CERTRALON 10/MG FC TAB 10/FC TAB

Indications

Approved Uses

Treatment of nasal and ocular symptoms of seasonal and perennial allergic rhinitis; treatment of chronic idiopathic urticaria.

Dosage & Administration

Dosing by Condition

Adults and children 6 years and over: one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

Initial Dose

10mg once daily (adults and children ≥12 years)

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

Children under 6 years of age: ask a doctor. Adults and children 6 years and over: one 10 mg tablet once daily.

Dose Adjustment Notes

Renal impairment: reduce dose (e.g., 5 mg once daily) in moderate impairment; avoid or use only with specialist advice in severe renal impairment/ESRD. Hepatic impairment: no adjustment usually needed unless concomitant renal impairment; consider lower dose if both hepatic and renal impairment.

How to Take

Swallow the 10 mg film‑coated tablet whole with water; may be taken with or without food; usually taken once daily.

Side Effects

Common Side Effects

Somnolence/drowsiness, fatigue, dry mouth, headache, dizziness; may also include nausea and pharyngitis/sore throat.

Safety & Warnings

Contraindications

Hypersensitivity to cetirizine. Stop use and ask a doctor if an allergic reaction occurs.

Warnings & Precautions

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

Age Restriction

CETRALON 10 mg film‑coated tablets: generally for adults and children ≥6 years; not recommended for children <6 years (tablet strength/form not suitable).

Driving Warning

May Cause Drowsiness

Drug Interactions

Interaction Severity

MODERATE: alcohol and other CNS depressants (e.g., benzodiazepines, opioids, sedative hypnotics) due to additive sedation. MINOR: theophylline (high doses may slightly reduce cetirizine clearance). MINOR: ritonavir (may increase cetirizine exposure).

Food Interaction

No restriction.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Children

Children under 6 years of age: ask a doctor. Adults and children 6 years and over: one 10 mg tablet once daily.

Elderly

Adults 65 years and over: ask a doctor

Kidney Impairment

Consumers with liver or kidney disease: ask a doctor

Liver Impairment

No routine adjustment for hepatic impairment alone; if hepatic impairment coexists with renal impairment, reduce to 5 mg once daily (or per renal function).

Storage & Patient Advice

Patient Counseling

Take 1 tablet (10 mg) once daily with or without food; do not exceed 10 mg/day. May cause drowsiness-avoid driving/operating machinery until you know the effect; avoid alcohol and other sedatives. Seek advice if you have kidney disease (dose may need reduction) or if symptoms persist/worsen (e.g., hives lasting >6 weeks).

Monitoring Requirements

No routine monitoring

Pharmacology

Mechanism of Action

Selective peripheral H1‑receptor antagonist that blocks histamine‑mediated symptoms (sneezing, rhinorrhea, pruritus, wheal/flare) with minimal anticholinergic activity and generally less CNS penetration than first‑generation antihistamines.

Onset of Action

20-60 minutes.

Duration of Effect

Approximately 24 hours.

Half-Life

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

Excretion

Primarily renal excretion: ~70% in urine (a substantial portion unchanged); minor fecal excretion ~10%.

Product Information

Available Dosage Forms

For this SFDA product: film‑coated tablet.

Composition per Dose

Each film-coated tablet: 10mg cetirizine hydrochloride

Generic Availability

Yes

Symptom Target

Allergy, Runny Nose

Sedating

Yes

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 18-07-2026