Losartan (Lexi-Drugs)

ALERT: US Boxed Warning
  Fetal toxicity:
Pronunciation

(loe SAR tan)

Brand Names: US

Cozaar

Brand Names: Canada

ACT Losartan; AG-Losartan; APO-Losartan; Auro-Losartan; BIO-Losartan; Cozaar; JAMP-Losartan; MINT-Losartan; MYLAN-Losartan [DSC]; PMS-Losartan; Priva-Losartan; RAN-Losartan; SANDOZ Losartan; Septa-Losartan; TEVA-Losartan; VAN-Losartan

Dosing: Adult

Hypertension: Oral: Initial: 50 mg once daily; titrate as needed based on patient response up to 100 mg daily in 1 to 2 divided doses (ACC/AHA [Whelton 2017]); maximum: 100 mg/day

Usual initial doses in patients receiving diuretics or those with intravascular volume depletion: 25 mg once daily

Diabetic nephropathy: Oral: Initial: 50 mg once daily; can be increased to 100 mg once daily based on blood pressure response

Hypertension with left ventricular hypertrophy: Oral: Initial: 50 mg once daily; can be increased to 100 mg once daily based on blood pressure response. Should be used in combination with a thiazide diuretic

Heart failure (off-label use): Initial: 25 to 50 mg once daily; titrate up as tolerated; target dose: 150 mg once daily (ACC/AHA [Yancy 2013]).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

No dosage adjustment necessary unless the patient is volume depleted; monitor closely.

Hemodialysis: Nondialyzable (both Losartan and the active metabolite)

Dosing: Hepatic Impairment: Adult

US labeling:

Mild to moderate hepatic impairment: Initial: 25 mg once daily

Severe hepatic impairment: There are no specific dosage adjustments provided in the manufacturer’s labeling (has not been studied); however, it may be advisable to initiate therapy at a reduced dosage.

Canadian labeling: Mild to severe hepatic impairment or a history of hepatic impairment: Initial: 25 mg once daily

Dosing: Pediatric

Hypertension:

Children ≥6 years and Adolescents: Oral: Initial: 0.7 mg/kg once daily; maximum initial dose: 50 mg/dose; titrate to desired effect; maximum daily dose: 1.4 mg/kg/day or 100 mg/day; may be administered once daily or divided twice daily (AAP [Flynn 2017]; NHBPEP 2004; NHLBI 2011); Note: Doses >1.4 mg/kg/day (or >100 mg/day) have not been studied (Shahinfar 2005).

Canadian labeling: Children ≥6 years and Adolescents ≤16 years: Oral: Cozaar prescribing information [Canada]:

≥20 kg to <50 kg: Initial: 25 mg once daily; titrate to desired effect; maximum dose: 50 mg/day

≥50 kg: Initial: 50 mg once daily; titrate to desired effect; maximum dose: 100 mg/day

Proteinuria reduction in children with chronic kidney disease: Limited data available: Children ≥4 years and Adolescents: Oral: Initial: 0.4 to 0.8 mg/kg/day; increase dose if no adverse effects occur and blood pressure remains >90th percentile or proteinuria does not fall <50% of baseline excretion; doses can be increased slowly up to 1 mg/kg/day (maximum: 50 mg/day); dosing based on experience from three retrospective clinical trials (Chandar 2007; Ellis 2003; Ellis 2004)

Marfan syndrome aortic-root dilation: Limited data available: Children and Adolescents 14 months to 16 years: Oral: Initial: 0.6 mg/kg/day for 3 weeks (while assessing for adverse events); then gradually increase dose to 1.4 mg/kg/day (maximum: 100 mg/day); dosing based on preliminary results of a small (n=18), nonrandomized, retrospective, clinical study (Brooke 2008)

Dosing: Renal Impairment: Pediatric

Children and Adolescents: Use is not recommended if CrCl <30 mL/minute/1.73 m2; nondialyzable (both losartan and the active metabolite).

Dosing: Hepatic Impairment: Pediatric

Children and Adolescents:

Mild to moderate impairment: There are no pediatric-specific dosing recommendations provided by the manufacturer; however, it is advisable to initiate at a reduced dose.

Severe impairment: There are no dosing recommendations provided by the manufacturer (has not been studied).

Use: Labeled Indications

Diabetic nephropathy: 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.

Hypertension: Management of hypertension in adults and children ≥6 years.

Guideline recommendations: The 2017 Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults recommends if monotherapy is warranted, in the absence of comorbidities (eg, cerebrovascular disease, chronic kidney disease, diabetes, heart failure, ischemic heart disease, etc.), that thiazide-like diuretics or dihydropyridine calcium channel blockers may be preferred options due to improved cardiovascular endpoints (eg, prevention of heart failure and stroke). ACE inhibitors and ARBs are also acceptable for monotherapy. Combination therapy may be required to achieve blood pressure goals and is initially preferred in patients at high risk (stage 2 hypertension or atherosclerotic cardiovascular disease [ASCVD] risk ≥10%) (ACC/AHA [Whelton 2017]).

