LEVOZAL SYRUP 200ML

Indications

Approved Uses

Symptomatic treatment of seasonal and perennial allergic rhinitis, Symptomatic treatment of chronic idiopathic urticaria.

Dosage & Administration

Dosing by Condition

Allergic rhinitis and chronic urticaria: Adults and adolescents ≥12 years: 5 mg once daily; Children 6-11 years: 2.5 mg once daily; Children 6 months-5 years: 1.25 mg once daily (use liquid 0.5 mg/mL: 10 mL=5 mg, 5 mL=2.5 mg, 2.5 mL=1.25 mg).

Initial Dose

Adults (≥12 years): 5mg once daily. Children (6-11 years): 2.5mg once daily. Children (6 months-5 years): 1.25mg once daily.

Maintenance Dose

5 mg (10 ml) once daily

Maximum Dose

Adults (≥12 years): 5mg per day. Children (6-11 years): 2.5mg per day. Children (6 months-5 years): 1.25mg per day.

Children's Dosage

2-5 years: 1.25 mg (2.5 ml) once daily; 6-11 years: 2.5 mg (5 ml) once daily; ≥12 years: 5 mg (10 ml) once daily

Dose Adjustment Notes

Dose adjustment is required in renal impairment (based on creatinine clearance); no adjustment is needed for hepatic impairment alone, but if hepatic impairment coexists with renal impairment, adjust according to renal function.

How to Take

Oral use once daily; may be taken with or without food; measure the dose accurately using an oral syringe/medicine spoon/cup; if drowsiness occurs, take in the evening.

Side Effects

Common Side Effects

Somnolence (drowsiness), fatigue, dry mouth, headache; upper respiratory symptoms such as nasopharyngitis/pharyngitis may occur (especially in children).

Side Effect Frequency

Common (1-10%): somnolence, headache, fatigue, dry mouth; additional common events reported especially in pediatrics include nasopharyngitis/URTI symptoms, cough, pyrexia, diarrhea, vomiting, epistaxis; uncommon (0.1-1%): abdominal pain/asthenia and other less frequent reactions

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to levocetirizine, cetirizine, hydroxyzine, or other piperazine derivatives; end-stage renal disease/severe renal impairment with CrCl <10 mL/min and in patients on hemodialysis.

Warnings & Precautions

Caution: somnolence-avoid alcohol/CNS depressants and hazardous activities until effects known; renal impairment/elderly-dose adjust based on CrCl; urinary retention risk in predisposed patients (e.g., prostatic hyperplasia, spinal cord lesion); counsel about possible pruritus after discontinuation.

Age Restriction

Approved for children ≥6 months (per product labeling); avoid use in infants <6 months unless specifically directed by a physician.

Driving Warning

May Cause Drowsiness

Drug Interactions

Interaction Severity

MODERATE: alcohol and other CNS depressants (additive sedation/impairment). MINOR: theophylline (slight decrease in clearance at higher theophylline doses). MINOR-MODERATE: ritonavir may increase levocetirizine exposure; monitor for increased sedation.

Food Interaction

No clinically significant food restriction; can be taken with or without food (food may delay time to peak effect but not overall exposure).

Alcohol Interaction

Avoid

Special Populations

Children

2-5 years: 1.25 mg (2.5 ml) once daily; 6-11 years: 2.5 mg (5 ml) once daily; ≥12 years: 5 mg (10 ml) once daily

Elderly

Dose reduction based on renal function (CrCl); start with lower doses and monitor for somnolence and dizziness due to age-related decline in renal clearance

Kidney Impairment

Adults/adolescents ≥12 years: CrCl 50-80 mL/min: 2.5 mg once daily; CrCl 30-50 mL/min: 2.5 mg every other day (q48h); CrCl 10-30 mL/min: 2.5 mg every 3 days (q72h); CrCl <10 mL/min or hemodialysis: contraindicated.

Liver Impairment

No dose adjustment for hepatic impairment alone; if hepatic impairment coexists with renal impairment, adjust according to renal function.

Storage & Patient Advice

Stopping the Medicine

Can be stopped without tapering; counsel that pruritus has been reported after discontinuation, particularly after long-term use.

Overdose

Likely symptoms: somnolence in adults; in children agitation/restlessness may occur (sometimes followed by drowsiness). Management: supportive/symptomatic care; consider decontamination if recent ingestion; no specific antidote; hemodialysis is not effective.

Patient Counseling

Take once daily by mouth; measure doses accurately (syringe/spoon/cup). May cause drowsiness-avoid driving/operating machinery until effects are known and avoid alcohol/other sedatives. Do not exceed the recommended dose; consult a clinician before use if you have kidney disease or are elderly. Store below 30°C and keep out of reach of children.

Pharmacology

Mechanism of Action

Selective peripheral histamine H1-receptor antagonist (inverse agonist) that reduces histamine-mediated allergic symptoms (e.g., sneezing, rhinorrhea, pruritus, wheal/flare).

Duration of Effect

24 hours.

Half-Life

Approximately 8 hours in adults (typical range ~7-10 hours)

Excretion

Primarily renal: ~85-86% excreted in urine largely as unchanged drug; minor fecal excretion (~13%)

Protein Binding

91-92%

Product Information

Available Dosage Forms

Syrup (this product: 0.5 mg/mL oral syrup); levocetirizine is also commonly available as film-coated tablets and oral solution in other products/markets.

Composition per Dose

Each 5 ml: 2.5 mg levocetirizine dihydrochloride (equivalent to 2.05 mg levocetirizine)

Generic Availability

Yes

Symptom Target

Allergy, Runny Nose

Sedating

Yes

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