Losartan potassium
Tablet, Film Coated · Oral
Uses
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 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 drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in Black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. Losartan potassium tablets may be administered with other antihypertensive agents. 1.2 Hypertensive Patients with Left Ventricular Hypertrophy Losartan potassium tablets are indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )]. 1.3 Nephropathy in Type 2 Diabetic Patients Losartan potassium tablets are indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, losartan potassium reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) [see Clinical Studies ( 14.3 )].
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 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 ( 12.3 ), Clinical Studies ( 14.1 ), and Warnings and Precautions ( 5.2 )]. Losartan potassium tablets are not recommended in pediatric patients less than 6 years of age or in pediatric patients with estimated glomerular filtration rate less than 30 mL/min/1.73 m 2 [see Use in Specific Populations ( 8.4 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14 )]. 2.2 Hypertensive Patients with Left Ventricular Hypertrophy The usual starting dose is 50 mg of losartan potassium tablets once daily. Hydrochlorothiazide 12.5 mg daily should be added and/or the dose of losartan potassium should be increased to 100 mg once daily followed by an increase in hydrochlorothiazide to 25 mg once daily based on blood pressure response [see Clinical Studies ( 14.2 )] . 2.3 Nephropathy in Type 2 Diabetic Patients The usual starting dose is 50 mg once daily. The dose should be increased to 100 mg once daily based on blood pressure response [see Clinical Studies ( 14.3 )] . 2.4 Dosage Modifications in Patients with Hepatic Impairment In patients with mild-to-moderate hepatic impairment the recommended starting dose of losartan potassium is 25 mg once daily. Losartan potassium has not been studied in patients with severe hepatic impairment [see Use in Specific Populations (8.8) and Clinical Pharmacology ( 12.3 )] . 2.5 Preparation of Suspension (for 200 mL of a 2.5 mg/mL suspension) Add 10 mL of Purified Water USP to an 8 ounce (240 mL) amber polyethylene terephthalate (PET) bottle containing ten 50 mg losartan potassium tablets. Immediately shake for at least 2 minutes. Let the concentrate stand for 1 hour and then shake for 1 minute to disperse the tablet contents. Separately prepare a 50/50 volumetric mixture of Ora-Plus™ and Ora-Sweet SF™. Add 190 mL of the 50/50 Ora-Plus™/Ora-Sweet SF™ mixture to the tablet and water slurry in the PET bottle and shake for 1 minute to disperse the ingredients. The suspension should be refrigerated at 2 to 8°C (36 to 46°F) and can be stored for up to 4 weeks. Shake the suspension prior to each use and return promptly to the refrigerator.
Dosage forms and strengths
Tablets: 25 mg; 50 mg; and 100 mg. (3) Losartan potassium tablets USP, 25 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z" on one side and "2"on other side. Losartan Potassium Tablets USP, 50 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z16" on one side and lip type breakline on other side. Losartan Potassium Tablets USP, 100 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z18" on one side and plain on other side.
Contraindications
Hypersensitivity to any component. ( 4 ) Coadministration with aliskiren in patients with diabetes. ( 4 ) Losartan potassium is contraindicated: In patients who are hypersensitive to any component of this product. For coadministration with aliskiren in patients with diabetes.
Warnings and precautions
Hypotension: Correct volume or salt depletion prior to administration of losartan potassium. ( 5.2 ) Monitor renal function and potassium in susceptible patients. ( 5.3 , 5.4 ) 5.1 Fetal Toxicity Losartan potassium 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. When pregnancy is detected, discontinue losartan potassium as soon as possible [see Use in Specific Populations ( 8.1 )]. 5.2 Hypotension in Volume- or Salt-Depleted Patients In patients with an activated renin-angiotensin system, such as volume- or salt-depleted patients (e.g., those being treated with high doses of diuretics), symptomatic hypotension may occur after initiation of treatment with losartan potassium. Correct volume or salt depletion prior to administration of losartan potassium [see Dosage and Administration ( 2.1 )] . 5.3 Renal Function Deterioration Changes in renal function including acute renal failure can be caused by drugs that inhibit the renin angiotensin system and by diuretics. Patients whose renal function may depend in part on the activity of the renin-angiotensin system (e.g., patients with renal artery stenosis, chronic kidney disease, severe congestive heart failure, or volume depletion) may be at particular risk of developing acute renal failure on losartan potassium. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on losartan potassium [see Drug Interactions ( 7.3 ) and Use in Specific Populations ( 8.7 )] . 5.4 Hyperkalemia Monitor serum potassium periodically and treat appropriately. Dosage reduction or discontinuation of losartan potassium may be required [see Adverse Reactions ( 6.1 )] . Concomitant use of other drugs that may increase serum potassium may lead to hyperkalemia [see Drug Interactions ( 7.1 )].
