Montelukast sodium oral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral formulations of montelukast.
Drugs List
Therapeutic Indications
Uses
Asthma with concomitant seasonal allergic rhinitis
Mild asthma: alternative to inhaled corticosteroids
Prevention of exercise-induced bronchospasm
Treatment (add-on therapy) of inadequately controlled mild-moderate asthma
Dosage
Montelukast can be added to a patient's existing treatment regimen. Other treatments should not be stopped in favour of taking montelukast, although the need for short acting 'as needed' beta-agonist therapy may be decreased.
If satisfactory control of asthma is not achieved at follow-up (usually within one month), evaluate the need for additional or alternative therapy based on the step system for asthma therapy.
Adults
10mg once a day in the evening.
Children
Not all formulations are suitable for children under 2 years.
Children 15 years and over
10mg once a day in the evening.
Children aged 6 to 15 years
5mg once a day in the evening.
Children aged 6 months to 6 years
4mg once a day in the evening.
Contraindications
Children under 6 months
Precautions and Warnings
Children aged 6 months to 15 years
Churg-Strauss syndrome
Breastfeeding
Galactosaemia
Glucose-galactose malabsorption syndrome
Lactose intolerance
Phenylketonuria
Pregnancy
Some formulations contain aspartame - caution in phenylketonuria
Advise ability to drive/operate machinery may be affected by side effects
Ensure patient has a fast acting bronchodilator available
Not all available brands/formulations are licensed for use in children
Not all formulations are licensed for all uses
Some formulations contain lactose
Reassess treatment if Churg-Strauss syndrome-type illness develops
Reassess treatment if neuropsychiatric reactions occur
Advise patient or carer to report any neuropsychiatric event
Do not substitute abruptly for inhaled or oral corticosteroids
Advise patient not to use for relief of acute attacks
Advise patient to seek medical advice if treatment is ineffective
Advise patients on the importance of taking treatment regularly
If montelukast is used in children aged 2 to 5 years with mild persistent asthma who have demonstrated an inability to use inhaled corticosteroids, then control of asthma symptoms should be periodically evaluated.
There are no data demonstrating that oral corticosteroids can be reduced when montelukast is given concomitantly.
Leukotriene receptor antagonists may be associated with the emergence of Churg-Strauss syndrome, physicians should be alerted if eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications and/or neuropathy occur and treatment regimes should be reassessed.
Pregnancy and Lactation
Pregnancy
Use montelukast with caution during pregnancy.
The manufacturer recommends montelukast is not used in pregnancy unless the potential benefit to the mother outweighs the potential risk to the foetus. Animal studies have not indicated harmful effects relating to effects on pregnancy, nor to the embryonal/foetal development. Available data suggests no increased risk of major birth defects with montelukast treatment.
Lactation
Use montelukast with caution during breastfeeding.
The manufacturer advises that montelukast is used during breastfeeding only if it is considered essential. Animal studies have shown that montelukast is excreted in milk but it is unknown if montelukast and/or its metabolites are excreted in human milk.
Side Effects
Abdominal pain
Aggression
Agitation
Anaphylaxis
Angioedema
Anxiousness
Arthralgia
Asthenia
Attention disturbances
Bruising
Cholestatic hepatitis
Churg-Strauss syndrome
Compulsive disorders
Depression
Diarrhoea
Disorientation
Dizziness
Dream abnormalities
Drowsiness
Dry mouth
Dyspepsia
Dysphemia
Eczema
Epistaxis
Erythema multiforme
Erythema nodosum
Fatigue
Hallucinations
Headache
Hepatic eosinophilic infiltration (rarely)
Hepatitis
Hepatobiliary disorders
Hostility
Hyperkinesia (children)
Hypersensitivity reactions
Hypoesthesia
Impaired memory
Increase in serum ALT/AST
Increased bleeding tendency
Insomnia
Irritability
Malaise
Muscle cramps
Myalgia
Nausea
Nightmares
Oedema
Palpitations
Paraesthesia
Pruritus
Psychomotor hyperactivity
Pulmonary eosinophilia
Pyrexia
Rash
Restlessness
Seizures
Sleep walking
Suicidal tendencies
Thirst
Tremor
Upper respiratory tract infection
Urticaria
Vomiting
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: August 2019
Reference Sources
Summary of Product Characteristics: Montelukast 4mg chewable tablets. Dr. Reddy's Laboratories (UK) Ltd. Revised August 2019.
Summary of Product Characteristics: Montelukast 5mg chewable tablets. Dr. Reddy's Laboratories (UK) Ltd. Revised August 2019.
Summary of Product Characteristics: Montelukast 10mg tablets. Dr. Reddy's Laboratories (UK) Ltd. Revised August 2019.
Summary of Product Characteristics: Singulair Paediatric 4mg granules. Merck Sharp & Dohme Ltd. Revised March 2020.
Summary of Product Characteristics: Singulair Paediatric 4mg tablets. Merck Sharp & Dohme Ltd. Revised March 2020.
Summary of Product Characteristics: Singulair Paediatric 5mg chewable tablets. Merck Sharp & Dohme Ltd. Revised March 2020.
Summary of Product Characteristics: Singulair 10mg tablets. Merck Sharp & Dohme Ltd. Revised March 2020.
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