Montelukast 10mg tablets
Requires a prescription from a doctor or prescriber
Cromoglicate and related therapy, leukotriene receptor antagonists
Safety information for pregnancy and breastfeeding
Official documents, adverse reaction reporting, and safety monitoring
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Official medicine documents
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Montelukast
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Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
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Suspected adverse reactions reported for Montelukast
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EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
31 branded products available
MHRA licensed products
View all licensed products for Montelukast on the MHRA register
Singulair 10mg tablets
Singulair 10mg tablets
Singulair 10mg tablets
Montelukast 10mg tablets
Montelukast 10mg tablets
Montelukast 10mg tablets
Montelukast 10mg tablets
Montelukast 10mg tablets
Montelukast 10mg tablets
Montelukast 10mg tablets
Montelukast 10mg tablets
Montelukast 10mg tablets
This is the NHS Drug Tariff indicative price used for reimbursement purposes. It may not reflect the price paid by patients or pharmacies.
View full Drug TariffSource: NHS Drug Tariff via NHSBSA. Derived from dm+d VMPP (Virtual Medicinal Product Pack) pricing data. Contains public sector information licensed under the Open Government Licence v3.0.
WHO defined daily dose (DDD)
10 mg
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via NHS dm+d BNF mapping files. Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity based on WHO Anatomical Therapeutic Chemical (ATC) classification and NHS BNF section grouping. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Clinical guidelines and formulary information
British National Formulary
Montelukast
Source: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.
NICE clinical guidance(2)
Asthma: diagnosis, monitoring and chronic asthma management (BTS, NICE, SIGN) (NG245)
Bronchiolitis in children: diagnosis and management (NG9)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
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Supply & product information
Official product databases and supply status monitoring
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. emc (electronic medicines compendium) is operated by Datapharm Ltd. Shortage information sourced from NHS Specialist Pharmacy Service (SPS), sps.nhs.uk.
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF codes from NHS Business Services Authority (NHSBSA). ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
80 found
Half-life
2.7 to 5.5 hours
Mechanism
Cysteinyl leukotrienes (CysLT) like LTC4, LTD4, and LTE4, among others, are eico…
Food interactions
1 warning
Human targets
2 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
64%
[L6301][L6304][L6307][L6310][L6325][L6328][L6331]…
Half-life
2.7 to 5.5 hours
Protein binding
99%
[L6301][L6304][L6307][L6325][L6328][L6331]
Volume of distribution
[L6301][L6304][L6307][L6325][L6328][L6331]
Metabolism
[L6301][L6304][L6307][L6310][L6325][L6328][L6331]…
Elimination
[L6301][L6304][L6307][L6310][L6325][L6328][L6331]…
Clearance
45 mL/min
[L6301][L6304][L6307][L6325][L6328][L6331]
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
(a) the prophylaxis and chronic treatment of asthma in adults and pediatric patients who are 12 months of age and older[L6301], although other regional health authorities specifically note this indication for adults and adolescents who are 15 years and older[L6304][L6307] and also include indications for preventing day and night-time symptoms, and the treatment of acetylsalicylic acid-sensitive asthma[L6304];
(b) the prevention of exercise-induced bronchoconstriction (EIB) in patients who are 6 years of age and older[L6301], although other regional health authorities specifically note this indication for adults and adolescents who are 15 years and older[L6304][L6307]; and
(c) the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 6 months of age and older[L6301], although other regional health authorities specifically note the relief of seasonal allergic rhinitis symptoms for adults and adolescents who are 15 years and older.
[L6304][L6307]
Furthermore, some formulations like chewable montelukast tablets may also be specifically indicated by particular regulatory bodies for the prophylaxis and chronic treatment of asthma, including the prevention of day and night-time symptoms, the treatment of acetylsalicylic acid based asthma, and the prevention of exercise-induced bronchoconstriction in adult and pediatric patients aged 2 and older[L6328], between the ages 2 and 5[L6325], or between the ages of 6 and 14 years.
[L6331]
Moreover, when employed for such indications montelukast is considered effective as monotherapy or when combined with other medications indicated for the maintenance treatment of chronic asthma.