Side effects
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 over 1000 patients on various doses (10 to 150 mg) of losartan potassium and over 300 patients given placebo, the adverse events that occurred in ≥2% of patients treated with losartan potassium and more commonly than placebo were: dizziness (3% vs. 2%), upper respiratory infection (8% vs. 7%), nasal congestion (2% vs. 1%), and back pain (2% vs. 1%). The following less common adverse reactions have been reported: Blood and lymphatic system disorders: Anemia. Psychiatric disorders: Depression. Nervous system disorders: Somnolence, headache, sleep disorders, paresthesia, migraine. Ear and labyrinth disorders: Vertigo, tinnitus. Cardiac disorders: Palpitations, syncope, atrial fibrillation, CVA. Respiratory, thoracic and mediastinal disorders: Dyspnea. Gastrointestinal disorders: Abdominal pain, constipation, nausea, vomiting. Skin and subcutaneous tissue disorders: Urticaria, pruritus, rash, photosensitivity. Musculoskeletal and connective tissue disorders: Myalgia, arthralgia. Reproductive system and breast disorders: Impotence. General disorders and administration site conditions: Edema. Cough Persistent dry cough (with an incidence of a few percent) has been associated with ACE-inhibitor use and in practice can be a cause of discontinuation of ACE-inhibitor therapy. Two prospective, parallel-group, double-blind, randomized, controlled trials were conducted to assess the effects of losartan on the incidence of cough in hypertensive patients who had experienced cough while receiving ACE-inhibitor therapy. Patients who had typical ACE-inhibitor cough when challenged with lisinopril, whose cough disappeared on placebo, were randomized to losartan 50 mg, lisinopril 20 mg, or either placebo (one study, n=97) or 25 mg hydrochlorothiazide (n=135). The double-blind treatment period lasted up to 8 weeks. The incidence of cough is shown in Table 1 below. Table 1 * Demographics = (89% Caucasian, 64% female) † Demographics = (90% Caucasian, 51% female) Study 1* HCTZ Losartan Lisinopril Cough 25% 17% 69% Study 2 † Placebo Losartan Lisinopril Cough 35% 29% 62% These studies demonstrate that the incidence of cough associated with losartan therapy, in a population that all had cough associated with ACE-inhibitor therapy, is similar to that associated with hydrochlorothiazide or placebo therapy. Cases of cough, including positive re-challenges, have been reported with the use of losartan in postmarketing experience. Hypertensive Patients with Left Ventricular Hypertrophy In the losartan Intervention for Endpoint (LIFE) study, adverse reactions with losartan potassium were similar to those reported previously for patients with hypertension. Nephropathy in Type 2 Diabetic Patients In the Reduction of Endpoints in NIDDM with the Angiotensin II Receptor Antagonist Losartan (RENAAL) study involving 1513 patients treated with losartan potassium or placebo, the overall incidences of reported adverse events were similar for the two groups. Discontinuations of losartan potassium because of side effects were similar to placebo (19% for losartan potassium, 24% for placebo). The adverse events, regardless of drug relationship, reported with an incidence of ≥4% of patients treated with losartan potassium and occurring with ≥2% difference in the losartan group vs. placebo on a background of conventional antihypertensive therapy, were asthenia/fatigue, chest pain, hypotension, orthostatic hypotension, diarrhea, anemia, hyperkalemia, hypoglycemia, back pain, muscular weakness, and urinary tract infection. 6.2 Postmarketing Experience The following additional adverse reactions have been reported in postmarketing experience with losartan potassium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure: Digestive: Hepatitis. General Disorders and Administration Site Conditions: Malaise. Hematologic: Thrombocytopenia. Hypersensitivity: Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, tongue, and/or swelling of the intestine has been reported; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Vasculitis, including Henoch-Schönlein purpura, has been reported. Anaphylactic reactions have been reported. Metabolic and Nutrition: Hyponatremia. Musculoskeletal: Rhabdomyolysis. Nervous System Disorders : Dysgeusia. Skin : Erythroderma.
