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Dosage/Direction for Use
Oral Allergic conditions Adult: 2.5-5 mg once daily. Child: 6 months-5 years 1.25 mg once daily. 6-11 years 2.5 mg once daily in the evening. >12 years Same as adult dose. Renal impairment: Patients undergoing dialysis: Contraindicated.
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Administration
Levocetirizine: May be taken with or without food.
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Contraindications
ESRD (CrCl < 10 mL/min) or undergoing haemodialysis.
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Special Precautions
Patient with increased risk of urinary retention (e.g. spinal cord lesion, prostatic hyperplasia), epileptic patients and at risk of convulsion. Children. Mild to moderate renal impairment. Pregnancy and lactation. Patient Counselling This drug may cause somnolence, fatigue and asthenia, if affected, do not drive or operate machinery. Monitoring Parameters Monitor renal function.
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Adverse Reactions
Significant: CNS depression, rebound pruritus.
Ear and labyrinth disorders: Otitis media.
Gastrointestinal disorders: Dry mouth, diarrhoea, vomiting, constipation, abdominal pain.
General disorders and administration site conditions: Fatigue, asthenia, pyrexia.
Nervous system disorders: Headache.
Psychiatric disorders: Sleep disorder, somnolence.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, pharyngitis, cough.
Vascular disorders: Epistaxis.
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Overdosage
Symptoms: Drowsiness; agitation, restlessness (children). Management: Symptomatic and supportive. Gastric lavage may be considered shortly following ingestion.
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Drug Interactions
Possible additive adverse CNS effects with CNS depressants (e.g. sedatives, tranquilizers).
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Food Interaction
Concomitant use with alcohol may result in additive CNS depression.
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Action
Levocetirizine, an antihistamine and is an active enantiomer of cetirizine. Its binding affinity to H1-receptor is twice than cetirizine. It selectively competes for H1 receptor sites on effector cells in the gastrointestinal tract, blood vessels and respiratory tract.
Onset: 1 hour. Duration: 24 hours. Absorption: Rapid and extensive oral absorption. Time to peak plasma concentration: 0.9 hours. Distribution: Volume of distribution: Approx 0.4 L/kg. Plasma protein binding: 91-92%. Metabolism: Metabolised by aromatic oxidation, N- and O-dealkylation (via CYPA4) and taurine conjugation. Excretion: Mainly via urine (85.4%); faeces (12.9%). Elimination half-life: Approx 8-9 hours. |
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Storage
Oral: Store between 20-25°C.
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CIMS Class
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ATC Classification
R06AE09 - levocetirizine ; Belongs to the class of piperazine derivatives used as systemic antihistamines.
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