AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE- amlodipine valsartan and hydrochlorothiazide tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Available from:

Sandoz Inc

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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).

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE- AMLODIPINE VALSARTAN AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
SANDOZ INC
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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._
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INDICATIONS AND USAGE
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DOSAGE AND ADMINISTRATION
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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
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WARNINGS AND PRECAUTIONS
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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