ZYRTEC 0.1% SUSP 75ML

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 (e.g., urticaria/angioedema) alongside standard care.

Dosage & Administration

Dosing by Condition

Allergic rhinitis or chronic urticaria: Adults and children ≥12 years: 10 mg once daily (or 5 mg twice daily). Children 6-11 years: 5-10 mg/day (commonly 5 mg once daily, may increase to 10 mg/day). Children 2-5 years: 2.5 mg once daily, may increase to 5 mg/day (as 5 mg once daily or 2.5 mg twice daily). Children 6-23 months: 2.5 mg once daily; 12-23 months may increase to 2.5 mg twice daily (max 5 mg/day) where labeled/clinically appropriate.

Initial Dose

Adults and children ≥12 years: 10 mg once daily

Maintenance Dose

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

Maximum Dose

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

Children's Dosage

1-2 years: 2.5 mg (2.5 mL) once daily. 2-5 years: 2.5 mg (2.5 mL) once daily, may increase to 5 mg/day in two divided doses. 6-11 years: 5 mg (5 mL) once daily or 2.5 mg twice daily

Dose Adjustment Notes

Dose reduction is required in renal impairment; hepatic impairment alone usually does not require adjustment, but consider reduction if hepatic disease is accompanied by renal impairment; elderly may need adjustment based on renal function.

How to Take

Oral use: measure the dose with an appropriate measuring device (oral syringe/cup) and take once daily as directed; may be taken with or without food; do not exceed the recommended dose. (This product is an oral solution-shaking is generally not required unless the label instructs.)

How to Prepare

N/A - ready-to-use oral solution (no reconstitution required)

Side Effects

Common Side Effects

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

Side Effect Frequency

Common (1-10%): somnolence, fatigue, dry mouth, dizziness, headache, nausea; pharyngitis is commonly reported (especially in pediatric studies)

Safety & Warnings

Contraindications

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

Warnings & Precautions

Use caution in renal impairment (dose reduction required) and in older adults due to reduced renal clearance; may cause somnolence-caution with driving/machinery and with alcohol/CNS depressants; caution in epilepsy/seizure risk; consider excipients in patients with sensitivities.

Age Restriction

Approved for use in children 6 months and older for certain indications (per product labeling); not recommended for infants <6 months unless specifically directed by a physician.

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

Additive CNS depression with alcohol and other CNS depressants (e.g., sedatives, opioids); clinically significant interactions are otherwise limited (theophylline/ritonavir effects are not typically clinically meaningful at usual doses; MAOI interaction is not established for cetirizine).

Interaction Severity

Clinically relevant interactions are mainly additive CNS depression with alcohol and other sedatives (e.g., benzodiazepines, opioids); other interactions are generally not clinically significant for most patients.

Food Interaction

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

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Caution

Breastfeeding

Not recommended

Children

1-2 years: 2.5 mg (2.5 mL) once daily. 2-5 years: 2.5 mg (2.5 mL) once daily, may increase to 5 mg/day in two divided doses. 6-11 years: 5 mg (5 mL) once daily or 2.5 mg twice daily

Elderly

Start at 5 mg once daily due to age-related reduction in renal clearance; titrate based on tolerability and renal function

Liver Impairment

No routine dose adjustment for hepatic impairment alone; if hepatic impairment coexists with renal impairment, dose should follow renal-adjustment recommendations (often 5 mg once daily in reduced renal function).

Storage & Patient Advice

Preparation Instructions

N/A - ready-to-use oral solution (no reconstitution required)

Stopping the Medicine

Safe to stop anytime (no taper needed); pruritus and/or urticaria can occur after discontinuation in some patients.

Overdose

Symptoms may include somnolence (or paradoxical agitation/restlessness, especially in children), tachycardia, and urinary retention; management is supportive (consider activated charcoal if early), no specific antidote, and hemodialysis is ineffective-seek urgent medical care.

Patient Counseling

Use an accurate measuring device; take once daily as directed and do not exceed the recommended dose; may be taken with or without food; may cause drowsiness-avoid driving/operating machinery until effects are known and avoid alcohol/other sedatives; seek advice if you have kidney disease (dose may need reduction); store below 25°C and keep out of reach of children.

Monitoring Requirements

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

Pharmacology

Mechanism of Action

Selective H1-receptor antagonist (inverse agonist) that blocks histamine-mediated symptoms, with relatively limited CNS penetration compared with first-generation antihistamines.

Onset of Action

20-60 minutes.

Duration of Effect

Approximately 24 hours.

Half-Life

Adults: ~8 hours (range ~7-10 hours); shorter in children; prolonged in renal impairment

Bioavailability

Approximately 70% (oral bioavailability)

Metabolism

Minimal hepatic metabolism; largely excreted unchanged; not meaningfully CYP450-mediated

Excretion

Primarily renal: ~60-70% excreted unchanged in urine; remainder mainly in feces (minor fraction)

Product Information

Available Dosage Forms

For this SFDA-registered product: Oral solution (1 mg/mL) in a bottle (75 mL).

Composition per Dose

Each 1 mL: 1 mg cetirizine hydrochloride

Generic Availability

Yes

OTC Alternatives

Other OTC second-generation antihistamines such as loratadine or fexofenadine (age-appropriate formulations), and where appropriate chlorpheniramine (more sedating).

Symptom Target

Allergy, Runny Nose

Sedating

Yes

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 09-08-2026