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 renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving losartan and NSAID therapy. The antihypertensive effect of angiotensin II receptor antagonists, including losartan, may be attenuated by NSAIDs, including selective COX-2 inhibitors. 7.4 Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. The Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 mL/min), randomized them to lisinopril or placebo on a background of losartan therapy and followed them for a median of 2.2 years. Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end stage renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group. In most patients no benefit has been associated with using two RAS inhibitors concomitantly. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function, and electrolytes in patients on losartan potassium and other agents that affect the RAS. Do not coadminister aliskiren with losartan potassium in patients with diabetes. Avoid use of aliskiren with losartan potassium in patients with renal impairment (GFR <60 mL/min).
Use in specific populations
Losartan potassium is not recommended in pediatric patients less than 6 years of age or in pediatric patients with glomerular filtration rate less than 30 mL/min/1.73 m 2 . ( 2.1 , 8.4 ) Hepatic Impairment: Recommended starting dose 25 mg once daily. ( 2.4 , 8.8 , 12.3 ) 8.1 Pregnancy Risk Summary Losartan potassium 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. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. When pregnancy is detected, discontinue losartan potassium as soon as possible (see Clinical Considerations). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. In patients taking losartan potassium during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation. If oligohydramnios is observed, discontinue losartan potassium, unless it is considered lifesaving for the mother. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe neonates with histories of in utero exposure to losartan potassium for hypotension, oliguria, and hyperkalemia. In neonates with a history of in utero exposure to losartan potassium, if oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. Data Animal Data Losartan potassium was administered orally to rats during the period of late gestation through lactation (Gestation Day 15 through Lactation Day 20) at doses of 10 mg/kg/day, 25 mg/kg/day, and 100 mg/kg/day. Losartan potassium has been shown to produce adverse effects in rat fetuses and neonates, including decreased body weight, delayed physical and behavioral development, mortality and renal toxicity. With the exception of neonatal weight gain (which was affected at doses as low as 10 mg/kg/day), doses associated with these effects exceeded 25 mg/kg/day (approximately three times the maximum recommended human dose of 100 mg on a mg/m 2 basis). These findings are attributed to drug exposure in late gestation and during lactation. Significant levels of losartan and its active metabolite were shown to be present in rat fetal plasma during late gestation and in rat milk. 8.2 Lactation Risk Summary It is not known whether losartan is excreted in human milk, but significant levels of losartan and its active metabolite were shown to be present in rat milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. 8.4 Pediatric Use Antihypertensive effects of losartan potassium 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 <30 mL/min/1.73 m 2 [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14.1 )] . 8.5 Geriatric Use Of the total number of patients receiving losartan potassium 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. In a controlled clinical study for the reduction in the combined risk of cardiovascular death, stroke and myocardial infarction in hypertensive patients with left ventricular hypertrophy, 2857 patients (62%) were 65 years and over, while 808 patients (18%) were 75 years and over. No overall differences in effectiveness or safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Pregnancy
8.1 Pregnancy Risk Summary Losartan potassium 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. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. When pregnancy is detected, discontinue losartan potassium as soon as possible (see Clinical Considerations). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo/Fetal Risk Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Fetal/Neonatal Adverse Reactions Oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension, and death. In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. In patients taking losartan potassium during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. Fetal testing may be appropriate, based on the week of gestation. If oligohydramnios is observed, discontinue losartan potassium, unless it is considered lifesaving for the mother. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe neonates with histories of in utero exposure to losartan potassium for hypotension, oliguria, and hyperkalemia. In neonates with a history of in utero exposure to losartan potassium, if oliguria or hypotension occurs, support blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. Data Animal Data Losartan potassium was administered orally to rats during the period of late gestation through lactation (Gestation Day 15 through Lactation Day 20) at doses of 10 mg/kg/day, 25 mg/kg/day, and 100 mg/kg/day. Losartan potassium has been shown to produce adverse effects in rat fetuses and neonates, including decreased body weight, delayed physical and behavioral development, mortality and renal toxicity. With the exception of neonatal weight gain (which was affected at doses as low as 10 mg/kg/day), doses associated with these effects exceeded 25 mg/kg/day (approximately three times the maximum recommended human dose of 100 mg on a mg/m 2 basis). These findings are attributed to drug exposure in late gestation and during lactation. Significant levels of losartan and its active metabolite were shown to be present in rat fetal plasma during late gestation and in rat milk.
