Sintel
Generic Name
sintel-400-mg-chewable-tablet
Manufacturer
Example Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| sintel 400 mg chewable tablet | ৳ 5.02 | ৳ 10.04 |
Description
Overview of the medicine
Sintel 400 mg Chewable Tablet is a leukotriene receptor antagonist, likely Montelukast, primarily indicated for the prevention and chronic treatment of asthma and the relief of symptoms of seasonal allergic rhinitis. It is crucial to note that 400 mg is an extremely high and non-standard strength for Montelukast chewable tablets, which are typically available in 4 mg or 5 mg strengths. This product's strength would be significantly above the recommended therapeutic dose.
Uses & Indications
Dosage
Adults
The standard adult dose of Montelukast is 10 mg once daily. A 400 mg dose is significantly higher than the recommended therapeutic range and would likely be an overdose. This strength is not recommended for therapeutic use.
Elderly
No dosage adjustment needed for elderly patients, however, a 400 mg dose is not recommended and highly supra-therapeutic.
Renal_impairment
No dosage adjustment needed for patients with renal impairment, but 400 mg is not a recommended dose and should be avoided.
How to Take
Take orally once daily in the evening, with or without food. Chew the tablet completely before swallowing. This 400 mg strength is not for standard use.
Mechanism of Action
Montelukast selectively antagonizes the CysLT1 receptor, preventing the action of leukotrienes (LTC4, LTD4, LTE4). Leukotrienes are potent inflammatory mediators released from mast cells and eosinophils that contribute to bronchoconstriction, mucus secretion, vascular permeability, and eosinophil recruitment in asthma and allergic rhinitis.
Pharmacokinetics
Onset
Within one day for asthma control, though full effects may take longer.
Excretion
Primarily excreted in feces via bile (approximately 86%), very little in urine.
Half life
Approximately 2.7 to 5.5 hours.
Absorption
Rapidly absorbed after oral administration. Peak plasma concentration achieved in 2-4 hours.
Metabolism
Extensively metabolized by CYP3A4, CYP2C9, and CYP2A6 in the liver.
Side Effects
Contraindications
- Hypersensitivity to montelukast or any component of the tablet
- Acute asthma attacks (not indicated for rapid relief of bronchospasm)
Drug Interactions
Rifampicin
May decrease montelukast plasma concentrations by inducing metabolism.
Phenobarbital
May decrease montelukast plasma concentrations.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In clinical studies, patients received up to 200 mg/day for 22 weeks and short-term studies up to 900 mg/day for approximately 1 week without clinically significant adverse events at *standard formulations*. However, a 400 mg *single dose* is highly supra-therapeutic and acute symptoms like abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity have been reported in post-marketing experience with montelukast overdose, particularly in children. Treatment is symptomatic and supportive.
Pregnancy & Lactation
Use during pregnancy only if clearly needed and potential benefits outweigh risks. Caution is advised during lactation as montelukast is excreted in breast milk.
Side Effects
Contraindications
- Hypersensitivity to montelukast or any component of the tablet
- Acute asthma attacks (not indicated for rapid relief of bronchospasm)
Drug Interactions
Rifampicin
May decrease montelukast plasma concentrations by inducing metabolism.
Phenobarbital
May decrease montelukast plasma concentrations.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
In clinical studies, patients received up to 200 mg/day for 22 weeks and short-term studies up to 900 mg/day for approximately 1 week without clinically significant adverse events at *standard formulations*. However, a 400 mg *single dose* is highly supra-therapeutic and acute symptoms like abdominal pain, somnolence, thirst, headache, vomiting, and psychomotor hyperactivity have been reported in post-marketing experience with montelukast overdose, particularly in children. Treatment is symptomatic and supportive.
Pregnancy & Lactation
Use during pregnancy only if clearly needed and potential benefits outweigh risks. Caution is advised during lactation as montelukast is excreted in breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
3 years from manufacturing date
Availability
Pharmacies, Hospitals
Approval Status
Approved (e.g., FDA, DGDA)
Patent Status
Generic available
Clinical Trials
Montelukast has been extensively studied in numerous clinical trials for asthma and allergic rhinitis across various age groups. However, specific clinical trials for a 400 mg chewable formulation are not known as this is not a standard or recommended strength.
Lab Monitoring
- No routine laboratory monitoring is required. Liver function tests may be considered in patients with pre-existing hepatic impairment or if symptoms of liver dysfunction appear.
Doctor Notes
- Emphasize that 400 mg is an unusual and potentially dangerous strength for Montelukast; confirm the intended dosage with the prescribing physician.
- Monitor for neuropsychiatric symptoms, especially in pediatric patients, given the potential for overdose at this strength.
- Not a rescue medication for acute asthma attacks.
Patient Guidelines
- Do not use Sintel 400 mg for acute asthma attacks.
- Consult a healthcare professional to confirm appropriate dosing, as 400 mg is not a standard therapeutic dose.
- Report any mood or behavior changes to your doctor immediately.
Missed Dose Advice
If a dose is missed, take the next dose at the usual time. Do not double the dose to compensate for a missed one. (Applicable for standard therapeutic doses)
Driving Precautions
May cause dizziness or drowsiness in some individuals. Patients should assess their reaction before driving or operating machinery.
Lifestyle Advice
- Avoid known allergens that trigger asthma or allergic rhinitis.
- Maintain a healthy diet and regular exercise (if not exercise-induced asthma).
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
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