Manufacturer

Marketed in India By

Bajaj Pharmaceuticals

Koronis Pharmaceutical Pvt Ltd

Contents

Oxykast-LC tab: montelukast 10 mg, levocetirizine hydrochloride 5 mg.

Class

Antiasthmatic & COPD Preparations / Antihistamines & Antiallergics

Indications

Listed in Dosage.

Dosage

Oral
Chronic asthma
Adult: 10 mg once daily in the evening.
Child: 2-5 yr: 4 mg daily; 6-14 yr: 5 mg daily; ≥15 yr: 10 mg once daily. All doses to be taken in the evening.
Oral
Allergic rhinitis
Adult: 10 mg once daily in the evening.
Oral
Prophylaxis of exercise-induced asthma
Adult: 10 mg at least 2 hr prior to exercise; do not admin additional doses within 24 hr.
Child: ≥15 yr: 10 mg at least 2 hr prior to exercise; do not admin additional doses within 24 hr

Overdosage

Symptoms: Abdominal pain, headache, psychomotor hyperactivity, vomiting, somnolence, thirst. Management: Symptom-directed and supportive. Not known if dialysis would be helpful.

Special Precautions

Not for the relief of acute bronchospasm. Not to be used as monotherapy for the prevention of exercise-induced bronchospasm. Patients in whom asthma is precipitated by aspirin or other NSAIDs should continue to avoid aspirin and NSAIDs. Do not abruptly substitute for oral or inhaled corticosteroids. Be alert for any signs of Churg-Strauss syndrome. Pregnancy and lactation. Children <6 mth.

Adverse Drug Reactions

Dizziness, fatigue, fever; rash; abdominal pain, dyspepsia, dental pain, gastroenteritis; increased AST; weakness; cough, nasal congestion. Aggression, agitation, angioedema, arthralgia, bleeding tendency, bruising, cholestasis, diarrhoea, dream abnormalities, drowsiness, oedema, eosinophilia, hallucinations, hepatic eosinophilic infiltration (rare), hepatitis, hypersensitivity, hypoaesthesia, insomnia, irritability, muscle cramps, myalgia, nausea, palpitation, pancreatitis, paraesthesia, pruritus, restlessness, seizure, urticaria, vasculitis, vomiting.
Potentially Fatal: Anaphylaxis, Churg-Strauss syndrome.

Drug Interactions

Metabolism may be increased with rifampicin, phenobarbital, phenytoin. Peripheral oedema may occur with prednisone.

Food Interaction

Serum levels may be reduced with St John's wort.

Pregnancy Category (US FDA)

Category B : Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1^sttrimester (and there is no evidence of a risk in later trimesters).

Mechanism of Action

Montelukast is a selective leukotriene receptor antagonist that blocks the effects of cysteinyl leukotrienes in the airways.
Absorption: Rapidly absorbed from the GI tract (oral). Peak plasma concentrations in 2-4 hr. Mean oral bioavailability: 64%.
Distribution: Protein-binding: >99%.
Metabolism: Extensively hepatic by CYP3A4, CYP2A6 and CYP2C9 isoenzymes.
Excretion: Principally via faeces; elimination half-life prolonged in mild to moderate hepatic impairment.

ATC Classification

R03DC03 - montelukast ; Belongs to the class of other systemic drugs used in the treatment of obstructive airway diseases, leukotriene receptor antagonists

Presentation/Packing