Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
LOSARTAN POTASSIUM (UNII: 3ST302B24A) (LOSARTAN - UNII:JMS50MPO89)
AvPAK
LOSARTAN POTASSIUM
LOSARTAN POTASSIUM 25 mg
ORAL
PRESCRIPTION DRUG
Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and nonfatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including losartan. 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 1 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, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive
Losartan potassium tablets, USP 25 mg, are white to off-white colored, oval shaped, biconvex, film coated tablets debossed with "25" on one side and "113" on the other side. NDC 50268-516-15 (10 Tablets per card, 5 cards per carton) Losartan potassium tablets, USP 50 mg, are white to off-white colored, oval shaped, biconvex, film coated tablets debossed with "114" on one side and breakline on the other side. NDC 50268-517-15 (10 Tablets per card, 5 cards per carton) Losartan potassium tablets, USP 100 mg, are white to off-white colored, oval shaped, biconvex, film coated tablets debossed with "100" on one side and "115" on the other side. NDC 50268-518-15 (10 Tablets per card, 5 cards per carton) Dispensed in Unit Dose package. For Institutional Use Only. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° - 86°F). [see USP Controlled Room Temperature]. Protect from light. Manufactured For: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 09/16 AV Rev. 09/18 (P) AvPAK
Abbreviated New Drug Application
LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET AvPAK ---------- PATIENT INFORMATION Losartan Potassium (loe SAR tan poe TASS ee um)Tablets, USP 25 mg, 50 mg, 100 mg Rx only Read the Patient Information that comes with losartan potassium tablets before you start taking 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 condition and treatment. What is the most important information I should know about losartan potassium tablets? • Losartan potassiumtabletscan 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 losartan potassium tablets, tell your doctor right away. What are losartan potassium tablets? Losartan potassium tablets are prescription medicine called an angiotensin receptor blocker (ARB). It is used: • alone or with other blood pressure medicines to lower high blood pressure (hypertension). • to lower the chance of stroke in patients with high blood pressure and a heart problem called left ventricular hypertrophy. Losartan potassium tablets may not help Black patients with this problem. • to slow the worsening of diabetic kidney disease (nephropathy) in patients with type 2 diabetes who have or had high blood pressure. Losartan potassium tablets have not been studied in children less than 6 years old or in 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. Losartan potassium tablets can help your blood vessels relax so your blood pressure is lower. Left Ventricular Hypertrophy (LVH) is an enlargement of the walls of the left chamber of the heart (the heart's main pumping chamber). LVH can happen from several things. High blood pressure is the most common cause of LVH. Type 2 Diabetes with Nephropathy. Type 2 Soma hati kamili
LOSARTAN POTASSIUM- LOSARTAN POTASSIUM TABLET AVPAK ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION LOSARTAN POTASSIUM TABLETS USP RX ONLY THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LOSARTAN POTASSIUM TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LOSARTAN POTASSIUM TABLETS. LOSARTAN POTASSIUM TABLETS, FOR ORAL USE RX ONLY INITIAL U.S. APPROVAL: 1995 WARNING: FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ WHEN PREGNANCY IS DETECTED, DISCONTINUE LOSARTAN POTASSIUM TABLETS AS SOON AS POSSIBLE. DRUGS THAT ACT DIRECTLY ON THE RENIN-ANGIOTENSIN SYSTEM CAN CAUSE INJURY AND DEATH TO THE DEVELOPING FETUS. (5.1) INDICATIONS AND USAGE Losartan potassium tablets are an angiotensin II receptor blocker (ARB) indicated for: (1) Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.1) Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy. There is evidence that this benefit does not apply to Black patients. (1.2) Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. (1.3) DOSAGE AND ADMINISTRATION Hypertension (2) Usual adult dose: 50 mg once daily. (2.1) Usual pediatric starting dose: 0.7 mg per kg once daily (up to 50 mg). (2.1) Hypertensive Patients with Left Ventricular Hypertrophy (2) Usual starting dose: 50 mg once daily. (2.2) Add hydrochlorothiazide 12.5 mg and/or increase losartan potassium tablets to 100 mg followed by an increase to hydrochlorothiazide 25 mg if further blood pressure response is needed. (2.2, 14.2) Nephropathy in Type 2 Diabetic Patients (2) Usual dose: 50 mg once daily. (2.3) Increase dose to 100 mg once daily if further blood pressure response is needed. (2.3) DOSAGE FORMS AND STRENGTHS Tablets: 25 mg; 50 mg; and Soma hati kamili