Hypertension with left ventricular hypertrophy: To reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy (LVH). Evidence suggests that this benefit does not apply to black patients.

Use: Off-Label: Adult

  Acute coronary syndrome (secondary prevention of cardiovascular events)Level of Evidence [G]

Based on the American Heart Association/American College of Cardiology (AHA/ACC) guidelines for the management of patients with non-ST-elevation acute coronary syndromes (NSTE-ACS) and the American College of Cardiology Foundation/American Heart Association (ACC/AHA) guidelines for the management of patients with STE-ACS, an ARB is recommended and effective in patients with NSTE-ACS or STE-ACS who have indications for but are intolerant of ACE inhibitors; this includes patients with heart failure, MI, or anterior MI who have a left ventricular ejection fraction (LVEF) ≤40%. In post-STE-ACS patients, initiate within the first 24 hours.

  Heart failure, intolerant of ACE inhibitorsLevel of Evidence [B, G]

Data from a randomized, double-blind, dose comparison study in patients with heart failure NYHA class II to IV supports the use of losartan at higher doses to reduce the rate of death or admission for heart failure in patients with heart failure Ref.

Based on the American College of Cardiology/American Heart Association (ACC/AHA) 2013 Heart Failure Guidelines, losartan is one of 3 effective and recommended angiotensin receptor blockers (ARBs) (ie, candesartan, losartan, and valsartan) in patients with heart failure with reduced ejection fraction (HFrEF) who cannot tolerate ACE inhibitors to reduce morbidity and mortality. The ACC/AHA also suggests that ARBs are reasonable first-line alternatives to ACE inhibitors in patients already maintained on an ARB for other indications.

  Stable coronary artery diseaseLevel of Evidence [G]

Based on the American College of Cardiology/American Heart Association guideline for the diagnosis and management of patients with stable ischemic heart disease, an ACE inhibitor or ARB should be prescribed in all patients with stable ischemic heart disease who also have hypertension, diabetes mellitus, LVEF <40%, or CKD unless contraindicated.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Atrial Fibrillation:

AHA/ACC/HRS, “2014 AHA/ACC/HRS Guideline for the Management of Patients with Atrial Fibrillation,” March 2014

Chronic Kidney Disease:

KDIGO 2012 Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease, January 2013

Coronary Artery Bypass Graft Surgery:

ACC/AHA, “2011 ACC/AHA Guideline for Coronary Artery Bypass Graft Surgery,” November 2011

AHA Scientific Statement, “Secondary Prevention After Coronary Artery Bypass Graft Surgery,” February 2015

Diabetes Mellitus:

American Diabetes Association, “Standards of Medical Care in Diabetes – 2018,” January 2018

Diabetes Canada, “Clinical Practice Guidelines for the Prevention and Management of Diabetes in Canada,” 2018

Heart Failure:

ACC/AHA, “2013 ACC/AHA Guideline for the Management of Heart Failure,” June 2013

ACC/AHA/HFSA, “2016 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure,” May 2016

“HFSA 2010 Comprehensive Heart Failure Practice Guideline,” July 2010

Hypertension:

“2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults,” November 2017.

AHA/ACC/ASH, “Treatment of Hypertension in Patients with Coronary Artery Disease: A Scientific Statement by the American Heart Association, American College of Cardiology and American Society of Hypertension,” May 2015

“ACC/AHA Expert Consensus Document on Hypertension in the Elderly,” 2011

AHA/ACC/CDC, “AHA/ACC/CDC Science Advisory: An Effective Approach to High Blood Pressure Control” November 2013

ASH/ISH, “Clinical Practice Guidelines for the Management of Hypertension in the Community: A Statement by the American Society of Hypertension and the International Society of Hypertension,” January 2014

Eighth Joint National Committee (JNC 8), “2014 Evidence-based Guideline for the Management of High Blood Pressure in Adults,” December 2013

“National High Blood Pressure Education Program Working Group on High Blood Pressure in Children and Adolescents,” May 2005

Ischemic Heart Disease:

ACC/AHA/AATS/PCNA/SCAI/STS, “2014 Focused Update of the Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease,” July 2014

ACC/AHA/ACP/AATS/PCNA/SCAI/STS, “2012 Guideline for the Diagnosis and Management of Patients with Stable Ischemic Heart Disease,” November 2012

AHA/ACC, “2014 AHA/ACC Guideline for the Management of Patients with Non-ST-Elevation Acute Coronary Syndromes,” September 2014

ACC/AHA “2013 guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines”, January 2013

Peripheral Arterial Disease:

ACC/AHA, “2011 ACC/AHA Focused Update of the Guideline for the Management of Patients with Peripheral Artery Disease (Updating the 2005 Guideline),” September 2011

Prevention:

“AHA/ACC Secondary Prevention and Risk Reduction Therapy for Patients with Coronary and Other Atherosclerotic Vascular Disease: 2011 Update,” November 2011

Surgery:

ACC/AHA, “2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery,” August 2014

Valvular Heart Disease:

AHA/ACC, “2014 AHA/ACC Guideline for the Management of Patients with Valvular Heart Disease,” March 2014

Administration: Oral

Administer without regard to meals; however, administer consistently with respect to food intake at about the same time every day.

