Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
VALSARTAN (UNII: 80M03YXJ7I) (VALSARTAN - UNII:80M03YXJ7I)
Proficient Rx LP
VALSARTAN
VALSARTAN 320 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, are available as tablets containing valsartan 320 mg. 320 mg tablets are unscored and biconvex and capsule-shaped. Store at 20-25o C (68-77o F); excursions permitted to 15-30o C (59-86o F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP).
Abbreviated New Drug Application
VALSARTAN- VALSARTAN TABLET Proficient Rx LP ---------- MEDICATION GUIDE Valsartan Tablets (val-SAR-tan), USP Read the Patient Information that comes with valsartan 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, ask your doctor or pharmacist. What is the most important information I should know about valsartan? Valsartan 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, tell your doctor right away. What is valsartan? Valsartan is 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 may lower the need for hospitalization that happens from heart failure. • improve the chance of living longer after a heart attack (myocardial infarction) in adults. Valsartan is 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 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 Belgenin tamamını okuyun
VALSARTAN- VALSARTAN TABLET PROFICIENT RX LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VALSARTAN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VALSARTAN. VALSARTAN (VALSARTAN) TABLET FOR ORAL USE. INITIAL U.S. APPROVAL: 1996 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ • • INDICATIONS AND USAGE Valsartan tablets are 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 80-320 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 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 SOLCO HEALTHCARE US, LLC AT 1-866-257-2597 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. 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) Treatment of HYPERTENSION, Belgenin tamamını okuyun