Not Scheduled (Over-the-Counter for most formulations)

Inhalation, Intranasal, Ophthalmic, Oral

• Inhalation solution for nebulisation: 20 mg/2 mL ampoule

• Nasal spray: 2% w/v (20 mg/mL)

• Ophthalmic drops: 2% w/v (5 mL, 10 mL bottles)

• Oral capsules: 100 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Bronchial Asthma — Prophylaxis (Inhaled) — Adults

Parameter Recommendation

Starting dose 20 mg via nebulisation 4 times daily

Titration Assess response after 4–6 weeks; may reduce frequency if well controlled

Usual maintenance dose 20 mg 3–4 times daily

Maximum dose 80 mg/day (20 mg 4 times daily)

Clinical Notes:

• Prophylactic use only — no role in acute bronchospasm or asthma exacerbations

• Requires regular use for efficacy; not for as-needed relief

• Assess response after 4–6 weeks; discontinue if no benefit

• May be used as steroid-sparing agent in mild persistent asthma

1. Allergic Conjunctivitis — Adults

Parameter Recommendation

Starting dose 1–2 drops of 2% solution into each affected eye 4–6 times daily

Titration Reduce frequency as symptoms improve

Usual maintenance dose 1–2 drops 3–4 times daily

Maximum dose 1–2 drops 6 times daily

Duration: Continue throughout allergen exposure period (e.g., pollen season)

Clinical Notes:

• Best results when initiated before allergen exposure season

• Advise patients to remove contact lenses before instillation

• May take 1–2 weeks for full effect

1. Allergic Rhinitis — Adults

Parameter Recommendation

Starting dose 1 spray (~5.2 mg) into each nostril 4–6 times daily

Titration Reduce to 3–4 times daily after symptom control

Usual maintenance dose 1 spray per nostril 3–4 times daily

Maximum dose 1 spray per nostril 6 times daily

Duration: Continue throughout allergen exposure period

Clinical Notes:

• Best initiated before allergen season for optimal prophylaxis

• Less effective than intranasal corticosteroids for moderate-severe symptoms

• Transient sneezing post-application is common

1. Food Allergy and GI Manifestations of Mastocytosis — Oral — Adults

Parameter Recommendation

Starting dose 200 mg orally 4 times daily (30 minutes before meals and at bedtime)

Titration May reduce after 2–3 months if good symptom control

Usual maintenance dose 200 mg 2–4 times daily

Maximum dose 40 mg/kg/day (maximum 800 mg/day in most adults)

Clinical Notes:

• Poorly absorbed systemically (<1%); acts locally on intestinal mucosa

• Used in patients with documented food allergy refractory to dietary measures

• Also used for GI symptoms in systemic mastocytosis (specialist indication)

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Systemic Mastocytosis (GI/Cutaneous symptoms) 200 mg orally 4 times daily Long-term based on response OFF-LABEL • Specialist only • Indian specialist practice; international retrospective data supportive

Exercise-Induced Bronchospasm (Prophylaxis) 20 mg inhaled 15–30 minutes before exercise Single pre-exercise dose OFF-LABEL • Alternative when beta-agonists not preferred

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Bronchial Asthma — Prophylaxis (Inhaled)

≥2 years 20 mg via nebulisation 3–4 times daily Use spacer/mask in young children

Parameter Recommendation

Starting dose 20 mg via nebulisation 3–4 times daily

Titration Assess after 4–6 weeks; reduce frequency if controlled

Usual maintenance dose 20 mg 2–3 times daily

Maximum dose 80 mg/day

Clinical Notes:

• Trial for minimum 4–6 weeks before assessing efficacy

• Use spacer device with MDI in children who can coordinate; nebuliser for younger children

• Not a substitute for inhaled corticosteroids in persistent asthma

1. Allergic Conjunctivitis

≥4 years 1–2 drops of 2% solution per eye 4 times daily

Parameter Recommendation

Starting dose 1 drop into each affected eye 4 times daily

Titration Reduce to 3 times daily after symptom control

Usual maintenance dose 1 drop 3–4 times daily

Maximum dose 2 drops 6 times daily

1. Allergic Rhinitis

≥5 years 1 spray per nostril 4 times daily

Parameter Recommendation

Starting dose 1 spray into each nostril 4 times daily

Titration Reduce to 3 times daily after control

Usual maintenance dose 1 spray per nostril 3–4 times daily

Maximum dose 1 spray per nostril 6 times daily

1. Food Allergy / GI Manifestations of Mastocytosis — Oral

2–14 years 100 mg orally 4 times daily (may increase to 200 mg 4 times daily)

14 years Adult dosing

Parameter Recommendation

Starting dose 100 mg orally 4 times daily (before meals and at bedtime)

Titration May increase based on response

Usual maintenance dose 100–200 mg 4 times daily

Maximum dose 40 mg/kg/day (maximum 800 mg/day)

Safety Monitoring:

• Assess symptom response after 4–6 weeks

• Monitor for GI tolerance (oral form)

• Assess technique of inhalation device use periodically

Secondary Indications — Paediatric (Off-label)

Indication Dose Duration Notes

Systemic Mastocytosis (GI symptoms) 20–40 mg/kg/day orally in 4 divided doses Long-term based on response OFF-LABEL • Specialist only • Case series evidence

Exercise-Induced Bronchospasm 20 mg inhaled 15–30 minutes before exercise Single pre-exercise dose OFF-LABEL • Age ≥5 years

Age Restrictions:

• Inhalation: Not recommended below 2 years except under specialist supervision

• Ophthalmic: Not recommended below 4 years except under specialist supervision

• Nasal: Not recommended below 5 years except under specialist supervision

• Oral: Not recommended below 2 years except under specialist supervision

No dose adjustment required — Negligible systemic absorption with all routes of administration. Drug acts locally at mucosal surfaces.