Administration: Pediatric

Oral: May be administered with or without food.

Dietary Considerations

Some products may contain potassium.

Storage/Stability

Store at 25°C (77°F); excursions are permitted to 15°C to 30°C (59°F to 86°F). Protect from light.

Extemporaneously Prepared

A 2.5 mg/mL losartan oral suspension may be made with tablets and a 1:1 mixture of Ora-Plus and Ora-Sweet SF. Combine 10 mL of purified water and ten losartan 50 mg tablets in a 240 mL amber polyethylene terephthalate bottle. Shake well for at least 2 minutes. Allow concentrate to stand for 1 hour, then shake for 1 minute. Separately, prepare 190 mL of a 1:1 mixture of Ora-Plus and Ora-Sweet SF; add to tablet and water mixture in the bottle and shake for 1 minute. Label “shake well” and “refrigerate”. Return promptly to refrigerator after each use. Stable for 4 weeks when stored in amber polyethylene terephthalate prescription bottles and refrigerated (Cozaar prescribing information 2018).

Cozaar (losartan) [prescribing information]. Whitehouse Station, NJ: Merck Sharp & Dohme; October 2018.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience diarrhea, cold-like symptoms, back pain, loss of strength, and energy or rhinorrhea. Have patient report immediately to prescriber signs of kidney problems (urinary retention, blood in urine, change in amount of urine passed, weight gain), signs of high potassium (abnormal heartbeat, confusion, dizziness, passing out, weak, shortness of breath, numbness or tingling feeling), signs of low blood sugar (dizziness, headache, fatigue, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating), severe dizziness, passing out, angina, or swelling of arms or legs (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patients should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
Contraindications

Hypersensitivity to losartan or any component of the formulation; concomitant use with aliskiren in patients with diabetes mellitus

Documentation of allergenic cross-reactivity for angiotensin receptor blockers is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Canadian labeling: Additional contraindications (not in US labeling): Concomitant use with aliskiren in patients with moderate-to-severe renal impairment (GFR <60 mL/minute/1.73 m2)

Warnings/Precautions

Concerns related to adverse effects:

• Angioedema: Angioedema has been reported rarely with some angiotensin II receptor antagonists (ARBs) and may occur at any time during treatment (especially following first dose). It may involve the head and neck (potentially compromising airway) or the intestine (presenting with abdominal pain). Patients with idiopathic or hereditary angioedema or previous angioedema associated with angiotensin-converting enzyme (ACE) inhibitor therapy may be at an increased risk. Prolonged frequent monitoring may be required, especially if tongue, glottis, or larynx are involved, as they are associated with airway obstruction. Patients with a history of airway surgery may have a higher risk of airway obstruction. Discontinue therapy immediately if angioedema occurs. Aggressive early management is critical. Intramuscular (IM) administration of epinephrine may be necessary. Do not readminister to patients who have had angioedema with ARBs.

• Hyperkalemia: May occur; risk factors include renal dysfunction, diabetes mellitus, concomitant use of potassium-sparing diuretics, potassium supplements and/or potassium containing salts. Use cautiously, if at all, with these agents and monitor potassium closely.

• Hypotension: Symptomatic hypotension may occur upon initiation in patients who are salt or volume depleted (eg, those treated with high-dose diuretics); correct volume depletion prior to administration. This transient hypotensive response is not a contraindication to further treatment with losartan.

• Renal function deterioration: May be associated with deterioration of renal function and/or increases in serum creatinine, particularly in patients with low renal blood flow (eg, renal artery stenosis, heart failure) whose glomerular filtration rate (GFR) is dependent on efferent arteriolar vasoconstriction by angiotensin II; deterioration may result in oliguria, acute renal failure, and progressive azotemia. Small increases in serum creatinine may occur following initiation; consider discontinuation only in patients with progressive and/or significant deterioration in renal function.

Disease-related concerns:

• Aortic/mitral stenosis: Use with caution in patients with significant aortic/mitral stenosis.

• Ascites: Avoid use in patients with ascites due to cirrhosis or refractory ascites; if use cannot be avoided in patients with ascites due to cirrhosis, monitor blood pressure and renal function carefully to avoid rapid development of renal failure (AASLD [Runyon 2012]).

• Hepatic impairment: Use with caution in patients with hepatic impairment or a history of hepatic impairment; dose adjustment needed.

• Renal artery stenosis: Use with caution in patients with unstented unilateral/bilateral renal artery stenosis. When unstented bilateral renal artery stenosis is present, use is generally avoided due to the elevated risk of deterioration in renal function unless possible benefits outweigh risks.

• Renal impairment: Use with caution with preexisting renal insufficiency.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Black patients: When used to reduce the risk of stroke in patients with HTN and LVH, may not be effective in the black population.

• Pregnancy: [US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected.

