EXFORGE HCT- 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:

Novartis Pharmaceuticals Corporation

INN (International Name):

AMLODIPINE BESYLATE

Composition:

AMLODIPINE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Exforge HCT (amlodipine, valsartan, and 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 angiotensin II receptor blocker (ARB) class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Exforge HCT. 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 B

Product summary:

Exforge HCT (amlodipine, valsartan, and hydrochlorothiazide) is available as film-coated tablets containing amlodipine besylate (6.9 mg or 13.9 mg, equivalent to 5 mg or 10 mg of amlodipine respectively), 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, and 10/320/25 mg. All strengths are packaged in bottles of 30 tablets. 5 mg amlodipine/160 mg valsartan /12.5 mg hydrochlorothiazide tablets – White, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VCL” on the other side.       Bottles of 30                   NDC 0078-0559-15 10 mg amlodipine/160 mg valsartan /12.5 mg hydrochlorothiazide tablets – Pale yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VDL” on the other side.       Bottles of 30                   NDC 0078-0561-15 5 mg amlodipine/160 mg valsartan /25 mg hydrochlorothiazide tablets – Yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VEL” on the other side.       Bottles of 30                   NDC 0078-0560-15 10 mg amlodipine/160 mg valsartan /25 mg hydrochlorothiazide tablets – Brown-yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VHL” on the other side.       Bottles of 30                   NDC 0078-0562-15 10 mg amlodipine/320 mg valsartan /25 mg hydrochlorothiazide tablets – Brown-yellow, non-scored, film-coated tablet, ovaloid, biconvex with beveled edge with debossing “NVR” on one side and “VFL” on the other side.       Bottles of 30                   NDC 0078-0563-15 Store at 20°C to 25°C (68°F 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 tight container (USP).

Authorization status:

New Drug Application

Summary of Product characteristics

EXFORGE HCT- AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM
COATED
NOVARTIS PHARMACEUTICALS CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EXFORGE HCT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EXFORGE HCT.
EXFORGE HCT (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 EXFORGE HCT 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
Exforge HCT 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. Exforge
HCT 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)
Limitations of Use
Exforge HCT is not indicated for initial treatment of hypertension.
(1)
DOSAGE AND ADMINISTRATION
Dose once-daily. Titrate up to a maximum dose of 10/320/25 mg. (2.1)
Exforge HCT 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)
Exforge HCT may be substituted for its individually titrated
components. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: (amlodipine/valsartan/hydrochlorothiazide mg) 5/160/12.5,
10/160/12.5, 5/160/25, 10/160/25,
10/320/25 (3)
CONTRAINDICATIONS
Anuria (4)
Hypersensitivity to sulfonamide-derived drugs (4)
Known hypersensitivity to any component (4)
Do not coadminister aliskiren with Exforge HCT in patients with
diabetes (4)
WARNINGS AND PRECAUTIONS
Hypotension: Correct volume depletion prior