IRBESARTAN AND HYDROCHLOROTHIAZIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N)

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

IRBESARTAN

Composition:

IRBESARTAN 150 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IRBESARTAN AND HYDROCHLOROTHIAZIDE- IRBESARTAN AND HYDROCHLOROTHIAZIDE
TABLET
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IRBESARTAN AND
HYDROCHLOROTHIAZIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS.
IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
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INDICATIONS AND USAGE
Irbesartan and hydrochlorothiazide tablets are a combination of
irbesartan, an angiotensin II receptor antagonist, and
hydrochlorothiazide, a thiazide diuretic, indicated for hypertension:
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DOSAGE AND ADMINISTRATION
GENERAL CONSIDERATIONS
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HYPE RTE NSIO N
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
WHEN PREGNANCY IS DETECTED, DISCONTINUE IRBESARTAN AND
HYDROCHLOROTHIAZIDE TABLETS 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)
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)
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, 5.7)
Initiate with 150 mg/12.5 mg. Titrate to 300 mg/12.5 mg then 300 mg/25
mg if needed. (2.2)
Replacement therapy: May be substituted for titrated components. (2.3)
150 mg irbesartan/12.5 mg hydrochlorothiazide tablets (3)
300 mg irbesartan/12.5 mg hydrochlorothiazide tablets (3)
Hypersensitivity to any component of this product (4)
Anuria (4)
Hypersensitivity to sulfonamide-derived drugs (4)
Do not coadminister aliskiren with irbesartan and hydrochlorothiazide
tablets in patients with diabetes (4)
H