• Surgical patients: In patients on chronic angiotensin receptor blocker (ARB) therapy, intraoperative hypotension may occur with induction and maintenance of general anesthesia; however, discontinuation of therapy prior to surgery is controversial. If continued preoperatively, avoidance of hypotensive agents during surgery is prudent (Hillis 2011). Based on current research and clinical guidelines in patients undergoing noncardiac surgery, continuing angiotensin-receptor blockers (ARB) is reasonable in the perioperative period. If ARBs are held before surgery, it is reasonable to restart postoperatively as soon as clinically feasible (ACC/AHA [Fleisher 2014]).

Geriatric Considerations

Serum concentrations of losartan and its metabolites are not significantly different and no initial dose adjustment is necessary even in low creatinine clearance states (<30 mL/minute). Many elderly may be volume depleted due to diuretic use and/or blunted thirst reflex resulting in inadequate fluid intake.

The AHA/ACC/ASH 2015 scientific statement on the treatment of hypertension in patients with CAD warns to use caution to avoid decreases in DBP <60 mm Hg especially in patients >60 years of age since reduced coronary perfusion may occur. When lowering SBP in older hypertensive patients with wide pulse pressures, very low DBP values (<60 mm Hg) may result. In patients with obstructive CAD, clinicians should lower blood pressure slowly and carefully monitor for any untoward signs or symptoms, especially those resulting from myocardial ischemia and worsening heart failure (AHA/ACC/ASH [Rosendorff 2015]).

Warnings: Additional Pediatric Considerations

Not recommended for use in children <6 years of age or in children with GFR <30 mL/minute/1.73m2 (no data exists).

Pregnancy Risk Factor

D

Pregnancy Considerations

[US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected. The use of drugs which act on the renin-angiotensin system are associated with oligohydramnios. Oligohydramnios, due to decreased fetal renal function, may lead to fetal lung hypoplasia and skeletal malformations. Use is also associated with anuria, hypotension, renal failure, skull hypoplasia, and death in the fetus/neonate. The exposed fetus should be monitored for fetal growth, amniotic fluid volume, and organ formation. Infants exposed in utero should be monitored for hyperkalemia, hypotension, and oliguria (exchange transfusions or dialysis may be needed). These adverse events are generally associated with maternal use in the second and third trimesters.

Untreated chronic maternal hypertension is also associated with adverse events in the fetus, infant, and mother. The use of angiotensin II receptor blockers is not recommended to treat chronic uncomplicated hypertension in pregnant women and should generally be avoided in women of reproductive potential (ACOG, 2013).

Breast-Feeding Considerations

It is not known if losartan is present in breast milk. Due to the potential for serious adverse reactions in the breastfeeding infant, the manufacturer recommends a decision be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of treatment to the mother.

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Incidences occurred with hypertensive patients unless otherwise specified.

1% to 10%:

Cardiovascular: Chest pain (type 2 diabetic nephropathy: ≥4%), hypotension (type 2 diabetic nephropathy: ≥4%), orthostatic hypotension (type 2 diabetic nephropathy: ≥4%), atrial fibrillation (<2%), cerebrovascular accident (<2%), edema (<2%), palpitations (<2%), syncope (<2%)

Central nervous system: Fatigue (type 2 diabetic nephropathy: ≥4%), myasthenia (type 2 diabetic nephropathy: ≥4%), dizziness (3%), depression (<2%), drowsiness (<2%), headache (<2%), migraine (<2%), paresthesia (<2%), sleep disorder (<2%), vertigo (<2%)

Dermatologic: Pruritus (<2%), skin photosensitivity (<2%), skin rash (<2%), urticaria (<2%)

Endocrine & metabolic: Hyperkalemia (type 2 diabetic nephropathy: ≥4%), hypoglycemia (type 2 diabetic nephropathy: ≥4%)

Gastrointestinal: Diarrhea (type 2 diabetic nephropathy: ≥4%), abdominal pain (<2%), constipation (<2%), nausea (<2%), vomiting (<2%)

Genitourinary: Urinary tract infection (type 2 diabetic nephropathy: ≥4%), impotence (<2%)

Hematologic & oncologic: Anemia (type 2 diabetic nephropathy: ≥4%; hypertension: <2%)

Neuromuscular & skeletal: Asthenia (type 2 diabetic nephropathy: ≥4%), back pain (hypertension and type 2 diabetic neuropathy: 2% to ≥4%), arthralgia (<2%), myalgia (<2%)

Otic: Tinnitus (<2%)

Respiratory: Upper respiratory tract infection (8%), cough (ARBs: 3%; Matchar 2008), nasal congestion (2%), dyspnea (<2%)

<1%, postmarketing, and/or case reports: Anaphylaxis, angioedema, dysgeusia, erythroderma, facial edema, glottis edema, Henoch-Schonlein purpura, hepatitis, hyponatremia, laryngeal edema, lip edema, malaise, pharyngeal edema, rhabdomyolysis, thrombocytopenia, tongue edema, vasculitis

