Mediclarum
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Losartan Potassium

25 mg · Tablet, Film Coated

  • Prescription only
  • Angiotensin 2 Receptor Blocker
Active substance
Losartan Potassium
Made by
Camber Pharmaceuticals, Inc.

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-10-09

What it is

Angiotensin 2 Receptor Blocker

Used for
  • Treatment of hypertension, to lower blood pressure in
The label’s usual adult dose

Usual adult dose: 50 mg once daily. ( 2.1 )

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 tablets 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 tablets is 25 mg once daily. Losartan potassium tablets has not been studied in patients with severe hepatic impairment [see Use in Special 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 TM and Ora-Sweet SF TM . Add 190 mL of the 50/50 Ora-Plus TM /Ora-Sweet SF TM 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.

Full directions ↓
Serious warning

FETAL TOXICITY When pregnancy is detected, discontinue losartan Potassium tablets as soon as possible.

All warnings ↓
Good to know
  • Prescription only
133other products contain Losartan Potassium — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is 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 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 tablets 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 )].

From the official label · 2025-10-09 · DailyMed

How it works

From this product’s own US prescribing label.

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.

Peak level after1 h
Half-life2 h
Mostly cleared after≈ 10 hfive half-lives — our arithmetic
PeakHalf gone10 h0
The shape is a standard model drawn from the two times above, not a measurement. How fast a medicine acts and wears off also depends on the dose, the form and the person.
How it leaves the body

After single doses of losartan administered orally, about 4% of the dose is excreted unchanged in the urine and about 6% is excreted in urine as active metabolite.

With food

A meal slows absorption of losartan and decreases its C max but has only minor effects on losartan AUC or on the AUC of the metabolite (~10% decrease).

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-10-09

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

  • FETAL TOXICITY 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 [see Warnings and Precautions (5.1)].
  • 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 )

Quoted from the official label, section “Boxed Warning”.

Do not take it if

  • 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 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • 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 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
  • 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 tablets 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 tablets is 25 mg once daily. Losartan potassium tablets has not been studied in patients with severe hepatic impairment [see Use in Special 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 TM and Ora-Sweet SF TM . Add 190 mL of the 50/50 Ora-Plus TM /Ora-Sweet SF TM 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • 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 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 tablets 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 tablets. Correct volume or salt depletion prior to administration of losartan potassium tablets [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 tablets 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 )].

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • 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 reninangiotensin 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, 25, 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.
  • IN SPECIFIC POPULATIONS
  • Losartan potassium tablets are 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 reninangiotensin 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, 25, 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. 8.6 Race In the LIFE study, Black patients with hypertension and left ventricular hypertrophy treated with atenolol were at lower risk of experiencing the primary composite endpoint compared with Black patients treated with losartan potassium (both cotreated with hydrochlorothiazide in the majority of patients). The primary endpoint was the first occurrence of stroke, myocardial infarction or cardiovascular death, analyzed using an intention-to-treat (ITT) approach. In the subgroup of Black patients (n=533, 6% of the LIFE study patients), there were 29 primary endpoints among 263 patients on atenolol (11%, 26 per 1000 patient-years) and 46 primary endpoints among 270 patients (17%, 42 per 1000 patient-years) on losartan potassium. This finding could not be explained on the basis of differences in the populations other than race or on any imbalances between treatment groups. In addition, blood pressure reductions in both treatment groups were consistent between Black and non-Black patients. Given the difficulty in interpreting subset differences in large trials, it cannot be known whether the observed difference is the result of chance. However, the LIFE study provides no evidence that the benefits of losartan potassium on reducing the risk of cardiovascular events in hypertensive patients with left ventricular hypertrophy apply to Black patients [see Clinical Studies ( 14.2 )]. 8.7 Renal Impairment Patients with renal insufficiency have elevated plasma concentrations of losartan and its active metabolite compared to subjects with normal renal function. No dose adjustment is necessary in patients with renal impairment unless a patient with renal impairment is also volume depleted [see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.3 ) and Clinical Pharmacology ( 12.3 )]. 8.8 Hepatic Impairment The recommended starting dose of losartan potassium tablets is 25 mg in patients with mild-to-moderate hepatic impairment. Following oral administration in patients with mild-to-moderate hepatic impairment, plasma concentrations of losartan and its active metabolite were, respectively, 5 times and 1.7 times those seen in healthy volunteers. losartan potassium has not been studied in patients with severe hepatic impairment [see Dosage and Administration ( 2.4 ) and Clinical Pharmacology ( 12.3 )].

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • 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 nhibition 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).

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • 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.

Quoted from the official label, section “Overdosage”.

Use in children

  • 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) ].

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • 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.

Quoted from the official label, section “Geriatric Use”.

