Schedule H

Oral

• Tablet: 10 mg, 20 mg

• Oral suspension: 5 mg/5 mL

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Allergic Rhinitis (Seasonal and Perennial)

Parameter Details

Starting dose 10 mg orally once daily

Titration May increase to 20 mg once daily if symptoms persist after 1 week

Usual maintenance dose 10–20 mg once daily

Maximum dose 20 mg/day

Clinical notes:

• Onset of action within 1–3 hours; peak effect at 3–6 hours

• Once-daily dosing sufficient for most patients

• Can be taken with or without food

• Non-sedating profile allows daytime use without affecting work/driving

1. Chronic Idiopathic Urticaria

Parameter Details

Starting dose 10 mg orally once daily

Titration Increase to 20 mg once daily if inadequate response after 1–2 weeks

Usual maintenance dose 10–20 mg once daily

Maximum dose 20 mg/day

Clinical notes:

• Non-sedating in majority; some patients may experience mild drowsiness

• Long-term use may be required; reassess periodically

• Effective for wheals and pruritus control

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Notes

Allergic conjunctivitis (systemic treatment) 10 mg once daily Short-term as needed OFF-LABEL; Used in Indian ENT and allergy practice as adjunct to topical therapy

PAEDIATRIC DOSING (Specialist Only)

⚠️ NOT RECOMMENDED in children below 2 years of age except under allergy specialist supervision.

Primary Indications (Approved / Standard in India)

1. Allergic Rhinitis

2–5 years 2.5 mg once daily (oral suspension) Not applicable 2.5 mg once daily 2.5 mg/day

6–11 years 5 mg once daily May increase to 10 mg if needed 5–10 mg once daily 10 mg/day

≥12 years 10 mg once daily May increase to 20 mg if needed 10–20 mg once daily 20 mg/day

Clinical notes:

• Use oral suspension for children unable to swallow tablets

• Administer at same time each day for consistent effect

1. Chronic Urticaria

2–5 years 2.5 mg once daily 2.5 mg/day

6–11 years 5 mg once daily 10 mg/day

≥12 years 10–20 mg once daily 20 mg/day

Clinical notes:

• Dose escalation only under specialist supervision

• Monitor for somnolence and behavioural changes in young children

Secondary Indications — Paediatric Doses (Off-label)

Indication Dose Age Notes

Atopic dermatitis (adjunctive for pruritus) 0.1 mg/kg once daily >2 years OFF-LABEL; Specialist (Dermatologist) only; Episodic use; Evidence: Indian dermatology practice

Safety Monitoring:

• Somnolence and sedation level

• Behavioural changes (irritability, hyperactivity)

• Dry mouth and appetite changes

Dialysis Limited data; not significantly dialyzed; use lowest effective dose

• Known hypersensitivity to ebastine or any excipients

• Congenital long QT syndrome or known QT prolongation

• Concomitant use with strong CYP3A4 inhibitors causing QT prolongation (ketoconazole, itraconazole, erythromycin, clarithromycin) without ECG monitoring

• Severe hepatic impairment (relative contraindication)

• Uncorrected hypokalaemia or hypomagnesaemia

• History of cardiac arrhythmias or QT prolongation

• Elderly patients with decreased hepatic function

• Concurrent use of other QT-prolonging medications

• Concomitant use with CYP3A4 inhibitors (may increase plasma levels)

• Patients with electrolyte imbalances

• Mild sedative effect possible in susceptible individuals; caution with driving initially

• Renal impairment (severe)

Parameter Details

Risk category Category C (insufficient human data; animal studies inconclusive)

General safety Limited human data; avoid unless clearly necessary

Preferred alternatives Cetirizine or Loratadine (more safety data in pregnancy)

When may be used Only if benefits outweigh risks; obstetrician consultation recommended

Monitoring Fetal growth monitoring if prolonged use required

Parameter Details

Compatibility Limited data; likely compatible for short-term use

Drug levels in milk Low (based on molecular weight and pharmacokinetics)

Preferred alternatives Loratadine or Cetirizine (more safety data available)

Infant monitoring Feeding behaviour, excessive sleepiness, irritability

Parameter Recommendation

Starting dose 10 mg once daily

Titration Cautious; avoid escalation to 20 mg unless necessary

Specific risks Diminished hepatic clearance, increased QTc prolongation risk, electrolyte disturbances

