Levocetirizine Dosing for Pediatric Patients
Levocetirizine dosing in children is strictly age-based according to FDA labeling, with children 6-11 years receiving 2.5 mg once daily, children 12 years and older receiving 5 mg once daily, and the drug being contraindicated in children under 6 years of age and in any child with kidney disease. 1
FDA-Approved Dosing by Age
Children 6-11 Years
Children 12 Years and Older
- Dose: 5 mg (1 tablet) once daily in the evening 1
- For less severe symptoms, 2.5 mg once daily may be appropriate 1
- Do not exceed 5 mg in 24 hours 1
Children Under 6 Years
- Do not use - this is an absolute contraindication per FDA labeling 1
Critical Contraindications and Precautions
Renal Impairment (Any Age)
- Consumers with kidney disease: do not use 1
- This is an absolute contraindication regardless of severity 2
- Levocetirizine is predominantly renally excreted, making renal function critical for safe use 3
- For moderate renal impairment (if the drug were to be used off-label in older populations), dose should be halved 3, 2
- For severe renal impairment (CrCl <10 mL/min), avoid entirely 3
Hepatic Impairment
- Use with caution in mild-to-moderate liver disease with dose reduction consideration 3
- Avoid in severe hepatic impairment, especially with concurrent renal impairment 3
Administration Considerations
Timing and Formulation
- Evening or bedtime dosing is recommended to minimize any potential sedative effects 3, 1
- Liquid formulations (oral drops) are preferred for younger children when used off-label for easier administration and better absorption 2
- Levocetirizine has minimal sedative effects at recommended doses compared to first-generation antihistamines 2
Important Safety Warning
- Do not combine with other antihistamine-containing products to prevent overdosage 2
- The drug should not be used "to make a child sleepy" as this is explicitly contraindicated 4
Alternative Considerations for Children Under 6 Years
Since levocetirizine is contraindicated in children under 6 years 1, consider these FDA-approved alternatives:
For Children 2-5 Years with Allergic Symptoms
- Cetirizine: 2.5 mg once or twice daily 4
- Loratadine: 5 mg once daily 4
- These second-generation antihistamines have well-documented safety profiles in young children 4
Critical Safety Note for Infants
- Avoid over-the-counter cough and cold medications (including first-generation antihistamines) in all children under 6 years due to significant safety concerns, with 69 deaths associated with antihistamines in this age group between 1969-2006 4