GlobalRPh Renal Dosing Masterv6.6
Evidence addition

Montelukast 10 mg tablets (adults)

Local official-label summaryBase record retrieved 2026-09-05See the evidence for this drug2 sources available - open source summaries, references and comparisons

Singulair

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Official source

Montelukast 10 mg tablets (adults) - selected U.S. labeling

Product / population
Adult asthma maintenance with oral 10 mg film-coated montelukast tablets. Excludes pediatric strengths and acute rescue treatment.
Renal measure
Qualitative renal guidance; no numeric renal function algorithm.
Labeled basic dosing

For asthma maintenance, give 10 mg orally once each evening. This is not treatment for an acute asthma attack.

Renal information and dialysis

The label recommends no dose change for renal insufficiency. Whether montelukast is removed by hemodialysis or peritoneal dialysis is unknown in the label.

Selected warnings and limits

Boxed warning: serious neuropsychiatric events, including suicidal thoughts or behavior. Discuss risks, stop the drug and contact a clinician promptly for new symptoms. For allergic rhinitis, reserve use for inadequate response or intolerance to alternatives.

Source revision: Label revision date not separately recorded; retrieval date is not the revision date. | Retrieved: 2026-09-05. Retrieval date is not the revision date.

Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97a682c2-7e00-4d07-a5ac-4436c977f842

Scope: Selected dosing/renal sections read; concise local summary, not full prescribing information. GlobalRPh v6.6.

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Source-first renal review

Evidence sources and renal implications

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Official product label

Montelukast 10 mg tablets (adults) - selected U.S. labeling

Adult asthma maintenance with oral 10 mg film-coated montelukast tablets. Excludes pediatric strengths and acute rescue treatment.

Renal method: Qualitative renal guidance; no numeric renal function algorithm.
Retrieved: 2026-09-05

Read local renal resultOpen original reference
Handbook

Renal Drug Handbook, fifth edition - Montelukast 10 mg tablets (adults)

Historical renal/RRT cross-check for the named ingredient; not a current U.S. prescribing instruction.

Renal method: Book table headings say GFR (mL/min); the preface states adjustment information is based on Cockcroft-Gault CrCl, not indexed eGFR. Do not substitute methods.
Retrieved: 2026-09-05

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Source presence is not independent validation. A label mirror is not a second independent source; review the original reference and exact formulation.

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Renal-context checklist: population, kidney trend and dialysis

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Renal dosing and precautions

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Official source

Montelukast 10 mg tablets (adults) - selected U.S. labeling

Adult asthma maintenance with oral 10 mg film-coated montelukast tablets. Excludes pediatric strengths and acute rescue treatment.

Method: Qualitative renal guidance; no numeric renal function algorithm.

Renal information and dialysisRead this complete source summary
Handbook source

Renal Drug Handbook, fifth edition - Montelukast 10 mg tablets (adults)

Historical renal/RRT cross-check for the named ingredient; not a current U.S. prescribing instruction.

Method: Book table headings say GFR (mL/min); the preface states adjustment information is based on Cockcroft-Gault CrCl, not indexed eGFR. Do not substitute methods.

Historical renal and dialysis observationsRead this complete source summary

No dialysis or renal heading shown? Read the complete source summary. Absence of a heading is not evidence that dose adjustment is unnecessary.

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Original content / product scopeMontelukast 10 mg tablets (adults) - selected U.S. labelingRenal Drug Handbook, fifth edition - Montelukast 10 mg tablets (adults)
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Exact product and population matter. This added page contains locally stored, source-specific clinical summaries. Historical handbook information, when present, is identified separately and may conflict with U.S. labeling. Confirm indication, population, kidney-function method, monitoring and the full prescribing information before applying a regimen.
Locally stored source content

Exact product and population

Product identity selected for the separately displayed source protocols below. Reference: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97a682c2-7e00-4d07-a5ac-4436c977f842

Product and population scope

Adult asthma maintenance with oral 10 mg film-coated montelukast tablets. Excludes pediatric strengths and acute rescue treatment.

RDM31-montelukast-adult-scope · Source section: Editorial scope tied to selected U.S. labelRenal section finder
Separate U.S. product-label layer

FDA / DailyMed dosing and renal information

Official

Montelukast 10 mg tablets (adults) - selected U.S. labeling

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U.S. product labeling / DailyMed · Adult asthma maintenance with oral 10 mg film-coated montelukast tablets. Excludes pediatric strengths and acute rescue treatment.

