Monikast 10
Description
đ Monikast â Montelukast
Manufacturer: SinoHealth Pharmaceuticals LTD
1. Presentation:
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Monikast 10 mg Tablet: Each film-coated tablet contains Montelukast Sodium equivalent to 10 mg Montelukast.
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Monikast 5 mg Chewable Tablet: Each tablet contains Montelukast Sodium equivalent to 5 mg Montelukast.
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Monikast 4 mg Oral Granules: Each sachet contains Montelukast Sodium equivalent to 4 mg Montelukast.
2. Description / Pharmacology:
Montelukast is a selective and orally active leukotriene receptor antagonist that inhibits the cysteinyl leukotriene receptor (CysLTâ).
The cysteinyl leukotrienes (LTCâ, LTDâ, LTEâ) are products of arachidonic acid metabolism and are released from various cells, including mast cells and eosinophils.
Cysteinyl leukotrienes are associated with airway edema, smooth muscle contraction, and inflammation, which contribute to the signs and symptoms of asthma and allergic rhinitis.
By blocking the CysLTâ receptor, Montelukast prevents leukotriene-mediated effects and helps maintain open airways and reduce allergic symptoms.
3. Indications:
Monikast is indicated for:
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Prophylaxis and chronic treatment of asthma
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Acute prevention of Exercise-Induced Bronchoconstriction (EIB)
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Relief of symptoms of Allergic Rhinitis (AR): Seasonal & Perennial Allergic Rhinitis
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4. Dosage & Administration:
Adults & Adolescents (âĨ15 years):
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Asthma or Seasonal Allergic Rhinitis: 10 mg tablet once daily.
Pediatric Patients:
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6â14 years: 5 mg chewable tablet once daily.
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2â5 years: 4 mg chewable tablet once daily.
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6 monthsâ5 years: 4 mg oral granules once daily (administer directly in mouth or mix with a spoonful of cold water or soft food).
Hepatic Insufficiency: No dosage adjustment required for mild-to-moderate impairment.
Renal Insufficiency: No dosage adjustment necessary.
Elderly: No adjustment required; pharmacokinetics are similar to younger adults.
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5. Drug Interactions:
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Compatible with common asthma treatments: Theophylline, prednisone, oral contraceptives, digoxin, and warfarin.
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No significant pharmacokinetic interactions observed.
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Phenobarbital (a hepatic enzyme inducer) decreases Montelukast AUC by ~40%; monitoring is advised.
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Rifampin and other strong CYP450 inducers may reduce efficacy â clinical monitoring recommended.
6. Contraindications:
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Hypersensitivity to Montelukast or any component of the formulation.
7. Side Effects:
Common:
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Diarrhea, fever, headache, nausea, vomiting, gastrointestinal discomfort, skin rash, upper respiratory tract infection.
Uncommon:
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Anxiety, abnormal behavior, dizziness, drowsiness, dry mouth, depression, muscle pain, irritability, seizure, sleep disorders.
Rare:
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Angioedema, disorientation, hepatic disorders, hallucinations, memory loss, suicidal tendency, tremor, erythema nodosum.
8. Pregnancy & Lactation:
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Montelukast crosses the placenta in animal studies; use only if clearly needed.
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Excreted in human milk; caution should be exercised during lactation.
9. Precautions & Warnings:
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Not for the treatment of acute asthma attacks (including status asthmaticus). Rescue medication should always be available.
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May be continued during acute exacerbations but should not replace inhaled corticosteroids abruptly.
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Not to be used as monotherapy for exercise-induced bronchospasm.
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Aspirin-sensitive asthmatics should continue to avoid aspirin and NSAIDs.
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Use under medical supervision if psychiatric symptoms appear (e.g., agitation, depression).
10. Overdose Effects:
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Most cases show no serious adverse effects.
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Possible symptoms: Abdominal pain, somnolence, thirst, headache, vomiting, psychomotor hyperactivity.
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Management: Gastric lavage, clinical observation, and supportive care.
11. Therapeutic Class:
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Leukotriene Receptor Antagonist
12. Storage Conditions:
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Store below 30°C, in a cool, dry place.
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Protect from light and moisture.
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Keep out of reach of children.




