Concise Prescribing Info
Contents
Levocetirizine diHCl
Indications/Uses
Symptomatic treatment of allergic rhinitis including persistent allergic rhinitis & chronic idiopathic urticaria.
Dosage/Direction for Use
Adult, adolescent ≥12 yr & childn 6-12 yr 5 mg daily. Renal impairment: Normal (CrCl ≥80 mL/min), mild (CrCl 50-79 mL/min 5 mg once daily, moderate (CrCl 30-49 mL/min) 5 mg once every 2 days, severe (CrCl <30 mL/min) 5 mg once every 3 days.
Administration
May be taken with or without food: Swallow whole w/ liqd.
Contraindications
Hypersensitivity to levocetirizine, cetirizine, hydroxyzine, or any piperazine derivatives. Severe renal impairment (CrCl <10 mL/min); ESRD, patients undergoing dialysis.
Special Precautions
Concurrent intake of alcohol. Patients w/ predisposing factors of urinary retention (eg, spinal cord lesion, prostatic hyperplasia); epilepsy & at risk of convulsion. Perform allergy skin test 3 days (wash out period) after treatment. Pruritus may occur. Contains lactose; not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to perform tasks that require judgement, motor or cognitive skills. Pregnancy & lactation. Use of FC tab is not recommended for childn <6 yr. Not recommended for infants & toddlers <2 yr.
Adverse Reactions
Headache, somnolence, dry mouth, fatigue.
Drug Interactions
Small decrease in clearance w/ theophylline. Increased exposure w/ ritonavir. Decreased absorption rate but extent of absorption is not reduced w/ food. Reduced alertness & impaired performance w/ alcohol or other CNS depressants.
MIMS Class
Antihistamines & Antiallergics
ATC Classification
R06AE09 - levocetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.
Presentation/Packing
Form
Xyzal FC tab 5 mg
Packing/Price
5 × 10's (Rp360,360/boks)
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