Renal method: Qualitative renal guidance; no numeric renal function algorithm.
Source date: Label revision date not separately recorded; retrieval date is not the revision date.
Retrieved: 2026-09-05

Selected dosing/renal sections read; concise local summary, not full prescribing information.

Labeled basic dosing

For asthma maintenance, give 10 mg orally once each evening. This is not treatment for an acute asthma attack.

RDM31-montelukast-adult-label-dose · Source locator: 2.1; 1.4

Renal information and dialysis

The label recommends no dose change for renal insufficiency. Whether montelukast is removed by hemodialysis or peritoneal dialysis is unknown in the label.

RDM31-montelukast-adult-label-renal · Source locator: 8.7; 10

Selected warnings and limits

Boxed warning: serious neuropsychiatric events, including suicidal thoughts or behavior. Discuss risks, stop the drug and contact a clinician promptly for new symptoms. For allergic rhinitis, reserve use for inadequate response or intolerance to alternatives.

RDM31-montelukast-adult-label-limits · Source locator: Boxed warning; 5.1

Source identity and provenance
Source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97a682c2-7e00-4d07-a5ac-4436c977f842
Retrieved
2026-09-05
DailyMed Set ID
97a682c2-7e00-4d07-a5ac-4436c977f842
Renal-function method
Qualitative renal guidance; no numeric renal function algorithm.
Source date/version
Label revision date not separately recorded; retrieval date is not the revision date.
Hash meaning
SHA-256 identifies this local summary, not original SPL XML or label PDF.
Local summary SHA-256
b3bb20350b6c0790027ad92538fc3a69ab17cbce00d0baf709ee1dc617c78560
Separate handbook layer

Renal Drug Handbook cross-check

Handbook

Renal Drug Handbook, fifth edition - Montelukast 10 mg tablets (adults)

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UK Renal Pharmacy Group / CRC Press · Historical renal/RRT cross-check for the named ingredient; not a current U.S. prescribing instruction.

Renal method: Book table headings say GFR (mL/min); the preface states adjustment information is based on Cockcroft-Gault CrCl, not indexed eGFR. Do not substitute methods.
Source date: Fifth edition, 2019
Retrieved: 2026-09-05

Historical source, separately displayed. Renal tables were read with page-image inspection.

Historical renal and dialysis observations

The historical renal bands all retain the usual dose. The book describes no dialysis removal in peritoneal, HD, high-flux/HDF and continuous modalities.

RDM31-montelukast-adult-book · Source locator: Dose in renal impairment; renal replacement therapies; Other information

Source-specific limits

The book's removal assertion is stronger than the selected label, which calls dialysis removal unknown. Renal no-adjustment does not remove the neuropsychiatric warning.

Source identity and provenance
Retrieved
2026-09-05
Handbook page
Printed page(s) 675; PDF page(s) 694
Renal-function method
Book table headings say GFR (mL/min); the preface states adjustment information is based on Cockcroft-Gault CrCl, not indexed eGFR. Do not substitute methods.
Source date/version
Fifth edition, 2019
U.S. product identity basis
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97a682c2-7e00-4d07-a5ac-4436c977f842
Hash meaning
SHA-256 identifies the local paraphrase; the source PDF is not redistributed.
Local summary SHA-256
9ab762c7164f0b38fdb000646c163ab5e21d0da67ab5b9fa54f26f7b02e24345

Provenance and preservation

Additional summaries stored on this page: 1 official-label, 0 RX List, 0 professional, 1 handbook. Empty additional-source groups are not shown. A missing layer is not a no-adjustment recommendation.

Original source
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=97a682c2-7e00-4d07-a5ac-4436c977f842
Source retrieval
2026-09-05. This is not the source publication or label revision date.
Original source type
multisource addition
Local text SHA-256
4641ada951e429bd8adc3e988166a0f39578523de83addcfd8df4d9b83ebdae7
Import versus clinical validation
Source-section locators identify where retained content came from. A source-section identifier does not assert that every numeric statement has been independently corroborated. The local text hash is not a hash of original HTML, an FDA PDF or SPL XML.

This page is an additional exact-product entry, not a recovered GlobalRPh monograph. Its primary scope text and separately attributed clinical summaries are locally included.

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