LORAHIST 10/MG TAB 10/TAB

Indications

Approved Uses

Symptomatic relief of allergic rhinitis (seasonal/perennial) and chronic idiopathic urticaria (hives).

Off-Label Uses

Off-label: allergic conjunctivitis symptom relief; pruritus from minor allergic skin reactions (e.g., insect bites); some physical urticarias (e.g., dermographism/cold urticaria) as symptomatic treatment.

Dosage & Administration

Dosing by Condition

Allergic rhinitis or chronic idiopathic urticaria: Adults and children ≥6 years: 10 mg once daily; Children 2-5 years: 5 mg once daily (requires suitable formulation).

Initial Dose

10 mg once daily

Maintenance Dose

10 mg once daily

Maximum Dose

10 mg per day

Children's Dosage

Children 2-5 years: 5 mg once daily; Children ≥6 years: 10 mg once daily. Not recommended under 2 years

Dose Adjustment Notes

In severe hepatic impairment or severe renal impairment (e.g., CrCl <30 mL/min), use 10 mg every other day (or 5 mg once daily if an appropriate formulation is available).

How to Take

Swallow 1 tablet (10 mg) by mouth with water; may be taken with or without food; usually taken once daily.

Side Effects

Common Side Effects

Headache, fatigue, dry mouth; somnolence/drowsiness can occur (usually low).

Safety & Warnings

Contraindications

Hypersensitivity to loratadine or any excipients/components

Warnings & Precautions

Use caution in hepatic impairment (and severe renal impairment); may cause rare somnolence; stop ~48 hours before skin allergy testing

Age Restriction

Not recommended for children under 2 years; 5 mg once daily for children 2-5 years (requires suitable formulation); 10 mg once daily for children ≥6 years.

Drug Interactions

Interaction Severity

MODERATE: Strong CYP3A4 and/or CYP2D6 inhibitors (e.g., ketoconazole, erythromycin/clarithromycin, cimetidine) may increase loratadine/desloratadine exposure; advise monitoring. MINOR: Alcohol/CNS depressants may add drowsiness in sensitive patients.

Food Interaction

No restriction

Special Populations

Children

Children 2-5 years: 5 mg once daily; Children ≥6 years: 10 mg once daily. Not recommended under 2 years

Kidney Impairment

GFR < 30 mL/min: 10 mg every other day.

Storage & Patient Advice

Stopping the Medicine

Safe to stop anytime

Overdose

Symptoms: somnolence, tachycardia, headache; management: supportive/symptomatic care, consider activated charcoal if recent ingestion; seek urgent medical attention; not effectively removed by hemodialysis

Patient Counseling

Take 1 tablet (10 mg) once daily; with or without food. Usually non-drowsy, but if you feel sleepy avoid driving and alcohol. Do not exceed 10 mg/day. Ask a clinician before use if you have severe liver or kidney disease or take strong CYP3A4/2D6 inhibitors. Store below 25°C. Seek medical advice if symptoms persist or worsen.

Monitoring Requirements

No routine monitoring

Pharmacology

Mechanism of Action

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

Onset of Action

1-3 hours.

Duration of Effect

Approximately 24 hours (once-daily effect).

Half-Life

Loratadine: ~8-12 hours; active metabolite (desloratadine/descarboethoxyloratadine): ~17-24 hours

Bioavailability

Approximately 40% (oral bioavailability; subject to first-pass metabolism)

Metabolism

Extensive hepatic metabolism via CYP3A4 and CYP2D6 to the active metabolite desloratadine (also known as descarboethoxyloratadine)

Product Information

Available Dosage Forms

Tablet (this product: 10 mg oral tablet).

Composition per Dose

Each tablet: 10 mg loratadine

Generic Availability

Yes

OTC Alternatives

Other OTC second-generation antihistamines: cetirizine, fexofenadine, desloratadine, levocetirizine.

Symptom Target

Allergy, Runny Nose

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 11-05-2026