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 Hetero Labs Limited at 1-866-495-1995 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:
  • Study 1* HCTZ Losartan Lisinopril cough 25% 17% 69% Study 2 † Placebo Losartan Lisinopril Cough 35% 29% 62% * Demographics = (89% Caucasian, 64% female) † Demographics = (90% Caucasian, 51% female) 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.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

  • 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 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 )].
  • The trademarks depicted herein are owned by their respective companies.
  • Manufactured for:
  • Camber Pharmaceuticals, Inc., Piscataway, NJ 08854 Manufactured by:
  • HETERO TM Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar - 509 301, India.
  • Revised: 08/2025 losartancamberlogo

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

  • FORMS AND STRENGTHS
  • Losartan potassium tablets USP, 25 mg are white to off white, film coated, oval shaped tablets debossed with 'I' on one side and '5' on the other side.
  • Losartan potassium tablets USP, 50 mg are white to off white, film coated, oval shaped tablets debossed with 'I' on one side and '6' on the other side with score line.
  • Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with 'H' on one side and '145' on the other side. Tablets:
  • 25 mg; 50 mg; and 100 mg. ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • Losartan potassium tablets USP, 25 mg are white to off-white, film coated, oval shaped tablets debossed with 'I' on one side and '5' on the other side.
  • Bottles of 30 tablets (NDC 31722-700-30) Bottles of 60 tablets (NDC 31722-700-60) Bottles of 90 tablets (NDC 31722-700-90) Bottles of 500 tablets (NDC 31722-700-05) Bottles of 1000 tablets (NDC 31722-700-10) Losartan potassium tablets USP, 50 mg are white to off-white, film coated, oval shaped tablets debossed with 'I' on one side and '6' on the other side with score line.
  • Bottles of 30 tablets (NDC 31722-701-30) Bottles of 60 tablets (NDC 31722-701-60) Bottles of 90 tablets (NDC 31722-701-90) Bottles of 500 tablets (NDC 31722-701-05) Bottles of 1000 tablets (NDC 31722-701-10) Losartan potassium tablets USP, 100 mg are white to off-white, film coated, tear drop shaped tablets debossed with 'H' on one side and '145' on the other side.
  • Bottles of 30 tablets (NDC 31722-702-30) Bottles of 60 tablets (NDC 31722-702-60) Bottles of 90 tablets (NDC 31722-702-90) Bottles of 500 tablets (NDC 31722-702-05) Bottles of 1000 tablets (NDC 31722-702-10) Storage
  • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • Keep container tightly closed.
  • Protect from light.

Quoted from the official label, section “How Supplied”.

What is in it

  • 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-l-[(2'-(lH-tetrazol-5-yl)[1,1'-biphenyl]-4-yl]methyl]-lH-imidazole-5-methanol mono potassium salt.
  • Its molecular formula is C 22 H 22 ClKN 6 O, and its structural formula is:
  • Losartan potassium, USP is a white to off-white powder with a molecular weight of 461.01.
  • It is freely soluble in water and slightly soluble in acetonitrile.
  • Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan.
  • Losartan potassium is available as tablets for oral administration containing either 25 mg, 50 mg or 100 mg of losartan potassium, USP and the following inactive ingredients:
  • crospovidone, lactose monohydrate, low substituted hydroxy propyl cellulose, magnesium stearate, microcrystalline cellulose and pregelatinized starch.
  • The tablets are coated with Opadry White which contains carnauba wax, hypromellose and titanium dioxide.
  • Losartan potassium tablets USP, 25 mg, 50 mg and 100 mg tablets 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.
  • The botanical source for pregelatinized starch is corn starch. losartanstructure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Lactoselactose monohydrateMilk sugar: matters with lactose intolerance or a milk allergy.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

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Details

Made byCamber Pharmaceuticals, Inc.
Active substanceLosartan Potassium
Used inHeart, blood pressure and circulation
Strength25 mg
FormTablet, Film Coated
RouteOral
Packs500 TABLET, FILM COATED in 1 BOTTLE · 1000 TABLET, FILM COATED in 1 BOTTLE
NDC31722-700

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

113 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

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Arbli10 mg/mLPrescription onlySuspension Scienture LLC · Losartan PotassiumCozaar25 mgPrescription onlyTablet, Film Coated Organon LLC · Losartan PotassiumCozaar50 mgPrescription onlyTablet, Film Coated Organon LLC · Losartan PotassiumCozaar100 mgPrescription onlyTablet, Film Coated Organon LLC · Losartan PotassiumLosartan Potassium25 mgPrescription onlyTablet, Film Coated NCS HealthCare of KY, LLC dba Vangard Labs · Losartan PotassiumLosartan Potassium50 mgPrescription onlyTablet, Film Coated NCS HealthCare of KY, LLC dba Vangard Labs · Losartan Potassium

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