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:

Aurobindo Pharma 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

Product summary:

Amlodipine, valsartan and hydrochlorothiazide is available as film-coated tablets containing amlodipine besylate USP (6.9 mg or 13.9 mg, equivalent to 5 mg or 10 mg of amlodipine respectively), with valsartan USP 160 mg or 320 mg, and hydrochlorothiazide USP 12.5 mg or 25 mg, providing for the following available combinations: 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. All strengths are packaged in bottles of 30, 90 and 500 tablets. Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP, 5 mg/160 mg/12.5 mg – White colored, ovaloid, beveled edge, biconvex film-coated tablet, debossed with ‘J’ on one side and ‘88’ on the other side. Bottles of 30                              NDC 65862-834-30 Bottles of 90                              NDC 65862-834-90 Bottles of 500                            NDC 65862-834-05 Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP, 10 mg/160 mg/12.5 mg – Pale yellow colored, ovaloid, beveled edge, biconvex film-coated tablet, debossed with ‘J’ on one side and ‘90’ on the other side. Bottles of 30                            NDC 65862-836-30 Bottles of 90                            NDC 65862-836-90 Bottles of 500                          NDC 65862-836-05 Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP, 5 mg/160 mg/25 mg – Yellow colored, ovaloid, beveled edge, biconvex film-coated tablet, debossed with ‘J’ on one side and ‘89’ on the other side. Bottles of 30                            NDC 65862-835-30 Bottles of 90                            NDC 65862-835-90 Bottles of 500                          NDC 65862-835-05 Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP, 10 mg/160 mg/25 mg – Brown colored, ovaloid, beveled edge, biconvex film-coated tablet, debossed with ‘J’ on one side and ‘91’ on the other side. Bottles of 30                            NDC 65862-837-30 Bottles of 90                            NDC 65862-837-90 Bottles of 500                          NDC 65862-837-05 Amlodipine, Valsartan and Hydrochlorothiazide Tablets USP, 10 mg/320 mg/25 mg – Brown colored, ovaloid, beveled edge, film-coated tablet, debossed with ‘J’ on one side and ‘92’ on the other side. Bottles of 30                            NDC 65862-838-30 Bottles of 90                            NDC 65862-838-90 Bottles of 500                          NDC 65862-838-05 Store at 20° to 25°C (68° to 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
AUROBINDO PHARMA 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 a
combination 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)
Limitation of Use
Amlodipine, valsartan and hydrochlorothiazide tablets are not
indicated for initial treatment of
hypertension.
DOSAGE AND ADMINISTRATION
Dose once-daily. Titrate up to a maximum dose of 10 mg/320 mg/25 mg.
(2.1)
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. (2.2)
Amlodipine, valsartan and hydrochlorothiazide tablets may be
substituted for its individually titrated
components. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: (amlodipine/valsartan/hydrochlorothiazid