ZYRTEC 10/MG FC TAB 10/FC TAB

Indications

Approved Uses

Relief of nasal and ocular symptoms of seasonal and perennial allergic rhinitis; treatment of uncomplicated skin manifestations of chronic idiopathic urticaria (including pruritus).

Off-Label Uses

Common off‑label uses include pruritus from other dermatoses (e.g., atopic dermatitis) and symptomatic relief of insect‑bite reactions; it is not a substitute for epinephrine in anaphylaxis.

Dosage & Administration

Dosing by Condition

Adults and children ≥12 years (allergic rhinitis or chronic idiopathic urticaria): 10 mg orally once daily (some patients may use 5 mg once daily if sensitive to sedation).

Initial Dose

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

Maintenance Dose

10mg once daily

Maximum Dose

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

Children's Dosage

Children under 6 years of age: ask a doctor

Dose Adjustment Notes

Renal impairment: reduce dose (commonly 5 mg once daily) when CrCl 11-31 mL/min; avoid/use only with medical advice in severe renal impairment (CrCl <10 mL/min) or dialysis. Hepatic impairment: no adjustment unless concomitant renal impairment.

How to Take

Swallow the film‑coated tablet whole with water; may be taken with or without food; usually taken once daily at the same time each day.

Side Effects

Common Side Effects

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

Safety & Warnings

Contraindications

Hypersensitivity to cetirizine, hydroxyzine, or any piperazine derivatives, Patients with severe renal impairment (creatinine clearance <10 ml/min).

Warnings & Precautions

Key warnings/precautions: may cause somnolence-caution with driving/operating machinery and with alcohol/CNS depressants; dose reduction in renal impairment; caution in patients with predisposition to urinary retention (e.g., prostatic hyperplasia/spinal cord lesion); caution in epilepsy or seizure risk; consider excipients (e.g., lactose) where relevant.

Age Restriction

For this product (cetirizine 10 mg film‑coated tablet, oral): generally for adults and children ≥6 years; younger children should use age-appropriate liquid/drops formulations.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Key interactions/cautions: alcohol and other CNS depressants (additive sedation); theophylline at high doses may slightly reduce cetirizine clearance; ritonavir can increase cetirizine exposure (monitor for sedation).

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 restriction.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Caution

Children

Children under 6 years of age: ask a doctor

Elderly

Start with 5mg once daily; use with caution due to increased risk of somnolence and falls; monitor renal function

Kidney Impairment

Adults/adolescents (tablet): CrCl ≥50 mL/min: 10 mg once daily; CrCl 30-49 mL/min: 5 mg once daily; CrCl 10-29 mL/min: 5 mg every other day; CrCl <10 mL/min or hemodialysis: not recommended/contraindicated.

Liver Impairment

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

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near next dose. Do not take two doses at the same time.

Patient Counseling

Take 1 tablet (10 mg) once daily with or without food; may cause drowsiness-avoid driving/operating machinery until you know the effect; avoid alcohol and other sedatives; seek advice if you have kidney disease; store below 25°C; consult a clinician if symptoms persist or worsen.

Monitoring Requirements

No routine monitoring

Pharmacology

Mechanism of Action

Selective peripheral H1‑receptor antagonist that blocks histamine‑mediated allergic symptoms (e.g., sneezing, rhinorrhea, pruritus, wheal/flare).

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).

Bioavailability

>70%.

Metabolism

Cetirizine undergoes minimal hepatic metabolism; the majority is excreted unchanged in urine, with only a small fraction metabolized (not a clinically significant CYP450 substrate).

Excretion

Primarily renal: about two‑thirds to ~70% excreted unchanged in urine; a smaller fraction is excreted in feces.

Protein Binding

93%.

Product Information

Available Dosage Forms

For this SFDA-registered product: film‑coated tablet (oral).

Composition per Dose

Each film-coated tablet: 10mg cetirizine hydrochloride

Generic Availability

Yes

OTC Alternatives

Loratadine, fexofenadine, levocetirizine (all OTC second‑generation antihistamines, availability may vary by market).

Symptom Target

Allergy, Runny Nose

Sedating

Yes

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 28-05-2026