Losartan Potassium 50 mg/1
Losartan Potassium · TABLET, FILM COATED · Northwind Health Company, LLC
Losartan Potassium is a tablet, film coated containing losartan potassium at 50 mg/1, taken oral. Manufactured by Northwind Health Company, LLC.
Key Facts
- Brand Name
- Losartan Potassium
- Generic Name
- Losartan Potassium
- NDC Code (Product)
51655-795- Manufacturer
- Northwind Health Company, LLC
- Strength
- 50 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA090083
- Marketing Start
- 01/19/2022
Recall History
Teva Pharmaceuticals USA
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Macleods Pharma Usa Inc
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Apotex Inc.
Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.
Golden State Medical Supply Inc.
CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.
Direct Rx
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
Camber Pharmaceuticals Inc
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Torrent Pharma Inc.
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Macleods Pharma Usa Inc
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Lupin Pharmaceuticals Inc.
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Camber Pharmaceuticals Inc
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Losartan potassium tablets are 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 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 car…
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 tablets 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 adju…
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 Zydus Pharmaceuticals USA Inc. at 1-877-993-8779 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 involving o…
Frequently Asked Questions
What is Losartan Potassium used for?
Losartan Potassium contains Losartan Potassium. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Losartan Potassium a controlled substance?
Losartan Potassium is not classified as a controlled substance by the DEA.
What is the generic name for Losartan Potassium?
The generic name for Losartan Potassium is Losartan Potassium. There are 6 other brand versions of Losartan Potassium.
What is the NDC code for Losartan Potassium 50 mg/1?
The NDC (National Drug Code) for Losartan Potassium 50 mg/1 is 51655-795, listed by Northwind Health Company, LLC.