IRBESARTAN AND HYDROCHLOROTHIAZIDE- irbesartan and hydrochlorothiazide tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals, Inc.

INN (International Name):

IRBESARTAN

Composition:

IRBESARTAN 300 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Irbesartan and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension. Irbesartan and hydrochlorothiazide tablets USP may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and hydrochlorothiazide tablets USP 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 irbesartan and hydrochlorothiazide tablets USP 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 like

Product summary:

Irbesartan and hydrochlorothiazide film-coated tablets have markings on one side and are available in the strengths and packages listed in the following table: 300 mg/12.5 mg peach, oval-shaped ML; 33 debossed on one side and plain on the reverse Bottle of 30 NDC 68071-2123-3  Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

IRBESARTAN AND HYDROCHLOROTHIAZIDE- IRBESARTAN AND HYDROCHLOROTHIAZIDE
TABLET,
FILM COATED
NUCARE PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IRBESARTAN AND
HYDROCHLOROTHIAZIDE TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS USP.
IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLETS, USP FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
WARNING: FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
• 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)
INDICATIONS AND USAGE
Irbesartan and hydrochlorothiazide tablet USP 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 co-administer aliskiren with irbesartan and
hydrochlorothiazide tablets in patients with diabetes ( 4)
WARNINGS AND PRECAUTIONS
Hypotensio