AMLODIPINE, VALSARTAN, AND HYDROCHLOROTHIAZIDE tablet film coated

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)

Mevcut itibaren:

Teva Pharmaceuticals USA, Inc.

INN (International Adı):

AMLODIPINE BESYLATE

Kompozisyon:

AMLODIPINE 5 mg

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

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