[L6304][L6328]
For instance, montelukast and inhaled corticosteroids can be used concomitantly to demonstrate additive effects to control asthma or to decrease the necessary inhaled corticosteroid dose while still maintaining clinical stability.
[L6304][L6328]
Additionally, in patients who continue to experience asthma symptoms, montelukast can also be combined with an 'as required' short-acting beta-agonist, an inhaled corticosteroid, or inhaled corticosteroid paired with a long-acting beta-agonist.
[L6304][L6328]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 561 interactions
[L6301][L6304][L6307][L6310][L6325][L6328][L6331]
The oral LD50 value determined for mice and rats is >5000 mg/kg.
[L6301][L6304][L6307][L6310][L6325][L6328][L6331]
Montelukast has not been studied in pregnant women.
[L6301][L6304][L6307][L6310][L6325][L6328][L6331]
Consequently, it should be used during pregnancy only if clearly needed.
[L6301][L6304][L6307][L6310][L6325][L6328][L6331]
Additionally, as it is unknown whether montelukast is excreted into human breast milk, there is also caution regarding the use of the medication in nursing mothers.
[L6301][L6304][L6307][L6310][L6325][L6328][L6331]
The plasma half-life of montelukast is somewhat prolonged in elderly patients, although no dosage adjustment is generally necessary.
[L6301][L6304][L6307][L6310][L6325][L6328][L6331]
In particular, CysLT-mediated airway bronchoconstriction, occluding mucous secretion, vascular permeability, and eosinophil recruitment are all types of effects that facilitate asthma.[L6301][L6304][L6307][L6310][L6325][L6328][L6331] Alternatively, in allergic rhinitis, CysLTs are released by the nasal mucosa when exposed to allergens during both early and late phase reactions and participate in eliciting symptoms of allergic rhinitis like a congested nose and airway.[L6301][L6304][L6307][L6310][L6325][L6328][L6331]
Subsequently, montelukast is a leukotriene receptor antagonist that binds with high affinity and selectivity to the CysLT type 1 receptor, which consequently assists in inhibiting any physiological actions of CysLTs like LTC4, LTD4, and LTE4 at the receptor that may facilitate asthma or allergic rhinitis.[L6301][L6304][L6307][L6310][L6325][L6328][L6331]
In particular, it has been documented that montelukast can cause bronchodilation as soon as within 2 hours of oral administration.[L6301][L6304][L6307][L6310][L6325][L6328][L6331] This action can also be additive to the bronchodilation caused by the concomitant use of a beta agonist.[L6301][L6304][L6307][L6310][L6325][L6328][L6331] Nevertheless, clinical investigations performed with adults 15 years of age and older revealed that no additional clinical benefit is obtained when doses of montelukast greater than 10 mg a day are used.[L6301][L6304][L6307][L6310][L6325][L6328][L6331]
Additionally, in clinical trials with adults and pediatric asthmatic patients aged 6 to 14 years, it was also determined that montelukast can reduce mean peripheral blood eosinophils by about 13% to 15% from baseline in comparison to placebo during double-blind treatment periods.[L6301][L6304][L6307][L6310][L6325][L6328][L6331] At the same time, in patients aged 15 years and older who were experiencing seasonal allergic rhinitis, the use of montelukast caused a median reduction of 13% in peripheral blood eosinophil counts when compared to placebo as well.[L6301][L6304][L6307][L6310][L6325][L6328][L6331]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L6301][L6304][L6307][L6310][L6325][L6328][L6331]
The oral bioavailability documented for the drug is 64%.
[L6301][L6304][L6307][L6310][L6325][L6328][L6331]
Furthermore, it seems that having a regular meal in the morning or even a high fat snack in the evening does not affect the absorption of montelukast.
[L6301][L6304][L6307][L6310][L6325][L6328][L6331]
[L6301][L6304][L6307][L6325][L6328][L6331]
[L6301][L6304][L6307][L6325][L6328][L6331]
[L6301][L6304][L6307][L6325][L6328][L6331]
[L6301][L6304][L6307][L6310][L6325][L6328][L6331]
In particular, it seems that the CYP2C8 enzymes play a significant role in the metabolism of the drug.
