LOHIST 10/MG TAB 10/TAB

Indications

Approved Uses

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

Off-Label Uses

None routinely recommended; perennial allergic rhinitis is on-label (not off-label).

Dosage & Administration

Dosing by Condition

Allergic rhinitis and urticaria - Adults and children ≥12 years: 10 mg once daily. Children 2-12 years (>30 kg): 10 mg once daily. Children 2-12 years (≤30 kg): 5 mg once daily

Initial Dose

10mg once daily for adults and children 6 years and older.

Maintenance Dose

10mg once daily for adults and children 6 years and older.

Maximum Dose

10mg per day for adults and children 6 years and older.

Children's Dosage

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

Dose Adjustment Notes

Severe hepatic impairment or severe renal impairment (e.g., GFR/CrCl <30 mL/min): 10 mg every other day (adults and children ≥6 years).

How to Take

Swallow the tablet whole with a glass of water. Can be taken with or without food.

Side Effects

Common Side Effects

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

Side Effect Frequency

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

Safety & Warnings

Contraindications

Hypersensitivity to loratadine or any component/excipient of the formulation.

Warnings & Precautions

Use with caution in severe hepatic or renal impairment (dose every other day); discontinue ~48 hours before allergy skin testing; consider excipients (e.g., lactose) in patients with intolerance if applicable to the specific product.

Age Restriction

Not recommended for children under 2 years (this 10 mg tablet is generally for ≥6 years/adults; use age-appropriate formulations for younger children).

Drug Interactions

Drug Interactions

CYP3A4/CYP2D6 inhibitors (e.g., ketoconazole, erythromycin, cimetidine) can increase loratadine/desloratadine exposure; clinically significant effects are usually minimal at recommended doses.

Interaction Severity

MODERATE: Strong CYP3A4/CYP2D6 inhibitors (e.g., ketoconazole, erythromycin/clarithromycin, cimetidine) may increase loratadine/desloratadine exposure; clinically significant effects are usually limited but caution is advised.

Food Interaction

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

Special Populations

Children

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

Kidney Impairment

Severe renal impairment (CrCl/GFR <30 mL/min): 10 mg every other day (adults and children ≥6 years); ages 2-5 years: 5 mg every other day (use appropriate formulation).

Storage & Patient Advice

Storage Conditions

Store below 25°C, in a dry place away from light

Missed Dose

Take 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.

Stopping the Medicine

Safe to stop anytime.

Overdose

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

Patient Counseling

Take 10 mg once daily (do not exceed 1 dose/24 h); may be taken with or without food; usually non-drowsy but drowsiness can occur-use caution with driving until you know your response; in severe liver or renal impairment use 10 mg every other day; store below 25°C; seek medical advice if symptoms persist or worsen.

Monitoring Requirements

No routine monitoring required for most patients. Monitor renal and hepatic function in patients with pre-existing impairment.

Pharmacology

Mechanism of Action

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

Onset of Action

1-3 hours.

Duration of Effect

Approximately 24 hours (once-daily effect).

Half-Life

Loratadine terminal half-life ~8-12 hours (reported mean ~8.4 h); active metabolite (desloratadine/descarboethoxyloratadine) ~17-24 hours (can be longer in some individuals).

Bioavailability

Oral bioavailability is not precisely established; loratadine undergoes extensive first-pass metabolism to active desloratadine (time to peak ~1-2 h for loratadine).

Metabolism

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

Excretion

Approximately 40% excreted in urine and ~42% in feces over about 10 days, predominantly as metabolites (minimal unchanged drug).

Protein Binding

Loratadine: ~97-99% protein bound; active metabolite (desloratadine): ~73-76% protein bound.

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

Cetirizine, fexofenadine, desloratadine, levocetirizine.

Symptom Target

Allergy, Runny Nose

Sedating

No

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