LEVOZYRT 5/MG TAB 30/TAB

Indications

Approved Uses

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

Dosage & Administration

Dosing by Condition

Allergic rhinitis (adults and children ≥12 years): 5 mg once daily in the evening; some patients may be adequately controlled by 2.5 mg once daily in the evening. Chronic idiopathic urticaria (adults and children ≥12 years): 5 mg once daily in the evening; some patients may be adequately controlled by 2.5 mg once daily in the evening. Children 6-11 years: 2.5 mg once daily in the evening. Children 6 months to 5 years: 1.25 mg once daily in the evening (oral solution). Children younger than 6 months: dose must be determined by physician.

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.

Children's Dosage

Children 6-11 years: 2.5 mg once daily in the evening (tablet or oral solution). Children 6 months to 5 years: 1.25 mg once daily in the evening (oral solution). Children younger than 6 months: use and dose must be determined by physician. Not recommended under 6 months without physician determination.

Dose Adjustment Notes

Dose adjustment is required in renal impairment based on creatinine clearance; no adjustment is needed for hepatic impairment alone, but if hepatic impairment coexists with renal impairment, adjust per renal function (including in the elderly).

How to Take

Swallow tablet whole with water; may be taken with or without food; take preferably in the evening

Side Effects

Common Side Effects

Somnolence, fatigue, dry mouth, headache; nasopharyngitis is also commonly reported (especially in pediatric data).

Side Effect Frequency

Common (≥1% to <10%): somnolence, fatigue/asthenia, dry mouth, headache; Uncommon (≥0.1% to <1%): abdominal pain, nausea; Rare (≥0.01% to <0.1%) or very rare (<0.01%): hypersensitivity reactions (e.g., angioedema/anaphylaxis), agitation/aggression, depression, hallucination, convulsions, palpitations, urinary retention.

Safety & Warnings

Contraindications

Hypersensitivity to levocetirizine or any ingredients of levocetirizine dihydrochloride tablets or to cetirizine; end-stage renal disease with creatinine clearance less than 10 mL/min or patients undergoing hemodialysis; children 6 months to 11 years of age with renal impairment

Warnings & Precautions

May cause somnolence-avoid driving/operating machinery until effects known; use caution and adjust dose in renal impairment (especially elderly); caution in patients at risk of urinary retention (e.g., prostatic hyperplasia, spinal cord lesions); avoid use in severe renal failure (CrCl <10 mL/min/dialysis).

Age Restriction

This 5 mg tablet is for adults and children ≥6 years; not recommended for children <6 years (use age-appropriate oral solution if needed).

Driving Warning

May Cause Drowsiness

Drug Interactions

Food Interaction

No restriction.

Special Populations

Children

Children 6-11 years: 2.5 mg once daily in the evening (tablet or oral solution). Children 6 months to 5 years: 1.25 mg once daily in the evening (oral solution). Children younger than 6 months: use and dose must be determined by physician. Not recommended under 6 months without physician determination.

Kidney Impairment

Adults and children ≥12 years with renal impairment: Mild (CrCl 50-80 mL/min): 2.5 mg once daily; Moderate (CrCl 30-50 mL/min): 2.5 mg once every other day; Severe (CrCl 10-30 mL/min): 2.5 mg twice weekly (once every 3-4 days); End-stage renal disease (CrCl <10 mL/min) or hemodialysis: contraindicated

Liver Impairment

No dose adjustment needed for isolated hepatic impairment; if hepatic impairment coexists with renal impairment, adjust based on renal function.

Storage & Patient Advice

Overdose

Symptoms: somnolence in adults; agitation/restlessness in children (may be followed by drowsiness). Management: symptomatic/supportive care; consider activated charcoal/gastric decontamination if recent; no specific antidote; not effectively removed by hemodialysis; seek urgent medical care.

Patient Counseling

Take one tablet once daily, preferably in the evening. This medication may cause drowsiness - avoid driving or operating heavy machinery until you know how it affects you. Do not drink alcohol while taking this medication. You can take it with or without food. If you have kidney problems, inform your doctor or pharmacist as your dose may need adjustment. Do not exceed the recommended dose. Store below 30°C.

Monitoring Requirements

No routine laboratory monitoring is required; consider assessing renal function in the elderly and in patients with known or suspected renal impairment.

Pharmacology

Mechanism of Action

Selective peripheral histamine H1-receptor antagonist that inhibits histamine-mediated allergic symptoms (with minimal anticholinergic activity).

Onset of Action

Within 1 hour.

Bioavailability

High oral bioavailability (approximately near-complete, ~100%).

Metabolism

Levocetirizine undergoes minimal metabolism (≈<14%); metabolites arise mainly via aromatic oxidation and N-/O-dealkylation, and it is not significantly metabolized by CYP enzymes (low CYP interaction potential).

Product Information

Available Dosage Forms

For this SFDA-registered product (Levozyrt, SFDA 1811211337): film-coated tablet (oral).

Composition per Dose

Each film-coated tablet: 5 mg levocetirizine dihydrochloride

Generic Availability

Yes

OTC Alternatives

Other OTC second-generation antihistamines: cetirizine, loratadine, fexofenadine.

Symptom Target

Allergy, Runny Nose

Sedating

Yes

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