Not specifically listed under Schedule H/H1/X (Ophthalmic formulation available as prescription product)

Ophthalmic (eye drops); Inhalation (metered dose inhaler — NOT AVAILABLE in India)

• Ophthalmic solution: Nedocromil sodium 2% w/v eye drops (5 mL)

• Metered dose inhaler (2 mg/actuation): NOT AVAILABLE in India

• INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Allergic Conjunctivitis (Seasonal and Perennial)

Ophthalmic Use — Nedocromil 2% Eye Drops

Parameter Details

Starting dose 1 drop in each affected eye twice daily

Titration May increase frequency to 4 times daily if inadequate response after 1 week

Usual maintenance dose 1 drop in each affected eye twice daily

Maximum dose 1 drop in each affected eye 4 times daily

Clinical notes:

• Prophylactic agent; NOT for acute symptom relief

• Onset of therapeutic effect requires 5–7 days of regular use

• Advise initiation before anticipated allergen exposure when possible

• Continue throughout allergen season or until symptom resolution

• Avoid contact lens wear during treatment; if essential, remove lenses before instillation and wait at least 15 minutes before reinsertion

1. Vernal Keratoconjunctivitis

Parameter Details

Starting dose 1 drop in each affected eye twice daily

Titration May increase to 4 times daily based on severity

Usual maintenance dose 1 drop twice to four times daily

Maximum dose 1 drop 4 times daily per eye

Clinical notes:

• Long-term prophylactic use; steroid-sparing effect beneficial in chronic cases

• May take 2–4 weeks for full therapeutic benefit in severe vernal keratoconjunctivitis

• Consider combination with topical antihistamines for faster symptom relief

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Notes

Asthma prophylaxis (mild persistent asthma) 2 inhalations (4 mg total) twice daily via MDI Long-term maintenance OFF-LABEL; Inhaler formulation NOT AVAILABLE in India; Specialist only; Evidence: International RCTs support preventive role; Not included in Indian asthma guidelines

PAEDIATRIC DOSING (Specialist Only)

⚠️ NOT RECOMMENDED in children below 3 years of age except under ophthalmologist supervision.

Primary Indications (Approved / Standard in India)

1. Allergic Conjunctivitis (Age ≥3 years)

Ophthalmic Use — Nedocromil 2% Eye Drops

3–12 years 1 drop in each affected eye twice daily May increase to 4 times daily if needed 1 drop twice daily 1 drop 4 times daily

12 years 1 drop in each affected eye twice daily May increase to 4 times daily if needed 1–2 drops twice to four times daily 2 drops 4 times daily

Clinical notes:

• Therapeutic effect may take 4–7 days of regular use

• Suitable for long-term prophylactic use; no steroid-related ocular complications

• Ensure proper instillation technique; parent/caregiver education important

1. Vernal Keratoconjunctivitis (Age ≥3 years)

3–12 years 1 drop in each affected eye Twice to four times daily

12 years 1–2 drops in each affected eye Twice to four times daily

Clinical notes:

• Longer duration needed to assess benefit (2–4 weeks)

• Steroid-sparing agent; preferred for chronic maintenance in children

Secondary Indications — Paediatric Doses (Off-label)

Indication Dose Notes

Asthma prophylaxis NOT RECOMMENDED Inhaler formulation NOT AVAILABLE in India; OFF-LABEL

Safety Monitoring:

• Ocular irritation or worsening symptoms

• Compliance with regular instillation

• Signs of infection (rule out if symptoms worsen)

No dose adjustment required.

Drug undergoes minimal systemic absorption via ocular route; negligible renal elimination.

Hepatic metabolism is negligible due to poor systemic absorption from ophthalmic use.

• Known hypersensitivity to nedocromil sodium or any excipients (including benzalkonium chloride in preserved formulations)

• Acute asthma attack or acute bronchospasm (if using inhaler formulation — not for relief therapy; inhaler NOT AVAILABLE in India)

• Delayed onset of action (5–7 days for ocular use); not suitable for acute symptom relief

• Contact lens users: preserved formulations may contain benzalkonium chloride which can be absorbed by soft contact lenses; remove lenses before instillation

• Avoid contamination of dropper tip; do not touch eye surface

• Discontinue and reassess if ocular irritation persists or worsens after 1–2 weeks

• Dry eye conditions may affect tolerability of eye drops

Parameter Details

Risk category Limited human data; animal studies suggest low risk

General safety Minimal systemic absorption from ocular use; likely low risk

Preferred alternatives Olopatadine, Ketotifen (more clinical experience in pregnancy)

