Aeron FT 5

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

Adults & adolescents (15 years & older)-

• 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.

Route of administration: Oral. Montelukast may be taken with or without food or as directed by the physician.

 

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

Healthcare Pharmaceuticals Ltd.