Pediatric use
8.4 Pediatric Use Antihypertensive effects of losartan potassium 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 <30 mL/min/1.73 m 2 [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14.1 )] .
Geriatric use
8.5 Geriatric Use Of the total number of patients receiving losartan potassium 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. In a controlled clinical study for the reduction in the combined risk of cardiovascular death, stroke and myocardial infarction in hypertensive patients with left ventricular hypertrophy, 2857 patients (62%) were 65 years and over, while 808 patients (18%) were 75 years and over. No overall differences in effectiveness or safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Overdosage
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.
Description
Losartan potassium is an angiotensin II receptor blocker acting on the AT 1 receptor subtype. Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[ p -( o -1 H tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C 22 H 22 ClKN 6 O, and its structural formula is: Losartan potassium, USP is white to off-white powder with a molecular weight of 461.01. It is freely soluble in water; soluble in isopropyl alcohol; slightly soluble in acetonitrile. Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan. Losartan potassium tablets, USP 25 mg, 50 mg and 100 mg contain potassium in the following amounts: 2.12 mg (0.054 mEq), 4.24 mg (0.108 mEq) and 8.48 mg (0.216 mEq), respectively. Each losartan potassium tablet, USP intended for oral administration contains 25 mg or 50 mg or 100 mg of losartan potassium. In addition, each tablet contains the following inactive ingredients: colloidal silica anhydrous, hydroxypropyl cellulose (low substituted), hypromellose, lactose monohydrate, magnesium stearate, maize starch (corn starch), microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, talc and titanium dioxide. Losapotatab1
Mechanism of action
12.1 Mechanism of Action Angiotensin II [formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II)] is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system, and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT 1 receptor found in many tissues, (e.g., vascular smooth muscle, adrenal gland). There is also an AT 2 receptor found in many tissues but it is not known to be associated with cardiovascular homeostasis. Neither losartan nor its principal active metabolite exhibits any partial agonist activity at the AT 1 receptor, and both have much greater affinity (about 1000-fold) for the AT 1 receptor than for the AT 2 receptor. In vitro binding studies indicate that losartan is a reversible, competitive inhibitor of the AT 1 receptor. The active metabolite is 10 to 40 times more potent by weight than losartan and appears to be a reversible, non-competitive inhibitor of the AT 1 receptor. Neither losartan nor its active metabolite inhibits ACE (kininase II, the enzyme that converts angiotensin I to angiotensin II and degrades bradykinin), nor do they bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
How supplied
Losartan Potassium Tablets USP, 25 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z" on one side and "2"on other side and are supplied as follows: NDC 68382-135-06 in bottle of 30 tablets NDC 68382-135-16 in bottle of 90 tablets NDC 68382-135-01 in bottle of 100 tablets NDC 68382-135-10 in bottle of 1,000 tablets NDC 68382-135-24 in bottle of 10,000 tablets Losartan Potassium Tablets USP, 50 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z16" on one side and lip type breakline on other side and are supplied as follows: NDC 68382-136-06 in bottle of 30 tablets NDC 68382-136-16 in bottle of 90 tablets NDC 68382-136-01 in bottle of 100 tablets NDC 68382-136-10 in bottle of 1,000 tablets NDC 68382-136-24 in bottle of 10,000 tablets Losartan Potassium Tablets USP, 100 mg are white to off-white, capsule-shaped, film-coated tablets debossed with the logo of "Z18" on one side and plain on other side and are supplied as follows: NDC 68382-137-06 in bottle of 30 tablets NDC 68382-137-16 in bottle of 90 tablets NDC 68382-137-01 in bottle of 100 tablets NDC 68382-137-10 in bottle of 1,000 tablets NDC 68382-137-77 in cartons of 100 tablets (10 x 10 unit-dose) Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from light. Dispense in a tight, light-resistant container.