[L6301][L6304][L6307][L6310][L6325][L6328][L6331]
Nevertheless, at therapeutic doses, the plasma concentrations of montelukast metabolites are undetectable at steady state in adults and pediatric patients.
[L6301][L6304][L6307][L6310][L6325][L6328][L6331]
[L6301][L6304][L6307][L6310][L6325][L6328][L6331]
[L6301][L6304][L6307][L6325][L6328][L6331]
Proteins and enzymes this drug interacts with in the body
The rank order of affinities for the leukotrienes is LTD4 >> LTE4 = LTC4 >> LTB4
PMID:19022417 PMID:21233389 PMID:22516296 PMID:23246375 PMID:24282679 PMID:24893149 PMID:31664810 PMID:8615788 PMID:8631361
Also catalyzes the oxygenation of arachidonate into 8-hydroperoxyicosatetraenoate (8-HPETE) and 12-hydroperoxyicosatetraenoate (12-HPETE) .
PMID:23246375
Displays lipoxin synthase activity being able to convert (15S)-HETE into a conjugate tetraene .
PMID:31664810
Although arachidonate is the preferred substrate, this enzyme can also metabolize oxidized fatty acids derived from arachidonate such as (15S)-HETE, eicosapentaenoate (EPA) such as (18R)- and (18S)-HEPE or docosahexaenoate (DHA) which lead to the formation of specialized pro-resolving mediators (SPM) lipoxin and resolvins E and D respectively, therefore it participates in anti-inflammatory responses .
PMID:17114001 PMID:21206090 PMID:31664810 PMID:32404334 PMID:8615788
Oxidation of DHA directly inhibits endothelial cell proliferation and sprouting angiogenesis via peroxisome proliferator-activated receptor gamma (PPARgamma) (By similarity). It does not catalyze the oxygenation of linoleic acid and does not convert (5S)-HETE to lipoxin isomers .
PMID:31664810
In addition to inflammatory processes, it participates in dendritic cell migration, wound healing through an antioxidant mechanism based on heme oxygenase-1 (HO-1) regulation expression, monocyte adhesion to the endothelium via ITGAM expression on monocytes (By similarity). Moreover, it helps establish an adaptive humoral immunity by regulating primary resting B cells and follicular helper T cells and participates in the CD40-induced production of reactive oxygen species (ROS) after CD40 ligation in B cells through interaction with PIK3R1 that bridges ALOX5 with CD40 .
PMID:21200133
May also play a role in glucose homeostasis, regulation of insulin secretion and palmitic acid-induced insulin resistance via AMPK (By similarity).
Can regulate bone mineralization and fat cell differentiation increases in induced pluripotent stem cells (By similarity)
Enzymes involved in drug metabolism — important for understanding drug interactions
Proteins that transport this drug across cell membranes
PMID:10873595 PMID:11159893 PMID:11932330 PMID:12724351 PMID:14610227 PMID:16908597 PMID:18501590 PMID:20507927 PMID:22201122 PMID:23531488 PMID:25132355 PMID:26383540 PMID:27576593 PMID:28408210 PMID:29871943 PMID:34628357
Responsible for the transport of estrone 3-sulfate (E1S) through the basal membrane of syncytiotrophoblast, highlighting a potential role in the placental absorption of fetal-derived sulfated steroids including the steroid hormone precursor dehydroepiandrosterone sulfate (DHEA-S) .
PMID:11932330 PMID:12409283
Also facilitates the uptake of sulfated steroids at the basal/sinusoidal membrane of hepatocytes, therefore accounting for the major part of organic anions clearance of liver .
PMID:11159893
Mediates the intestinal uptake of sulfated steroids .
PMID:12724351 PMID:28408210
Mediates the uptake of the neurosteroids DHEA-S and pregnenolone sulfate (PregS) into the endothelial cells of the blood-brain barrier as the first step to enter the brain .