When may be used Consider if preferred alternatives ineffective; obstetrician consultation recommended

Monitoring Fetal monitoring not typically required for topical ocular use

Parameter Details

Compatibility Likely compatible with breastfeeding

Drug levels in milk Expected to be negligible (minimal systemic absorption)

Preferred alternatives Olopatadine, Ketotifen (if systemic concerns exist)

Infant monitoring No specific monitoring required; observe for any ocular reactions if accidental exposure

Effect on milk production None expected

Parameter Recommendation

Starting dose Standard adult dosing (1 drop twice daily)

Titration Not required unless increasing frequency

Specific risks Dry eye syndrome common in elderly; may affect tolerability; reduced tear film may delay drug clearance

Recommendation Reinforce compliance; therapeutic effect may be slower; assess tear film status

None reported with ophthalmic use.

No clinically significant systemic interactions expected due to negligible systemic absorption.

Interacting Agent Effect Recommendation

Soft contact lenses Preservative (benzalkonium chloride) may be absorbed by lenses causing irritation Remove contact lenses before instillation; wait at least 15 minutes before reinsertion

Other topical ocular medications Potential dilution or washout effect Separate administration by at least 5–10 minutes; instil nedocromil last if using multiple drops

• Burning or stinging sensation upon instillation (transient)

• Ocular irritation

• Dry eyes

• Unpleasant taste (due to nasolacrimal drainage)

• Conjunctival hyperaemia

• Headache

• Nasal congestion (rare, via nasolacrimal drainage)

Adverse Effect Clinical Notes

Hypersensitivity reactions Rare; includes periocular oedema, eyelid swelling, contact dermatitis — discontinue immediately

Severe ocular reactions Severe persistent irritation, corneal changes — discontinue and refer to ophthalmologist

Anaphylaxis Very rare; immediate discontinuation and emergency management if occurs

Bronchospasm With inhaled formulation only (NOT AVAILABLE in India); discontinue if occurs

Phase Parameters

Baseline None routinely required; document baseline symptom severity

After initiation Monitor for ocular irritation or worsening symptoms within first 1–2 weeks; assess compliance

Long-term Reassess symptom control at regular intervals; check adherence if no clinical improvement after 2 weeks; periodic ophthalmological examination for chronic use

Ophthalmic Formulations (2% eye drops):

• Nedocrom (Ajanta Pharma)

• Restagel-N (Indoco Remedies)

• EyeCrom (Micro Labs)

• Alocril (available in some regions)

• Various local generic brands

Inhaler Formulations: NOT AVAILABLE in India

Note: NOT included in NLEM 2022; prices not NPPA-controlled; private sector pricing only; not available through routine government supply.

1. Prophylactic agent only — Not suitable for acute allergic symptom relief; counsel patients that therapeutic effect takes 5–7 days to manifest; combine with antihistamine drops if immediate relief needed.

1. Steroid-sparing benefit — Particularly valuable in vernal keratoconjunctivitis in children where long-term steroid use risks cataract and glaucoma; safe for prolonged maintenance.

1. Do not confuse with sodium cromoglycate — Both are mast cell stabilisers but are different molecules; nedocromil has additional anti-inflammatory properties.

1. Inhaler NOT AVAILABLE in India — Do not prescribe or recommend inhaled nedocromil for asthma; use sodium cromoglycate inhaler or other prophylactic agents instead.

1. Contact lens precaution — Essential to remove lenses before instillation due to preservative absorption; wait at least 15 minutes before reinsertion.

1. Compliance critical — Regular use required for benefit; one-time or as-needed use is ineffective; emphasize importance of continuing throughout allergen season.

nedocromil; mast cell stabiliser; allergic conjunctivitis; vernal keratoconjunctivitis; ophthalmic; prophylactic; paediatric-safe; steroid-sparing; pregnancy-limited-data; inhaler-not-available-India

RxIndia v1.0 — 09 Jan 2025

• CDSCO (Drug approval database)

• National Formulary of India (NFI)

• Indian Pharmacopoeia

• API Textbook of Medicine

• AIIMS Pharmacology Index

• IAP Guidelines for allergic eye conditions

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (supportive for mechanism and off-label information)

• Indian ophthalmology specialist practice protocols

• Manufacturer product inserts (Ajanta Pharma, Indoco Remedies)