Levocetirizine: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Myanmar prescribing information.

Generic Medicine Info

Indications and Dosage

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.

CrCl (mL/min)	Dosage
<10	Contraindicated.
10-30	2.5 mg once twice weekly.
30-50	2.5 mg every other day.
50-80	2.5 mg once daily.

Administration

May be taken with or without food.

Contraindications

ESRD (CrCl < 10 mL/min) or undergoing haemodialysis.

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.

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.

Pregnancy Category (US FDA)

PO: B

Patient Counseling Information

This drug may cause somnolence, fatigue and asthenia, if affected, do not drive or operate machinery.

Monitoring Parameters

Monitor renal function.

Overdosage

Symptoms: Drowsiness; agitation, restlessness (children). Management: Symptomatic and supportive. Gastric lavage may be considered shortly following ingestion.

Drug Interactions

Possible additive adverse CNS effects with CNS depressants (e.g. sedatives, tranquilizers).

Food Interaction

Concomitant use with alcohol may result in additive CNS depression.

Action

Description: 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.
Pharmacokinetics:
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.

Chemical Structure

Storage

Store between 20-25°C.

MIMS Class

Antihistamines & Antiallergics

ATC Classification

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

References

Anon. Levocetirizine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 11/06/2019.

Anon. Levocetirizine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 21/01/2014.

Buckingham R (ed). Levocetirizine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/06/2019.

Joint Formulary Committee. Levocetirizine Hydrochloride. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 11/06/2019.

Levocetirizine Dihydrochloride Solution (Camber Pharmaceuticals, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 11/06/2019.

Levocetirizine Dihydrochloride Tablet, Film Coated (Micro Labs Limited). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 11/06/2019.

Levocetirizine Syrup (Unimed Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 11/06/2019.

Levocetirizine Tablet (Unimed Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 11/06/2019.

McEvoy GK, Snow EK, Miller J et al (eds). Levocetirizine Dihydrochloride. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 21/01/2014.

Xyzal (UCB Farchim S.A.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 21/01/2014.

Xyzal Oral Solution and Tablets. U.S. FDA. https://www.fda.gov/. Accessed 21/01/2014.

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