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:

LUPIN LIMITED

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including amlodipine, hydrochlorothiazide, and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with amlodipine, valsartan and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High

Product summary:

Amlodipine, valsartan and 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 combination: 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, 90 and 500 tablets. Amlodipine, valsartan and hydrochlorothiazide tablets, 5 mg/160 mg/12.5 mg – White to off-white, capsule shaped, film coated, biconvex tablets, debossed with 'LU' on one side and 'W41' on the other side. Bottles of 30               NDC 68180-771-06 Bottles of 90               NDC 68180-771-09 Bottles of 500             NDC 68180-771-02 Amlodipine, valsartan and hydrochlorothiazide tablets, 10 mg/160 mg/12.5 mg – Mustard colored, capsule shaped, film coated, biconvex tablets, debossed with 'LU' on one side and 'W43' on the other side. Bottles of 30               NDC 68180-772-06 Bottles of 90               NDC 68180-772-09 Bottles of 500             NDC 68180-772-02 Amlodipine, valsartan and hydrochlorothiazide tablets, 5 mg/160 mg/25 mg – Yellow colored, capsule shaped, film coated, biconvex tablets, debossed with 'LU' on one side and 'W42' on the other side. Bottles of 30               NDC 68180-773-06 Bottles of 90               NDC 68180-773-09 Bottles of 500             NDC 68180-773-02 Amlodipine, valsartan and hydrochlorothiazide tablets, 10 mg/160 mg/25 mg – Beige colored, capsule shaped, film coated, biconvex tablets, debossed with 'LU' on one side and 'W44' on the other side. Bottles of 30               NDC 68180-774-06 Bottles of 90               NDC 68180-774-09 Bottles of 500             NDC 68180-774-02 Amlodipine, valsartan and hydrochlorothiazide tablets, 10 mg/320 mg/25 mg – Light brick red colored, capsule shaped, film coated, biconvex tablets, debossed with 'LU' on one side and 'W45' on the other side. Bottles of 30               NDC 68180-775-06 Bottles of 90               NDC 68180-775-09 Bottles of 500             NDC 68180-775-02 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE- AMLODIPINE, VALSARTAN
AND
HYDROCHLOROTHIAZIDE TABLET, FILM COATED
LUPIN LIMITED
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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._
WHEN PREGNANCY IS DETECTED, DISCONTINUE AMLODIPINE, VALSARTAN AND
HYDROCHLOROTHIAZIDE 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, valsartan and hydrochlorothiazide tablets are combination
tablets 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
DOSAGE AND ADMINISTRATION
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 following antihypertensive
classes: calcium channel blockers, angiotensin
receptor blockers, and diuretics.
Amlodipine, valsartan and hydrochlorothiazide tablets may be
substituted for its individually titrated components (2).
DOSAGE FORMS AND STRENGTHS
Tablets: (amlodipine/valsartan/hydrochlorothiazide) 5 mg/160 mg/12.5
mg, 10 mg/160 mg/12.5 mg, 5 mg/160 mg/25 mg,
10 mg/160 mg/25 mg and 10 mg/320 mg/25 mg (3)
CONTRAINDIC