Levocetrizine Dihydrochloride 0.1%
Renal impairment. May impair ability to drive or operate machinery. Lactation: expected to be excreted in breast milk, avoid
Allergic rhinitis, Chronic idiopathic urticaria
Lactation. End-stage renal disease (CrCl <10 ml/min) or haemodialysis patients. Child 6-11 yr with renal impairment.
N/A
1-10% Dry mouth,Fatigue,Nasopharyngitis,Pharyngitis Frequency Not Defined Somnolence, dizziness, pyrexia, cough, epistaxis, diarrhoea, vomiting, constipation, otitis media, dysuria, urinary retention, blurred vision, angioedema, paraesthesia, dystonia, oculogyric crisis, myoclonus, extrapyramidal symptoms.
Levocetirizine is an active isomer of cetirizine which selectively competes w/ histamine for H1-receptor sites on effector cells in the GI tract, blood vessels and resp tract.
Possible additive adverse CNS effects w/ CNS depressants (e.g. sedatives, tranquilizers).
Pregnancy 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 Animal data In animal reproduction studies, there was no evidence of fetal harm with administration of levocetirizine by oral route to pregnant rats and rabbits, during period of organogenesis, at doses up to 390 times and 470 times, respectively, maximum recommended human dose (MRHD) in adults Rats treated during late gestation and lactation period, had no effects on pup development at oral doses up to approximately 60 times the MRHD in adults; in mice treated during late gestation and lactation period, drug administered by oral route to dams had no effects on pup development at a dose that was approximately 25 times the MRHD in adults; however, lower pup weight gain during lactation was observed at a dose that was 95 times MRHD in adults Lactation There are no data on presence of levocetirizine in human milk, effects on breastfed infant, or on milk production; however, drug has been reported to be present in human breast milk; in mice and beagle dogs, studies indicated cetirizine was excreted in milk; when a drug is present in animal milk, it is likely the drug will be present in human milk; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Oral Seasonal allergic rhinitis, Chronic idiopathic urticaria Adult: 5mg once daily
Oral Seasonal allergic rhinitis, Chronic idiopathic urticaria Children 12 years of age and older: 5mg once daily Children 6 to 11 years of age: 2.5mg (1/2 tablet or 1 teaspoon oral solution) once daily Children 6 months to 5 years of age: 1.25 mg (1/2 teaspoon oral solution) once daily
>12 years CrCl: 50-80 mL/min: 2.5 mg PO qDay CrCl: 30-50 mL/min: 2.5 PO qODay CrCl: 10-30 mL/min: 2.5 mg every 3-4 days CrCl: <10 mL/min, hemodialysis: Contraindicated
May be taken with or without food.
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