/320/25 (3) CONTRAINDICATIONS • • • • WARNINGS AND PRECAUTIONS • • • • • • ADVERSE REACTIONS Most common adverse events (≥ 2% incidence) are dizziness, peripheral edema, headache, dyspepsia, fatigue, muscle WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINE, VALSARTAN, AND HYDROCHLOROTHIAZIDE 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) Amlodipine, valsartan, and hydrochlorothiazide tablets are a combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), valsartan, an angiotensin II receptor blocker (ARB), and hydrochlorothiazide, a thiazide diuretic. Amlodipine, valsartan, and hydrochlorothiazide tablets are indicated for the treatment of hypertension to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes, and myocardial infarctions. (1) Not indicated for initial therapy Dose once-daily. Titrate up to a maximum dose of 10/320/25 mg Amlodipine, valsartan, and hydrochlorothiazide tablets may be used as add-on/switch therapy for patients not adequately controlled on any two of the fol Olvassa el a teljes dokumentumot