Singulair (Montelukast) Safety in End-Stage Renal Disease
Montelukast is safe to use at standard doses in patients with ESRD, including those on dialysis, without any dose adjustment required.
Dosing and Pharmacokinetic Considerations
No dose adjustment is necessary for montelukast in ESRD patients because the drug undergoes hepatic metabolism and biliary excretion, with negligible renal excretion 1.
The standard dose of 10 mg once daily should be maintained in ESRD patients, as montelukast's elimination is independent of renal function 1.
Montelukast is highly protein-bound (>99.9%), making it unlikely to be significantly removed by dialysis, similar to other highly protein-bound medications 2, 1.
The drug's pharmacokinetic parameters (plasma clearance of approximately 45-48 ml/min, half-life of 4.5-5.1 hours, and bioavailability of 58-66%) remain stable and are not affected by renal impairment 1.
Clinical Evidence in ESRD Population
Montelukast has been specifically studied and proven effective in hemodialysis patients for treating uremic pruritus, demonstrating a 35% reduction in pruritus compared to 7% with placebo (P = 0.002) 3.
In the clinical trial of 16 hemodialysis patients receiving montelukast 10 mg daily for 20 days, the drug showed satisfactory patient compliance with minimal adverse effects 3.
Only one patient in the study experienced anemia during treatment, but this was later diagnosed as myelodysplastic syndrome unrelated to montelukast therapy 3.
Safety Monitoring in ESRD
ESRD patients are at heightened risk for adverse drug reactions due to polypharmacy, multiple comorbidities, and altered pharmacokinetics, making medication reconciliation critical 2, 4.
While montelukast itself requires no adjustment, clinicians should be vigilant about drug-drug interactions, as 50 different DDIs of various clinical significance have been identified in ESRD populations, with 64% of DDIs associated with adverse drug reactions 4.
Medication reconciliation should be performed at every care transition for ESRD patients taking montelukast, particularly when moving between hospital, dialysis unit, and rehabilitation settings 2.
Practical Clinical Application
Unlike many medications that require dose reduction or interval adjustment in ESRD (such as ethambutol, pyrazinamide, and levofloxacin which require thrice-weekly dosing) 2, montelukast maintains its standard daily dosing regimen.
The drug can be administered without regard to dialysis timing, as it is not significantly cleared by hemodialysis or peritoneal dialysis 5, 1.
No therapeutic drug monitoring is required for montelukast in ESRD patients, unlike medications such as cycloserine or aminoglycosides that necessitate serum concentration monitoring 2.