LEVOZAL 5/MG FC TAB 20/FC TAB

Indications

Approved Uses

Perennial allergic rhinitis (children 6 years and older), seasonal allergic rhinitis, chronic idiopathic urticaria

Off-Label Uses

Pruritus (e.g., associated with atopic dermatitis/eczema) is a commonly used off‑label symptomatic use; other off‑label uses may exist but are not core.

Dosage & Administration

Dosing by Condition

Allergic rhinitis (adults and children ≥12 years): 5 mg once daily in the evening. Chronic idiopathic urticaria (adults and children ≥12 years): 5 mg once daily in the evening. Children 6-11 years: 2.5 mg once daily in the evening. Children 2-5 years: 1.25 mg once daily in the evening (oral solution only)

Initial Dose

5mg once daily in the evening for adults.

Maintenance Dose

5mg once daily in the evening for adults.

Maximum Dose

5mg per day for adults and children ≥12 years; 2.5mg per day for children 6-11 years.

Children's Dosage

6-11 years: 2.5 mg once daily (1/2 tablet); under 6 years: not recommended for this formulation

Dose Adjustment Notes

Dose adjustment is required in renal impairment based on creatinine clearance; no adjustment is needed for hepatic impairment alone (but consider renal function if hepatic disease is associated with reduced CrCl).

How to Take

Swallow the 5 mg film‑coated tablet whole with water; may be taken with or without food; once daily, commonly in the evening (especially if it causes drowsiness).

Side Effects

Common Side Effects

Somnolence, fatigue, dry mouth, headache, dizziness; upper respiratory symptoms such as nasopharyngitis/pharyngitis can occur.

Side Effect Frequency

Common (1-10%): somnolence, dry mouth, fatigue, headache. Uncommon (0.1-1%): asthenia, abdominal pain. Post-marketing/rare: palpitations, tachycardia, hypersensitivity reactions (e.g., rash, pruritus, urticaria, angioedema), dyspnea, nausea, urinary retention, weight increase.

Safety & Warnings

Contraindications

Hypersensitivity to levocetirizine, cetirizine, hydroxyzine, or piperazine derivatives; end‑stage renal disease/severe renal impairment with CrCl <10 mL/min and patients on dialysis (contraindicated).

Warnings & Precautions

Renal impairment (dose reduction/avoid if severe); somnolence-caution with driving/machinery and with alcohol/CNS depressants; risk of urinary retention in predisposed patients (e.g., prostatic hyperplasia, spinal cord lesions); pruritus may occur after discontinuation (especially after long-term use).

Age Restriction

For this 5 mg film‑coated tablet: use in adults and children ≥6 years; not recommended for children <6 years (tablet strength/form not suitable).

Driving Warning

May Cause Drowsiness

Drug Interactions

Drug Interactions

CNS depressants/alcohol (additive sedation); ritonavir (may increase levocetirizine exposure); theophylline (may slightly reduce clearance).

Interaction Severity

MODERATE: Alcohol and other CNS depressants (additive sedation/impairment). Ritonavir may increase levocetirizine exposure-use caution. No established major interactions; theophylline interaction is not clinically significant for levocetirizine.

Food Interaction

No clinically significant food restriction; can be taken with or without food (food may delay Tmax but does not meaningfully reduce overall exposure).

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Children

6-11 years: 2.5 mg once daily (1/2 tablet); under 6 years: not recommended for this formulation

Elderly

Start at the lowest dose; dosing should be selected with caution, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased renal function.

Kidney Impairment

Adults/adolescents ≥12 years (5 mg tablet): CrCl 50-80 mL/min: 2.5 mg once daily; CrCl 30-50 mL/min: 2.5 mg once every other day; CrCl 10-30 mL/min: 2.5 mg twice weekly (every 3-4 days); CrCl <10 mL/min or dialysis: 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 scheduled dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Safe to stop without tapering; however, pruritus (sometimes severe) can occur after discontinuation, especially after long-term use.

Overdose

Symptoms: somnolence in adults; agitation/restlessness (may precede somnolence) in children. Management: symptomatic/supportive; consider gastric decontamination if recent; no specific antidote; hemodialysis is not effective.

Patient Counseling

Take 5 mg once daily (often in the evening); may take with or without food; may cause drowsiness-avoid driving/operating machinery until effects are known; avoid alcohol/other sedatives; tell a clinician if you have kidney disease (dose may need adjustment); store below 30°C; seek medical advice if symptoms persist/worsen.

Monitoring Requirements

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

Pharmacology

Mechanism of Action

Selective peripheral histamine H1‑receptor antagonist (inverse agonist), reducing histamine‑mediated allergic symptoms (e.g., sneezing, rhinorrhea, pruritus, urticaria).

Onset of Action

Within 1 hour.

Duration of Effect

24 hours.

Bioavailability

≥85%.

Metabolism

Minimal hepatic metabolism (roughly <14%); most of the dose is excreted unchanged.

Excretion

Primarily renal elimination, mostly unchanged in urine (about ~85%); minor fecal excretion.

Protein Binding

Approximately 90% (about 91-92%)

Product Information

Available Dosage Forms

For this product (LEVOZAL): film‑coated tablet for oral use (5 mg). Levocetirizine also exists in other markets as an oral solution, but that is not the dosage form of this SFDA-registered product.

Composition per Dose

Each film-coated tablet: 5 mg levocetirizine dihydrochloride

Generic Availability

Yes

OTC Alternatives

Other OTC non-sedating/less-sedating antihistamines: cetirizine, loratadine, fexofenadine (and desloratadine where available).

Symptom Target

Allergy, Runny Nose

Sedating

Yes

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 30-08-2026