Monitoring ECG if on other QT-prolonging drugs; monitor electrolytes

Recommendation Prefer lower doses; avoid combination with other QT-prolonging agents

Interacting Drug/Class Effect Recommendation

Ketoconazole, Itraconazole Strong CYP3A4 inhibition → marked increase in ebastine levels → QT prolongation risk AVOID combination

Erythromycin, Clarithromycin CYP3A4 inhibition → increased ebastine levels → QT prolongation AVOID combination; if essential, ECG monitoring mandatory

Class IA antiarrhythmics (quinidine, procainamide) Additive QT prolongation AVOID combination

Class III antiarrhythmics (amiodarone, sotalol) Additive QT prolongation AVOID combination

Other QT-prolonging drugs (haloperidol, ondansetron at high doses) Additive QT prolongation risk Avoid or use with ECG monitoring

Interacting Drug/Class Effect Recommendation

Rifampicin CYP3A4 induction → decreased ebastine levels → reduced efficacy Monitor clinical response; may need higher dose

Phenytoin, Carbamazepine, Phenobarbital CYP3A4 induction → reduced ebastine efficacy Monitor clinical response

Grapefruit juice CYP3A4 inhibition → increased ebastine levels Avoid large quantities of grapefruit juice

Alcohol and CNS depressants Potential additive sedative effect (though ebastine generally non-sedating) Advise caution

Cimetidine Mild CYP3A4 inhibition → slightly increased ebastine levels Monitor; usually not clinically significant

• Headache

• Dry mouth

• Drowsiness (uncommon at standard doses; less than first-generation antihistamines)

• Pharyngitis

• Abdominal discomfort / dyspepsia

• Fatigue

• Nausea

Adverse Effect Clinical Notes

QT interval prolongation Especially at doses >20 mg or with interacting drugs; monitor ECG in high-risk patients

Torsades de pointes Rare; associated with drug interactions and electrolyte imbalance

Hypersensitivity reactions / Angioedema Rare; discontinue immediately if occurs

Hepatic dysfunction Very rare; monitor LFTs in long-term or high-dose use

Anaphylaxis Rare; discontinue and provide emergency treatment

Phase Parameters

Baseline ECG if cardiac history, concurrent QT-prolonging drugs, or elderly; hepatic function if liver disease suspected

After initiation Clinical response at 1–2 weeks; watch for sedation or allergic reaction

Long-term Liver function tests if prolonged treatment (>3 months); ECG if high dose or interacting drugs added; reassess need for continued therapy

• Ebastel (Glenmark)

• Ebast (Micro Labs)

• Ebull

• Eltin

• Ebzel

• Histazine-E

Note: NOT included in NLEM 2022; prices not NPPA-controlled; significant brand variation exists.

1. Less sedating than first-generation antihistamines — Suitable for patients requiring alertness (students, drivers, machine operators).

1. Once-daily dosing improves compliance — Particularly beneficial in chronic allergic conditions requiring long-term treatment.

1. Safe for children ≥2 years — Oral suspension formulation facilitates accurate paediatric dosing.

1. QT prolongation risk with drug interactions — Avoid concurrent use with azole antifungals and macrolide antibiotics; if unavoidable, ECG monitoring is essential.

1. Combination with Montelukast — Useful in patients with allergic rhinitis and concurrent asthma or where antihistamine alone provides inadequate relief.

1. Comparable efficacy to cetirizine and loratadine — Choice often based on patient tolerance, sedation profile, and cost considerations.

ebastine; antihistamine; second-generation; allergic rhinitis; urticaria; non-sedating; QT-prolongation-risk; paediatric-use; CYP3A4 substrate; montelukast-combination; Schedule H

RxIndia v1.0 — 09 Jan 2025

• CDSCO (Approved formulations and product labels)

• Indian Pharmacopoeia

• National Formulary of India (NFI)

• API Textbook of Medicine

• AIIMS Paediatric Drug Formulary

• IAP Drug Dosing Guidelines

• Manufacturer product inserts (Glenmark, Micro Labs)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Indian ENT and Allergy specialist practice inputs