Patient information
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 ( 5.1 ) and Use in Specific Populations ( 8.1 )]. 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 ( 7.1 )] .
Label text from the FDA structured product label by Zydus Pharmaceuticals USA Inc. (revised Jul 20, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Losartan Potassium in 184 products
Losartan potassium NDC products (184)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-7888 | Losartan Potassium 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-4645 | Losartan Potassium 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-4712 | Losartan Potassium 100 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-4910 | Losartan Potassium 50 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-4914 | Losartan Potassium 100 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-5480 | Losartan Potassium 50 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-5626 | Losartan Potassium 25 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-6714 | Losartan Potassium 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7794 | Losartan Potassium 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7795 | Losartan Potassium 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7945 | Losartan Potassium 50 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-7946 | Losartan Potassium 50 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-4489 | Losartan Potassium 50 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-3403 | Losartan Potassium 100 mg/1 Tablet | A-S Medication Solutions | ANDA |
| 50090-2622 | Losartan Potassium 25 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 11788-102 | Losartan Potassium 100 mg/1 Tablet | AiPing Pharmaceutical, Inc. | ANDA |
| 11788-101 | Losartan Potassium 50 mg/1 Tablet | AiPing Pharmaceutical, Inc. | ANDA |
| 11788-100 | Losartan Potassium 25 mg/1 Tablet | AiPing Pharmaceutical, Inc. | ANDA |
| 62332-029 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-027 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 62332-028 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Inc. | ANDA |
| 46708-447 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Limited | ANDA |
| 46708-446 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Limited | ANDA |
| 46708-445 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Alembic Pharmaceuticals Limited | ANDA |
| 68084-348 | Losartan Potassium 100 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 68084-346 | Losartan Potassium 25 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 68084-347 | Losartan Potassium 50 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 71610-465 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-224 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-466 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-207 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-155 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-083 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-439 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 71610-440 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Aphena Pharma Solutions - Tennessee, LLC | ANDA |
| 65862-201 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-202 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-203 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 71335-1174 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-0262 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1102 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1136 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1221 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-2083 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1582 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1580 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 71335-1235 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 72162-2506 | Losartan Potassium 25 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-2507 | Losartan Potassium 50 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-2508 | Losartan Potassium 100 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 31722-701 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-700 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-702 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Camber Pharmaceuticals, Inc. | ANDA |
| 55154-2327 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-6643 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-4783 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-2333 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-2326 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 55154-2089 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Cardinal Health 107, LLC | ANDA |
| 67046-1510 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-1470 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-1088 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-0702 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 72189-082 | Losartan Potassium 25 mg/1 Tablet, Film Coated | DIRECT RX | ANDA |
| 72189-096 | Losartan Potassium 50 mg/1 Tablet, Film Coated | DIRECT RX | ANDA |
| 72189-100 | Losartan Potassium 25 mg/1 Tablet, Film Coated | DIRECT RX | ANDA |
| 72189-097 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Direct_Rx | ANDA |
| 72189-303 | Losartan Potassium 25 mg/1 Tablet, Film Coated | DirectRx | ANDA |
| 62207-741 | Losartan Potassium 25 mg/1 Tablet | Granules India Ltd | ANDA |
| 62207-742 | Losartan Potassium 50 mg/1 Tablet | Granules India Ltd | ANDA |
| 62207-743 | Losartan Potassium 100 mg/1 Tablet | Granules India Ltd | ANDA |
| 70010-743 | Losartan Potassium 100 mg/1 Tablet | Granules Pharmaceuticals Inc. | ANDA |
| 70010-742 | Losartan Potassium 50 mg/1 Tablet | Granules Pharmaceuticals Inc. | ANDA |
| 70010-741 | Losartan Potassium 25 mg/1 Tablet | Granules Pharmaceuticals Inc. | ANDA |
