Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Sandoz Inc
AMLODIPINE BESYLATE
AMLODIPINE 5 mg
ORAL
PRESCRIPTION DRUG
Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of
Amlodipine, valsartan, hydrochlorothiazide tablets are available as film-coated tablets containing amlodipine besylate equivalent to 5 mg or 10 mg of amlodipine free-base with valsartan 160 mg or 320 mg, and hydrochlorothiazide 12.5 mg or 25 mg, providing for the following available combinations: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg. All strengths are packaged in bottles of 30 tablets. 5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide tablets - White, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VCL” on the other side. 10 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide tablets - Pale yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VDL” on the other side. 5 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide tablets - Yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VEL” on the other side. 10 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide tablets - Brown-yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VHL” on the other side. 10 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide tablets - Brown-yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VFL” on the other side. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F), [see USP controlled room temperature.] Protect from moisture. Dispense in tight container (USP).
New Drug Application Authorized Generic
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE- AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED SANDOZ INC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE TABLETS. AMLODIPINE, VALSARTAN, 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 Amlodipine/Valsartan/Hydrochlorothiazide Tablets (mg): 5/160/12.5, 10/160/12.5, 5/160/25, 10/160/25, 10/320/25 (3) CONTRAINDICATIONS • • • • WARNINGS AND PRECAUTIONS • • • • • • ADVERSE REACTIONS WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINE, VALSARTAN, 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, 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, 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, hydrochlorothiazide tablets may be used as add-on/switch therapy for patients not adequately controlled on any two of the following antihypertensive classes: calcium channel blockers, angiotensin receptor blockers, and diuretics. Amlodipine, valsartan, hydrochlorothiazide tablets may be substit Przeczytaj cały dokument