Monfast-ODT
Generic Name
Montelukast 4 mg Orally Disintegrating Tablet
Manufacturer
General Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
monfast odt 4 mg tablet | ৳ 7.00 | ৳ 70.00 |
Description
Overview of the medicine
Monfast-ODT 4 mg Tablet is a leukotriene receptor antagonist used for the prophylaxis and chronic treatment of asthma and for the relief of symptoms of seasonal and perennial allergic rhinitis. This orally disintegrating tablet is especially suitable for children.
Uses & Indications
Dosage
Adults
For asthma/allergic rhinitis: 10 mg once daily, in the evening. (Note: 4 mg ODT is primarily for pediatric use).
Elderly
No dosage adjustment is generally required for elderly patients.
Renal_impairment
No dosage adjustment is required for patients with renal impairment.
Pediatric_2_to_5_years
4 mg once daily, in the evening.
Pediatric_6_to_14_years
5 mg once daily, in the evening.
How to Take
Take Monfast-ODT once daily in the evening, with or without food. The tablet should not be swallowed whole. Either place it directly on the tongue and allow it to dissolve before swallowing, or mix it with a small amount (e.g., a spoonful) of soft food (like applesauce, mashed carrots, breast milk, or ice cream) at room temperature. Do not store the mixture for future use; administer within 15 minutes.
Mechanism of Action
Montelukast selectively blocks the cysteinyl leukotriene 1 (CysLT1) receptor. Leukotrienes are potent inflammatory mediators released from various cells including mast cells and eosinophils, leading to bronchoconstriction, mucus secretion, vascular permeability, and eosinophil recruitment. By blocking CysLT1 receptors, montelukast inhibits these actions, resulting in reduced airway inflammation and improved pulmonary function.
Pharmacokinetics
Onset
Clinical effects on asthma control are generally observed within 1 day of starting treatment.
Excretion
Excreted almost exclusively in the feces via bile (approximately 86%), with less than 0.2% excreted in urine.
Half life
Plasma elimination half-life ranges from 2.7 to 5.5 hours.
Absorption
Rapidly absorbed after oral administration. Peak plasma concentration (Tmax) is reached in approximately 2-4 hours for conventional tablets. For ODT, Tmax might be slightly faster.
Metabolism
Extensively metabolized in the liver by cytochrome P450 enzymes, primarily CYP3A4, CYP2C9, and CYP2C8.
Side Effects
Contraindications
- Known hypersensitivity to montelukast or any component of the formulation.
Drug Interactions
Rifampicin
May decrease the plasma concentration of montelukast by inducing hepatic metabolism. Patients should be monitored for clinical response.
Phenobarbital
May decrease the plasma concentration of montelukast by inducing hepatic metabolism. Patients should be monitored for clinical response.
Storage
Store below 30°C in a dry place, protected 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. There is no specific antidote. Treatment should be symptomatic and supportive.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. It is unknown if montelukast is excreted in human milk; caution should be exercised when administered to a nursing mother.
Side Effects
Contraindications
- Known hypersensitivity to montelukast or any component of the formulation.
Drug Interactions
Rifampicin
May decrease the plasma concentration of montelukast by inducing hepatic metabolism. Patients should be monitored for clinical response.
Phenobarbital
May decrease the plasma concentration of montelukast by inducing hepatic metabolism. Patients should be monitored for clinical response.
Storage
Store below 30°C in a dry place, protected 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. There is no specific antidote. Treatment should be symptomatic and supportive.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. It is unknown if montelukast is excreted in human 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 and hospitals
Approval Status
Approved by DGDA
Patent Status
Generic available, patent expired
WHO Essential Medicine
YesClinical Trials
Montelukast has been extensively studied in clinical trials for its efficacy and safety in asthma and allergic rhinitis across various age groups. Ongoing research explores its potential in other inflammatory conditions.
Lab Monitoring
- No specific routine laboratory monitoring is required. However, liver function tests may be considered in patients with pre-existing liver impairment or if symptoms suggestive of liver dysfunction develop.
Doctor Notes
- Emphasize the importance of monitoring for neuropsychiatric events, especially in pediatric and adolescent patients, and instruct parents/guardians to report any changes.
- Clarify that montelukast is a prophylactic and controller medication, not a rescue inhaler for acute asthma attacks.
- Advise patients on proper administration of ODT, ensuring it dissolves on the tongue or is mixed with appropriate soft food.
Patient Guidelines
- Take this medicine exactly as prescribed by your doctor, usually once daily in the evening.
- Do not use Monfast-ODT for treating acute asthma attacks; it is for prevention and chronic management.
- Inform your doctor immediately if you experience any mood changes, agitation, or suicidal thoughts.
- Continue taking the medicine even if you feel better, as stopping abruptly can worsen symptoms.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Monfast-ODT may cause dizziness or drowsiness in some individuals. If you experience these effects, avoid driving or operating machinery.
Lifestyle Advice
- Avoid known asthma and allergy triggers.
- Maintain a healthy lifestyle, including regular exercise and a balanced diet (as advised by your doctor).
- Ensure good indoor air quality.
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