Classes
DEA Class; OTC
Common Brand Names; Xyzal Allergy 24HR Tablets, Xyzal Allergy 24HR Oral Solution, Xyzal
- Antihistamines, 2nd Generation
Description
Selective low-sedating antihistamine; the drug is the R-enantiomer of cetirizine
Prescription products are used for seasonal allergic rhinitis, perennial allergic rhinitis, and chronic idiopathic urticaria in adults and pediatric patients 6 months and older
Some non-prescription products are available for use in adults and children as young as 2 years of age
Indications
Indicated for the management of symptoms of seasonal allergies or perennial allergies, including allergic rhinitis.
Contraindications
Hypersensitivity to levocetirizine or cetirizine
ESRD (CrCl <10 mL/min) or patients undergoing hemodialysis
Children aged 6 month to <12 years with renal impairment
Adverse Effects
- Dry mouth
- Fatigue
- Nasopharyngitis
- Pharyngitis
- CNS depression
- Drowsiness
- Sedation ranging from mild drowsiness to deep sleep (most frequent)
- Dizziness
- Lassitude
- Disturbed coordination
- Restlessness, insomnia, tremors, euphoria, nervousness, delirium, palpitation, seizures is less common
- Epigastric distress
- Anorexia
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Cholestasis, hepatitis, hepatic failure, hepatic function abnormality, jaundice is rare
- Tachycardia, palpitation ECG changes (eg, widened QRS)
- Arrhythmias (eg, extrasystole, heart block)
- Hypotension
- Hypertension
Warnings
Caution in narrow angle glaucoma, stenosing peptic ulcer, or pyloroduodenal obstruction
Pruritus may rebound within several days of stopping therapy, following long term use
May cause CNS depression and impair physical or mental abilities; avoid performin tasks that require mental alertness, including operating heavy machinery or driving
Urinary retention may occur; use caution in patients at risk of urinary retention, including prostatic hyperplasia and spinal cord injuries
Use caution in patients with mild to severe renal impairment
Avoid alcohol or other CNS depressants
Pregnancy and Lactation
Available data from published literature and postmarketing experience in pregnant women are insufficient to identify any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes
There are no data on presence of levocetirizine in human milk, effects on breastfed infant, or on milk production
Maximum Dosage
5 mg/day PO.
5 mg/day PO.
5 mg/day PO.
12 years: 5 mg/day PO.
6 to 11 years: 2.5 mg/day PO.
3 to 5 years: 1.25 mg/day PO.
1 to 2 years: 1.25 mg/day PO; up to 0.125 mg/kg/dose PO twice daily has been used off-label for atopic dermatitis.
6 to 11 months: 1.25 mg/day PO.
Less than 6 months: Safety and efficacy have not been established.
How supplied
Levocetirizine dihydrochloride
tablet
- 5mg
oral solution
- 2.5mg/5mL
