From the FDA Drug Label
DIRECTIONS adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor The recommended pediatric dosing for Rupatadine is:
- Children 6 years and over: 1 tablet daily, not more than 1 tablet in 24 hours
- Children under 6 years of age: ask a doctor 1
From the Research
Rupatadine pediatric dosing should be based on weight, with 2.5 mL (2.5 mg) for children 2-11 years weighing 10-25 kg and 5 mL (5 mg) for those weighing over 25 kg, as this provides similar exposure to that in adults and is supported by the most recent and highest quality study 2.
Key Considerations
- The dosage strategy for rupatadine in pediatric patients depends on body weight rather than age, as demonstrated by a population pharmacokinetic study 2.
- For children aged 2-11 years, the recommended dose is adjusted based on weight: 2.5 mL (2.5 mg) for those weighing 10-25 kg and 5 mL (5 mg) for those over 25 kg.
- Rupatadine is a second-generation antihistamine used to treat allergic rhinitis and urticaria in children, providing relief from symptoms like sneezing, itching, and rash by blocking histamine H1 receptors.
- The medication has a long duration of action, allowing for once-daily dosing, and is generally well-tolerated with minimal sedative effects compared to first-generation antihistamines.
Safety and Efficacy
- Studies have shown that rupatadine is effective in reducing symptoms of allergic rhinitis and urticaria in children, with significant improvements in quality of life 3, 4, 5.
- The safety profile of rupatadine in pediatric patients is favorable, with rare and non-serious adverse reactions reported in clinical trials 3, 4, 5.
- However, it is essential to consider potential interactions, such as with erythromycin, ketoconazole, or grapefruit juice, due to CYP450 metabolism 6.
Clinical Application
- Rupatadine should be taken on an empty stomach, without food, to ensure optimal absorption and efficacy.
- Dose adjustments may be necessary for patients with kidney or liver impairment, highlighting the need for careful consideration of individual patient factors.
- Common side effects, although generally mild, include headache, drowsiness, and fatigue, which should be monitored and managed appropriately.