Provair 5 ODT

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

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 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 who are hypersensitive to any component of this product.

 

Side Effects

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, muscle complaints, oedema, seizure, anomalous feeling, sleep disturbances are all uncommon symptoms.

Angioedema, disorientation, eosinophilic granulomatosis with polyangiitis, erythema nodosum, hallucination, hepatic problems, memory loss, palpitations, pulmonary eosinophilia, suicidal tendencies, tremor are all uncommon symptoms.

 

Pregnancy & Lactation

In pregnant women, there are no sufficient and well-controlled trials. Montelukast should only be used during pregnancy if it is absolutely necessary. Montelukast is a medication that is secreted in breast milk. When Montelukast is given to a nursing woman, vigilance should be observed.

 

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

Leukotriene receptor antagonists

 

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

UniMed UniHealth Pharmaceuticals Ltd.