Monalast 10

Generic

Montelukast Sodium

 

Indications

Montelukast Sodium is prescribed 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 secreted 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.

 

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 conditions, bioavailability and other variables were not significantly noticed.

 

Contraindications

Montelukast is contraindicated in patients with hypersensitivity to any component of this product.

 

Side Effects

Generally, Montelukast is well-tolerated. Side effects include dizziness, headache, diarrhea, restlessness, abdominal pain, cough, fever, asthenia, rash and upper respiratory tract infection.

 

Pregnancy & Lactation

There are no adequate and well-controlled studies of Montelukast in pregnant women. Because animal reproductive studies are not always predictive of human response, so Montelukast should be used during pregnancy only if clearly needed. It is not known if Montelukast is excreted in human milk. Because many drugs are excreted inhuman milk, so caution should be exercised when Montelukast is given to a nursing mother.

 

Precautions & Warnings

Montelukast is not recommended for bronchospasm reversal in acute asthma attacks, including status asthmatic. Agitation, anger, anxiety, depression, disorientation, attention disturbances, dream abnormalities, hallucinations, insomnia, irritability, memory impairment, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor are all neuropsychiatric occurrences.

 

Therapeutic Class

Antibodies to leukotriene receptors

 

Storage Conditions

Protect from light and moisture by storing in a cool, dry place below 30°C. Keep out of children's reach.

 

Pharmaceutical Name

Ziska Pharmaceuticals Ltd.