IRBESARTAN AND HYDROCHLOROTHIAZIDE tablet, film coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Proficient Rx LP

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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

Ringkasan produk:

Irbesartan and hydrochlorothiazide tablets USP are available as follows: 150 mg/12.5 mg: Light pink to pink, film-coated, capsule-shaped tablets, debossed with “TEVA” on one side of the tablet and “7238” on the other side and are available in bottles of 30 (NDC 0093-8238-56) and 90 (NDC 0093-8238-98). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

IRBESARTAN AND HYDROCHLOROTHIAZIDE- IRBESARTAN AND HYDROCHLOROTHIAZIDE
TABLET,
FILM COATED
PROFICIENT RX LP
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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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4.
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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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, 5.8)
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)
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)
Hypotension: Correct volume-depletion pr