Description
Generic
Montelukast Sodium
Indications
Montelukast Sodium is used for the prevention and treatment of asthma.
Exercise-Induced Bronchoconstriction: Acute Prevention (EIB)
Allergic Rhinitis (AR) Symptom Relief: Seasonal & Perennial Allergic Rhinitis
Pharmacology
Montelukast inhibits the cysteinyl leukotriene receptor and is a selective and orally active leukotriene receptor antagonist (CysLT1). Arachidonic acid metabolism produces cysteinyl leukotrienes (LTC4, LTD4, LTE4), which are produced by a variety of cells, including mast cells and eosinophils. The pathophysiology of asthma and allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, have been linked to cysteinyl leukotrienes and leukotriene receptor occupation, all of which contribute to the signs and symptoms of asthma.
Dosage & Administration
- Asthma & Allergic Rhinitis: 10 mg/day
- Exercise-Induced Bronchoconstriction: 10 mg/day
Pediatric patients (6 to 14 years)-
- Asthma & Allergic Rhinitis: 5 mg/day
- Exercise-Induced Bronchoconstriction: 5 mg/day
Pediatric patients (6 months to 5 years)-
- Asthma & Allergic Rhinitis: 4 mg/day
- Exercise-Induced Bronchoconstriction: Not recommended
Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. For prevention of Acute prevention of Exercise-Induced Bronchoconstriction, a single dose should be taken at least 2 hours before exercise.
Interaction
When montelukast is combined with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and CYP enzyme inducers, no dose adjustment is required.
With regard to food and others: With food and other circumstances, bioavailability and other variables were not substantially detected.
Contraindications
Patients who are hypersensitive to any component of Montelukast should avoid using it.
Side Effect
Common: Diarrhoea, fever, gastrointestinal discomfort, headache, nausea, vomiting, skin reactions, upper respiratory tract infection.
Uncommon: Akathisia, anxiety, arthralgia, asthenia, abnormal behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscle complaints, oedema, seizure, abnormal sensation, sleep disorders.
Rare: Angioedema, concentration impaired, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic disorders, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor.
Pregnancy & Lactation
In pregnant women, there are no appropriate and well-controlled trials. Montelukast should only be taken during pregnancy if it is absolutely necessary. Montelukast is a medication that is secreted in breast milk. When Montelukast is administered to a nursing woman, vigilance should be used.
Precautions & Warnings
Montelukast is not recommended for bronchospasm reversal in acute asthma episodes, including status asthmatic. Agitation, anger, anxiety, depression, disorientation, attention disturbances, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal ideation and conduct (including suicide), and tremor are all neuropsychiatric occurrences.
Therapeutic Class
Leukotriene receptor antagonists
Storage Conditions
Protect against light and moisture by storing in a cool, dry area below 30°C. Keep out of children’s reach.
Pharmaceutical Name
Eskayef Pharmaceuticals Ltd.