EXFORGE HCT- amlodipine valsartan and hydrochlorothiazide tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288), VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Boleh didapati daripada:

Physicians Total Care, Inc.

INN (Nama Antarabangsa):

AMLODIPINE BESYLATE

Komposisi:

AMLODIPINE 10 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension [see Dosage and Administration (2)]. Because of the hydrochlorothiazide component, Exforge HCT is contraindicated in patients with anuria or hypersensitivity to other sulfonamide-derived drugs. Pregnancy Category D Valsartan, like other drugs that act on the renin angiotensin system, can cause fetal and neonatal morbidity and death when used during the second or third trimester of pregnancy. If Exforge HCT is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Angiotensin II receptor antagonists, like valsartan, and angiotensin converting enzyme (ACE) inhibitors exert similar effects on the renin-angiotensin system. In several dozen published cases, ACE inhibitor use during the second and third trimesters of pregnancy was as

Ringkasan produk:

Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) is available as film-coated tablets containing amlodipine besylate equivalent to 10 mg of amlodipine free-base with valsartan 320 mg and hydrochlorothiazide 25 mg, providing for the following available combination: 10/320/25 mg. 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. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F), [see USP controlled room temperature.] Protect from moisture. Dispense in tight container (USP).

Status kebenaran:

New Drug Application

Ciri produk

EXFORGE HCT - AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET,
FILM COATED
PHYSICIANS TOTAL CARE, INC.
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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, HYDROCHLOROTHIAZIDE) TABLETS
INITIAL U.S. APPROVAL: 2009
WARNING: AVOID USE IN PREGNANCY
WHEN PREGNANCY IS DETECTED, DISCONTINUE EXFORGE HCT AS SOON AS
POSSIBLE. DRUGS THAT ACT DIRECTLY ON
THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY OR DEATH TO THE
DEVELOPING FETUS. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions: Acute Angle-Closure Glaucoma (5.11) 2/2011
INDICATIONS AND USAGE
Exforge HCT is for the treatment of hypertension (1)
Not indicated for initial therapy
DOSAGE AND ADMINISTRATION
Dose once-daily
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.
Exforge HCT may be substituted for its individually titrated
components for patients on amlodipine, valsartan and
hydrochlorothiazide (2).
The full blood pressure lowering effect was achieved 2 weeks after
being on the maximal dose of Exforge HCT (2).
DOSAGE FORMS AND STRENGTHS
Tablets: (amlodipine/valsartan/hydrochlorothiazide mg) (3)
5/160/12.5 (3)
10/160/12.5 (3)
5/160/25 (3)
10/160/25 (3)
10/320/25 (3) (3)
CONTRAINDICATIONS
Anuria; Hypersensitivity to sulfonamide-derived drugs (4)
WARNINGS AND PRECAUTIONS
Avoid fetal or neonatal exposure (5.1)
Symptomatic hypotension with volume- or salt-depletion. Correct
volume-depletion prior to administration (5.2)
Increased angina and/or myocardial infarction (5.3)
Avoid in patients with severely impaired hepatic (2.1, 5.4) or renal
function (creatinine clearance ≤30 mL/min) (2.1, 5.5)
Observe for signs of fluid or electrolyte imbalance (5.10)
Thiazide diuretics may cause an exacerbation or activation of systemic
lu