AVALIDE- irbesartan and hydrochlorothiazide tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

sanofi-aventis U.S. LLC

INN (इंटरनेशनल नाम):

irbesartan

रचना:

irbesartan 150 mg

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

AVALIDE® (irbesartan and hydrochlorothiazide) tablets are 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 (14.2)]

उत्पाद समीक्षा:

AVALIDE® (irbesartan and hydrochlorothiazide) film-coated tablets have markings on both sides and are available in the strengths and packages listed in the following table: Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F) [see USP Controlled Room Temperature].

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

AVALIDE- IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED
SANOFI-AVENTIS U.S. LLC
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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) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
WHEN PREGNANCY IS DETECTED, DISCONTINUE AVALIDE AS SOON AS POSSIBLE.
(5.1, 8.1)
DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE
INJURY AND DEATH
TO THE DEVELOPING FETUS. (5.1, 8.1)
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
<30 mL/min). (2.1, 5.8)
HYPERTENSION
Initiate with 150/12.5 mg. Titrate to 300/12.5 mg then 300/25 mg if
needed. (2.2)
Replacement therapy: May be substituted for titrated components. (2.3)
DOSAGE FORMS AND STRENGTHS
150 mg irbesartan/12.5 mg hydrochlorothiazide tablets (3)
300 mg irbesartan/12.5 mg hydrochlorothiazide tablets (3)
CONTRAINDICATIONS
Hypersensitivity to any component of this product. (4)
Anuria. (4)
Hypersensitivity to sulfonamide-derived drugs. (4)
Do not coadminister aliskiren with AVALIDE in patients with diabetes.
(4)
WARNINGS AND PRECAUTIONS
Hypotension: Correct volume depletion prior to administration. (5.2)
Impaired renal function. (5.7)
Thiazide diuretics may cause an exacerbation or activation of systemic
lupus erythematosus. (5.4)
Acute angle-closure glaucoma, acute myopia, and choroidal effusion.
(5.8)