AVALIDE- irbesartan and hydrochlorothiazide tablet AVALIDE- irbesartan and hydrochlorothiazide tablet, film coated

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)

Boleh didapati daripada:

Physicians Total Care, Inc.

INN (Nama Antarabangsa):

IRBESARTAN

Komposisi:

IRBESARTAN 150 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

AVALIDE® (irbesartan-hydrochlorothiazide) Tablets is indicated for the treatment of hypertension. AVALIDE may be used in patients whose blood pressure is not adequately controlled on monotherapy. AVALIDE may also be used as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. The choice of AVALIDE as initial therapy for hypertension should be based on an assessment of potential benefits and risks. Patients with stage 2 (moderate or severe) hypertension are at relatively high risk for cardiovascular events (such as strokes, heart attacks, and heart failure), kidney failure, and vision problems, so prompt treatment is clinically relevant. The decision to use a combination as initial therapy should be individualized and may be shaped by considerations such as the baseline blood pressure, the target goal, and the incremental likelihood of achieving goal with a combination compared with monotherapy. Data from Studies V and VI [see Clinical Studies (14

Ringkasan produk:

Enter section text here AVALIDE® (irbesartan-hydrochlorothiazide) 150/12.5 mg and 300/12.5 mg tablets are peach, biconvex, and oval with a heart debossed on one side and "2775" or "2776" on the reverse side. The 300/25 mg film-coated tablet is pink, biconvex, and oval with a heart debossed on one side and "2788" on the reverse side. AVALIDE® Tablets are supplied as follows: Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].

Status kebenaran:

New Drug Application

Ciri produk

AVALIDE - IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET
AVALIDE - IRBESARTAN 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
AVALIDE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AVALIDE. AVALIDE (IRBESARTAN AND
HYDROCHLOROTHIAZIDE) TABLET FOR ORAL USE
AVALIDE (IRBESARTAN AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED FOR
ORAL USE INITIAL U.S. APPROVAL: 1997
WARNING: USE IN PREGNANCY
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
WHEN PREGNANCY IS DETECTED, DISCONTINUE AVALIDE AS SOON AS POSSIBLE.
WHEN USED IN PREGNANCY DURING
THE SECOND AND THIRD TRIMESTERS, DRUGS THAT ACT DIRECTLY ON THE
RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY
AND EVEN DEATH TO THE DEVELOPING FETUS. (5.1)
INDICATIONS AND USAGE
AVALIDE is a combination of irbesartan, an angiotensin II receptor
antagonist, and hydrochlorothiazide, a thiazide diuretic,
indicated for hypertension:
In patients not adequately controlled with monotherapy (1)
As initial therapy in patients likely to need multiple drugs to
achieve their blood pressure goals (1).
DOSAGE AND ADMINISTRATION
GENERAL CONSIDERATIONS
Maximum effects within 2 to 4 weeks after dose change (2.1).
Renal impairment: Not recommended for patients with severe renal
impairment (creatinine clearance less than 30
mL/min) (2.1, 5.8).
HYPE RTE NSIO N
Not controlled on monotherapy: Initiate with 150/12.5 mg. Titrate to
300/12.5 mg then 300/25 mg if needed. One tablet
daily (2.2).
Replacement therapy: May be substituted for titrated components (2.3).
Initial therapy: Initiate with 150/12.5 mg once daily for 1 to 2 weeks
and titrate as needed up to maximum of 300/25 mg
once daily (2.4).
DOSAGE FORMS AND STRENGTHS
150 mg irbesartan/12.5 mg hydrochlorothiazide tablets (3)
300 mg irbesartan/12.5 mg hydrochlorothiazide tablets (3)
300 mg irbesartan/25 mg hydrochlorothiazide tablets (3)
CONTRAINDICATIONS
Hypersensitivity to any component of this product