PMID:16908597 PMID:25132355
Also plays a role in the reuptake of neuropeptides such as substance P/TAC1 and vasoactive intestinal peptide/VIP released from retinal neurons .
PMID:25132355
May act as a heme transporter that promotes cellular iron availability via heme oxygenase/HMOX2 and independently of TFRC .
PMID:35714613
Also transports heme by-product coproporphyrin III (CPIII), and may be involved in their hepatic disposition .
PMID:26383540
Mediates the uptake of other substrates such as prostaglandins D2 (PGD2), E1 (PGE1) and E2 (PGE2), taurocholate, L-thyroxine, leukotriene C4 and thromboxane B2 (PubMed:10873595, PubMed:14610227, PubMed:19129463, PubMed:29871943, Ref.25). May contribute to regulate the transport of organic compounds in testis across the blood-testis-barrier (Probable). Shows a pH-sensitive substrate specificity which may be ascribed to the protonation state of the binding site and leads to a stimulation of substrate transport in an acidic microenvironment .
PMID:14610227 PMID:19129463 PMID:22201122
The exact transport mechanism has not been yet deciphered but most likely involves an anion exchange, coupling the cellular uptake of organic substrate with the efflux of an anionic compound .
PMID:19129463 PMID:20507927 PMID:26277985
Hydrogencarbonate/HCO3(-) acts as a probable counteranion that exchanges for organic anions .
PMID:19129463
Cytoplasmic glutamate may also act as counteranion in the placenta .
PMID:26277985
An inwardly directed proton gradient has also been proposed as the driving force of E1S uptake with a (H(+):E1S) stoichiometry of (1:1) PMID:20507927
ATC R03DC03
ATC R03DC53
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
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Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Montelukast
Additional database identifiers
Drugs Product Database (DPD)
11784
Drugs Product Database (DPD)
11783
ChemSpider
4444507
BindingDB
50052024
PDB
MTK
ZINC
ZINC000003831151
HUGO Gene Nomenclature Committee (HGNC)
HGNC:17451
GenAtlas
CYSLTR1
GeneCards
CYSLTR1
GenBank Gene Database
AF119711
GenBank Protein Database
5353887
Guide to Pharmacology
269
UniProt Accession
CLTR1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:435
GenAtlas
ALOX5
GeneCards
ALOX5
GenBank Gene Database
J03600
GenBank Protein Database
187193
Guide to Pharmacology
1385
UniProt Accession
LOX5_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:9604
GenAtlas
PTGS1
GeneCards
PTGS1
GenBank Gene Database
M31822
GenBank Protein Database
387018
Guide to Pharmacology
1375
UniProt Accession
PGH1_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2610
GenAtlas
CYP2A6
GeneCards
CYP2A6
GenBank Gene Database
X13897
Guide to Pharmacology
1321
UniProt Accession
CP2A6_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2637
GenAtlas
CYP3A4
GeneCards
CYP3A4
GenBank Gene Database
M18907
Guide to Pharmacology
1337
UniProt Accession
CP3A4_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2623
GenAtlas
CYP2C9
GeneCards
CYP2C9
GenBank Gene Database
AY341248
Guide to Pharmacology
1326
UniProt Accession
CP2C9_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:2622
GenAtlas
CYP2C8
GeneCards
CYP2C8
GenBank Gene Database
M17397
Guide to Pharmacology
1325
UniProt Accession
CP2C8_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:10962
GenAtlas
SLCO2B1
GeneCards
SLCO2B1
GenBank Gene Database
AB026256
GenBank Protein Database
5006263
Guide to Pharmacology
1224
UniProt Accession
SO2B1_HUMAN
International reference pricing
Reference pricing from DrugBank. Prices are indicative and may not reflect current UK costs.
Source: DrugBank. Used under CC BY-NC 4.0 academic licence for non-commercial purposes.
Patent information
All patents expired, 3 expired
Source: DrugBank · CC BY-NC 4.0. Patent data sourced from national patent offices. Expiry dates may not reflect extensions, regulatory exclusivity periods, or legal challenges.
DrugBank citations
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