Schedule H

Oral

• Tablets: 5 mg

• Orodispersible Tablets: 5 mg

• Syrup/Oral Solution: 2.5 mg/5 mL (0.5 mg/mL)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Allergic Rhinitis (Seasonal and Perennial)

Adults and Adolescents ≥12 years:

Parameter Recommendation

Starting dose 5 mg orally once daily

Titration Not required

Usual maintenance dose 5 mg once daily

Maximum dose 5 mg/day

Clinical Notes:

• Onset of action within 1 hour of administration

• Duration of effect approximately 24 hours

• May be taken without regard to food

• Minimal CNS penetration; preferred when sedation must be avoided

1. Chronic Idiopathic Urticaria (Chronic Spontaneous Urticaria)

Adults and Adolescents ≥12 years:

Parameter Recommendation

Starting dose 5 mg orally once daily

Titration Not routinely required at standard dose

Usual maintenance dose 5 mg once daily

Maximum dose 5 mg/day (licensed); up to 10 mg/day under specialist supervision

Clinical Notes:

• Long-term use often required; does not cause tachyphylaxis

• Reassess clinical need every 3–6 months

• No specific time of day preference; consistency in timing preferred

Secondary Indications – Adults Only (Off-label)

Indication Dose Duration Notes Evidence Basis

Refractory Chronic Urticaria Up to 10 mg once daily Individualised; reassess every 4–6 weeks OFF-LABEL; Specialist only International urticaria guidelines; Indian dermatology specialist practice

Insect Bite/Arthropod Allergy 5 mg once daily Short course (3–7 days) OFF-LABEL Common Indian dermatology practice

Allergic Conjunctivitis (adjunctive) 5 mg once daily Symptom-based duration OFF-LABEL Used alongside topical therapy in Indian practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Indications: Allergic Rhinitis and Chronic Idiopathic Urticaria

6–11 months 1 mg (2 mL) once daily Syrup only Specialist supervision mandatory

1–5 years 1.25 mg (2.5 mL) once daily Syrup preferred Monitor for paradoxical excitability

6–11 years 2.5 mg (5 mL) once daily Syrup or tablet if able to swallow Evening dosing may help if mild sedation occurs

≥12 years 5 mg once daily Tablet, orodispersible tablet, or syrup Adult dosing applies

Dosing Pattern for Paediatrics:

Parameter Recommendation

Starting dose As per age table above

Titration Not applicable

Usual maintenance dose Same as starting dose

Maximum dose Age-appropriate dose as above; do not exceed

Safety Monitoring in Children:

• Monitor for sedation, irritability, or paradoxical excitation

• Assess feeding patterns in infants

• Watch for behavioural changes or sleep disturbances

Age Restriction Statement:

Not recommended below 6 months of age. Use in infants 6–11 months should be under paediatrician or allergy specialist supervision only.

Secondary Indications – Paediatrics (Off-label)

NOT AVAILABLE in India — No documented off-label paediatric indications in Indian sources.

Moderate impairment (eGFR 30–59) Use with caution; no specific dose defined in Indian sources

Notes:

• Desloratadine and its metabolite 3-hydroxydesloratadine are renally excreted

• Limited pharmacokinetic data in severe renal impairment in Indian population

• Monitor for increased adverse effects if used in renal impairment

Notes:

• Metabolised primarily via CYP3A4 and glucuronidation

• Plasma levels may increase in hepatic dysfunction

• Monitor for enhanced sedation or adverse effects

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

• Hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency (for syrups containing sorbitol or sucrose)

• Children below 6 months of age

• Moderate to severe renal impairment (requires dose modification)

• Moderate to severe hepatic impairment (increased plasma levels possible)

• Elderly patients with impaired renal or hepatic function

• History of seizures (rare CNS stimulation reported, particularly in children)

• Patients performing activities requiring alertness until individual response known

• Concurrent use of CNS depressants

Parameter Details

Risk Category Not formally classified in India; limited human data; animal studies show no teratogenicity

Overall Safety Considered low risk based on available data

Recommendation Use only if benefit clearly outweighs potential risk; avoid in first trimester if possible

Preferred Alternatives Chlorpheniramine (more safety data in pregnancy), Cetirizine, Loratadine

Monitoring Monitor maternal sedation, allergic symptom control; routine fetal monitoring

Parameter Details

Breastfeeding Compatibility Likely compatible; excreted in breast milk in low amounts

Milk Levels Low (extrapolated from loratadine data; desloratadine is active metabolite)

Preferred Alternatives Cetirizine or loratadine (more breastfeeding safety data available)

