AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE- amlodipine besylate valsartan 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:

Par Pharmaceutical, Inc.

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amlodipine/valsartan/hydrochlorothiazide is 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/hydrochlorothiazide. 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 Blood Pressure Education P

Product summary:

Amlodipine/valsartan/hydrochlorothiazide is 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 or 10/320/25 mg. All strengths are packaged in bottles of 30, 90 and 500 tablets. 5 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets - White to off-white, film coated, oval shaped biconvex tablets, debossed with "P" on one side of the tablet and "172" on the other Bottles of 30 NDC 49884-172-11 Bottles of 90 NDC 49884-172-09 Bottles of 500 NDC 49884-172-05 10 mg amlodipine /160 mg valsartan /12.5 mg hydrochlorothiazide Tablets – Peach to light brown, film coated, oval shaped biconvex tablets, debossed with "P" on one side of the tablet and "174" on the other. Bottles of 30 NDC 49884-174-11 Bottles of 90 NDC 49884-174-09 Bottles of 500 NDC 49884-174-05 5 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets – Yellow, film-coated, oval shaped biconvex tablets debossed with “P” on one side of the tablet and “173” on the other. Bottles of 30 NDC 49884-173-11 Bottles of 90 NDC 49884-173-09 Bottles of 500 NDC 49884-173-05 10 mg amlodipine /160 mg valsartan /25 mg hydrochlorothiazide Tablets – Bright yellow, film-coated oval shaped, biconvex tablets debossed with “P” on one side of the tablet and “185” on the other. Bottles of 30 NDC 49884-185-11 Bottles of 90 NDC 49884-185-09 Bottles of 500 NDC 49884-185-05 10 mg amlodipine /320 mg valsartan /25 mg hydrochlorothiazide Tablets – White to off white, film coated, oval shaped biconvex tablets, debossed with "P" on one side of the tablet and "175" on the other Bottles of 30 NDC 49884-175-11 Bottles of 90 NDC 49884-175-09 Bottles of 500 NDC 49884-175-05 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15º to 30°C (59º 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, HYDROCHLOROTHIAZIDE- AMLODIPINE BESYLATE
VALSARTAN HYDROCHLOROTHIAZIDE TABLET, FILM COATED
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE- AMLODIPINE BESYLATE
VALSARTAN HYDROCHLOROTHIAZIDE TABLET, FILM COATED
PAR PHARMACEUTICAL, 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
RX ONLY
WARNING: FETAL TOXICITY
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING
WHEN PREGNANCY IS DETECTED, DISCONTINUE
AMLODIPINE/VALSARTAN/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/hydrochlorothiazide is 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 is 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/hydrochlorothiazide is not indicated for initial
treatment of hypertension.
DOSAGE AND ADMINISTRATION
Dose once-daily. Titrate up to a maximum dose of 10/320/25 mg
Amlodipine/valsartan/hydrochlorothiazide 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 may be substituted for its
individually titrated components
(2).
DOSAGE FORMS AND STRENGTHS
Tablets: (amlodipine/valsartan/hy