MedPath

Montelukast

Generic Name
Montelukast
Brand Names
Singulair
Drug Type
Small Molecule
Chemical Formula
C35H36ClNO3S
CAS Number
158966-92-8
Unique Ingredient Identifier
MHM278SD3E

Overview

Montelukast was first approved for clinical use by the US FDA in 1998 as Merck's brand name Singulair. The medication is a member of the leukotriene receptor antagonist (LTRA) category of drugs. Although capable of demonstrating effectiveness, the use of such LTRAs like montelukast is typically in addition to or complementary with the use of inhaled corticosteroids or other agents in asthma step therapy. Regardless, in 2008-2009, there were FDA-led investigations into the possibility of montelukast to elicit neuropsychiatric effects like agitation, hallucinations, suicidal behaviour, and others in individuals who used the medication. And although these kinds of effects are currently included in the official prescribing information for montelukast, the drug still sees extensive use worldwide via millions of prescriptions annually and has since become available as a generic and as a brand name product.

Background

Montelukast was first approved for clinical use by the US FDA in 1998 as Merck's brand name Singulair. The medication is a member of the leukotriene receptor antagonist (LTRA) category of drugs. Although capable of demonstrating effectiveness, the use of such LTRAs like montelukast is typically in addition to or complementary with the use of inhaled corticosteroids or other agents in asthma step therapy. Regardless, in 2008-2009, there were FDA-led investigations into the possibility of montelukast to elicit neuropsychiatric effects like agitation, hallucinations, suicidal behaviour, and others in individuals who used the medication. And although these kinds of effects are currently included in the official prescribing information for montelukast, the drug still sees extensive use worldwide via millions of prescriptions annually and has since become available as a generic and as a brand name product.

Indication

Montelukast is indicated for: (a) the prophylaxis and chronic treatment of asthma in adults and pediatric patients who are 12 months of age and older, although other regional health authorities specifically note this indication for adults and adolescents who are 15 years and older and also include indications for preventing day and night-time symptoms, and the treatment of acetylsalicylic acid-sensitive asthma; (b) the prevention of exercise-induced bronchoconstriction (EIB) in patients who are 6 years of age and older, although other regional health authorities specifically note this indication for adults and adolescents who are 15 years and older; 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, although other regional health authorities specifically note the relief of seasonal allergic rhinitis symptoms for adults and adolescents who are 15 years and older. 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, between the ages 2 and 5, or between the ages of 6 and 14 years. 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. 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. 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.

Associated Conditions

  • Asthma
  • Exercise-Induced Bronchospasm
  • Perennial Allergic Rhinitis (PAR)
  • Seasonal Allergic Rhinitis

FDA Approved Products

montelukast sodium
Manufacturer:RPK Pharmaceuticals, Inc.
Route:ORAL
Strength:10 mg in 1 1
Approved: 2023/06/12
NDC:53002-5441
montelukast sodium
Manufacturer:Camber Pharmaceuticals, Inc.
Route:ORAL
Strength:4 mg in 1 1
Approved: 2021/06/18
NDC:31722-727
Montelukast Sodium
Manufacturer:Proficient Rx LP
Route:ORAL
Strength:10 mg in 1 1
Approved: 2023/03/01
NDC:71205-778
MONTELUKAST SODIUM
Manufacturer:Direct_Rx
Route:ORAL
Strength:10 mg in 1 1
Approved: 2023/04/11
NDC:72189-418
Montelukast
Manufacturer:AvPAK
Route:ORAL
Strength:10 mg in 1 1
Approved: 2024/01/08
NDC:50268-556

Singapore Approved Products

MONTELAIR TABLET 10MG
Manufacturer:Hovid Bhd
Form:TABLET
Strength:10mg
Online:Yes
Approved: 2015/05/26
Approval:SIN14788P
MONAST 4 MONTELUKAST SODIUM PAEDIATRIC CHEWABLE TABLET 4MG
Manufacturer:Hetero Labs Limited
Form:TABLET, CHEWABLE
Strength:4.000 mg
Online:Yes
Approved: 2016/02/19
Approval:SIN14954P
ACTAMONE F.C. TABLET 10 MG
Manufacturer:Actavis Ltd.
Form:TABLET, FILM COATED
Strength:10.00 mg
Online:Yes
Approved: 2016/05/25
Approval:SIN15017P
Lukakline Chewable Tablet 4mg
Manufacturer:Dr. Reddy's Laboratories Limited FTO-III
Form:TABLET, CHEWABLE
Strength:4 mg
Online:Yes
Approved: 2013/03/21
Approval:SIN14330P
Lukakline Tablet 10 mg
Manufacturer:Dr. Reddy's Laboratories Limited (FTO-III)
Form:TABLET, FILM COATED
Strength:10 mg
Online:Yes
Approved: 2012/06/07
Approval:SIN14154P

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