Usual Adult Dose for Urticaria

5 mg orally once a day in the evening

Comments: Some patients may be adequately controlled on 2.5 mg orally once a day in the evening.

Use: For the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria

Usual Adult Dose for Allergic Rhinitis

Seasonal Allergic Rhinitis (OTC): 5 mg orally once a day in the evening; some patients may be adequately controlled on 2.5 mg once a day

Usual Pediatric Dose for Allergic Rhinitis

Perennial Allergic Rhinitis:
6 months to 2 years: 1.25 mg orally once a day in the evening

Comments: The recommended dose in pediatric patients 6 months to 2 years should not be exceeded.

Use: For the relief of symptoms associated with perennial allergic rhinitis

Seasonal Allergic Rhinitis (OTC):
6 to 11 years: 2.5 mg orally once a day in the evening
12 years or older: 5 mg orally once a day in the evening; some patients may be adequately controlled on 2.5 mg once a day

Comments: Avoid use in patients less than 6 years.

Usual Pediatric Dose for Urticaria

6 months to 5 years: 1.25 mg orally once a day in the evening
6 to 11 years: 2.5 mg orally once a day in the evening
12 years or older: 5 mg orally once a day in the evening; some patients may be adequately controlled on 2.5 mg once a day

Comments: The recommended doses in pediatric patients 6 months to 12 years should not be exceeded.

Use: For the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria

Renal Dose Adjustments

Pediatric patients 6 months to 11 years with impaired renal function: Contraindicated

Adults and children 12 years or older:

• Mild renal dysfunction (CrCl 50 to 80 mL/min): 2.5 mg orally once a day
• Moderate renal dysfunction (CrCl 30 to 50 mL/min): 2.5 mg orally once every other day
• Severe renal dysfunction (CrCl 10 to 30 mL/min): 2.5 mg orally twice a week (administered once every 3 to 4 days)
• End-stage renal disease (CrCl less than 10 mL/min): Contraindicated

Liver Dose Adjustments

No adjustment recommended.

Precautions

Safety and efficacy have not been established in patients younger than 6 months.

OTC: Safety and efficacy have not been established in patients younger than 6 years.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: Contraindicated
Peritoneal dialysis: Data not available

Other Comments

Administration advice:

• May be taken with or without food.
• The tablets are scored and may be broken if appropriate.

• A dose of 5 mg (10 mL) oral solution is bioequivalent to a 5 mg oral tablet.

• Avoid engaging in hazardous occupations requiring complete mental alertness, including operating heavy machinery or driving a motor vehicle following administration.
• Avoid exceeding the recommended daily dose as ingestion of higher than the recommended dose increases the risk for somnolence.
• Avoid concomitant use with alcohol or other central nervous system depressants.

Frequently asked questions

• Is Xyzal available over-the-counter?