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

Substrate of CYP2C9 (major), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Aliskiren: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Aliskiren may enhance the hypotensive effect of Angiotensin II Receptor Blockers. Aliskiren may enhance the nephrotoxic effect of Angiotensin II Receptor Blockers. Management: Aliskiren use with ACEIs or ARBs in patients with diabetes is contraindicated. Combined use in other patients should be avoided, particularly when CrCl is less than 60 mL/min. If combined, monitor potassium, creatinine, and blood pressure closely. Risk D: Consider therapy modification

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Risk D: Consider therapy modification

Amphetamines: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Angiotensin II: Receptor Blockers may diminish the therapeutic effect of Angiotensin II. Risk C: Monitor therapy

Angiotensin-Converting Enzyme Inhibitors: Angiotensin II Receptor Blockers may enhance the adverse/toxic effect of Angiotensin-Converting Enzyme Inhibitors. Angiotensin II Receptor Blockers may increase the serum concentration of Angiotensin-Converting Enzyme Inhibitors. Management: In US labeling, use of telmisartan and ramipril is not recommended. It is not clear if any other combination of an ACE inhibitor and an ARB would be any safer. Consider alternatives to the combination when possible. Risk D: Consider therapy modification

Antifungal Agents (Azole Derivatives, Systemic): May decrease the metabolism of Losartan. Applicable Isavuconazonium considerations are addressed in separate monographs.Exceptions: Isavuconazonium Sulfate. Risk C: Monitor therapy

Antihepaciviral Combination Products: May increase the serum concentration of Losartan. Management: Per antihepaciviral combination product US prescribing information, consider decreasing the losartan dose and monitoring for evidence of hypotension and worsening renal function if these agents are used in combination. Risk D: Consider therapy modification

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]).Risk C: Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Bosentan: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Brigatinib: May diminish the antihypertensive effect of Antihypertensive Agents. Brigatinib may enhance the bradycardic effect of Antihypertensive Agents. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Bromperidol: Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Bromperidol may diminish the hypotensive effect of Blood Pressure Lowering Agents. Risk X: Avoid combination

CycloSPORINE (Systemic): Angiotensin II Receptor Blockers may enhance the hyperkalemic effect of CycloSPORINE (Systemic). Risk C: Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D: Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP2C9 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Risk D: Consider therapy modification

Dapoxetine: May enhance the orthostatic hypotensive effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Dexmethylphenidate: May diminish the therapeutic effect of Antihypertensive Agents. Risk C: Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Drospirenone: Angiotensin II Receptor Blockers may enhance the hyperkalemic effect of Drospirenone. Risk C: Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Risk D: Consider therapy modification

Enzalutamide: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP2C9 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP2C9 substrate should be performed with caution and close monitoring. Risk D: Consider therapy modification

Eplerenone: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Fluconazole: May decrease the serum concentration of Losartan. Specifically, fluconazole may decrease the serum concentration of E3174, the more potent active metabolite of losartan. Risk C: Monitor therapy

Heparin: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Heparins (Low Molecular Weight): May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Herbs (Hypertensive Properties): May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Levodopa-Containing Products: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Containing Products. Risk C: Monitor therapy

Lithium: Angiotensin II Receptor Blockers may increase the serum concentration of Lithium. Management: Lithium dosage reductions will likely be needed following the addition of an angiotensin II receptor antagonist. Risk D: Consider therapy modification

Lorlatinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Avoid concurrent use of lorlatinib with any CYP3A4 substrates for which a minimal decrease in serum concentrations of the CYP3A4 substrate could lead to therapeutic failure and serious clinical consequences. Risk D: Consider therapy modification

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Methylphenidate: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

MiFEPRIStone: May increase the serum concentration of CYP2C9 Substrates (High risk with Inhibitors). Management: Use CYP2C9 substrates at the lowest recommended dose, and monitor closely for adverse effects, during and in the 2 weeks following mifepristone treatment. Risk D: Consider therapy modification

Mitotane: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Risk D: Consider therapy modification

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nicorandil: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: Angiotensin II Receptor Blockers may enhance the adverse/toxic effect of Nonsteroidal Anti-Inflammatory Agents. Specifically, the combination may result in a significant decrease in renal function. Nonsteroidal Anti-Inflammatory Agents may diminish the therapeutic effect of Angiotensin II Receptor Blockers. The combination of these two agents may also significantly decrease glomerular filtration and renal function. Risk C: Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider therapy modification

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Pitolisant: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Combined use of pitolisant with a CYP3A4 substrate that has a narrow therapeutic index should be avoided. Other CYP3A4 substrates should be monitored more closely when used with pitolisant. Risk D: Consider therapy modification

Potassium Salts: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Potassium-Sparing Diuretics: Angiotensin II Receptor Blockers may enhance the hyperkalemic effect of Potassium-Sparing Diuretics. Risk C: Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Resveratrol: May decrease serum concentrations of the active metabolite(s) of Losartan. Resveratrol may increase the serum concentration of Losartan. Risk C: Monitor therapy

RifAMPin: May decrease the serum concentration of Losartan. Risk C: Monitor therapy

Rifapentine: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Risk C: Monitor therapy

