| Generic Name: |
MONTELUKAST SODIUM + LEVOCETIRIZINE HYDROCHLORIDE
|
| Therapeutic Category: |
Anti-allergic / Anti-asthmatic
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| Pharmacological Class: |
leukotriene receptor antagonist
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| Composition: |
Each film-coated tablet contains: Montelukast Sodium – 10 mg Levocetirizine Hydrochloride – 5 mg
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| Pregnancy Category: |
B
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| Presentation: |
Available in the pack size as 10 tablets X 10 blisters
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| Mechanism of Action: |
Trigger (allergen, dust, pollen, NSAIDs)
↓
Leukotrienes and Histamine are released in lungs and nasal passages
↓
Montelukast binds to CysLT1 receptors → blocks leukotriene action
Levocetirizine blocks H1 receptors → inhibits histamine action
↓
Combined effect:
→ Reduces bronchoconstriction
→ Decreases nasal congestion, sneezing, itching, and inflammation
↓
Improved symptom control in allergic rhinitis and asthma
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| Indications: |
Montelukast + Levocetirizine is indicated for the treatment of:
- Allergic Rhinitis (Seasonal & Perennial)
- Asthma (as add-on therapy)
- Urticaria
- Chronic Rhinosinusitis
- Dust/Pollen-induced allergic symptoms
More effective than monotherapy in controlling both upper and lower respiratory tract allergic
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| Dosage: |
Route of administration: Oral
For treatment of allergic rhinitis and chronic asthma (Adults):
Consider administration of a tablet per day in the evening.
For Prophylaxis of exercise-induced asthma (Adults):
Consider administration of 10 mg of Montelukast + Levocetirizine Hydrochloride, at least two hours before exercise.
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| Pharmacokinetics: |
- Well absorbed orally.
- Montelukast: Metabolized in liver, excreted in feces.
- Levocetirizine: Minimal metabolism, excreted unchanged in urine.
- High protein binding: Montelukast (~99%), Levocetirizine (~90%).
- Half-life: Montelukast (2.7–5.5 hrs), Levocetirizine (7–10 hrs).
- No major interaction → Suitable for once-daily dosing.
|
| Adverse Effects: |
- Drowsiness or sedation.
- Headache
Dry mouth.
- Nausea, abdominal pain.
- Fatigue.
- Diarrhea or constipation.
- Skin rash.
- Liver enzyme elevation (rare).
|
| Contraindications: |
- Contraindicated in patients with known hypersensitivity to montelukast, levocetirizine or cetirizine, or to any of the excipients. Observed reactions range from urticaria to anaphylaxis.
- Contraindicated in patients with end stage renal disease at less than 10 ml/min creatinine clearance, and patients undergoing haemodialysis.
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| Drug Interactions: |
- Montelukast Sodium + Levocetirizine Hydrochloride may interact with phenytoin, CNS depressants, rifarnpicin, prednisone and phenobarbital.
- Do not consume alcohol while taking Montelukast + Levocetirizine Hyd rochloride.
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| Special warning and precautions: |
- Montelukast Sodium + Levocetirizine Hydrochloride 10mg/5 mg Tablet is not recommended in patients with severe kidney disease.
- Montelukast Sodium + Levocetirizine Hydrochloride 10mg/5 mg Tablet should be used with caution in patients with severe liver disease. Dose adjustment of Tablet may be needed.
- Patients with known aspirin sensitivity should continue avoidance of aspirin or non-steroidal anti-inflammatory agents while taking montelukast.
- Levocetirizine Hydrochloride should be used with caution in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as Levocetirizine Hydrochloride may increase the risk of urinary Retention. Discontinue Levocetirizine Hydrochloride if urinary retention occurs.
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