Schedule H

Inhalation (MDI, nebulisation), Intranasal

• Metered Dose Inhaler (MDI): 20 mcg/actuation

• Respules/Nebuliser solution: 250 mcg/mL (1 mL, 2 mL units); 500 mcg/2 mL

• Nasal spray: 0.03% (21 mcg/spray), 0.06% (42 mcg/spray)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Chronic Obstructive Pulmonary Disease (COPD) — Maintenance and Acute Exacerbation

A. MDI Route (Adults)

Step Dose Clinical Notes

Starting dose 40 mcg (2 puffs) four times daily Use with spacer for optimal drug delivery

Titration Not applicable Fixed dosing regimen

Usual maintenance dose 40 mcg (2 puffs) three to four times daily May combine with SABA for enhanced bronchodilation

Maximum dose 320 mcg/day (16 puffs) Higher doses rarely provide additional benefit

B. Nebulisation Route (Adults)

Step Dose Clinical Notes

Starting dose 250–500 mcg three to four times daily Dilute in 2–4 mL normal saline

Titration Not applicable Dose based on severity

Usual maintenance dose 500 mcg three to four times daily Often combined with salbutamol 2.5–5 mg

Maximum dose 2 mg/day Under specialist supervision

Key points:

• Onset of action: 15–30 minutes; peak effect: 1–2 hours; duration: 4–6 hours

• More effective when combined with short-acting β2-agonist (SABA)

• For maintenance COPD, consider switching to long-acting muscarinic antagonist (LAMA) such as tiotropium

1. Bronchial Asthma — Acute Severe Exacerbation (Adjunctive Use)

Setting Dose Clinical Notes

Emergency/Acute severe 500 mcg via nebulisation combined with salbutamol 2.5–5 mg Give every 20 minutes for first hour (3 doses)

Subsequent doses 500 mcg every 4–6 hours with SABA Continue based on clinical response

Maximum in acute setting Up to 2 mg in first hour Under emergency/ICU supervision

Key points:

• NOT for monotherapy in asthma — always combine with SABA

• NOT indicated for long-term asthma control or maintenance therapy

• Benefits mainly in severe acute exacerbations; limited role in mild-moderate attacks

1. Rhinorrhoea — Perennial Allergic and Non-Allergic Rhinitis

Nasal Spray (Adults)

Step Dose Clinical Notes

Starting dose 42 mcg (2 sprays of 0.03% or 1 spray of 0.06%) per nostril two to three times daily Onset within 15–30 minutes

Titration Not applicable Adjust frequency based on symptom control

Usual maintenance dose 42 mcg per nostril three times daily Short-term use preferred

Maximum dose 168 mcg per nostril per day Prolonged use may cause nasal dryness

Key points:

• Particularly effective for watery rhinorrhoea (anterior rhinorrhoea)

• Less effective for nasal congestion or sneezing

• Useful when antihistamines are ineffective or contraindicated

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Sialorrhoea (drooling) in neurological conditions 500 mcg nebulised TID or nasal spray applied to buccal mucosa Ongoing based on response OFF-LABEL; Specialist only; Evidence: Small studies; Indian neurology practice

Acute viral rhinitis (symptomatic relief) 42 mcg per nostril TID ≤4 days OFF-LABEL; Limited evidence; symptomatic use only

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Acute Asthma / Acute Wheezing (Adjunctive with SABA)

Nebulisation — Age/Weight-Based Dosing

Age/Weight Ipratropium Dose Combine With Frequency

<2 years 125–250 mcg Salbutamol 2.5 mg Every 20 min × 3 doses, then Q4–6H PRN

2–12 years (<20 kg) 250 mcg Salbutamol 2.5 mg Every 20 min × 3 doses, then Q4–6H PRN

2–12 years (≥20 kg) 500 mcg Salbutamol 5 mg Every 20 min × 3 doses, then Q4–6H PRN

12 years 500 mcg Salbutamol 5 mg Adult dosing schedule

MDI via Spacer (with mask for younger children)

Age Dose Frequency

2–12 years 40 mcg (2 puffs) Every 4–6 hours as needed

12 years 40–80 mcg (2–4 puffs) Every 4–6 hours as needed

Safety monitoring:

• Monitor heart rate (less tachycardia than with SABA alone)

• Observe for paradoxical bronchospasm

• Assess clinical response (oxygen saturation, work of breathing)

• Protect eyes during nebulisation (risk of mydriasis and acute glaucoma)

Secondary Indications — Paediatrics (Off-label)

Indication Dose Duration Notes

Rhinorrhoea (allergic/non-allergic) Nasal spray 21–42 mcg per nostril TID Short-term only OFF-LABEL; Age >6 years; Monitor for nasal dryness and epistaxis

Minimum age: Not recommended below 2 years of age except under paediatric pulmonologist/intensivist supervision in acute severe bronchospasm

No dose adjustment required.

Ipratropium has minimal systemic absorption (<20% from respiratory tract, <2% from GI tract) and renal impairment does not significantly affect drug exposure.