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Sodium Phosphates: Angiotensin II Receptor Blockers may enhance the nephrotoxic effect of Sodium Phosphates. Specifically, the risk of acute phosphate nephropathy may be enhanced. Management: Consider avoiding this combination by temporarily suspending treatment with ARBs, or seeking alternatives to oral sodium phosphate bowel preparation. If the combination cannot be avoided, maintain adequate hydration and monitor renal function closely. Risk D: Consider therapy modification

St John’s Wort: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Risk D: Consider therapy modification

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Risk C: Monitor therapy

Tolvaptan: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Trimethoprim: May enhance the hyperkalemic effect of Angiotensin II Receptor Blockers. Risk C: Monitor therapy

Yohimbine: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Monitoring Parameters

Baseline and periodic blood pressure; electrolytes, renal function

Heart Failure:

Within 1 to 2 weeks after initiation, reassess blood pressure (including postural blood pressure changes), renal function, and serum potassium; follow closely after dose changes. Patients with systolic blood pressure <80 mm Hg, low serum sodium, diabetes mellitus, and impaired renal function should be closely monitored (ACC/AHA [Yancy 2013]).

Hypertension: The 2017 Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults (ACC/AHA [Whelton 2017]):

Confirmed hypertension and known CVD or 10-year ASCVD risk ≥10%: Target blood pressure <130/80 mm Hg is recommended

Confirmed hypertension without markers of increased ASCVD risk: Target blood pressure <130/80 mm Hg may be reasonable

Diabetes and hypertension: The American Diabetes Association (ADA) guidelines (ADA 2018):

Patients ≥18 to ≤65 years: Goal of therapy is SBP <140 mm Hg and DBP <90 mm Hg.

Patients ≥18 to ≤65 years and at high risk of cardiovascular disease: Goal of therapy is SBP <130 mm Hg and DBP <80 mm Hg (if can be achieved without undue treatment burden).

Patients ≥65 years (healthy or complex/intermediate health): Goal of therapy is SBP <140 mm Hg and DBP <90 mm Hg.

Patients ≥65 years (very complex/poor health): Goal of therapy is SBP <150 mm Hg and DBP <90 mm Hg.

Advanced Practitioners Physical Assessment/Monitoring

Obtain renal function tests, electrolytes, and urinalysis. Repeat during the first few weeks of therapy. Assess other medicines patient may be taking; alternate therapy or dosage adjustments may be needed. Monitor blood pressure on a regular basis during therapy. Assess for signs of angioedema.

Nursing Physical Assessment/Monitoring

Check ordered labs and report abnormalities. Monitor blood pressure on a regular basis during therapy. Monitor for hypotension and signs of angioedema.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral, as potassium:

Cozaar: 25 mg

Cozaar: 50 mg [scored]

Cozaar: 100 mg

Generic: 25 mg, 50 mg, 100 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral, as potassium:

Cozaar: 25 mg, 50 mg, 100 mg

Generic: 25 mg, 50 mg, 100 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • C09CA01
Generic Available (US)

Yes

Pricing: US

Tablets (Cozaar Oral)

25 mg (per each): $3.32

50 mg (per each): $4.45

100 mg (per each): $6.07

Tablets (Losartan Potassium Oral)

25 mg (per each): $1.67 – $3.08

50 mg (per each): $2.26 – $2.27

100 mg (per each): $3.08 – $3.10

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

As a selective and competitive, nonpeptide angiotensin II receptor antagonist, losartan blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II; losartan interacts reversibly at the AT1 and AT2 receptors of many tissues and has slow dissociation kinetics; its affinity for the AT1 receptor is 1000 times greater than the AT2 receptor. Angiotensin II receptor antagonists may induce a more complete inhibition of the renin-angiotensin system than ACE inhibitors, they do not affect the response to bradykinin, and are less likely to be associated with nonrenin-angiotensin effects (eg, cough and angioedema). Losartan increases urinary flow rate and in addition to being natriuretic and kaliuretic, increases excretion of chloride, magnesium, uric acid, calcium, and phosphate.

Pharmacodynamics/Kinetics

Note: No significant differences in pharmacokinetic parameters have been identified across studied pediatric age groups (6 to 16 years) and adult population.

Onset of action: ~6 hours

Absorption: Well absorbed; slowed with food

Distribution: Vd: Losartan: 34 L; E-3174 (active metabolite): 12 L

Protein binding, plasma: High, >98%; primarily to albumin

Metabolism: Hepatic (~14%) via CYP2C9 and 3A4 to active metabolite, E-3174 (10 to 40 times more potent than losartan); extensive first-pass effect

Bioavailability: ~33%; AUC of E-3174 (active metabolite) is 4 times greater than losartan; extemporaneously prepared suspension and tablet have similar bioavailability of losartan and E-3174

Half-life elimination:

Losartan: Children 6 to 16 years: 2.3 ± 0.8 hours; Adults: 2.1 ± 0.7 hours

E-3174 (active metabolite): Children 6 to 16 years: 5.6 ± 1.2 hours; Adults: 7.4 ± 2.4 hours

Time to peak, serum: Losartan: Children: 2 hours, Adults: 1 hour; E-3174 (active metabolite): Children: 4.1 hours, Adults: 3.5 hours

Excretion: Urine (35%; ~4% as unchanged drug, ~6% as E-3174 [active metabolite]); feces (~60% [oral])

Clearance: Adults:

Plasma: Losartan: 600 mL/minute; E-3174 (active metabolite): 50 mL/minute

Renal: Losartan: 75 L/minute; E-3174 (active metabolite): 25 mL/minute

Pharmacodynamics/Kinetics: Additional Considerations

Renal function impairment: Plasma concentrations and AUC of losartan and its active metabolite are increased 50% to 90% and renal clearance reduced 55% to 85% in patients with mild (CrCl 50 to 74 mL/minute) and moderate (CrCl 30 to 49 mL/minute) renal impairment.

