Schedule H

Oral

Tablets:

• Loratadine 10 mg (conventional tablets)

Orally Disintegrating Tablets (ODT):

• Loratadine 10 mg (dispersible/melt tablets)

Oral Liquid:

• Loratadine Syrup 5 mg/5 mL (30 mL, 60 mL, 100 mL bottles)

Fixed-Dose Combinations (commonly available):

• Loratadine + Pseudoephedrine (for allergic rhinitis with congestion)

• Loratadine + Ambroxol (for allergic conditions with respiratory congestion)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Allergic Rhinitis (Seasonal and Perennial)

For relief of nasal and non-nasal symptoms including sneezing, rhinorrhoea, nasal pruritus, ocular itching, and lacrimation

Parameter Dosing Details

Starting dose 10 mg orally once daily

Titration Not required

Usual maintenance dose 10 mg once daily

Maximum dose 10 mg/day

Key Clinical Notes:

• Onset of action: 1–3 hours; peak effect at 8–12 hours

• Duration of action: ≥24 hours (allows once-daily dosing)

• May be taken with or without food

• Less sedating than first-generation antihistamines at standard doses

• Consider combining with intranasal corticosteroids for moderate-severe allergic rhinitis

1. Chronic Spontaneous Urticaria (Chronic Idiopathic Urticaria)

For relief of pruritus and reduction of hives

Parameter Dosing Details

Starting dose 10 mg orally once daily

Titration If inadequate response, may increase to 20 mg/day (off-label, specialist guidance)

Usual maintenance dose 10 mg once daily

Maximum dose 10 mg/day (standard); up to 20 mg/day under specialist supervision (off-label)

Key Clinical Notes:

• First-line therapy for chronic urticaria

• Effective in reducing wheal and flare response

• Up-dosing (up to 4× standard dose) may be considered in refractory cases per international guidelines — requires specialist supervision

1. Allergic Conjunctivitis

For relief of ocular itching, redness, and lacrimation associated with allergic conjunctivitis

Parameter Dosing Details

Starting dose 10 mg orally once daily

Titration Not required

Usual maintenance dose 10 mg once daily

Maximum dose 10 mg/day

Key Clinical Notes:

• Often used in conjunction with topical antihistamine/mast cell stabiliser eye drops

• Provides relief of both nasal and ocular symptoms in allergic rhinoconjunctivitis

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Notes

Atopic Dermatitis (Pruritus Relief) (OFF-LABEL) 10 mg once daily Short-term adjunctive use Dermatologist discretion. For nocturnal pruritus, sedating antihistamines may be more effective. Evidence: Indian dermatology specialist practice.

Refractory Chronic Urticaria (Updosing) (OFF-LABEL) 20–40 mg/day in divided doses Under specialist supervision Dermatologist/Allergist only. Based on EAACI/GA²LEN guidelines for updosing second-generation antihistamines.

Allergic Cough (OFF-LABEL) 10 mg once daily 2–4 weeks trial ENT/Pulmonology input. Limited evidence; trial therapy for suspected allergic aetiology.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Allergic rhinitis, chronic urticaria, allergic conjunctivitis

⚠️ Minimum age: 2 years (for syrup formulation)

Age-Based Dosing:

2–5 years Syrup 5 mg/5 mL 5 mg (5 mL or 1 tsp) Once daily 5 mg/day

6–11 years Syrup or Tablet 10 mg (10 mL syrup or 1 tablet) Once daily 10 mg/day

≥12 years Tablet or Syrup 10 mg Once daily 10 mg/day (adult dosing)

Weight-Based Alternative (for children 2–12 years):

Body Weight Dose

<30 kg 5 mg once daily

≥30 kg 10 mg once daily

Key Clinical Notes:

• Give at same time each day for consistent effect

• Syrup formulation preferred for younger children

• ODT tablets may be used in children ≥6 years who can handle disintegrating tablets

• Generally well-tolerated; sedation less common than with first-generation antihistamines

Secondary Indications — Paediatric (Off-label)

Not applicable — no widely established off-label paediatric indications in Indian practice.

