AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE tablet

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:

REMEDYREPACK INC.

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, USP 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 mg/160 mg/12.5 mg, 5 mg/160 mg/25 mg, 10 mg/160 mg/12.5 mg, 10 mg/160 mg/25 mg, and 10 mg/320 mg/25 mg. All strengths are packaged in bottles of 30, 100, 500 tablets and 100 (10X10) unit dose blister package. 5 mg amlodipine/160 mg valsartan/12.5 mg hydrochlorothiazide Tablets – White to off-white colored, oval shaped, biconvex, film coated tablets debossed with "1326" on one side and plain on other side. Bottles of 30                                                 NDC 13668-326-30 Bottles of 100                                                NDC 13668-326-01 Bottles of 500                                                NDC 13668-326-05 Carton of 100 tablets (10 x 10 unit-dose)     NDC 13668-326-74 5 mg amlodipine/160 mg valsartan/25 mg hydrochlorothiazide Tablets – Yellow colored, capsule shaped, biconvex, film coated tablets debossed with "1329" on one side and plain on other side. Bottles of 30                                                 NDC 13668-329-30 Bottles of 100                                                NDC 13668-329-01 Bottles of 500                                                NDC 13668-329-05 Carton of 100 tablets (10 x 10 unit-dose)     NDC 13668-329-74 10 mg amlodipine/160 mg valsartan/12.5 mg hydrochlorothiazide Tablets – Pale yellow colored, oval shaped, biconvex, film coated tablets debossed with "1327" on one side and plain on other side. Bottles of 30                                                 NDC 13668-327-30 Bottles of 100                                                NDC 13668-327-01 Bottles of 500                                                NDC 13668-327-05 Carton of 100 tablets (10 x 10 unit-dose)     NDC 13668-327-74   10 mg amlodipine/160 mg valsartan/25 mg hydrochlorothiazide Tablets – Brown-yellow colored, capsule shaped, biconvex, film coated tablets debossed with "1328" on one side and plain on other side. Bottles of 30                                                 NDC 13668-328-30 Bottles of 100                                                NDC 13668-328-01 Bottles of 500                                                NDC 13668-328-05 Carton of 100 tablets (10 x 10 unit-dose)     NDC 13668-328-74 10 mg amlodipine/320 mg valsartan/25 mg hydrochlorothiazide Tablets – Brown-yellow colored, capsule shaped, biconvex, film coated tablets debossed with "1325" on one side and plain on other side. Bottles of 30                                                 NDC 13668-325-30 Bottles of 100                                                NDC 13668-325-01 Bottles of 500                                                NDC 13668-325-05 Carton of 100 tablets (10 x 10 unit-dose)     NDC 13668-325-74 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDE- AMLODIPINE, VALSARTAN
AND
HYDROCHLOROTHIAZIDE TABLET
REMEDYREPACK 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._
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)
INDICATIONS AND USAGE
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
DOSAGE AND ADMINISTRATION
Dose once-daily. Titrate up to a maximum dose of 10 mg/320 mg/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 mg) 5/160/12.5,
5/160/25, 10/160/12.5, 10/160/25, 10/320/25 (3) (3)
CONTRAINDICATIONS
Anuria (4)
Hypersensitivity t