Monasic
Generic Name
Montelukast
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| monasic 4 mg chewable tablet | ৳ 7.00 | ৳ 70.00 |
Description
Overview of the medicine
Monasic 4 mg Chewable Tablet contains Montelukast, a leukotriene receptor antagonist. It is used to prevent and treat asthma symptoms, including exercise-induced bronchoconstriction, and to relieve symptoms of seasonal and perennial allergic rhinitis in children aged 2 to 5 years.
Uses & Indications
Dosage
Adults
Not applicable for this strength; adults typically use 10 mg tablets.
Elderly
Not applicable for this strength; elderly patients typically use 10 mg tablets if required.
Renal_impairment
No dosage adjustment is required for patients with renal impairment.
How to Take
For children aged 2 to 5 years: One 4 mg chewable tablet daily, taken in the evening. The tablet should be chewed thoroughly before swallowing. For asthma, it should be taken in the evening. For allergic rhinitis, the timing may be individualized to patient needs. Patients who have both asthma and allergic rhinitis should take only one tablet daily in the evening.
Mechanism of Action
Montelukast selectively antagonizes the cysteinyl leukotriene 1 (CysLT1) receptor. Cysteinyl leukotrienes (LTC4, LTD4, LTE4) are potent inflammatory eicosanoids released from various cells, including mast cells and eosinophils, which bind to CysLT1 receptors in the airways and mediate bronchoconstriction, mucus secretion, vascular permeability, and eosinophil recruitment. By blocking these receptors, Montelukast inhibits the actions of leukotrienes, leading to bronchodilation, reduced airway inflammation, and decreased symptoms of asthma and allergic rhinitis.
Pharmacokinetics
Onset
Within one day for asthma and allergic rhinitis.
Excretion
Primarily excreted in feces via bile (approximately 86%), with less than 0.2% excreted in urine.
Half life
Approximately 2.7 to 5.5 hours.
Absorption
Rapidly absorbed after oral administration. Peak plasma concentration reached in 2-4 hours. Bioavailability for 4 mg chewable tablet is about 63-73%.
Metabolism
Extensively metabolized by cytochrome P450 enzymes (CYP3A4, CYP2C9, CYP2C8) in the liver.
Side Effects
Contraindications
- Hypersensitivity to montelukast or any component of the tablet.
Drug Interactions
Rifampin
May decrease the plasma concentrations of montelukast.
Phenobarbital
May decrease the area under the curve (AUC) of montelukast by approximately 40%.
Other medications
No significant interactions with common asthma medications (e.g., prednisone, theophylline, oral contraceptives, terfenadine, digoxin, warfarin).
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In cases of overdose, the most commonly reported adverse events were abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity. No specific antidote is known. Treatment should be symptomatic and supportive.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed. Montelukast is excreted in breast milk; caution should be exercised when administered to a nursing mother.
Side Effects
Contraindications
- Hypersensitivity to montelukast or any component of the tablet.
Drug Interactions
Rifampin
May decrease the plasma concentrations of montelukast.
Phenobarbital
May decrease the area under the curve (AUC) of montelukast by approximately 40%.
Other medications
No significant interactions with common asthma medications (e.g., prednisone, theophylline, oral contraceptives, terfenadine, digoxin, warfarin).
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In cases of overdose, the most commonly reported adverse events were abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity. No specific antidote is known. Treatment should be symptomatic and supportive.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed. 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 to 36 months from manufacturing date
Availability
Available in pharmacies
Approval Status
FDA approved, DGDA approved
Patent Status
Generic available
Clinical Trials
Montelukast has been extensively studied in numerous clinical trials demonstrating its efficacy and safety for asthma and allergic rhinitis in pediatric and adult populations. Ongoing post-marketing surveillance and studies continue to monitor its long-term effects, particularly regarding neuropsychiatric events.
Lab Monitoring
- Routine liver function tests may be considered in patients with pre-existing liver impairment.
- Monitor for neuropsychiatric symptoms.
Doctor Notes
- Counsel parents/caregivers on the potential for neuropsychiatric events and to report any changes immediately.
- Emphasize that Montelukast is for prophylaxis and chronic treatment, not for acute asthma attacks.
- Consider alternative treatments if neuropsychiatric symptoms persist or worsen.
Patient Guidelines
- Take one chewable tablet daily in the evening, as prescribed by your doctor.
- Chew the tablet completely before swallowing.
- Do not stop taking this medication suddenly, even if you feel better, without consulting your doctor.
- This medication is not for immediate relief of acute asthma attacks; use a fast-acting inhaler for such attacks.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Monasic may cause dizziness or drowsiness in some individuals. Patients should be advised to ascertain their reactions to Monasic before driving or operating machinery.
Lifestyle Advice
- Avoid known asthma and allergy triggers.
- Maintain a healthy lifestyle, including regular exercise (if appropriate) and a balanced diet.
- Discuss any concerns about neuropsychiatric symptoms with your doctor immediately.
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