Generic

Montelukast Sodium

Indications

Montelukast Sodium is used to treat the following conditions:

• Asthma prevention and long-term treatment
• Exercise-Induced Bronchoconstriction Acute Prevention (EIB)
• Allergic Rhinitis (AR) Symptom Relief: Seasonal & Perennial Allergic Rhinitis

Pharmacology

Montelukast is an orally active, selective leukotriene receptor antagonist that blocks the cysteinyl leukotriene receptor (CysLT1). The cysteinyl leukotrienes (LTC4, LTD4, LTE4) are arachidonic acid metabolic products that are produced by a variety of cells, including mast cells and eosinophils. Cysteinyl leukotrienes and leukotriene receptor occupancy have been linked to the pathophysiology of asthma and allergic rhinitis, such as airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, all of which contribute to asthma symptoms.

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

When combined with theophylline, prednisone, prednisolone, terfenadine, digoxin, warfarin, gemfibrozil, itraconazole, thyroid hormones, sedative-hypnotics, nonsteroidal anti-inflammatory agents, benzodiazepines, decongestants, oral contraceptives, and Cytochrome P450 (CYP) enzyme inducers, no dose adjustment is required. With regard to food and others: Food and other circumstances had no significant effect on bioavailability or other conditions.

Contraindications

Montelukast is not recommended for people who are allergic to any of its ingredients.

Side Effects

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

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

Angioedema, poor concentration, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic problems, memory loss, palpitations, pulmonary eosinophilia, suicidal ideation, tremor are all rare.

Pregnancy & Lactation

In pregnant women, there are no appropriate and well-controlled trials. Montelukast should only be taken during pregnancy if absolutely necessary. Montelukast can be found in breast milk. When giving Montelukast to a nursing woman, extreme caution should be used.

Precautions & Warnings

Montelukast is not approved for the treatment of bronchospasm in acute asthma episodes, including status asthmatic patients. Agitation, anger, anxiety, melancholy, disorientation, disruption in concentration, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal ideation and conduct (including suicide), and tremor are examples of neuropsychiatric events.

Therapeutic Class

Antagonists of leukotriene receptors.

Storage Conditions

Store in a cool, dry location below 30°C, away from light and moisture. Keep out of children’s reach.

Pharmaceutical Name

Square Pharmaceuticals Ltd.