Ladfield Losartan 50 Tablets_

Losartan potassium tablet is an angiotensin II receptor blocker (ARB) indicated for: • 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. …

• Hypertension • Usual adult dose: 50 mg once daily. • Usual pediatric starting dose: 0.7 mg per kg once daily (up to 50 mg)
• Hypertensive Patients with Left Ventricular Hypertrophy • Usual starting dose: 50 mg once daily. • 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
• Nephropathy in Type 2 Diabetic Patients • Usual dose: 50 mg once daily. • Increase dose to 100 mg once daily if further blood pressure response is needed
• Hypertension Adult Hypertension The usual starting dose of losartan potassium tablet is 50 mg once daily
• The dosage can be increased to a maximum dose of 100 mg once daily as needed to control blood pressure [see Clinical Studies ]
• A starting dose of 25 mg is recommended for patients with possible intravascular depletion (e.g., on diuretic therapy)
• Pediatric Hypertension The usual recommended starting dose is 0.7 mg per kg once daily (up to 50 mg total) administered as a tablet or a suspension [see Dosage and Administration ]
• Dosage should be adjusted according to blood pressure response
• Doses above 1.4 mg per kg (or in excess of 100 mg) daily have not been studied
• In pediatric patients [see Clinical Pharmacology , Clinical Studies , and Warnings and Precautions ] . …

• Losartan potassium tablets, 25 mg are white to off white, film coated, oval shaped tablets debossed with "I16" on one side and plain on other side. • Losartan potassium tablets, 50 mg are white to off white, film coated, oval shaped scored tablets debossed with "I" and "17" on either side of the score line on one side and plain on other side. …

• Antihypertensive effects of losartan potassium tablets have been established in hypertensive
• Pediatric patients aged 6 to 16 years
• Safety and effectiveness have not been established
• In pediatric patients under the age of 6 or in pediatric patients with glomerular filtration rate

Of the total number of patients receiving losartan potassium tablets in controlled clinical studies for hypertension, 391 patients (19%) were 65 years and over, while 37 patients (2%) were 75 years and over. In a controlled clinical study for renal protection in type 2 diabetic patients with proteinuria, 248 patients (33%) were 65 years and over. …

• Advise the patient to read the FDA-approved patient labeling (Patient Information)
• Pregnancy Advise female patients of childbearing age about the consequences of exposure to losartan potassium tablets during pregnancy
• Discuss treatment options with women planning to become pregnant
• Tell patients to report pregnancies to their physicians as soon as possible [see Warnings and Precautions and Use in Specific Populations ]
• Potassium Supplements Advise patients receiving losartan potassium tablets not to use potassium supplements or salt substitutes containing potassium without consulting their healthcare provider [see Drug Interactions ] . …

Losartan potassium tablets, are contraindicated: • In patients who are hypersensitive to any component of this product. • For coadministration with aliskiren in patients with diabetes. • Hypersensitivity to any component. ( 4 ) • Coadministration with aliskiren in patients with diabetes. ( 4 )

• Agents increasing Serum Potassium: Risk of hyperkalemia. ( 7.1 ) • Lithium: Risk of lithium toxicity. ( 7.2 ) • NSAIDs: Increased risk of renal impairment and reduced diuretic, natriuretic, and antihypertensive effects. ( 7.3 ) • Dual inhibition of the Renin-Angiotensin System: Increased risk of renal impairment, hypotension, syncope, and hyperkalemia. ( 7.4 ) 7.1 Agents Increasing Serum Potassium Coadministration of losartan with other drugs that raise serum potassium levels may result in hyperkalemia. Monitor serum potassium in such patients. …

• Hypotension: Correct volume or salt depletion prior to administration of losartan potassium tablets. ( 5.2 ) • Monitor renal function and potassium in susceptible patients. ( 5.3 , 5.4 ) 5.1 Fetal Toxicity Losartan potassium tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. …

Most common adverse reactions (incidence ≥2% and greater than placebo) are: dizziness, upper respiratory infection, nasal congestion, and back pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

8.1 Pregnancy Risk Summary Losartan potassium tablets can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. …

Significant lethality was observed in mice and rats after oral administration of 1000 mg/kg and 2000 mg/kg, respectively, about 44 and 170 times the maximum recommended human dose on a mg/m 2 basis. Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted. Neither losartan nor its active metabolite can be removed by hemodialysis.

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