Indicated for:

Perennial Allergic Rhinitis:

• The relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age.

Chronic Idiopathic Urticaria:

• The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.

XYZAL is contraindicated in patients with end-stage renal disease (CL_cr< 10 mL/min) and patients undergoing hemodialysis and children 6 months to 11 years of age with impaired renal function.

Avoid concurrent use of alcohol or other central nervous system depressants with XYZAL.

In clinical trials the occurrence of somnolence, fatigue, and asthenia has been reported in some patients under therapy with XYZAL. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness, and motor coordination such as operating machinery or driving a motor vehicle after ingestion of XYZAL

Urinary retention has been reported post-marketing with XYZAL. XYZAL should be used with caution in patients with predisposing factors of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia) as XYZAL may increase the risk of urinary retention. Discontinue XYZAL if urinary retention occurs.

Since levocetirizine is the principal pharmacologically active component of cetirizine, one should take into account the fact that the following adverse events could also potentially occur under treatment with XYZAL: orofacial dyskinesia, severe hypotension, cholestasis, glomerulonephritis, stillbirth, tic, myoclonus, extrapyramidal symptoms, and acute generalized exanthematous pustulosis (AGEP).

Co-administration with Ritonavir increased the plasma AUC of cetirizine.

There are no adequate and well-controlled studies in pregnant women. 

Cetirizine has been reported to be excreted in human breast milk. Because levocetirizine is also expected to be excreted in human milk, use of XYZAL in nursing mothers is not recommended. 

GoToSource

• Use in patients under the age of 6 months. GoToSource

• Otitis media. GoToSource

• Mosquito bite reactions. GoToSource

Somnolence (sleepiness) and pyrexia (fever). GoToSource

Exacerbations of allergic diseases, tonsillitis (inflammation of the tonsils), viral infection, rhinorrhea, laryngitis, viral urinary tract infections, gastroenteritis (inflammation of the stomach and intestines), bronchitis (inflammation of bronchial tubes), allergic rhinitis, conjunctivitis (inflammation of conjunctiva of the eye), worsening atopic dermatitis, otitis media, aggression and agitation. GoToSource

Pharyngitis, influenza, fatigue and febrile seizures. GoToSource

Blurred vision, palpitations, tachycardia (rapid heart heart) urinary retention and glaucoma. GoToSource

Fixed drug eruption. GoToSource

Liver injury. GoToSource

Upper respiratory tract infections. GoToSource

No major injury lawsuits reported.