Tab Bilasure-M - Contraindications

Absolute Contraindications

1. Hypersensitivity - Do not use if you are allergic to Bilastine, Montelukast, or any excipient in the tablet. This is the primary contraindication for both components.

Precautions / Relative Contraindications (use with caution or avoid)

• History of depression, anxiety, suicidal ideation, or any psychiatric disorder. Montelukast carries an FDA black box warning for serious neuropsychiatric events including agitation, aggression, hallucinations, insomnia, and suicidal thinking/behavior.

• Limited safety data available. Avoid unless clearly prescribed by a doctor. Both components should be used only if the benefit outweighs the risk.

• No established safety data for passage into breast milk. Avoid unless directed by a physician.

• Montelukast is hepatically metabolised; use with caution in patients with significant liver disease. Elevated liver enzymes have been reported.

• Use with caution; dose adjustment may be needed.

• This adult-dose formulation (Bilastine 20 mg + Montelukast 10 mg) is not appropriate for young children.

• Some formulations of montelukast contain aspartame; such formulations are contraindicated in PKU patients.

Important Drug Interactions to Note

• Alcohol - Avoid; increases CNS depression and drowsiness risk.
• Ketoconazole / Erythromycin - Inhibit CYP3A4, potentially raising bilastine levels.
• Rifampicin / Phenobarbital - CYP inducers that can reduce montelukast efficacy.
• Fruit juices (grapefruit, orange, apple) - Reduce bilastine absorption; take on empty stomach.

Key Reminder