ZERTAZINE 5/MG/5/ML SYRUP 100ML

Indications

Approved Uses

Symptomatic relief of seasonal allergic rhinitis and perennial allergic rhinitis; treatment of uncomplicated skin manifestations of chronic idiopathic urticaria (including pruritus).

Off-Label Uses

Common off-label uses include pruritus related to atopic dermatitis/eczema, insect-bite hypersensitivity reactions, and as an adjunct for histamine-mediated symptoms in angioedema/urticaria (not for acute airway compromise).

Dosage & Administration

Dosing by Condition

Allergic rhinitis or chronic idiopathic urticaria: Adults and children ≥6 years: 5-10 mg (5-10 mL) once daily. Adults ≥65 years: 5 mg (5 mL) once daily. Children 2-5 years: 2.5 mg (2.5 mL) once daily; may increase to 5 mg/day (5 mL once daily or 2.5 mL BID). Children <2 years: ask a doctor. Liver/kidney disease: ask a doctor.

Initial Dose

Adults and children ≥12 years: 10 mg once daily (10 ml syrup)

Maintenance Dose

Adults: 10 mg once daily; Children 6-11 years: 5-10 mg daily; Children 2-5 years: 2.5-5 mg daily

Maximum Dose

Adults: 10 mg per day; Children 6-11 years: 10 mg per day; Children 2-5 years: 5 mg per day

Children's Dosage

Children 6 years and over: 5 mg (5 ml) or 10 mg (10 ml) once daily depending on symptom severity, not to exceed 10 mg per day. Children 2-5 years: 2.5 mg (2.5 ml) once daily, may increase to maximum 5 mg daily given as 5 ml once daily or 2.5 ml every 12 hours. Children 6-23 months: 2.5 mg (2.5 ml) once daily, may increase to maximum 5 mg daily given as 2.5 ml every 12 hours. Children under 2 years: ask a doctor.

Dose Adjustment Notes

Dose reduction is required in renal impairment (including in older adults if renal function is reduced); hepatic impairment alone usually does not require adjustment, but use caution especially if concomitant renal impairment is present.

How to Take

Shake well before each use; measure the dose with an oral syringe/medicine spoon (not a household spoon); may be taken with or without food; usually given once daily (preferably at the same time each day).

Side Effects

Common Side Effects

Somnolence (sleepiness), headache, fatigue, dry mouth, dizziness, sore throat, abdominal pain.

Side Effect Frequency

Common adverse effects include somnolence (1.3-4.2%), abdominal pain (1.9-5.6%), coughing (2.8-4.4%), diarrhea (1.3-3.1%), epistaxis (1.9-3.7%), bronchospasm (1.9-3.1%), nausea (1.9-2.8%), and vomiting (1-2.5%). No adverse effects are listed as 'very common (>10%)' in clinical trials.

Safety & Warnings

Contraindications

Hypersensitivity to cetirizine, hydroxyzine, or other piperazine derivatives; severe renal impairment/end-stage renal disease with CrCl <10 mL/min (including dialysis).

Warnings & Precautions

Caution in renal impairment (dose adjust); may cause somnolence-avoid alcohol/CNS depressants and use caution with driving; caution in patients with risk of urinary retention (e.g., prostatic hyperplasia/spinal cord lesion); caution in epilepsy or seizure risk; pruritus may occur after stopping long-term use.

Age Restriction

OTC labeling: from 2 years of age; ask doctor under 2 years. Prescription labeling: from 6 months for perennial allergic rhinitis/chronic urticaria.

Drug Interactions

Drug Interactions

Alcohol and other CNS depressants (additive sedation); theophylline at high doses may slightly reduce cetirizine clearance; ritonavir may increase cetirizine exposure.

Interaction Severity

MODERATE: Alcohol and other CNS depressants (e.g., benzodiazepines, opioids, sedative-hypnotics) due to additive sedation/psychomotor impairment. MINOR: Theophylline at high doses may slightly reduce cetirizine clearance; ritonavir may increase cetirizine exposure.

Food Interaction

No clinically significant food restriction; may be taken with or without food.

Special Populations

Children

Children 6 years and over: 5 mg (5 ml) or 10 mg (10 ml) once daily depending on symptom severity, not to exceed 10 mg per day. Children 2-5 years: 2.5 mg (2.5 ml) once daily, may increase to maximum 5 mg daily given as 5 ml once daily or 2.5 ml every 12 hours. Children 6-23 months: 2.5 mg (2.5 ml) once daily, may increase to maximum 5 mg daily given as 2.5 ml every 12 hours. Children under 2 years: ask a doctor.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule; do not double doses.

Stopping the Medicine

Can be stopped without tapering, but counsel that pruritus/urticaria may rarely occur after discontinuation (especially after long-term use) and seek advice if severe.

Overdose

Symptoms: somnolence (common), agitation/restlessness (especially in children), tachycardia, urinary retention; management: supportive/symptomatic care, consider activated charcoal if recent ingestion; no specific antidote and hemodialysis is not effective-seek urgent medical attention/poison center.

Patient Counseling

Shake well and measure doses with a proper device; may cause drowsiness-avoid driving/operating machinery until effects are known; avoid alcohol and other sedatives; do not exceed recommended dose; consult a clinician before use if kidney disease (dose may need reduction) and use caution in significant liver disease; store below 30°C and protect from light (per SFDA).

Monitoring Requirements

No routine monitoring required; monitor renal function in patients with known renal impairment

Pharmacology

Mechanism of Action

Selective peripheral histamine H1-receptor antagonist that blocks histamine-mediated allergic symptoms with minimal anticholinergic activity and generally low CNS penetration at usual doses.

Onset of Action

20-60 minutes.

Duration of Effect

Approximately 24 hours.

Half-Life

Approximately 8 hours in healthy adults (commonly cited range ~7-10 hours); prolonged in renal impairment.

Bioavailability

>70%.

Metabolism

Minimal hepatic metabolism; most of the dose is excreted unchanged in urine; not significantly metabolized by CYP450 enzymes.

Excretion

Primarily renal elimination: ~70% recovered in urine (a substantial portion as unchanged drug); ~10% recovered in feces.

Protein Binding

93%.

Product Information

Available Dosage Forms

For this SFDA-registered product: Oral syrup (1 mg/mL) in a 100 mL bottle.

Composition per Dose

Each 5 ml: 5 mg cetirizine hydrochloride (1 mg/ml)

Generic Availability

Yes

OTC Alternatives

Other OTC second-generation antihistamines: loratadine, fexofenadine, levocetirizine; (where available) desloratadine. First-generation options (e.g., chlorpheniramine) are alternatives but more sedating.

Symptom Target

Allergy, Runny Nose

Sedating

Yes

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 24-07-2026