CLARA 10/MG TAB 10/TAB

Indications

Approved Uses

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

Off-Label Uses

None to list as a definitive off-label indication for this product; examples sometimes used in practice include symptomatic relief of pruritus from other allergic dermatoses/insect bites, but these are not established labeled indications.

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 a 5 mg formulation); for this CLARA 10 mg tablet, use is practically aligned to patients who can take 10 mg (typically ≥6 years/appropriate weight).

Initial Dose

10mg once daily.

Maintenance Dose

10mg once daily.

Maximum Dose

10mg per day in adults and children ≥12 years

Children's Dosage

Children 2-5 years: 5 mg once daily (requires 5 mg formulation); Children ≥6 years: 10 mg once daily. Not recommended under 2 years. Weight-based dosing (≤30 kg vs >30 kg) is not the standard dosing criterion; age is the primary determinant.

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).

Side Effects

Common Side Effects

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

Side Effect Frequency

Common (≥1% to <10%): headache, somnolence, fatigue; dry mouth and nausea are generally uncommon (<1%) in adults; tachycardia/palpitations and hypersensitivity reactions are rare/very rare.

Safety & Warnings

Contraindications

Hypersensitivity to loratadine (or desloratadine) or to any excipients/components of the formulation.

Warnings & Precautions

Use with caution in severe hepatic impairment (dose adjustment) and severe renal impairment; avoid use <2 years; stop and seek care if hypersensitivity occurs; phenylalanine/PKU warning applies only to orally disintegrating/chewable formulations containing aspartame (not typical for standard tablets).

Age Restriction

Not recommended for children <2 years (tablet strength/form not appropriate; safety/efficacy not established).

Driving Warning

Loratadine is non-sedating and does not typically cause drowsiness at recommended doses. A driving warning is not standard for this medication; however, individual sensitivity may vary, and patients should be advised to assess their personal response before driving.

Drug Interactions

Interaction Severity

MODERATE: strong CYP3A4/2D6 inhibitors (e.g., ketoconazole, erythromycin/clarithromycin, cimetidine) may increase loratadine/desloratadine concentrations; MINOR: alcohol/CNS depressants-additive sedation is possible but usually limited at recommended doses.

Food Interaction

May be taken with or without food; food can delay Tmax and may increase exposure slightly, but no clinically meaningful restriction is required.

Special Populations

Children

Children 2-5 years: 5 mg once daily (requires 5 mg formulation); Children ≥6 years: 10 mg once daily. Not recommended under 2 years. Weight-based dosing (≤30 kg vs >30 kg) is not the standard dosing criterion; age is the primary determinant.

Kidney Impairment

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

Liver Impairment

Severe hepatic impairment: 10 mg every other day (alternative: 5 mg once daily if a 5 mg strength/form is available).

Storage & Patient Advice

Stopping the Medicine

Safe to stop anytime

Patient Counseling

Take 10 mg once daily (do not exceed 10 mg/day); may be taken with or without food; drowsiness is uncommon but possible-use caution with driving/alcohol until you know your response; tell a clinician if you have severe liver/kidney disease (may need every-other-day dosing); stop 48 hours before allergy skin testing; store below 25°C.

Monitoring Requirements

No routine monitoring

Pharmacology

Mechanism of Action

Selective peripheral histamine H1-receptor antagonist (often described as an inverse agonist) that reduces histamine-mediated allergic symptoms with minimal CNS penetration at usual doses.

Onset of Action

1-3 hours.

Metabolism

Extensive hepatic metabolism primarily via CYP3A4 and CYP2D6 to the active metabolite desloratadine (descarboethoxyloratadine).

Protein Binding

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

Product Information

Available Dosage Forms

For this product (CLARA): Tablet (oral).

Composition per Dose

Each tablet: 10mg loratadine

Generic Availability

Yes

Symptom Target

Allergy, Runny Nose

Sedating

No

Reviewed by Al Mujtama Pharmacy Medical Review Team. Last reviewed 30-07-2026