What is the maximum recommended dose of Rupatadine (Rupatadine) for adults and children over 12 years?

Maximum Recommended Dose of Rupatadine

The maximum recommended dose of rupatadine is 10 mg once daily for adults and children 6 years and older, with no more than 1 tablet in 24 hours. 1

Standard Dosing Guidelines

• Adults and children ≥6 years: The FDA-approved dose is 1 tablet (10 mg) daily, not exceeding 1 tablet in 24 hours 1
• Children <6 years: Rupatadine is not approved for use in this age group; consultation with a physician is required 1

Special Population Considerations

Hepatic or Renal Impairment

• Patients with liver or kidney disease should consult a physician before using rupatadine, as dosage adjustments may be necessary 1

Evidence for Higher Doses in Clinical Practice

While the FDA-approved maximum is 10 mg daily, clinical trial data demonstrates that rupatadine can be safely increased to 20 mg once daily when the 10 mg dose provides insufficient symptom control:

Chronic Spontaneous Urticaria

• Japanese clinical trials evaluated both 10 mg and 20 mg doses in patients aged 12 to <65 years with chronic spontaneous urticaria 2
• Both doses showed superior efficacy compared to placebo, with the 20 mg dose showing slightly greater improvement in pruritus scores (least squares mean difference of -2.121 vs -1.956 for 10 mg) 2
• No dose-related increase in adverse drug reactions was observed between 10 mg and 20 mg doses 2
• Somnolence was the only adverse drug reaction reported in ≥2 subjects, with no serious or clinically significant adverse events at either dose 2

Long-Term Safety Data

• A 52-week open-label trial in 206 Japanese patients with pruritic skin diseases allowed updosing from 10 mg to 20 mg after Week 2 3
• The overall adverse drug reaction rate was 18.0%, with somnolence being most common (14.1%) 3
• No serious or clinically significant adverse drug reactions were reported with long-term use at either dose 3
• A separate 12-month European safety study in 324 patients with persistent allergic rhinitis confirmed good long-term safety and tolerability at 10 mg/day 4

Pediatric Dosing Considerations

Weight-Based Dosing in Children 2-11 Years

• Population pharmacokinetic studies support weight-based dosing using oral solution (1 mg/mL) 5:
  • Children weighing 10-25 kg: 2.5 mL (2.5 mg)
  • Children weighing ≥25 kg: 5 mL (5 mg)
• This weight-based strategy provides similar drug exposure between age groups 2-5 and 6-11 years, comparable to the 10 mg adult dose 5

Clinical Context for Dose Selection

For standard treatment: Start with 10 mg once daily, which is effective and well-tolerated for allergic rhinitis and chronic urticaria 6, 4

For inadequate response: Increasing to 20 mg once daily is supported by clinical trial evidence showing maintained safety profile without clinically significant increase in adverse effects 2, 3

Important Safety Considerations

• Rupatadine should not be administered concomitantly with known CYP3A4 inhibitors 6
• No drug-drug interactions have been demonstrated with azithromycin, fluoxetine, or lorazepam 6
• The medication has a favorable cardiovascular safety profile with no clinically relevant ECG abnormalities or QTc prolongation observed in long-term studies 4