Clear Statement: NOT recommended below 2 years of age except under paediatric allergist/dermatologist supervision.

Safety Monitoring in Children:

• Monitor for paradoxical CNS excitation (rare, more common in young children)

• Observe for sedation (uncommon but possible)

• Ensure appropriate formulation and dose for age/weight

Mild-Moderate impairment (CrCl 30–80 mL/min) No dose adjustment required

Severe impairment (CrCl <30 mL/min) 10 mg every 48 hours (alternate day dosing)

Haemodialysis 10 mg every 48 hours; not significantly dialysed

Note: Loratadine undergoes extensive first-pass hepatic metabolism to active metabolite desloratadine. Hepatic impairment significantly increases drug exposure.

• Known hypersensitivity to loratadine, desloratadine, or any formulation excipient

• Children below 2 years of age (except under specialist supervision)

• Hepatic impairment — reduced drug clearance; dose adjustment may be required

• Severe renal impairment — consider alternate day dosing

• Elderly patients — may have age-related hepatic/renal decline affecting drug clearance

• Epilepsy — rare reports of lowered seizure threshold (generally considered safe)

• Concurrent use with other CNS depressants — may have additive effects (though minimal)

• Phenylketonuria — some ODT formulations contain aspartame; check excipients

• History of QT prolongation — theoretical concern at very high doses (clinically not significant at standard doses)

• Performance of skilled tasks — generally non-sedating, but rare sedation possible; advise caution initially

Parameter Details

Risk Category Generally considered safe; extensive human data without evidence of increased risk (Category B equivalent)

Preferred alternatives Loratadine and cetirizine are both preferred second-generation antihistamines in pregnancy

When may be used Acceptable throughout pregnancy when antihistamine required; preferred over first-generation antihistamines

Monitoring No specific fetal monitoring required; use lowest effective dose

Parameter Details

Compatibility Compatible with breastfeeding

Preferred alternatives Loratadine and cetirizine are both acceptable; loratadine may have slightly lower milk transfer

Drug levels in milk Low — loratadine and active metabolite desloratadine are excreted in breast milk at low concentrations

Infant monitoring Monitor for irritability, sedation, or feeding difficulties (uncommon); generally well-tolerated

Parameter Recommendation

Starting dose 10 mg once daily (standard); consider 5 mg or 10 mg alternate days if frail or hepatic/renal concerns

Titration Not typically required

Special risks Age-related decline in hepatic and renal function may increase drug exposure; assess renal/hepatic function before dosing. Generally better tolerated than first-generation antihistamines (less sedation, less anticholinergic effects).

Monitoring Monitor for sedation, dizziness (though uncommon)

Interacting Drug Mechanism & Effect Management

Ketoconazole, Itraconazole (strong CYP3A4 inhibitors) Increased loratadine plasma levels (~3-fold) due to CYP3A4 inhibition Generally well-tolerated; no routine dose adjustment required, but monitor for adverse effects

Erythromycin, Clarithromycin (CYP3A4 inhibitors) Increased loratadine levels (~2-fold) Usually safe; monitor for adverse effects

Ritonavir, other protease inhibitors CYP3A4 inhibition; increased loratadine exposure Use with caution; monitor

QT-prolonging drugs (at high loratadine doses) Theoretical additive QT prolongation risk Clinically not significant at standard 10 mg dose; avoid very high doses with QT-prolonging agents

Note: Unlike terfenadine and astemizole (withdrawn), loratadine has minimal effect on cardiac repolarisation at therapeutic doses and is not associated with clinically significant QT prolongation or torsades de pointes.

