Romilast-L 10 Tab

Side Effects of Romilast-L 10 Tab

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.

Contraindications

NA

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.

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.

How to Use

Take orally with food and water, as directed by your physician.

How to Store

Keep in a cool, dry place away from sunlight and moisture.

Safety Concerns

• Alcohol: Avoid during treatment.
• Breastfeeding: Not recommended.
• Pregnancy: Contraindicated.
• Liver/Kidney: Use with caution.

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This content is for educational purposes only. Please consult your doctor before use.