ZERTAZINE 10/MG FC TAB 10/FC TAB

Indications

Approved Uses

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

Off-Label Uses

Symptomatic relief of pruritus in atopic dermatitis and other pruritic dermatoses; insect-bite hypersensitivity reactions (adjunct).

Dosage & Administration

Dosing by Condition

Adults and adolescents ≥12 years (allergic rhinitis or chronic idiopathic urticaria): 10 mg orally once daily (alternative: 5 mg once daily if sensitive to sedation). Children 6-11 years: 5 mg once daily (may increase to 10 mg/day depending on response/tolerability; formulation-dependent).

Initial Dose

10mg once daily

Maintenance Dose

10mg once daily

Maximum Dose

10mg per day in adults and children 6 years and over; ask a doctor for patients with renal or hepatic impairment

Children's Dosage

6-11 years: 5mg or 10mg once daily. Children under 6 years: ask a doctor

Dose Adjustment Notes

Renal impairment: reduce dose (commonly to 5 mg once daily) when CrCl 11-31 mL/min; avoid or use only with specialist advice if CrCl <10 mL/min or on dialysis. Hepatic impairment: no adjustment unless concomitant renal impairment; if both hepatic and renal impairment, use reduced dose (e.g., 5 mg once daily).

How to Take

Swallow the 10 mg film‑coated tablet whole with water; may be taken with or without food; take once daily (preferably at the same time each day).

Side Effects

Common Side Effects

Somnolence, headache, dry mouth, fatigue, dizziness, pharyngitis, nausea, abdominal pain

Side Effect Frequency

Very common (>10%): somnolence. Common (1-10%): headache, dizziness, dry mouth, fatigue, pharyngitis, nausea, abdominal pain.

Safety & Warnings

Contraindications

Hypersensitivity to cetirizine, hydroxyzine, or any piperazine derivatives, Severe renal impairment (CrCl <10 mL/min)

Warnings & Precautions

May cause somnolence-caution with driving/operating machinery and avoid alcohol/CNS depressants; use caution and adjust dose in renal impairment; caution in patients with seizure risk; caution in patients predisposed to urinary retention (e.g., prostatic hyperplasia/spinal cord lesions); use caution in elderly (often reduced renal function).

Age Restriction

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

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

CNS depressants (including alcohol) may increase sedation; theophylline at high doses can slightly reduce cetirizine clearance; ritonavir can increase cetirizine exposure.

Interaction Severity

MODERATE: Alcohol and other CNS depressants (additive sedation/psychomotor impairment). MINOR: Theophylline at high doses (slight decrease in cetirizine clearance).

Food Interaction

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

Alcohol Interaction

Avoid

Special Populations

Pregnancy

B

Breastfeeding

Caution

Children

6-11 years: 5mg or 10mg once daily. Children under 6 years: ask a doctor

Elderly

Adults 65 years and over: ask a doctor

Kidney Impairment

CrCl ≥50 mL/min: 10 mg once daily; CrCl 30-49 mL/min: 5 mg once daily; CrCl 10-29 mL/min: 5 mg once daily; CrCl <10 mL/min or hemodialysis: not recommended (dialysis does not effectively remove cetirizine).

Liver Impairment

No routine hepatic dose adjustment is required; if hepatic impairment coexists with renal impairment, dose according to renal function (often 5 mg once daily).

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.

Stopping the Medicine

Safe to stop anytime. Rare cases of severe itching have been reported after discontinuation following prolonged use.

Overdose

Symptoms: somnolence (most common), dizziness, agitation/restlessness (especially in children), tachycardia, tremor, and urinary retention; Management: supportive/symptomatic care, consider activated charcoal if recent ingestion; no specific antidote; dialysis is ineffective.

Patient Counseling

Take 10 mg once daily (same time each day); may take with or without food. Drowsiness can occur-avoid driving/operating machinery until you know your response. Avoid alcohol and other sedatives due to additive drowsiness. Tell a clinician if you have kidney disease (dose reduction may be needed). Seek medical advice if symptoms persist or worsen.

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 with minimal anticholinergic activity and generally less CNS sedation than first-generation antihistamines (though drowsiness can occur).

Onset of Action

20-60 minutes

Duration of Effect

Approximately 24 hours.

Half-Life

Approximately 8 hours in healthy adults (commonly reported range ~6.5-10 hours).

Bioavailability

>70%

Metabolism

Minimal/limited hepatic metabolism; predominantly excreted unchanged in urine (with a minor metabolized fraction).

Excretion

Primarily renal excretion, largely as unchanged drug (majority in urine).

Protein Binding

UNVERIFIABLE

Product Information

Available Dosage Forms

For this product (ZERTAZINE; SFDA 144-325-04): Film‑coated tablet for oral use.

Composition per Dose

Each film-coated tablet: 10mg cetirizine hydrochloride

Generic Availability

Yes

OTC Alternatives

Other OTC oral antihistamines: loratadine, fexofenadine, and (where available) chlorpheniramine.

Symptom Target

Allergy, Runny Nose

Sedating

Yes

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 06-08-2026