Infant Monitoring Observe for sedation, irritability, changes in feeding pattern, or poor weight gain

Recommendation Acceptable for use; prefer single daily dose after a feeding to minimise infant exposure

Parameter Recommendation

Starting dose 5 mg once daily

Titration Not required; consider 2.5 mg daily if renal or hepatic impairment suspected

Special Considerations Assess renal and hepatic function before prescribing

Monitoring Watch for confusion, sedation, dry mouth, urinary retention

Fall Risk Lower than first-generation antihistamines but still monitor

Polypharmacy Caution Assess for additive anticholinergic burden with other medications

Interacting Drug Mechanism/Effect Management

Ketoconazole CYP3A4 inhibitor; increases desloratadine plasma levels Monitor for increased adverse effects; usually no dose adjustment needed

Erythromycin CYP3A4 inhibitor; modest increase in desloratadine levels Monitor; clinical significance generally low

Ritonavir and other strong CYP3A4 inhibitors May significantly increase desloratadine exposure Use with caution; monitor for adverse effects

Note: Desloratadine has low potential for clinically significant QT prolongation; no major cardiac interactions documented at standard doses.

Interacting Drug/Class Effect Management

Alcohol Potential for additive CNS depression (minimal with desloratadine) Advise caution; clinical significance usually minimal

Other CNS depressants (benzodiazepines, opioids) Possible additive sedation Monitor; usually not significant at standard doses

Anticholinergic drugs Additive dry mouth, urinary retention, constipation Monitor especially in elderly

Azithromycin, Clarithromycin Theoretical CYP3A4 interaction; rare QT concerns Monitor; no dose adjustment usually required

Fluoxetine, Paroxetine CYP2D6 inhibition; minor increase in desloratadine levels Monitor for CNS effects; clinically insignificant in most cases

• Headache

• Dry mouth

• Fatigue

• Pharyngitis (more common in children)

• Somnolence (less frequent than first-generation antihistamines)

• Nausea

• Dizziness

• Myalgia

Adverse Effect Notes

Hypersensitivity reactions (including anaphylaxis, angioedema) Rare; discontinue immediately if suspected

Tachycardia, palpitations Rare; evaluate and discontinue if symptomatic

Seizures Very rare; mainly in paediatric population or overdose; discontinue immediately

Hepatic enzyme elevation Rare; monitor liver function if symptoms suggest hepatotoxicity

Psychomotor hyperactivity (paradoxical) Rare; mostly in children; discontinue if occurs

After initiation Monitor for efficacy and sedation at 1–2 weeks

Long-term use (>4 weeks) Periodic assessment of symptom control; renal and hepatic function annually in elderly or at-risk patients

Chronic Urticaria Urticaria Activity Score (UAS7) for objective disease monitoring

• Deslor (Torrent)

• Dazit (Sun Pharma)

• Deslorid (Cipla)

• Lorfast-D (Cadila)

• Clarinex (MSD) — limited availability

• Deslogen (Alkem)

• Deltos (Mankind)

Fixed-Dose Combinations:

• Allercet-D (Aristo) — Desloratadine + Pseudoephedrine

• Deslor-M (Torrent) — Desloratadine + Montelukast

NLEM Status: NOT included in NLEM 2022; not under NPPA price ceiling

1. Active metabolite advantage: Desloratadine is the active metabolite of loratadine with a longer half-life (~27 hours), allowing reliable once-daily dosing with more predictable efficacy.

1. Non-sedating profile: Among the least sedating second-generation antihistamines; suitable for patients requiring alertness (drivers, machine operators).

1. No tachyphylaxis: Can be used long-term for chronic urticaria without loss of efficacy; reassess need periodically.

1. Dose escalation in refractory urticaria: Up to 10 mg/day (off-label) may be used by dermatologists in resistant cases; document rationale and consent.

1. Food does not affect absorption: Can be administered with or without food, improving patient compliance.

1. Orodispersible tablet utility: Useful in patients with swallowing difficulties or those preferring convenience; dissolves rapidly without water.

desloratadine; antihistamine; H1-blocker; allergic rhinitis; chronic urticaria; non-sedating; second-generation antihistamine; dermatology; paediatric-safe; Schedule H

RxIndia v1.0 — 10 Jan 2025

• CDSCO approved product inserts (Indian manufacturers)

• Indian Pharmacopoeia / National Formulary of India 2021

• API Textbook of Medicine (24th Edition)

• AIIMS Standard Treatment Guidelines

• IAP Drug Formulary

• Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) treatment recommendations

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (supportive reference)