Current pediatric guidance on rupatadine

• Age limit: Current UK and Canadian prescribing information limits rupatadine oral solution to children aged 2 to 11 years. Safety and effectiveness in children under 2 years have not been established, and Canadian labeling says it should not be administered below age 2. Therefore, it is not recommended for a 5-month-old infant. See the current UK oral-solution SmPC and Canadian product monograph.
• Approved pediatric uses, where licensed: Symptomatic treatment of allergic rhinitis and urticaria/hives in ages 2 to 11 years. Approval and availability differ by country. The Health Canada regulatory summary describes this pediatric indication.
• Label dosing for the 1 mg/mL oral solution, ages 2 to 11 only:
  • 10 kg to less than 25 kg: 2.5 mL (2.5 mg) once daily
  • 25 kg or more: 5 mL (5 mg) once daily
    This is label information, not a recommendation to start treatment without a clinician's advice.
• Tablets: 10 mg tablets are generally for adolescents aged 12 years and older, not young children.
• Key safety cautions: Do not use with a known rupatadine allergy. Prescribing information advises avoiding strong CYP3A4 inhibitors, such as ketoconazole, itraconazole, voriconazole, clarithromycin, and HIV protease inhibitors, and avoiding grapefruit. Extra care is needed with heart-rhythm risk, low potassium, liver impairment, or drugs that prolong QT interval. Sleepiness and headache are among the commonly reported adverse effects. The UK SmPC provides the interaction details.

Evidence update