Country: United States
Language: English
Source: NLM (National Library of Medicine)
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)
Camber Pharmaceuticals, Inc.
VALSARTAN
VALSARTAN 40 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 is available as tablets containing valsartan USP, 40 mg, 80 mg, 160 mg, or 320 mg. All strengths are packaged in bottles and unit dose blister packages as described below. Valsartan Tablets USP, 40 mg are yellow coloured, capsule shaped, biconvex, film coated tablets, debossed with 'H' on one side and '182' on the other side, 18 and 2 separated by a score line. They are supplied as Bottle of 30 Tablets (NDC 31722-745-30) Bottle of 90 Tablets (NDC 31722-745-90) Bottle of 500 Tablets (NDC 31722-745-05) Blister Card of 10 Unit-Dose tablets (Alu-Alu) (NDC 31722-745-31) Blister Pack of 100 (10 x 10) Unit-Dose tablets (Alu-Alu) (NDC 31722-745-32) Valsartan Tablets USP, 80 mg are pink coloured, round shaped, biconvex, film coated tablets, debossed with '183' on one side and 'H' on the other side. They are supplied as Bottle of 30 Tablets (NDC 31722-746-30) Bottle of 90 Tablets (NDC 31722-746-90) Bottle of 500 Tablets (NDC 31722-746-05) Blister Card of 10 Unit-Dose tablets (Alu-Alu) (NDC 31722-746-31) Blister Pack of 100 (10 x 10) Unit-Dose tablets (Alu-Alu) (NDC 31722-746-32) Valsartan Tablets USP, 160 mg are yellowish brown coloured, oval shaped, biconvex, film coated tablets, debossed with '184' on one side and 'H' on the other side. They are supplied as Bottle of 30 Tablets (NDC 31722-747-30) Bottle of 90 Tablets (NDC 31722-747-90) Bottle of 500 Tablets (NDC 31722-747-05) Blister Card of 10 Unit-Dose tablets (Alu-Alu) (NDC 31722-747-31) Blister Pack of 100 (10 x 10) Unit-Dose tablets (Alu-Alu) (NDC 31722-747-32) Valsartan Tablets USP, 320 mg are dark grey-violet colored, capsule shaped, biconvex, film coated tablets, debossed with '185' on one side and 'H' on the other side. They are supplied as Bottle of 30 Tablets (NDC 31722-748-30) Bottle of 90 Tablets (NDC 31722-748-90) Bottle of 500 Tablets (NDC 31722-748-05) Blister Card of 10 Unit-Dose tablets (Alu-Alu) (NDC 31722-748-31) Blister Pack of 100 (10 x 10) Unit-Dose tablets (Alu-Alu) (NDC 31722-748-32) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).
Abbreviated New Drug Application
Camber Pharmaceuticals, Inc. ---------- SPL MEDGUIDE SECTION 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 a 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 tablet 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 short of breath, so you may have to rest a lot. Wha Read the complete document
VALSARTAN - VALSARTAN TABLET, FILM COATED CAMBER PHARMACEUTICALS, INC. ---------- 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 TABLETS 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 tablet is an 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 to IV); valsartan tablets significantly reduced hospitalization for heart failure (1.2) • Post-myocardial infarction: for the reduction of cardiovascular mortality in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infrarction (1.3) DOSAGE AND ADMINISTRATION INDICATION STARTING DOSE DOSE RANGE TARGET MAINTENANCE DOSE* Adult Hypertension (2.1) 80 or 160 mg once daily 80-320 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 40-160 mg total) --- Heart Failure (2.3) 40 mg twice daily 40-160 mg twice daily 160 mg twice daily Post-Myocardial Infarction (2.4) 20 mg twice daily 20-160 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 tablets in patients with diabetes (4) WARNINGS AND PRECAUTIONS • Observe for signs and symptoms of hypote Read the complete document