Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I), HYDROCHLOROTHIAZIDE (UNII: 0J48LPH2TH) (HYDROCHLOROTHIAZIDE - UNII:0J48LPH2TH)
Physicians Total Care, Inc.
VALSARTAN
VALSARTAN 80 mg
ORAL
PRESCRIPTION DRUG
Diovan HCT (valsartan and hydrochlorothiazide, USP) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including hydrochlorothiazide and the ARB class to which valsartan principally belongs. There are no controlled trials demonstrating risk reduction with Diovan HCT. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Comm
Diovan HCT (valsartan and hydrochlorothiazide, USP) is available as non-scored tablets containing valsartan/hydrochlorothiazide 80/12.5 mg, 160/12.5 mg, 160/25 mg, 320/12.5 mg and 320/25 mg. Strengths are available as follows. 80/12.5 mg Tablet - Light orange, ovaloid with slightly convex faces debossed CG on one side and HGH on the other side. 160/12.5 mg Tablet - Dark red, ovaloid with slightly convex faces debossed CG on one side and HHH on the other side. 160/25 mg Tablet - Brown orange, ovaloid with slightly convex faces debossed NVR on one side and HXH on the other side. 320/12.5 mg Tablet - Pink, ovaloid with beveled edge, debossed NVR on one side and HIL on the other side. 320/25 mg Tablet - Yellow, ovaloid with beveled edge, debossed NVR on one side and CTI on the other side. Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).
New Drug Application
DIOVAN HCT - VALSARTAN AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED PHYSICIANS TOTAL CARE, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DIOVAN HCT SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR_ _DIOVAN HCT. DIOVANHCT (VALSARTAN AND HYDROCHLOROTHIAZIDE USP) TABLETS INITIAL U.S. APPROVAL: 1998 WARNING: AVOID USE IN PREGNANCY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WHEN PREGNANCY IS DETECTED, DISCONTINUE DIOVAN HCT AS SOON AS POSSIBLE. DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND EVEN DEATH TO THE DEVELOPING FETUS. (5.1) RECENT MAJOR CHANGES Indications and Usage: Benefits of lowering blood pressure (1) 12/2011 Warnings and Precautions: Acute Angle-Closure Glaucoma (5.9) 2/2011 INDICATIONS AND USAGE Diovan HCT is the combination tablet of valsartan (Diovan), an angiotensin II receptor blocker (ARB) and hydrochlorothiazide (HCTZ), a diuretic. Diovan HCT is indicated for the treatment of hypertension, to lower blood pre ssure : 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) Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions . 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) Diovan HCT may be administered with or without food. HYPE RTE NSIO N ADD-ON THERAPY OR INITIAL THERAPY: Initiate with 160/12.5 mg. Titrate upwards as needed to a maximum dose of 320/25 mg. One tablet daily (2.2, 2.4) REPLACEMENT THERAPY: may be substituted for titrated components (2.3) DOSAGE FORMS AND STRENGTHS Tablets (valsartan/HCTZ mg): 80/12.5, 160/12.5, 160/25, 320/12.5, 320/25 (3) CONTRAINDICATIONS Anuria; Hypersensitivity to an Đọc toàn bộ tài liệu