ZERTAZINE 10/MG FC TAB 20/FC TAB

Indications

Approved Uses

Seasonal allergic rhinitis, perennial allergic rhinitis, and chronic idiopathic urticaria.

Off-Label Uses

Common off‑label uses include pruritus related to atopic dermatitis and other allergic dermatoses, insect bite reactions, and as an adjunct for histamine‑mediated symptoms in anaphylaxis (after epinephrine).

Dosage & Administration

Dosing by Condition

Allergic rhinitis (adults/children ≥12 years): 10mg once daily or 5mg twice daily. Chronic urticaria (adults): 10mg once daily. Children 6-11 years: 5mg once daily or 2.5mg twice daily (using 5mg product). Children 2-5 years: 2.5mg once or twice daily (using syrup).

Initial Dose

10mg once daily

Maintenance Dose

10mg once daily

Maximum Dose

10mg per day in adults; 5mg per day in children 2-5 years; 10mg per day in children 6-11 years

Children's Dosage

2-5 years: 2.5mg once or twice daily (max 5mg/day); 6-11 years: 5mg once daily or 2.5mg twice daily (max 10mg/day); ≥12 years: 10mg once daily

Dose Adjustment Notes

Renal impairment: dose reduction is required (e.g., CrCl 30-49 mL/min: 5 mg once daily; CrCl 10-29 mL/min: 5 mg every other day; avoid/use not recommended in end‑stage renal disease or CrCl <10 mL/min). Hepatic impairment: no adjustment usually needed unless concomitant renal impairment.

How to Take

Swallow 1 film‑coated tablet (10 mg) whole with water; may be taken with or without food.

Side Effects

Common Side Effects

Somnolence (drowsiness), fatigue, dry mouth, headache, dizziness; may also include pharyngitis/sore throat and gastrointestinal upset (e.g., nausea/abdominal pain).

Side Effect Frequency

Common (1-10%): somnolence, fatigue, dry mouth, headache, dizziness; nausea and pharyngitis/sore throat are also commonly reported.

Safety & Warnings

Contraindications

Hypersensitivity to cetirizine, hydroxyzine, or other piperazine derivatives (or any excipients); severe renal impairment/ESRD (CrCl <10 mL/min) is generally contraindicated/avoid.

Warnings & Precautions

Caution in renal impairment (dose adjust); may cause somnolence-avoid driving/operating machinery until effects known; avoid alcohol/other CNS depressants; caution in patients with seizure risk; caution in urinary retention/prostatic hypertrophy; elderly may be more sensitive (often due to reduced renal function).

Age Restriction

For this 10 mg film‑coated tablet: generally for adults and children ≥6 years; not recommended for children <6 years (use age-appropriate liquid/drops if needed).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Main clinically relevant interaction is additive CNS depression with alcohol and other sedatives/CNS depressants; other interactions are generally minimal/clinically insignificant at usual doses.

Interaction Severity

MODERATE: Alcohol and other CNS depressants (additive sedation/impairment). No major interactions are routinely established for cetirizine at usual doses.

Food Interaction

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

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Category B

Breastfeeding

Caution

Children

2-5 years: 2.5mg once or twice daily (max 5mg/day); 6-11 years: 5mg once daily or 2.5mg twice daily (max 10mg/day); ≥12 years: 10mg once daily

Elderly

Start with 5mg once daily; increase to 10mg if tolerated and needed; monitor renal function as clearance may be reduced

Kidney Impairment

CrCl 30-49 mL/min: 5 mg once daily; CrCl 10-29 mL/min: 5 mg every other day; CrCl <10 mL/min (including ESRD/dialysis): avoid/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

Missed Dose

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

Patient Counseling

Take 1 tablet (10 mg) once daily by mouth; may take with or without food. May cause drowsiness-use caution with driving/machinery and avoid alcohol/other sedatives. Do not exceed the recommended dose; seek advice if you have kidney disease. Store below 30°C.

Monitoring Requirements

No routine monitoring required; monitor renal function in patients with pre-existing renal impairment

Pharmacology

Mechanism of Action

Selective peripheral histamine H1‑receptor antagonist that blocks histamine‑mediated allergic symptoms (e.g., sneezing, rhinorrhea, pruritus, urticaria) with relatively low CNS/anticholinergic activity at usual doses.

Onset of Action

20-60 minutes.

Duration of Effect

Approximately 24 hours (supports once‑daily dosing).

Half-Life

Approximately 8 hours in healthy adults (commonly cited range ~7-10 hours); prolonged in elderly and in renal impairment (and may be increased in hepatic impairment).

Bioavailability

>70%.

Metabolism

Minimal/limited hepatic metabolism; not significantly metabolized by CYP450; largely excreted unchanged.

Excretion

Primarily renal: ~70% excreted in urine (mostly unchanged); ~10% excreted in feces.

Product Information

Available Dosage Forms

For this product (ZERTAZINE): Film‑coated tablet (oral).

Composition per Dose

Each film-coated tablet: 10mg cetirizine hydrochloride.

Generic Availability

Yes

OTC Alternatives

Other OTC antihistamines include loratadine and fexofenadine; first‑generation options such as chlorpheniramine are also OTC but more sedating.

Symptom Target

Allergy, Runny Nose

Sedating

Yes

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 25-05-2026