CLARITINE 10/MG TAB 10/TAB

Indications

Approved Uses

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

Dosage & Administration

Dosing by Condition

Allergic rhinitis or chronic idiopathic urticaria: Adults and children ≥6 years: 10 mg orally once daily; severe hepatic/renal impairment: 10 mg every other day.

Initial Dose

10mg orally once daily.

Maintenance Dose

10mg orally once daily.

Maximum Dose

10mg per 24 hours.

Children's Dosage

Children 2 to 5 years of age: 5 mg once daily (syrup); Children ≥6 years: 10 mg once daily; Children under 2 years: Use and dose must be determined by doctor (tablet: children under 6 ask doctor)

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, somnolence, fatigue, dry mouth, nausea, nervousness

Side Effect Frequency

Common (≥1%): headache, somnolence, fatigue; other events such as dry mouth and nausea are generally uncommon/rare, and tachycardia/palpitations and hypersensitivity reactions are rare/very rare.

Safety & Warnings

Contraindications

Hypersensitivity to loratadine or to any excipients/ingredients in the product.

Warnings & Precautions

Use with caution in hepatic impairment (may require reduced frequency) and in severe renal impairment; discontinue and seek care if hypersensitivity occurs; may cause rare somnolence-use caution with driving if affected; excipient-related cautions depend on formulation (e.g., lactose intolerance if lactose-containing; PKU warning applies to ODTs with aspartame, not standard tablets).

Age Restriction

Not recommended for children under 2 years; for this 10 mg tablet, use is generally for ≥6 years (2-5 years require pediatric liquid formulations/dosing).

Drug Interactions

Food Interaction

No clinically significant food restriction; may be taken with or without food.

Special Populations

Children

Children 2 to 5 years of age: 5 mg once daily (syrup); Children ≥6 years: 10 mg once daily; Children under 2 years: Use and dose must be determined by doctor (tablet: children under 6 ask doctor)

Kidney Impairment

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

Storage & Patient Advice

Stopping the Medicine

Safe to stop anytime

Overdose

Symptoms: somnolence, tachycardia, headache; management: symptomatic/supportive care, consider activated charcoal (and/or gastric decontamination if very recent ingestion), and seek urgent medical attention; loratadine is not effectively removed by hemodialysis.

Patient Counseling

Take 1 tablet (10 mg) once daily with or without food; do not exceed 1 tablet/day. Usually non-drowsy, but if you feel sleepy avoid driving/alcohol. Tell a clinician if you have severe liver or kidney disease (may need every-other-day dosing). Store below 30°C.

Monitoring Requirements

No routine monitoring

Pharmacology

Mechanism of Action

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

Onset of Action

1-3 hours.

Duration of Effect

Approximately 24 hours.

Bioavailability

Oral bioavailability is not near 100%; loratadine undergoes substantial first-pass metabolism (systemic availability is limited/variable).

Metabolism

Extensive hepatic first-pass metabolism primarily via CYP3A4 and CYP2D6 to the active metabolite desloratadine (also known as descarboethoxyloratadine).

Product Information

Available Dosage Forms

For this SFDA-registered product: Tablet (oral).

Composition per Dose

Each tablet: 10mg loratadine

Generic Availability

Yes

OTC Alternatives

Cetirizine, levocetirizine, fexofenadine, desloratadine.

Symptom Target

Allergy, Runny Nose

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 12-08-2026