Interacting Drug Effect Management

Rifampicin (CYP3A4 inducer) Reduced loratadine levels; potential decreased efficacy Monitor for reduced antihistamine effect; may need alternative

Phenytoin, Carbamazepine, Phenobarbital (CYP inducers) Reduced loratadine efficacy Monitor clinical response

Cimetidine Modest increase in loratadine levels Generally not clinically significant

Alcohol Potential additive CNS depression (though minimal with loratadine) Advise moderation

Other CNS depressants (benzodiazepines, opioids) Theoretical additive sedation Generally safe; loratadine is minimally sedating

Grapefruit juice May increase loratadine absorption Clinical significance low; no specific restriction needed

Adults:

• Headache (most common)

• Fatigue

• Somnolence/Drowsiness (less common than first-generation antihistamines, but possible)

• Dry mouth

• Nausea

• Nervousness

Children:

• Headache

• Fatigue

• Nervousness/Hyperactivity (paradoxical CNS stimulation in young children)

• Abdominal pain

Adverse Effect Clinical Notes

Hypersensitivity Reactions Anaphylaxis, angioedema, severe urticaria paradoxically (rare). Discontinue immediately.

Hepatotoxicity Rare reports of elevated transaminases. Discontinue if hepatitis suspected.

Seizures Very rare; reported in predisposed patients or overdose

Tachycardia/Palpitations Uncommon; usually at high doses

Severe Skin Reactions Very rare reports of fixed drug eruption

During treatment Clinical assessment for efficacy and adverse effects. Monitor for sedation (uncommon).

Long-term use LFTs if prolonged use in patients with hepatic concerns. Clinical response assessment.

Plain Loratadine:

• Claritin® (Bayer/MSD)

• Lorfast® (Cipla)

• Loratin® (various)

• Lormeg® (Alkem)

• Allercet-L® (Cadila)

• Loranox® (Sun Pharma)

• Lorinol® (various)

• Histafree® (various)

Orally Disintegrating Tablets:

• Lorfast MT® (Cipla)

• Claritin Reditabs® (limited availability)

Fixed-Dose Combinations:

• Lorfast-D® (Loratadine + Pseudoephedrine)

• Various combinations with pseudoephedrine/ambroxol

Note: Loratadine is NOT listed in NLEM 2022. Not under NPPA price control. Widely available. Although Schedule H, often dispensed OTC in practice.

1. Preferred antihistamine in pregnancy and lactation — Loratadine (along with cetirizine) has extensive safety data and is considered first-choice among second-generation antihistamines when antihistamine therapy is needed during pregnancy or breastfeeding.

1. Less sedating than cetirizine — At equivalent doses, loratadine causes less sedation than cetirizine. Consider loratadine for patients who report drowsiness with cetirizine or need to remain alert.

1. Once-daily dosing improves compliance — Long duration of action (≥24 hours) allows convenient once-daily dosing, which improves adherence in chronic allergic conditions.

1. Combination therapy for allergic rhinitis — For moderate-severe allergic rhinitis, combining loratadine with intranasal corticosteroids provides superior symptom control compared to either agent alone.

1. Updosing in chronic urticaria — For refractory chronic spontaneous urticaria, updosing loratadine up to 4× the standard dose (40 mg/day) may be effective under specialist supervision — this is off-label but supported by international guidelines.

1. Adjust dose in hepatic and severe renal impairment — Unlike many other second-generation antihistamines, loratadine requires dose reduction (alternate day dosing) in significant hepatic or severe renal impairment due to reduced clearance.

loratadine; antihistamine; second-generation-H1-blocker; allergic-rhinitis; urticaria; non-sedating; pregnancy-safe; lactation-safe; paediatric-safe; once-daily

RxIndia v1.0 — 06 Jun 2025

• CDSCO Approved Drug Formulations List

• Indian Pharmacopoeia 2022

• National Formulary of India (NFI) 2021

• API Textbook of Medicine (11th Edition)

• ICMR Guidelines on Allergic Rhinitis Management

• IAP Drug Formulary — Paediatric Allergy Management

• AIIMS Standard Treatment Guidelines

• Harrison's Principles of Internal Medicine (21st Edition)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (14th Edition)

• Product package inserts (Lorfast®, Claritin®)