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What is contraindications of tab bilasure m

Bilasure-M contains Bilastine + Montelukast - a combination antihistamine and leukotriene receptor antagonist used for allergic rhinitis and urticaria. Key contraindications include hypersensitivity to either component, and caution in hepatic impairment.
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Bilasure M bilastine montelukast tablet contraindications

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Here is a complete summary of the contraindications of Tab Bilasure-M (Bilastine 20 mg + Montelukast 10 mg):

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)

Neuropsychiatric conditions (Montelukast - Black Box Warning)
  • 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.
Pregnancy
  • Limited safety data available. Avoid unless clearly prescribed by a doctor. Both components should be used only if the benefit outweighs the risk.
Breastfeeding
  • No established safety data for passage into breast milk. Avoid unless directed by a physician.
Hepatic impairment
  • Montelukast is hepatically metabolised; use with caution in patients with significant liver disease. Elevated liver enzymes have been reported.
Renal impairment
  • Use with caution; dose adjustment may be needed.
Children under 12 years
  • This adult-dose formulation (Bilastine 20 mg + Montelukast 10 mg) is not appropriate for young children.
Phenylketonuria (PKU)
  • 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

Bilasure-M should be taken on an empty stomach (at least 1 hour before or 2 hours after food), as food significantly reduces bilastine absorption. Sources: Drugcarts - Bilasure M | 1mg - Bilasure M | DailyMed - Montelukast
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