Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)
Cardinal Health
VALSARTAN
VALSARTAN 80 mg
ORAL
PRESCRIPTION DRUG
Valsartan tablets are 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 the class to which valsartan principally belongs. There are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan tablets. 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 Committee on Prevention, Detection,
Valsartan Tablets USP, 80 mg are pale red colored, round, beveled edge, biconvex, film-coated tablets debossed with 'I' on one side and '8' on other side. Overbagged with 10 tablets per bag, NDC 55154-4676-0 Valsartan Tablets USP, 160 mg are grey-orange colored, ovaloid, beveled edge, biconvex, film-coated tablets debossed with 'I' on one side and '67' on other side. Overbagged with 10 tablets per bag, NDC 55154-4678-0 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.
Abbreviated New Drug Application
VALSARTAN- VALSARTAN TABLET, FILM COATED CARDINAL HEALTH ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VALSARTAN TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALSARTAN TABLETS. VALSARTAN TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1996 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • INDICATIONS AND USAGE Valsartan is an angiotensin II receptor blocker (ARB) indicated for: • • • DOSAGE AND ADMINISTRATION INDIC ATIO N STARTING DOSE DOSE RANGE TARGET MAINTENANCE DOSE * Adult Hypertension (2.1) 80 or 160 mg once daily 80 to 320 mg once daily --- Pediatric Hypertension (6 to 16 years) (2.2) 1.3 mg/kg once daily (up to 40 mg total) 1.3 to 2.7 mg/kg once daily (up to 40 to 160 mg total) --- Heart Failure (2.3) 40 mg twice daily 40 to 160 mg twice daily 160 mg twice daily Post-Myocardial Infarction (2.4) 20 mg twice daily 20 to 160 mg twice daily 160 mg twice daily DOSAGE FORMS AND STRENGTHS Tablets: 40 mg (scored), 80 mg, 160 mg, and 320 mg (3) CONTRAINDICATIONS Known hypersensitivity to any component; Do not coadminister aliskiren with valsartan tablets in patients with diabetes (4) WARNINGS AND PRECAUTIONS • • ADVERSE REACTIONS HYPERTENSION: Most common adverse reactions are headache, dizziness, viral infection, fatigue and abdominal pain (6.1) HEART FAILURE: Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia (6.1) POST-MYOCARDIAL INFARCTION: Most common adverse reactions which caused patients to discontinue therapy are hypotension, cough and increased blood creatinine (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT AUROBINDO PHARMA USA, INC. AT 1-866-850-2876 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • WHEN PREGNANCY IS DETECTED, DISCONTINUE VALSARTAN AS SOON AS POSSIBLE. (5.1) DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELO Lees het volledige document