Hepatic function impairment: Plasma concentrations of losartan are increased 5 times and active metabolite increased 1.7 times in patients with mild to moderate alcoholic cirrhosis. Total plasma clearance of losartan is reduced ~50% and oral bioavailability is about doubled.

Gender: Plasma losartan concentrations are about twice as high in hypertensive women as hypertensive men, but plasma concentrations of active metabolite are similar.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Patients may experience orthostatic hypotension as they stand up after treatment; especially if lying in dental chair for extended periods of time. Use caution with sudden changes in position during and after dental treatment.

Effects on Bleeding

No information available to require special precautions

Index Terms

DuP 753; Losartan Potassium; MK594

FDA Approval Date
April 14, 1995
References

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Amsterdam EA, Wenger NK, Brindis RG, et al; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association for Clinical Chemistry. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines [published correction appears in J Am Coll Cardiol. 2014;64(24):2713-2714]. J Am Coll Cardiol. 2014;64(24):e139-e228. doi: 10.1016/j.jacc.2014.09.017.[PubMed 25260718]

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Esposito F, Galfetti M, Lava SA, et al, “Fetopathy Probably Associated to Self-Medication With a Blocker of the Renin-Angiotensin System,” Arch Gynecol Obstet, 2011, 284(5):1321.[PubMed 21792547]

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Fihn SD, Gardin JM, Abrams J, et al, “2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons,” Circulation, 2012, 126(25):3097-137.[PubMed 23166211]

Fleisher LA, Fleischmann KE, Auerbach AD, et al. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;130(24):e278-e333.[PubMed 25085961]

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Granger CB, McMurray JJ, Yusuf S, et al, “Effects of Candesartan in Patients With Chronic Heart Failure and Reduced Left-Ventricular Systolic Function Intolerant to Angiotensin-Converting-Enzyme Inhibitors: The CHARM-Alternative Trial,” Lancet, 2003, 362(9386):772-6.[PubMed 13678870]

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Brand Names: International

Accord (PY); Acetensa (ID); Alsartan-50 (ET); Amosar (EG); Angioten (ID); Angizaar (SG); Arados (EC); ARB (KR); Bepsar (PH); Bicosa (KR); Carlos (BD); Convertal (PY, UY); Cosaar (AT, CH); Cosal (KR); Cosartal (IE); Cosca (KR); Coxco (TW); Cozaar (AE, AU, BB, BE, BH, BM, BR, BS, BZ, CL, CN, CR, CY, CZ, DK, DO, EC, EE, EG, ES, FI, FR, GB, GR, GT, GY, HK, HN, HR, HU, ID, IE, IS, JM, JO, KR, KW, LB, LT, LU, MT, MX, MY, NI, NL, NO, NZ, PA, PE, PH, PK, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, SR, SV, TH, TR, TT, TW, VE, VN); Cozaarex (AR); Cozatan (IE, MT); Cozavan (AU); Czartan (LK); Doxar (PH); Ecozar (PH); Hyperten (SG); Insaar (ID); Kanzar (EG); Karozaar (KR); Koinsar (ID); Lacine (LB); Lara (LK); Lasa (TW); Lifezar (PH); Lodial (RO); Lok (LK); Loranta (TH); Lorista (LV, UA); Lortaan (IT); Lorzaar (DE); Losa K (KR); Losacar (IN, MY); Losacor (AR, HK, PE); Losagen (SG, ZW); Losaltan (KR); Losanet (LB, QA); Losar (ZW); Losar-Denk (TZ); Losardex (IL); Losargard (PH); Losarmax (KR); Losarpex (BD); Losart (BD, BH); Losartas (SG, ZW); Losartin (KR); Lotan (HR); Lotanos (IE); Lotim (HR); Lowtan (TW); Lozap (BG, LV, UA); Lozaris (TH); Lozarsin (SG); Lozato (KR); Medzart (PH); Myzaar (IE); Normoten (PH); Ocsaar (IL); Osartil (HK); Parten-50 (PH); Presartan (ZW); Rocatan (KR); Rosa (KR); Rosatan (BD); Rotamax (KR); Rozasaltan (KR); Santesar (ID); Sartens (LV); Sartocad (SG); Satoren (CO, CR, DO, EC, GT, HN, NI, PA, SV); Sentor (UA); Sluxdin (TW); Sortiva (BH, QA); Tanzaril (TH); Tosan (TH); Tozaar (ET, IN); Tozaar-50 (ZW); Valosar (ZW); Zaart (HK); Zartan (KR, ZA); Zosaar (MY); Zylovaal (MY); Zyltan (ET, LK)