| 68180-307 | Losartan Potassium 25 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-378 | Losartan Potassium 100 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-212 | Losartan Potassium 100 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-377 | Losartan Potassium 50 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-210 | Losartan Potassium 25 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-211 | Losartan Potassium 50 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-376 | Losartan Potassium 25 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-309 | Losartan Potassium 100 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 68180-308 | Losartan Potassium 50 mg/1 Tablet | Lupin Pharmaceuticals, Inc. | ANDA |
| 33342-046 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA |
| 33342-045 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA |
| 33342-044 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Macleods Pharmaceuticals Limited | ANDA |
| 0904-7047 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-7048 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0904-7049 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Major Pharmaceuticals | ANDA |
| 0615-7959 | Losartan Potassium 50 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-7960 | Losartan Potassium 100 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 0615-7958 | Losartan Potassium 25 mg/1 Tablet, Film Coated | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA |
| 72603-342 | Losartan Potassium 100 mg/1 Tablet, Film Coated | NorthStar RxLLC | ANDA |
| 72603-341 | Losartan Potassium 50 mg/1 Tablet, Film Coated | NorthStar RxLLC | ANDA |
| 72603-340 | Losartan Potassium 25 mg/1 Tablet, Film Coated | NorthStar RxLLC | ANDA |
| 51655-828 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-418 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-791 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-795 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 51655-918 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Northwind Health Company, LLC | ANDA |
| 72205-143 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Novadoz Pharmaceuticals LLC | ANDA |
| 72205-142 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Novadoz Pharmaceuticals LLC | ANDA |
| 72205-141 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Novadoz Pharmaceuticals LLC | ANDA |
| 68071-5040 | Losartan Potassium 50 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5209 | Losartan Potassium 50 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-1517 | Losartan Potassium 50 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,iNc. | ANDA |
| 68071-2203 | Losartan Potassium 100 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2216 | Losartan Potassium 100 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2344 | Losartan Potassium 100 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2690 | Losartan Potassium 50 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4471 | Losartan Potassium 50 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5212 | Losartan Potassium 50 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5181 | Losartan Potassium 100 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5175 | Losartan Potassium 50 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5147 | Losartan Potassium 25 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4943 | Losartan Potassium 50 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5041 | Losartan Potassium 25 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5114 | Losartan Potassium 25 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3846 | Losartan Potassium 100 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals.Inc. | ANDA |
| 72789-163 | Losartan Potassium 25 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-854 | Losartan Potassium 50 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-954 | Losartan Potassium 100 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-955 | Losartan Potassium 50 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-282 | Losartan Potassium 25 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-029 | Losartan Potassium 25 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-044 | Losartan Potassium 100 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-164 | Losartan Potassium 50 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-165 | Losartan Potassium 100 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-179 | Losartan Potassium 50 mg/1 Tablet, Film Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68788-8189 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8186 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-4160 | Losartan Potassium 50 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-4127 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-4091 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-4007 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7665 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals, Inc. | ANDA |
| 63187-808 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-830 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-708 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-357 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-296 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-675 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-598 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-281 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 71205-226 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 42708-152 | Losartan Potassium 50 mg/1 Tablet, Film Coated | QPharma, Inc. | ANDA |
| 42708-151 | Losartan Potassium 25 mg/1 Tablet, Film Coated | QPharma, Inc. | ANDA |
| 42708-125 | Losartan Potassium 25 mg/1 Tablet, Film Coated | QPharma, Inc. | ANDA |
