Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
West-Ward Pharmaceuticals Corp.
IRBESARTAN
IRBESARTAN 150 mg
ORAL
PRESCRIPTION DRUG
Irbesartan and hydrochlorothiazide is indicated for the treatment of hypertension. Irbesartan and hydrochlorothiazide may be used in patients whose blood pressure is not adequately controlled on monotherapy. Irbesartan and hydrochlorothiazide 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 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 combination compared with monotherapy
Irbesartan and Hydrochlorothiazide Tablets USP The 150 mg/12.5 mg tablets are light red speckled, round biconvex tablets, debossed with product identification “54” over “857” on one side and plain on the other side. NDC 0054-0254-13: Bottle of 30 Tablets NDC 0054-0254-22: Bottle of 90 Tablets NDC 0054-0254-29: Bottle of 500 Tablets The 300 mg/12.5 mg tablets are light yellow speckled, modified oval biconvex tablets, debossed with product identification “54 948” on one side and plain on the other side. NDC 0054-0255-13: Bottle of 30 Tablets NDC 0054-0255-22: Bottle of 90 Tablets NDC 0054-0255-29: Bottle of 500 Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
IRBESARTAN AND HYDROCHLOROTHIAZIDE- IRBESARTAN AND HYDROCHLOROTHIAZIDE TABLET WEST-WARD PHARMACEUTICALS CORP. ---------- 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._ • • INDICATIONS AND USAGE Irbesartan and hydrochlorothiazide is a combination of irbesartan, an angiotensin II receptor antagonist, and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension: • • DOSAGE AND ADMINISTRATION GENERAL CONSIDERATIONS • • HYPE RTE NSIO N • • DOSAGE FORMS AND STRENGTHS • • CONTRAINDICATIONS • • • • WARNINGS AND PRECAUTIONS • • • • ADVERSE REACTIONS Most common adverse events (≥5% on irbesartan and hydrochlorothiazide and more often than on placebo) are dizziness, 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) 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 coad Baca dokumen lengkapnya