Note: Minimal hepatic metabolism; no clinically significant hepatic effects expected

• Known hypersensitivity to ipratropium bromide, atropine, or atropine derivatives

• Known hypersensitivity to any excipient in the formulation (including soya lecithin in some MDI preparations — caution in soya/peanut allergy)

• Narrow-angle glaucoma — nebulised drug or mist from MDI can enter eyes and precipitate acute angle-closure glaucoma; use tight-fitting mask during nebulisation

• Prostatic hypertrophy — risk of urinary retention (low with inhaled route, but be vigilant)

• Bladder neck obstruction

• Myasthenia gravis — theoretical worsening possible

• Paradoxical bronchospasm — may occur rarely; discontinue immediately if wheezing worsens

• Cystic fibrosis patients — may be at higher risk of GI motility disturbances

Parameter Recommendation

Safety category Limited human data; animal studies show no teratogenicity; generally considered safe due to minimal systemic absorption

Preferred alternatives Salbutamol (SABA) is first-line for acute bronchospasm in pregnancy

When it may be used May add to SABA in severe acute asthma if benefit outweighs theoretical risk

Monitoring Maternal respiratory status; fetal heart rate in severe exacerbations

Parameter Recommendation

Compatibility Likely compatible — minimal systemic absorption; unlikely to reach significant levels in breast milk

Drug levels in milk Expected to be very low/negligible

Preferred alternatives Salbutamol if bronchodilator needed

Infant monitoring Observe for irritability, dry mouth, feeding difficulties (unlikely)

• Recommended starting dose: Standard adult doses; no specific reduction required

• Titration: Not applicable for ipratropium

• Additional risks:

• Higher prevalence of narrow-angle glaucoma — ensure proper nebulisation technique to avoid ocular exposure

• Prostatic hypertrophy common — monitor for urinary symptoms

• May have impaired inhaler technique — assess and re-educate regularly

• Cognitive impairment may lead to incorrect device use

• Monitoring: Assess symptom relief and watch for anticholinergic side effects

Drug Interaction Management

Other anticholinergic inhalers (tiotropium, umeclidinium, glycopyrronium) Additive anticholinergic effects; no additional bronchodilator benefit from combining SAMA with LAMA AVOID concurrent use — duplication of therapy

Note: Few clinically significant major drug interactions due to minimal systemic absorption

Drug Interaction Management

Systemic anticholinergics (antimuscarinics, TCAs, antihistamines with anticholinergic activity) Additive anticholinergic effects (dry mouth, urinary retention, constipation, confusion in elderly) Use with caution; monitor for cumulative anticholinergic burden

Non-selective beta-blockers (propranolol, carvedilol) May partially antagonise bronchodilator effect Use cardioselective beta-blockers if needed; monitor respiratory response

Potassium-sparing agents (when combined with SABA) Theoretical interaction; minimal clinical relevance for ipratropium alone Monitor if using high-dose combined nebulisation

• Dry mouth (most common with inhalation)

• Cough

• Pharyngeal irritation

• Headache

• Bitter/metallic taste

• Nausea

• Nasal dryness and epistaxis (with nasal spray)

Reaction Action Required

Paradoxical bronchospasm Discontinue immediately; administer alternative bronchodilator; may need adrenaline

Acute angle-closure glaucoma (eye pain, blurred vision, halos around lights) Discontinue; urgent ophthalmology referral

Severe hypersensitivity reaction (urticaria, angioedema, anaphylaxis) Discontinue permanently; emergency management

Urinary retention Discontinue if severe; urology input if needed

After initiation Symptom relief typically within 30–60 minutes; assess inhaler/nebuliser technique

During acute use Oxygen saturation, respiratory rate, work of breathing

Long-term Periodic assessment of COPD control; exacerbation frequency; check for anticholinergic side effects (dry mouth, urinary symptoms); reassess need for continuing SAMA vs switching to LAMA

Single-ingredient products:

• Ipravent (Cipla) — MDI, respules

• Tropium (Lupin) — respules

• Ipraset (Intas)

Fixed-dose combinations (Ipratropium + Salbutamol):

• Duolin (Cipla) — MDI, respules (most widely used)

• Combivent (Boehringer Ingelheim)

• Duonase, Iprasal, Iprasol — various manufacturers

Nasal spray:

• Ipravent Nasal (Cipla)

• Atrohist, Atronase — other manufacturers

NLEM status: Ipratropium bromide nebulisation solution is included in NLEM 2022 — ceiling price applicable under NPPA

• Combine with SABA for best effect: Ipratropium alone has slower onset than salbutamol; combination provides additive bronchodilation especially in COPD and severe acute asthma

• Not a rescue inhaler: Onset of 15–30 minutes makes it unsuitable for immediate symptom relief — always pair with SABA

• Protect the eyes: During nebulisation, use well-fitting face mask or mouthpiece; mist entering eyes can precipitate acute glaucoma

• SAMA vs LAMA: For COPD maintenance, tiotropium (LAMA) provides once-daily dosing with better adherence; reserve ipratropium for acute exacerbations or as add-on

• Nasal spray pearls: Most effective for watery rhinorrhoea; less useful for congestion or sneezing; good option when antihistamines cause excessive sedation

• Check inhaler technique: Particularly in elderly patients — poor technique leads to treatment failure

COPD; asthma adjunct; bronchodilator; SAMA; anticholinergic; nebulisation; Duolin; rhinorrhoea; glaucoma caution; NLEM India

RxIndia v1.1 — 14 Jun 2025

• CDSCO Approved Product Information

• Indian Pharmacopoeia 2022

• NLEM 2022 (National List of Essential Medicines)

• API Textbook of Medicine (11th Edition)

• IAP Guidelines on Childhood Asthma Management

• AIIMS Emergency Department Protocols

• ICMR COPD and Asthma Management Modules

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (13th Edition)

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