IRBESARTAN AND HYDROCHLOROTHIAZIDE - irbesartan and hydrochlorothiazide tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Rising Pharmaceuticals, Inc.

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

Irbesartan and Hydrochlorothiazide Tablets USP, 150 mg/12.5 mg are peach colored, film-coated biconvex oval shaped tablets, debossed with “H 35” on one side and plain on the other side.                         Bottles of 30               NDC 64980-382-03                         Bottles of 90               NDC 64980-382-09                     Irbesartan and Hydrochlorothiazide Tablets USP, 300 mg/12.5 mg are peach colored, film-coated biconvex oval shaped tablets, debossed with “H 36” on one side and plain on the other side.                         Bottles of 30               NDC 64980-383-03                         Bottles of 90               NDC 64980-383-09             Irbesartan and Hydrochlorothiazide Tablets USP, 300 mg/25 mg are pink colored, film-coated biconvex oval shaped tablets, debossed with “H 37” on one side and plain on the other side.                         Bottles of 30               NDC 64980-384-03                         Bottles of 90               NDC 64980-384-09                        Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.]

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

IRBESARTAN AND HYDROCHLOROTHIAZIDE - IRBESARTAN AND
HYDROCHLOROTHIAZIDE TABLET,
FILM COATED
RISING 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._
WHEN PREGNANCY IS DETECTED, DISCONTINUE IRBESARTAN AND
HYDROCHLOROTHIAZIDE 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 tablets are 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)
HYPE RTE NSIO N
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)
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. (4)
Anuria. (4)
Hypersensitivity to sulfonamide-derived drugs. (4)
Do not coadminister aliskiren with irbesartan and hydrochlorothiazide
tablets in patients with diabetes. (4)
WARNINGS AND PRECAUTIONS
Hypotension: Correct v