Proair 5 mg (Chewable Tablet)
Medicine Details
| Category | Details |
|---|---|
| Generic | Montelukast sodium |
| Company | Arges life science limited |
| Also available as |
Title
Proair 5 mg Chewable Tablet
Categories
- Asthma
- Allergic Rhinitis
- Leukotriene Receptor Antagonist
Description
Proair 5 mg Chewable Tablet is a selective and orally active leukotriene receptor antagonist. It is indicated for prophylaxis and chronic treatment of asthma, acute prevention of Exercise-Induced Bronchoconstriction (EIB), and relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis. The pharmacology involves inhibiting the cysteinyl leukotriene receptor (CysLT1) and targeting the pathophysiology of asthma & allergic rhinitis, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process. Dosage and administration vary based on age, with considerations for hepatic insufficiency, renal insufficiency, and elderly use. Proair has no apparent increase in adverse reactions when administered with other therapies for asthma. Contraindications include hypersensitivity to any component of the product. Common side effects may include gastrointestinal discomfort, headache, and upper respiratory tract infection. Storage conditions require storing in a cool & dry place below 30°C, protecting from light & moisture, and keeping out of reach of children.
Color Options
- White
Dimensions
5 mg tablet
Functions
- Prophylaxis and chronic treatment of asthma
- Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
- Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis
Materials
- Leukotriene Receptor Antagonist
Technical Specifications
- Molecular Formula: C35H36ClNO3S
Design Elements
- Chewable Tablet
Usability Features
- Can be taken with or without food
Dosage for Adults and Adolescents
10 mg tablet once daily
Dosage for Pediatric Patients (6 to 14 years of age)
5 mg tablet once daily
Dosage for Pediatric Patients (2 to 5 years of age)
4 mg tablet once daily
Dosage for Pediatric Patients (6 months to 5 years of age)
- 4 mg oral granules once daily
- Can be administered directly in the mouth or mixed with food or cold water
Use in Pediatric Patients
Safety and efficacy established in asthma patients 6 months to 14 years of age
Hepatic Insufficiency
No dosage adjustment required for mild-to-moderate hepatic insufficiency
Renal Insufficiency
No dosage adjustment recommended
Elderly Use
Similar pharmacokinetic profile and oral bioavailability as in younger adults, with slightly longer plasma half-life
Interaction with Other Therapies
No clinically important effects on the pharmacokinetics of theophylline, prednisone, oral contraceptives, terfenadine, digoxin, and warfarin
Additional Interaction Studies
Used concomitantly with a wide range of commonly prescribed drugs without evidence of clinical adverse interactions
Specific Interaction with Phenobarbital
Phenobarbital decreased the AUC of Proair by approximately 40% following a single 10mg dose
No Dosage Adjustment for Proair
Recommended when co-administered with potent cytochrome P450 enzyme inducers
Contraindications
Hypersensitivity to any component of the product
Common Side Effects
- Diarrhoea
- Fever
- Gastrointestinal discomfort
- Headache
- Nausea
- Vomiting
- Skin reactions
- Upper respiratory tract infection
Uncommon Side Effects
- Akathisia
- Anxiety
- Arthralgia
- Asthenia
- Abnormal behavior
- Depression
- Dizziness
- Drowsiness
- Dry mouth
- Haemorrhage
- Irritability
- Malaise
- Muscle complaints
- Oedema
- Seizure
- Abnormal sensation
- Sleep disorders
Rare Side Effects
- Angioedema
- Concentration impaired
- Disorientation
- Eosinophilic granulomatosis with polyangiitis
- Erythema nodosum
- Hallucination
- Hepatic disorders
- Memory loss
- Palpitations
- Pulmonary eosinophilia
- Suicidal tendencies
- Tremor
Pregnancy & Lactation
Crosses the placenta following oral dosing in rats and rabbits; caution should be exercised when given to nursing mothers
Precautions & Warnings
- Not indicated for use in the reversal of bronchospasm in acute asthma attacks
- Should not be used as monotherapy for the treatment and management of exercise induced bronchospasm
Overdose Effects
Adverse experiences consistent with the safety profile of Proair, supportive measures are recommended
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
Chemical Structure (Molecular Formula)
C35H36ClNO3S
Chemical Structure (Image)
https://medex.com.bd/storage/res/g-res-768-montelukast-sodium-chemical-structure-drK1lRHjspWQ7613gJoZ.svg
Effect On Airways
Helps keep airways open and enables easy breathing by blocking leukotrienes
Onset of Effect
1-3 hours after administration
Duration of Effect
Approximately 24 hours
Missed Dose Instructions
Take missed dose as soon as possible; do not double up on doses
Pregnancy Warnings
Avoid use unless clearly needed
General Instructions
- Take exactly as prescribed by a doctor
- Do not change dose without doctor's advice
- Not a fast-acting rescue medicine for asthma attacks
- Avoid triggers for asthma attacks
- Consult doctor before use during pregnancy or breastfeeding