Losartan (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(loe SAR tan)

Brand Names: US

Cozaar

Brand Names: Canada

Cozaar

Warning
  • Do not take if you are pregnant. Use during pregnancy may cause birth defects or loss of the unborn baby. If you get pregnant or plan on getting pregnant while taking this drug, call your doctor right away.
What is this drug used for?
  • It is used to treat high blood pressure.
  • It is used to protect kidney function in diabetic patients who have protein loss.
  • It is used to lower the chance of stroke in people with high blood pressure and some certain heart problems.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • For all patients taking this drug:
  • If you have an allergy to losartan or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have kidney problems.
  • If you are taking a drug that has aliskiren in it and you also have high blood sugar (diabetes) or kidney problems. Check with your doctor or pharmacist if you are not sure if a drug you take has aliskiren in it.
  • If you are breast-feeding or plan to breast-feed.
  • Children:
  • If your child is younger than 6 years of age. Do not give this drug to a child younger than 6 years of age.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Have your blood pressure checked often. Talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If you are taking a salt substitute that has potassium in it, a potassium-sparing diuretic, or a potassium product, talk with your doctor.
  • If you are on a low-salt or salt-free diet, talk with your doctor.
  • If you are taking this drug and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • If you are taking lithium, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this drug.
  • Talk with your doctor before you drink alcohol.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
  • This drug may not work as well in black patients. Talk with the doctor.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of a high potassium level like a heartbeat that does not feel normal; change in thinking clearly and with logic; feeling weak, lightheaded, or dizzy; feel like passing out; numbness or tingling; or shortness of breath.
  • Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
  • Very bad dizziness or passing out.
  • Chest pain.
  • Swelling in the arms or legs.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Signs of a common cold.
  • Dizziness.
  • Diarrhea.
  • Feeling tired or weak.
  • Back pain.
  • Stuffy nose.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Take with or without food.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • To gain the most benefit, do not miss doses.
  • A liquid (suspension) can be made if you cannot swallow pills. Talk with your doctor or pharmacist.
  • If a liquid (suspension) is made, shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • If a liquid (suspension) is made from the tablets, store in a refrigerator. Do not freeze. Throw away any part not used after 28 days.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Losartan (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(loe SAR tan)

Brand Names: US

Cozaar

Brand Names: Canada

Cozaar

Warning
  • If your child is or may be pregnant:
  • Do not give this drug to your child if she is pregnant. Use during pregnancy may cause birth defects or loss of the unborn baby. If your child gets pregnant or plans on getting pregnant while taking this drug, call the doctor right away.
What is this drug used for?
  • It is used to treat high blood pressure.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has kidney problems.
  • If your child is taking a drug that has aliskiren in it and your child also has high blood sugar (diabetes) or kidney problems. Check with the doctor or pharmacist if you are not sure if a drug your child takes has aliskiren in it.
  • If your child is younger than 6 years of age. Do not give this drug to a child younger than 6 years of age.
  • If your child is breast-feeding a baby:
  • Talk with the doctor if your child is breast-feeding a baby or plans to breast-feed a baby.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • To lower the chance of feeling dizzy or passing out, have your child rise slowly if your child has been sitting or lying down. Have your child be careful going up and down stairs.
  • Have your child’s blood pressure checked often. Talk with your child’s doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If your child is taking a salt substitute that has potassium in it, a potassium-sparing diuretic, or a potassium product, talk with your child’s doctor.
  • If your child is on a low-salt or salt-free diet, talk with your child’s doctor.
  • If your child is taking this drug and has high blood pressure, talk with the doctor before giving OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • If your child is taking lithium, talk with the doctor. Your child may need to have blood work checked more closely while taking it with this drug.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • Have your child be careful in hot weather or while your child is being active. Have your child drink lots of fluids to stop fluid loss.
  • Tell the doctor if your child has too much sweat, fluid loss, throwing up, or diarrhea. This may lead to low blood pressure.
  • This drug may not work as well in black patients. Talk with the doctor.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of a high potassium level like a heartbeat that does not feel normal; change in thinking clearly and with logic; feeling weak, lightheaded, or dizzy; feel like passing out; numbness or tingling; or shortness of breath.
  • Signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
  • Very bad dizziness or passing out.
  • Chest pain.
  • Swelling in the arms or legs.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Signs of a common cold.
  • Dizziness.
  • Diarrhea.
  • Feeling tired or weak.
  • Back pain.
  • Stuffy nose.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • Give this drug with or without food.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • To gain the most benefit, do not miss giving your child doses.
  • A liquid (suspension) can be made if your child cannot swallow pills. Talk with your child’s doctor or pharmacist.
  • If a liquid (suspension) is made, shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • If a liquid (suspension) is made from the tablets, store in a refrigerator. Do not freeze. Throw away any part not used after 28 days.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.