LORINE FM 10/MG TAB 10/TAB

Indications

Approved Uses

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

Dosage & Administration

Dosing by Condition

Allergic rhinitis (≥12 years): 10 mg once daily. Chronic idiopathic urticaria (≥12 years): 10 mg once daily. (Pediatrics 2-11 years dosing uses liquid/5 mg formulations and is not applicable to this 10 mg tablet-only product.)

Initial Dose

10 mg orally once a day.

Maintenance Dose

10 mg orally once a day.

Maximum Dose

10mg per day in adults

Children's Dosage

Children 2-12 years weighing ≤30kg: 5mg once daily; weighing >30kg: 10mg once daily. Not recommended under 2 years

Dose Adjustment Notes

Severe hepatic impairment or severe renal impairment (e.g., CrCl <30 mL/min): 10 mg every other day (or 5 mg once daily if using a 5 mg formulation).

How to Take

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

Side Effects

Common Side Effects

Headache, fatigue, dry mouth; drowsiness/somnolence can occur but is generally uncommon at recommended doses.

Safety & Warnings

Contraindications

Hypersensitivity to loratadine or any excipients

Warnings & Precautions

Use with caution in hepatic impairment (and severe renal impairment); may cause rare somnolence; discontinue ~48 hours before skin allergy testing; not recommended <2 years.

Age Restriction

Not recommended for children <2 years; for this 10 mg tablet, use is generally for ≥6 years (2-5 years require a pediatric formulation/dose).

Driving Warning

Does not cause drowsiness; lacks central nervous system depressant effects

Drug Interactions

Drug Interactions

Ketoconazole, erythromycin, and cimetidine (CYP3A4/2D6 inhibition) can increase loratadine/desloratadine exposure; clinically significant effects are uncommon at usual doses.

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Children

Children 2-12 years weighing ≤30kg: 5mg once daily; weighing >30kg: 10mg once daily. Not recommended under 2 years

Kidney Impairment

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

Liver Impairment

Severe hepatic impairment: 10 mg every other day.

Storage & Patient Advice

Missed Dose

Take the missed dose as soon as remembered; if it is close to the next dose, skip the missed dose and resume the regular schedule; do not double doses.

Patient Counseling

Take 1 tablet (10 mg) once daily with or without food; do not exceed 1 tablet/day. Although usually non-drowsy, drowsiness can occur-use caution with driving until you know your response and avoid alcohol if it makes you sleepy. Ask a clinician before use if you have severe liver or kidney disease (may need every-other-day dosing). Store below 30°C; seek medical advice if symptoms persist or worsen.

Pharmacology

Mechanism of Action

Selective peripheral histamine H1-receptor antagonist that reduces histamine-mediated allergic symptoms with minimal CNS penetration at recommended doses.

Onset of Action

1-3 hours.

Duration of Effect

Approximately 24 hours.

Bioavailability

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

Excretion

Approximately 40% excreted in urine and ~42% in feces, predominantly as metabolites (minimal unchanged drug)

Protein Binding

Loratadine: 97-99% protein bound; Desloratadine: ~73-76% protein bound

Product Information

Available Dosage Forms

Tablet (this product: oral tablet).

Composition per Dose

Each tablet: 10mg loratadine

OTC Alternatives

Cetirizine, levocetirizine, fexofenadine; (first-generation option: chlorpheniramine).

Symptom Target

Allergy, Runny Nose

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 26-05-2026