Montela 4

Generic

Montelukast Sodium

 

Indications

Montelukast Sodium is indicated for:

• Prophylaxis and chronic treatment of asthma
• Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
• Relief of symptoms of 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 & 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.

 

 Administration

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

 

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 suitable for reversing the bronchospasm of an acute asthma attack (including the state of asthma). Neuropsychiatric events include agitation, hostility, anxiety, depression, disorientation, attention disorders, abnormal dreams, hallucinations, insomnia, irritability, memory disorders, irritability, sleepwalking, suicidal thoughts and behaviors (including suicide), and tremors.

 

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

Delta Pharma Ltd.