GLOZAL 5/MG FC TAB 30/FC TAB

Indications

Approved Uses

Allergic rhinitis (seasonal and perennial), chronic idiopathic urticaria, allergic conjunctivitis

Dosage & Administration

Dosing by Condition

Allergic rhinitis and chronic idiopathic urticaria: Adults and adolescents ≥12 years: 5 mg orally once daily; Children 6-11 years: 2.5 mg once daily (requires a suitable formulation); Children 2-5 years: 1.25 mg once daily (requires oral solution).

Initial Dose

5 mg once daily in the evening.

Maintenance Dose

5 mg once daily in the evening.

Maximum Dose

5 mg per day for adults.

Children's Dosage

Children 6 to 11 years: 2.5 mg once daily in the evening.

Dose Adjustment Notes

Dose adjustment is required in renal impairment (based on creatinine clearance); no adjustment is generally needed for hepatic impairment alone, but adjust if concomitant renal impairment is present.

How to Take

Swallow the 5 mg film‑coated tablet whole with water; may be taken with or without food; take once daily (evening dosing is optional/preferred if drowsiness occurs).

Side Effects

Common Side Effects

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

Side Effect Frequency

Common (1-10%): somnolence, headache, fatigue, dry mouth; Uncommon (0.1-1%): abdominal pain; Frequency not known/rare: hypersensitivity reactions (e.g., rash, pruritus, urticaria), palpitations/tachycardia (rare).

Safety & Warnings

Contraindications

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

Warnings & Precautions

May cause somnolence/fatigue-avoid driving/operating machinery until effects known; use caution and adjust dose in renal impairment (especially elderly); use caution in patients with risk of urinary retention (e.g., prostatic hyperplasia, spinal cord lesions); avoid alcohol/CNS depressants if sedation occurs.

Age Restriction

Not recommended/indicated for children <6 years for this 5 mg film‑coated tablet; use age‑appropriate pediatric formulations if needed (tablet generally for ≥6 years).

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). MINOR: theophylline (may slightly reduce clearance).

Food Interaction

No restriction.

Alcohol Interaction

Avoid

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Caution

Children

Children 6 to 11 years: 2.5 mg once daily in the evening.

Elderly

Standard adult dosing, but caution is advised. Dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased renal function.

Kidney Impairment

Adjust by creatinine clearance: 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 based on renal function.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if it is almost time for the next dose; do not double the dose

Stopping the Medicine

Safe to stop without tapering; however, pruritus (sometimes severe) has been reported after discontinuation, especially after prolonged use.

Overdose

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

Patient Counseling

Take 1 tablet (5 mg) once daily with or without food; if drowsy, take in the evening. May cause sleepiness-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. If a dose is missed, take when remembered unless near next dose-do not double.

Monitoring Requirements

No routine laboratory monitoring is required; assess/monitor renal function when clinically indicated (e.g., elderly or known renal impairment) to guide dosing.

Pharmacology

Mechanism of Action

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

Onset of Action

Within 1 hour.

Duration of Effect

24 hours.

Bioavailability

High oral bioavailability (approximately 100%).

Metabolism

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

Excretion

Primarily renal elimination, with ~85% excreted unchanged in urine.

Protein Binding

Approximately 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

Other OTC oral second‑generation antihistamines: cetirizine, loratadine, fexofenadine.

Symptom Target

Allergy, Runny Nose

Sedating

Yes

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