País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Hisun Pharmaceuticals USA Inc.
IRBESARTAN
IRBESARTAN 150 mg
ORAL
PRESCRIPTION DRUG
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 likelihood of achieving
Irbesartan and hydrochlorothiazide tablets, USP have markings on both sides and are available in the strengths and packages listed in the following table: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
IRBESARTAN AND HYDROCHLOROTHIAZIDE- IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED HISUN PHARMACEUTICALS USA INC. ---------- 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 USEINITIAL U.S. APPROVAL: 1997 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WHEN PREGNANCY IS DETECTED, DISCONTINUE IBESARTAN 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, USP 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, 5.7) HYPE RTE NSIO N 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 irbesartan and hydrochlorothiazide in patients with diabetes ( 4) WARNINGS AND PRECAUTIONS Hypotension: Correct volume-depletion prior to administration. ( 5.2) Impaired re Leer el documento completo