Generic

Montelukast Sodium

Indications

Montelukast Sodium is used to treat the following conditions: Asthma prophylaxis and chronic therapy Acute prevention of Exercise-Induced Bronchoconstriction (EIB) Allergic Rhinitis (AR): 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

Adults and adolescents (15 years and older): 10 mg/day Asthma and Allergic Rhinitis: 10 mg/day Exercise-Induced Bronchoconstriction: 10 mg/day Pediatric patients (6-14 years): 5 mg/day Asthma and Allergic Rhinitis: 5 mg/day Exercise-Induced Bronchoconstriction: 5 mg/day

Asthma and Allergic Rhinitis: 4 mg/day Exercise-Induced Bronchoconstriction: Not advised Patients with both asthma and allergic rhinitis should take just one dosage daily in the evening. A single dose should be given at least 2 hours before to activity to avoid Acute Exercise-Induced Bronchoconstriction.

 Administration

Oral administration is the most common route of administration. Montelukast can be taken with or without meals, depending on the doctor’s instructions.

Interaction

With medicine: No dose adjustment is needed when montelukast is co-administered with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, non-steroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers.

With food and others: Bioavailability and other conditions were not significantly observed with food & other conditions.

Contraindications

Patients who are hypersensitive to any component of Montelukast should avoid using it.

Side Effect

Diarrhoea, fever, gastrointestinal distress, headache, nausea, vomiting, skin responses, upper respiratory tract infection are all common symptoms.

Akathisia, anxiety, arthralgia, asthenia, aberrant behavior, depression, dizziness, drowsiness, dry mouth, haemorrhage, irritability, malaise, muscular complaints, oedema, seizure, odd feeling, sleep problems are all uncommon symptoms.

Angioedema, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic problems, memory loss, palpitations, pulmonary eosinophilia, suicidal inclinations, tremor are all uncommon symptoms.

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, and suicidal ideation and conduct are all examples of neuropsychiatric events.

Therapeutic Class

Leukotriene receptor antagonists

Storage Conditions

Keep away from light and heat in a dry area. Keep out of children’s reach.

Pharmaceutical Name

Eskayef Pharmaceuticals Ltd.