LEVOZIN 5/MG FC TAB 20/FC TAB

Indications

Approved Uses

Seasonal allergic rhinitis, perennial allergic rhinitis, chronic idiopathic urticaria

Off-Label Uses

Pruritus (e.g., associated with atopic dermatitis/eczema) and other histamine-mediated itch conditions (off-label).

Dosage & Administration

Dosing by Condition

Allergic Rhinitis & Chronic Urticaria (Adults & Children ≥12 years): 5 mg once daily in the evening; some may respond to 2.5 mg once daily. Allergic Rhinitis & Chronic Urticaria (Children 6-11 years): 2.5 mg once daily in the evening. Allergic Rhinitis & Chronic Urticaria (Children 6 months-5 years): 1.25 mg once daily in the evening.

Initial Dose

5 mg once daily in the evening.

Maintenance Dose

2.5 mg to 5 mg once daily in the evening.

Maximum Dose

Adults: 5 mg per day. Children 6-11 years: 2.5 mg per day.

Children's Dosage

6-11 years: 2.5 mg once daily (½ tablet); under 6 years: not recommended for tablets

Dose Adjustment Notes

Dose reduction is required in renal impairment based on creatinine clearance; no adjustment is needed for hepatic impairment alone, but follow renal-based adjustment if hepatic and renal impairment coexist.

How to Take

Swallow the tablet whole with water. Can be taken with or without food. It is typically recommended to be taken in the evening.

Side Effects

Common Side Effects

Somnolence, fatigue, dry mouth, headache, dizziness, nasopharyngitis

Side Effect Frequency

Common (≥1%): somnolence, fatigue, dry mouth, headache, nasopharyngitis; other events such as pharyngitis/cough/pyrexia are more prominent in pediatric solution studies and are not consistently “common” across adult tablet data.

Safety & Warnings

Contraindications

Hypersensitivity to levocetirizine, cetirizine, hydroxyzine, or other piperazine derivatives; end-stage renal disease/severe renal impairment (CrCl <10 mL/min) and patients on hemodialysis; contraindicated in pediatric patients (typically 6 months-11 years) with renal impairment due to inability to appropriately adjust dose with available strengths/forms.

Warnings & Precautions

May cause somnolence-caution with driving/operating machinery; avoid or limit alcohol/other CNS depressants; adjust dose in renal impairment and use caution in elderly; use caution in patients with risk factors for urinary retention (e.g., prostatic hyperplasia, spinal cord lesion).

Age Restriction

Not recommended/approved for children under 2 years for the 5 mg film-coated tablet; pediatric use below 2 years requires age-appropriate formulations and dosing.

Drug Interactions

Interaction Severity

MODERATE: Alcohol and other CNS depressants (additive sedation). MINOR: Ritonavir (may increase exposure). MINOR: Theophylline (may slightly reduce clearance at higher theophylline doses).

Food Interaction

No restriction.

Special Populations

Children

6-11 years: 2.5 mg once daily (½ tablet); under 6 years: not recommended for tablets

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 every 48 hours; CrCl 10-30 mL/min: 2.5 mg every 72 hours; CrCl <10 mL/min or hemodialysis: contraindicated.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if it is almost time for the next dose. Do not take two doses at the same time.

Stopping the Medicine

Safe to stop anytime. However, severe itching has been reported in some cases after stopping long-term use.

Overdose

Symptoms: somnolence/drowsiness in adults; in children agitation/restlessness may occur (sometimes followed by drowsiness). Management: symptomatic and supportive care; consider gastric decontamination if recent ingestion; no specific antidote; hemodialysis is not effective.

Patient Counseling

Take 5 mg once daily (with or without food); may cause drowsiness-avoid driving/operating machinery until effects are known; avoid alcohol/CNS depressants; seek advice before use if you have kidney disease and do not exceed the recommended dose.

Monitoring Requirements

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

Pharmacology

Mechanism of Action

Selective peripheral H1-receptor antagonist that inhibits histamine-mediated allergic symptoms (e.g., sneezing, rhinorrhea, pruritus, urticaria).

Onset of Action

Within 1 hour.

Duration of Effect

24 hours.

Half-Life

Approximately 6-10 hours in adults.

Bioavailability

High oral bioavailability (approximately near-complete; commonly cited ~85% or higher).

Metabolism

Minimal hepatic metabolism; less than 14% of the dose is metabolized

Excretion

Primarily renal; ~85% excreted unchanged in urine.

Protein Binding

91-92%

Product Information

Available Dosage Forms

Film-coated tablet (oral)

Composition per Dose

Each film-coated tablet: 5 mg levocetirizine as dihydrochloride

Generic Availability

Yes

OTC Alternatives

Cetirizine, loratadine, fexofenadine (OTC antihistamine alternatives).

Symptom Target

Allergy, Runny Nose

Sedating

Yes

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