• Known hypersensitivity to sodium cromoglycate or any formulation excipient

• Acute asthma attack or status asthmaticus (ineffective; not a bronchodilator)

• Not for acute symptom relief — prophylactic use only; ensure patient understands this

• Discontinue if no benefit after 4–6 weeks of regular use

• Should not replace inhaled corticosteroids as first-line controller therapy in persistent asthma

• Contact lens use (ophthalmic form) — remove lenses before instillation; wait 15 minutes before reinsertion

• Nasal spray may cause transient sneezing and irritation — may affect compliance

• Paradoxical bronchospasm possible with inhaled form (rare) — discontinue if occurs

Parameter Information

Risk Category Generally considered safe (minimal systemic absorption)

Overall Safety Safe for use during pregnancy when indicated

Preferred Alternatives Inhaled corticosteroids (budesonide) are preferred first-line for asthma prophylaxis

When May Be Used May be used when inhaled steroids not tolerated or as adjunct therapy

Monitoring Maternal asthma control; fetal growth with any asthma medication

Parameter Information

Compatibility Compatible with breastfeeding

Expected Milk Levels Negligible — minimal systemic absorption

Preferred Alternatives None needed — sodium cromoglycate is safe

Decision May use without interrupting breastfeeding

Infant Monitoring Not required

Parameter Recommendation

Starting dose Standard adult dosing for all routes

Titration Standard titration

Special considerations Well tolerated in elderly; no specific age-related concerns

Extra monitoring Ensure proper inhaler/nebuliser technique; cognitive decline may affect compliance with frequent dosing

Risk factors None specific to sodium cromoglycate

None known — Sodium cromoglycate has negligible systemic absorption and does not undergo hepatic metabolism. No CYP450 interactions.

Interacting Drug Effect Management

Other inhaled medications Potential for dilution effect or altered deposition if administered simultaneously Allow 5–10 minutes between different inhaled medications

Inhaled corticosteroids Additive benefit for asthma prophylaxis; no adverse interaction Safe to combine; use as adjunct therapy

Inhaled Form:

• Throat irritation

• Cough

• Transient bronchospasm (paradoxical)

• Unpleasant taste

Ophthalmic Form:

• Transient stinging/burning on instillation

• Temporary blurred vision

• Eye irritation

Nasal Spray:

• Transient sneezing post-application

• Nasal irritation and dryness

• Epistaxis (rare)

Oral Form:

• Nausea

• Abdominal discomfort

• Diarrhoea

• Skin rash (uncommon)

Adverse Effect Clinical Action

Anaphylaxis (extremely rare) Immediate discontinuation; emergency management

Severe bronchospasm (paradoxical — inhaled form) Discontinue immediately; administer bronchodilator

Angioedema Discontinue; supportive management

Pulmonary infiltrates with eosinophilia (very rare) Discontinue; investigate; pulmonology referral

After initiation (4–6 weeks) Assess symptom response; PEFR/symptom diary for asthma; determine if therapy should continue

Long-term Periodic assessment of efficacy; ensure proper device technique; reassess need for continued therapy seasonally

Inhalation:

• Intal (Sanofi)

• Cromal (Cipla)

• Astacrom (Sun Pharma)

Nasal Spray:

• Rynacrom (Sanofi)

• Cromolin Nasal (Cipla)

Ophthalmic:

• Cromal Eye Drops (Cipla)

• Crolom (Allergan)

• Cromosol (FDC)

Oral Capsules:

• Cromal Capsules (Cipla)

• Nalcrom (Sanofi) — limited availability

Note: Not included in NLEM 2022. Available over-the-counter for most formulations. Limited availability of oral capsules in some regions.

• Prophylactic agent only — has no role in acute asthma or acute allergic symptoms; ensure patients understand this to avoid confusion with reliever medications

• Requires regular consistent use — efficacy depends on regular dosing (typically QID); poor compliance due to frequent dosing is a major limitation

• Best started before allergen exposure — for seasonal allergic rhinitis and conjunctivitis, initiate 2–4 weeks before expected allergen season for optimal prophylaxis

• Less effective than inhaled corticosteroids for asthma — position in therapy is as adjunct or alternative when ICS not tolerated; not first-line for persistent asthma

• Trial period of 4–6 weeks required — assess efficacy after adequate trial; discontinue if no benefit

• Excellent safety profile — minimal systemic absorption makes it safe in pregnancy, lactation, and paediatric populations; good option when safety is primary concern

Sodium Cromoglycate; cromolyn sodium; mast cell stabiliser; asthma prophylaxis; allergic conjunctivitis; allergic rhinitis; food allergy; mastocytosis; non-steroidal; pregnancy-safe; lactation-safe; paediatric-safe; OTC

RxIndia v1.0 — 05 Jan 2025

• CDSCO Approved Drug Formulations Database

• Indian Pharmacopoeia 2022

• National Formulary of India 2021

• AIIMS Paediatric Drug Formulary

• API Textbook of Medicine, 11th Edition

• IAP Guidelines on Asthma and Allergy Management

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Indian specialist respiratory and ophthalmology protocols

• Manufacturer Product Inserts (India-licensed formulations)