Losartan potassium Tablets, 25 mg 25 mg/1

losartan potassium · TABLET · Bryant Ranch Prepack

No Recall History

Plain English

Losartan potassium Tablets, 25 mg is a tablet containing losartan potassium at 25 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name: Losartan potassium Tablets, 25 mg
Generic Name: losartan potassium
NDC Code (Product): 72162-1696
Manufacturer: Bryant Ranch Prepack
Strength: 25 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: ANDA201170
Marketing Start: 09/18/2012

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue4,065 reports

diarrhoea3,116 reports

nausea2,798 reports

drug ineffective2,699 reports

dyspnoea2,560 reports

headache2,462 reports

dizziness2,338 reports

pain2,178 reports

off label use1,875 reports

cough1,850 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Losartan potassium 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. ( 1.3 ) 1.1 Hypertension Losartan potassium is 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 m…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Hypertension • 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 • Usual starting dose: 50 mg once daily. ( 2.2 ) • Add hydrochlorothiazide 12.5 mg and/or increase Losartan potassium 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 • Usual dose: 50 mg once daily. ( 2.3 ) • Increase dose to 100 mg once daily if further blood pressure response is needed. ( 2.3 ) 2.1 Hypertension Adult Hypertension The usual starting dose of Losartan potassium 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 (14.1) ]. 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 (2.5) ] . Dosage should be…

Contraindications

4 CONTRAINDICATIONS Losartan potassium is 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 )

Drug Interactions

7 DRUG INTERACTIONS 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. 7.2 Lithium Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists. Monitor serum lithium levels during concomitant use. 7.3 Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists (including losartan) may result in deterioration of rena…

Adverse Reactions

6 ADVERSE REACTIONS 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 Jubilant Cadista Pharmaceuticals Inc. at 1-800-313-4623 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. Hypertension Losartan potassium has been evaluated for safety in more than 3300 adult patients treated for essential hypertension and 4058 patients/subjects overall. Over 1200 patients were treated for over 6 months and more than 800 for over one year. Treatment with Losartan potassium was well-tolerated with an overall incidence of adverse events similar to that of placebo. In controlled clinical trials, discontinuation of therapy for adverse events occurred in 2.3% of patients treated with Losartan potassium and 3.7% of patients given placebo. In 4 clinical trials i…

Frequently Asked Questions

What is Losartan potassium Tablets, 25 mg used for?

Losartan potassium Tablets, 25 mg contains losartan potassium. It is a tablet taken oral. Consult your doctor for specific uses.

Is Losartan potassium Tablets, 25 mg a controlled substance?

Losartan potassium Tablets, 25 mg is not classified as a controlled substance by the DEA.

What is the generic name for Losartan potassium Tablets, 25 mg?

The generic name for Losartan potassium Tablets, 25 mg is losartan potassium. There are 11 other brand versions of losartan potassium.

What is the NDC code for Losartan potassium Tablets, 25 mg 25 mg/1?

The NDC (National Drug Code) for Losartan potassium Tablets, 25 mg 25 mg/1 is 72162-1696, listed by Bryant Ranch Prepack.

Product NDC

72162-1696

Package NDC

72162-1696-0

Other Losartan Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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