Concise Prescribing Info
Levocetirizine diHCl
Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) & urticaria.
Dosage/Direction for Use
Adult, adolescents ≥12 yr & childn 6-12 yr 5 mg once daily (1 tab, 10 mL soln or 20 drops). Soln/drops Childn 2-6 yr 2.5 mg (2.5 mL soln or 5 drops bid). Patients w/ renal impairment w/ CrCl 50-≥80 mL/min 5 mg once daily. 30-49 mL/min 5 mg once every 2 days. <30 mL/min 5 mg once every 3 days.
May be taken with or without food: Soln: Measure appropriate vol w/ oral syringe & pour in a spoon or dilute in a glass of water. Drink immediately. Oral drops: Pour drops in a spoon or diluted in water & take orally. If dilution is used, the vol of water to which the drops are added needs to be adapted according to the quantity of water the patient is able to swallow. The diluted soln should be taken immediately. When counting the drops, the bottle should be held vertically (top down). In case of lack of flow of drops, if the right amount of drops has not been delivered, turn the bottle over in upright position, then hold it top down again & continue counting the drops.
Hypersensitivity to levocetirizine, cetirizine, hydroxyzine, or to any piperazine derivatives. Severe renal impairment (CrCl <10 mL/min).
Special Precautions
Alcohol intake. Predisposing factors of urinary retention (eg, spinal cord lesion, prostatic hyperplasia). Renal & hepatic impairment. May affect ability to drive or operate machinery. Pregnancy & lactation. Infant & childn <2 yr. Tab: Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Childn <6 yr. Soln: Contains maltitol which is not recommended for patients w/ fructose intolerance. Soln/drops: Contains methyl & propyl parahydroxybenzoate which may cause allergic reactions.
Adverse Reactions
Headache, somnolence; dry mouth; fatigue. Soln/drops: Sleep disorders; diarrhea, constipation.
Drug Interactions
Small decrease in clearance w/ theophylline. Increased exposure w/ ritonavir. CNS effects w/ alcohol & other CNS depressants.
MIMS Class
Antihistamines & Antiallergics
ATC Classification
R06AE09 - levocetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.
Xyzal FC tab 5 mg
Xyzal oral drops 5 mg/mL
10 mL x 1's
Xyzal soln 500 mcg/mL
75 mL x 1's
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