Xyzal Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Levocetirizine diHCl

Indications/Uses

Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis) & urticaria.

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Dosage/Direction for Use

FC tab Adult & adolescent ≥12 yr & childn 6-12 yr 5 mg daily. Oral drops Adult & adolescent ≥12 yr & childn 6-12 yr 5 mg (20 drops) daily, 2-6 yr 2.5 mg daily in 2 intakes of 1.25 mg (5 drops bid). Patient w/ renal impairment, eGFR 50-<90 mL/min 5 mg once daily, eGFR 30-<60 mL/min 5 mg once every 2 days, eGFR 15-<30 mL/min (not requiring dialysis) 5 mg once every 3 days. Oral soln Adult & adolescent ≥12 yr & childn 6-12 yr 5 mg (10 mL) daily, 2-6 yr 2.5 mg daily in 2 intakes of 1.25 mg (2.5 mL bid).

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Overdosage

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Administration

May be taken with or without food: FC tab: Swallow whole w/ liqd. Oral drops: Pour in a spoon or dilute in water. 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. Oral soln: Measure appropriate vol w/ oral syringe & pour in a spoon or in a glass of water. Drink immediately.

Contraindications

Hypersensitivity to levocetirizine, cetirizine, hydroxyzine, or to any piperazine derivatives. ESRD w/ eGFR <15 mL/min (requiring dialysis treatment).

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Special Precautions

Patients w/ predisposing factors of urinary retention (eg, spinal cord lesion, prostatic hyperplasia); epilepsy or risk of convulsion. Inhibited response to allergy skin test; wash out period of 3 days is required. Pruritus may occur when levocetirizine is stopped. Concurrent intake of alcohol. Lactation. Not recommended in infants & toddlers <2 yr. FC tab: Not recommended in childn <6 yr. Contains lactose; should not be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Oral soln: Contains maltitol; should not be taken by patients w/ rare hereditary problems of fructose intolerance. Contains methyl parahydroxybenzoate & propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).

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Use In Pregnancy & Lactation

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Adverse Reactions

Somnolence. Adult & adolescents >12 yr: Headache; dry mouth; fatigue. Ped patients 6 mth to <6 yr: Sleep disorders; diarrhoea, constipation.

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Drug Interactions

Small decrease in clearance w/ theophylline. Increased exposure w/ ritonavir. Decreased rate of absorption w/ food. Concurrent administration w/ alcohol may cause additional reductions in alertness & impairment of performance.

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Storage

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Description

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Action

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MIMS Class

Antihistamines & Antiallergics

ATC Classification

R06AE09 - levocetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.

Regulatory Classification

Presentation/Packing

Form

Xyzal FC tab 5 mg

Packing/Price

30's

Form

Xyzal oral drops 5 mg/mL

Packing/Price

10 mL x 1's

Form

Xyzal oral soln 500 mcg/mL

Packing/Price

75 mL x 1's

Xyzal

levocetirizine

Manufacturer:

Aesica Pharmaceuticals

Distributor:

GlaxoSmithKline