What is the max dose of rupatadine for urticaria?

Maximum Dose of Rupatadine for Urticaria

The maximum dose of rupatadine for urticaria is 20 mg once daily, which can be safely used when the standard 10 mg dose provides inadequate symptom control. 1, 2

Standard Dosing

• The FDA-approved starting dose is 10 mg once daily (1 tablet per 24 hours) for adults and children 6 years and older. 1
• This standard dose should be tried first, as it demonstrates significant efficacy with a favorable safety profile in chronic spontaneous urticaria. 2, 3

Dose Escalation Strategy

• When 10 mg daily provides insufficient relief after 2 weeks, the dose can be increased to 20 mg once daily. 2, 4
• The 20 mg dose showed superior pruritus reduction (63.3% vs 44.9% for placebo) compared to 10 mg (57.5% vs 44.9% for placebo), though both doses were statistically superior to placebo. 3
• Both 10 mg and 20 mg doses demonstrated sustained efficacy and safety over 52 weeks of continuous use. 4

Safety Profile at Maximum Dose

• The 20 mg dose maintains an acceptable safety profile, with somnolence being the primary adverse effect (21.43% at 20 mg vs 5.41% at 10 mg). 5
• No serious or clinically significant adverse events were observed at either dose in Japanese clinical trials involving 277 patients. 2, 4
• The overall adverse drug reaction rate at 20 mg (17.4%) was comparable to 10 mg (20.9%), with no dose-related increase in serious events. 2

Practical Dosing Algorithm

1. Start with rupatadine 10 mg once daily 1, 2
2. Assess response after 2 weeks 2, 4
3. If inadequate control, increase to 20 mg once daily 2, 4
4. Continue effective dose for duration of urticaria activity 4

Special Population Considerations

• Patients with liver or kidney disease should consult a physician before using rupatadine, as dose adjustments may be necessary. 1
• Children under 6 years should not use rupatadine without physician guidance. 1
• For children aged 2-11 years, liquid formulation (1 mg/ml) is available with weight-based dosing, though the maximum dose in this age group differs from adults. 6

Common Pitfall to Avoid

• Do not exceed 20 mg daily or take more than one dose in 24 hours, as this exceeds the established safety profile and provides no additional benefit. 1, 2