Monasic
Generic Name
Montelukast 5 mg Chewable Tablet
Manufacturer
Example Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| monasic 5 mg chewable tablet | ৳ 8.50 | ৳ 85.00 |
Description
Overview of the medicine
Monasic 5 mg Chewable Tablet contains Montelukast, a leukotriene receptor antagonist used for the prophylaxis and chronic treatment of asthma and for the relief of symptoms of seasonal allergic rhinitis in children aged 6 to 14 years.
Uses & Indications
Dosage
Adults
Not typically recommended for adults as 5 mg chewable tablets. Adults usually take 10 mg film-coated tablets.
Elderly
No dosage adjustment is necessary for elderly patients.
Renal_impairment
No dosage adjustment is necessary for patients with renal impairment.
Pediatric_6_14_years
One 5 mg chewable tablet once daily in the evening. For asthma, take in the evening. For allergic rhinitis, the time of administration may be individualized. For exercise-induced bronchoconstriction, take at least 2 hours before exercise, and not more than once daily.
How to Take
Monasic 5 mg Chewable Tablet should be chewed thoroughly before swallowing. It can be taken orally once daily in the evening, with or without food. It is important to continue taking this medication regularly, even if symptoms improve.
Mechanism of Action
Montelukast selectively antagonizes the CysLT1 receptor, blocking the action of leukotrienes (LTC4, LTD4, LTE4) which are potent inflammatory mediators involved in the pathophysiology of asthma and allergic rhinitis.
Pharmacokinetics
Onset
Clinical improvement in asthma control typically occurs within 1 day of starting treatment, with significant improvement seen within 1 week.
Excretion
Montelukast and its metabolites are primarily excreted in feces via bile (approximately 86%), with very little (less than 0.2%) excreted via urine.
Half life
The plasma elimination half-life is approximately 2.7 to 5.5 hours in adults. In children, it is generally shorter.
Absorption
Rapidly absorbed after oral administration. Mean oral bioavailability is approximately 64% for the 5 mg chewable tablet. Peak plasma concentrations are achieved in approximately 2 hours.
Metabolism
Extensively metabolized by cytochrome P450 enzymes, primarily CYP3A4, 2C8, and 2C9, in the liver.
Side Effects
Contraindications
- Known hypersensitivity to montelukast or any of its excipients.
- Monasic is not indicated for the relief of acute asthma attacks and should not be used as monotherapy during acute bronchospasm.
Drug Interactions
Rifampin
Coadministration with rifampin may decrease montelukast plasma concentrations by approximately 40% due to increased metabolism, but no dosage adjustment is generally recommended for Montelukast.
Phenobarbital
Coadministration with phenobarbital may decrease montelukast plasma concentrations by approximately 40%, but no dosage adjustment is recommended.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach and sight of children.
Overdose
In post-marketing experience and clinical trials, there have been reports of acute overdose with montelukast. Symptoms commonly observed include abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity. There is no specific antidote; supportive and symptomatic treatment is recommended.
Pregnancy & Lactation
Pregnancy Category B. Use during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus. Montelukast is excreted in breast milk; caution should be exercised when administered to a nursing mother.
Side Effects
Contraindications
- Known hypersensitivity to montelukast or any of its excipients.
- Monasic is not indicated for the relief of acute asthma attacks and should not be used as monotherapy during acute bronchospasm.
Drug Interactions
Rifampin
Coadministration with rifampin may decrease montelukast plasma concentrations by approximately 40% due to increased metabolism, but no dosage adjustment is generally recommended for Montelukast.
Phenobarbital
Coadministration with phenobarbital may decrease montelukast plasma concentrations by approximately 40%, but no dosage adjustment is recommended.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach and sight of children.
Overdose
In post-marketing experience and clinical trials, there have been reports of acute overdose with montelukast. Symptoms commonly observed include abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity. There is no specific antidote; supportive and symptomatic treatment is recommended.
Pregnancy & Lactation
Pregnancy Category B. Use during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus. Montelukast is excreted in breast milk; caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved by FDA/DGDA
Patent Status
Patent Expired
WHO Essential Medicine
YesClinical Trials
Montelukast has been extensively evaluated in numerous clinical trials for its efficacy and safety in pediatric and adult populations with asthma and allergic rhinitis, demonstrating significant improvements in lung function, symptom scores, and quality of life.
Lab Monitoring
- No routine laboratory monitoring is required for montelukast.
- Liver function tests may be monitored if liver impairment is suspected or develops, as rare cases of elevated liver enzymes have been reported.
Doctor Notes
- Counsel patients and caregivers on the potential for neuropsychiatric events (e.g., agitation, depression, suicidal thoughts) and instruct them to report any changes immediately.
- Emphasize that Montelukast is for maintenance therapy and NOT for acute bronchospasm. Patients should always have a rescue inhaler readily available.
- Monitor for adherence to therapy and overall control of asthma/allergic rhinitis symptoms, considering reassessment if control is suboptimal.
Patient Guidelines
- Do not stop taking Monasic without consulting your doctor, even if you feel better, as symptoms may return.
- Monasic is not intended for the rapid relief of acute asthma attacks; always carry your rescue inhaler for such emergencies.
- Report any new or worsening neuropsychiatric symptoms, such as agitation, aggression, depression, sleep disturbances, or suicidal thoughts, to your doctor immediately.
- Ensure the tablet is thoroughly chewed before swallowing, especially for children.
Missed Dose Advice
If a dose of Monasic is missed, the patient should take the next dose at the usual scheduled time. Do not take a double dose to make up for a missed one. Continue with the regular dosing schedule.
Driving Precautions
Monasic may cause dizziness or drowsiness in some individuals. Patients should be advised to exercise caution when driving or operating machinery until they know how Monasic affects them.
Lifestyle Advice
- Avoid known triggers that worsen asthma or allergic rhinitis symptoms, such as allergens (pollen, dust mites) or irritants (smoke, strong odors).
- Maintain a healthy lifestyle, including a balanced diet and regular physical activity, as advised by your healthcare provider.
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