Montex 10Tablet

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

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, suicidal ideation and conduct (including suicide), and tremor are all neuropsychiatric occurrences.

Therapeutic Class

Leukotriene receptor antagonists

Storage Conditions

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

Pharmaceutical Name

Ibn Sina Pharmaceuticals Ltd.