| 42708-113 | Losartan Potassium 50 mg/1 Tablet, Film Coated | QPharma, Inc. | ANDA |
| 42708-055 | Losartan Potassium 50 mg/1 Tablet, Film Coated | QPharma, Inc. | ANDA |
| 82009-043 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-044 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Quallent Pharmaceuticals Health LLC | ANDA |
| 82009-042 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Quallent Pharmaceuticals Health LLC | ANDA |
| 67296-2225 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Redpharm Drug | ANDA |
| 70518-0245 | Losartan Potassium 50 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-0718 | Losartan Potassium 100 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4695 | Losartan Potassium 100 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-4289 | Losartan Potassium 100 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-3894 | Losartan Potassium 25 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-3489 | Losartan Potassium 25 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-3282 | Losartan Potassium 50 mg/1 Tablet | REMEDYREPACK INC. | ANDA |
| 70518-2132 | Losartan Potassium 25 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-2316 | Losartan Potassium 50 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 43547-362 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Solco Healthcare US, LLC | ANDA |
| 43547-361 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Solco Healthcare US, LLC | ANDA |
| 43547-360 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Solco Healthcare US, LLC | ANDA |
| 60760-786 | Losartan Potassium 50 mg/1 Tablet, Film Coated | St. Mary's Medical Park Pharmacy | ANDA |
| 64380-934 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Strides Pharma Science Limited | ANDA |
| 64380-935 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Strides Pharma Science Limited | ANDA |
| 64380-933 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Strides Pharma Science Limited | ANDA |
| 29300-144 | Losartan Potassium 25 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-145 | Losartan Potassium 50 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 29300-146 | Losartan Potassium 100 mg/1 Tablet | Unichem Pharmaceuticals (USA), Inc. | ANDA |
| 87441-053 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Unit Dose Solutions, Inc. | ANDA |
| 87441-052 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Unit Dose Solutions, Inc. | ANDA |
| 72865-141 | Losartan Potassium 25 mg/1 Tablet, Film Coated | XLCare Pharmaceuticals, Inc. | ANDA |
| 72865-142 | Losartan Potassium 50 mg/1 Tablet, Film Coated | XLCare Pharmaceuticals, Inc. | ANDA |
| 72865-143 | Losartan Potassium 100 mg/1 Tablet, Film Coated | XLCare Pharmaceuticals, Inc. | ANDA |
| 65841-729 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Zydus Lifesciences Limited | ANDA |
| 65841-730 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Zydus Lifesciences Limited | ANDA |
| 65841-731 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Zydus Lifesciences Limited | ANDA |
| 68382-137 | Losartan Potassium 100 mg/1 Tablet, Film Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
| 68382-136 | Losartan Potassium 50 mg/1 Tablet, Film Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
| 68382-135 | Losartan Potassium 25 mg/1 Tablet, Film Coated | Zydus Pharmaceuticals USA Inc. | ANDA |
Losartan potassium recalls
- D-0895-2023 Jul 12, 2023 · Class II · Terminated
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet. - D-1163-2022 Jul 6, 2022 · Class II · Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - D-1162-2022 Jul 6, 2022 · Class II · Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - D-1161-2022 Jul 6, 2022 · Class II · Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - D-0974-2022 Jun 8, 2022 · Class II · Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - D-0973-2022 Jun 8, 2022 · Class II · Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - D-0972-2022 Jun 8, 2022 · Class II · Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - D-0832-2022 May 11, 2022 · Class II · Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - D-0840-2022 May 11, 2022 · Class II · Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - D-0839-2022 May 11, 2022 · Class II · Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - D-0838-2022 May 11, 2022 · Class II · Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - D-0834-2022 May 11, 2022 · Class II · Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - D-0833-2022 May 11, 2022 · Class II · Terminated
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits - D-0341-2021 May 5, 2021 · Class II · Terminated
CGMP deviation: Product found to contain trace amounts of NMBA - D-1457-2019 Jul 17, 2019 · Class II · Terminated
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. - D-1458-2019 Jul 17, 2019 · Class II · Terminated
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products. - D-1041-2019 Mar 27, 2019 · Class II · Ongoing
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient - D-1042-2019 Mar 27, 2019 · Class II · Ongoing
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient - D-1043-2019 Mar 27, 2019 · Class II · Ongoing
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Frequently asked questions
What is Losartan potassium used for?
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…
What are the side effects of Losartan potassium?
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… See the full label for the complete list.
Who makes Losartan potassium?
Losartan potassium is listed by 42 labelers in the FDA NDC directory, including A-S Medication Solutions, AiPing Pharmaceutical, Inc., Alembic Pharmaceuticals Inc., Alembic Pharmaceuticals Limited.
Has Losartan potassium been recalled?
The FDA enforcement database lists 19 recalls for Losartan potassium, most recently D-0895-2023 (class ii): Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.