Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
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 Pre
Valsartan Tablets USP are available as follows: 160 mg tablets are yellow colored, oval shaped, biconvex, film coated tablets, debossed with 'C4' on one side and 'C' on other side. Bottle of 30’s NDC 70934-270-30 Store at 20°C to 25°C (68°C to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).
Abbreviated New Drug Application
VALSARTAN- VALSARTAN TABLET Denton Pharma, Inc. DBA Northwind Pharmaceuticals ---------- PATIENT INFORMATION Valsartan Tablets (val-sar’-tan) Read the Patient Information that comes with valsartan tablets before you take it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or treatment. If you have any questions about valsartan tablets, ask your doctor or pharmacist. What is the most important information I should know about valsartan tablets? Valsartan tablets can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking valsartan tablets, tell your doctor right away. What are valsartan tablets? Valsartan tablets are prescription medicine called an angiotensin receptor blocker (ARB). It is used in adults to: • lower high blood pressure (hypertension) in adults and children, 6 to 16 years of age. • treat heart failure in adults. In these patients, valsartan tablets may lower the need for hospitalization that happens from heart failure. Valsartan tablets are not for children under 6 years of age or children with certain kidney problems. High Blood Pressure (Hypertension). Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. Valsartan tablets can help your blood vessels relax so your blood pressure is lower. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack. High blood pressure makes the heart work harder to pump blood throughout the body and causes damage to the blood vessels. If high blood pressure is not treated, it can lead to stroke, heart attack, heart failure, kidney failure and vision problems. Heart Failure occurs when the heart is weak and cannot pump enough blood to your lungs and the rest of your body. Just walking or moving can make you s Lue koko asiakirja
VALSARTAN- VALSARTAN TABLET DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS ---------- 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._ 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 DEVELOPING FETUS. ( 5.1) INDICATIONS AND USAGE Valsartan tablets are angiotensin II receptor blocker (ARB) indicated for: Treatment of HYPERTENSION, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1) Treatment of HEART FAILURE (NYHA class II-IV); Valsartan tablets significantly reduced hospitalization for heart failure ( 1.2) DOSAGE AND ADMINISTRATION INDIC ATIO N STARTING DOSE DOSE RANGE T ARG E T MAINTENANCE DOSE* Adult Hypertension ( 2.1) 80 or 160 mg once daily 80 mg to 320 mg once daily --- Pediatric Hypertension (6-16 years) ( 2.2) 1.3 mg/kg once daily (up to 40 mg total) 1.3-2.7 mg/kg once daily (up to 40 mg to 160 mg total) --- Heart Failure ( 2.3) 40 mg twice daily 40 mg to 160 mg twice daily 160 mg twice daily * as tolerated by patient DOSAGE FORMS AND STRENGTHS Tablets (mg): 40 (scored), 80, 160, 320 (3) CONTRAINDICATIONS Known hypersensitivity to any component; Do not coadminister aliskiren with valsartan in patients with diabetes ( 4) WARNINGS AND PRECAUTIONS Observe for signs and symptoms of hypotension ( 5.2) Monitor renal function and potassium in susceptible patients ( 5.3, 5.4) 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, diarrh Lue koko asiakirja