schedule H

Inhalation

• Inhalation powder in hard capsules: 18 mcg per capsule (for use with HandiHaler® or equivalent device)

• Metered dose inhaler (MDI): 2.5 mcg per actuation

• Respimat® soft-mist inhaler: 2.5 mcg per puff

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Chronic Obstructive Pulmonary Disease (COPD) — Maintenance Bronchodilator

Parameter Dry Powder Capsule (HandiHaler) Soft-Mist Inhaler (Respimat)

Starting dose 18 mcg once daily 5 mcg (2 puffs) once daily

Titration Not applicable Not applicable

Usual maintenance dose 18 mcg once daily 5 mcg (2 puffs) once daily

Maximum dose 18 mcg/day 5 mcg/day

Clinical Notes:

• NOT indicated for acute bronchospasm or rescue therapy

• Administer at the same time each day

• For HandiHaler: capsule must be punctured and drug inhaled with forceful deep inspiration

• Respimat preferred for patients with poor inspiratory flow or dexterity issues

1. Asthma — Maintenance Controller (Add-on therapy when ICS + LABA insufficient)

Parameter Respimat Only

Starting dose 5 mcg (2 puffs) once daily

Titration Not applicable

Usual maintenance dose 5 mcg (2 puffs) once daily

Maximum dose 5 mcg/day

Clinical Notes:

• Reserved for moderate-to-severe asthma uncontrolled on ICS + LABA

• Requires pulmonologist supervision

• Dry powder form NOT approved for asthma in India

• Continue ICS and LABA alongside; do not use as monotherapy

Secondary Indications — Adults (Off-label, if any)

Indication Dose Duration Supervision Label Status Evidence Basis

Bronchiectasis (non-CF) with airflow obstruction 18 mcg once daily via HandiHaler Long-term if benefit documented Specialist only OFF-LABEL Small RCTs; Indian pulmonology practice

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Age Restriction: Tiotropium Respimat is approved for children ≥6 years for asthma in some countries. INDIAN PAEDIATRIC INDICATION NOT EXPLICITLY APPROVED BY CDSCO OR IAP.

Asthma — Add-on Maintenance Therapy (Specialist Use Only)

≥6 to <12 years 2.5 mcg (1 puff) once daily via Respimat May increase after 4–6 weeks if inadequate response 2.5–5 mcg once daily 5 mcg/day OFF-LABEL in India

≥12 years 5 mcg (2 puffs) once daily via Respimat Not applicable 5 mcg once daily 5 mcg/day OFF-LABEL in India

Safety Monitoring:

• Monitor FEV1 response at 4–6 weeks

• Ensure adherence to ICS therapy

• Assess inhaler technique regularly

Children <6 years: NOT RECOMMENDED except in clinical trial settings

Secondary Indications — Paediatric Doses (Off-label, if any)

Not applicable.

• Known hypersensitivity to tiotropium, atropine, or atropine derivatives (e.g., ipratropium)

• Hypersensitivity to inhaled lactose (for dry powder capsule formulation)

• Use as rescue therapy for acute bronchospasm

• Narrow-angle glaucoma: May precipitate or worsen acute angle-closure if mist/powder contacts eyes

• Urinary retention: Use cautiously in men with prostatic hyperplasia or bladder neck obstruction

• Moderate-to-severe renal impairment: Increased risk of systemic anticholinergic effects

• Inhalation technique: Suboptimal technique significantly reduces drug delivery and efficacy

• Do NOT nebulise: Product not designed for nebuliser use

• Paradoxical bronchospasm: Discontinue immediately if occurs

• Cardiovascular disease: Use cautiously in patients with recent myocardial infarction or unstable arrhythmia

Parameter Recommendation

Risk category/Safety statement Limited human data; animal studies suggest low risk

Preferred alternatives Inhaled corticosteroids (ICS) and LABAs (e.g., budesonide, formoterol) are better studied in pregnancy

When it may be used When benefit clearly outweighs risk in moderate-to-severe COPD/asthma uncontrolled on other agents

Monitoring Pulmonary function; fetal growth on ultrasound if prolonged use

Parameter Recommendation

Compatibility Likely compatible due to minimal systemic absorption via inhalation

Preferred alternatives Continue if clinically necessary for disease control

Expected drug levels in milk Negligible (low systemic absorption)

Infant monitoring Observe for signs of anticholinergic exposure: poor feeding, dry mouth, irritability (unlikely)

Parameter Recommendation

Starting dose Same as younger adults (no age-based dose adjustment)

Titration Not required; slower titration unnecessary unless comorbidities present

Extra risks Dry mouth, urinary retention, constipation, confusion — especially with severe renal impairment or anticholinergic polypharmacy

Device preference Respimat may be preferred over DPI in those with poor inspiratory effort

Interacting Drug(s) Effect/Mechanism Recommendation

Other inhaled antimuscarinics (e.g., ipratropium, glycopyrronium, umeclidinium) Additive anticholinergic effects — increased risk of dry mouth, urinary retention, constipation, confusion Avoid concurrent use

Systemic anticholinergics (e.g., oxybutynin, tolterodine) Additive anticholinergic burden Avoid or use with extreme caution

Interacting Drug(s) Effect/Mechanism Recommendation

Inhaled beta-agonists (salbutamol, formoterol, salmeterol) Often co-administered; additive cardiovascular effects (tachycardia, tremor) possible Monitor; generally safe combination

Inhaled corticosteroids (ICS) Commonly used together for asthma/COPD Safe combination; no dose adjustment

Potassium-lowering agents (loop/thiazide diuretics) Hypokalaemia may increase arrhythmia risk when combined with beta-agonists Monitor potassium if triple therapy

Tricyclic antidepressants, sedating antihistamines Increased total anticholinergic burden Monitor for adverse effects

Note: Tiotropium is primarily renally excreted with no significant CYP450 interactions.

• Dry mouth (xerostomia) — most frequent

• Constipation

• Cough post-inhalation

• Pharyngitis / throat irritation

• Headache

• Sinusitis

Adverse Effect Clinical Significance

Paradoxical bronchospasm Discontinue immediately; treat as acute bronchospasm

Acute angle-closure glaucoma Can occur if mist/powder contacts eye; urgent ophthalmology referral

Urinary retention Particularly in elderly men with prostatic hypertrophy; may require catheterisation

Hypersensitivity reactions Rash, urticaria, angioedema, anaphylaxis — discontinue permanently

Supraventricular tachycardia / atrial fibrillation Rare; monitor in patients with pre-existing cardiac disease

Timing Parameter

Baseline Spirometry (FEV1, FVC); symptom burden assessment (mMRC, CAT score for COPD)

After initiation (4–6 weeks) Assess bronchodilator response; review inhaler technique; evaluate symptom improvement

Long-term Monitor for dry mouth, urinary symptoms; intraocular pressure in glaucoma-prone patients; renal function if impaired at baseline

Renal impairment Monitor for systemic anticholinergic side effects

Spiriva® Boehringer Ingelheim Dry powder capsule; Respimat

Tiova® Cipla Dry powder capsule

Tiova Respimat® Cipla Soft-mist inhaler

T Spiriva® Sun Pharma Dry powder capsule

Tiomate® Cipla FDC with LABA (DPI) — note: fixed-dose combination

Note: May be available at subsidised rates in government settings under NLEM provisions for COPD.

1. Device selection matters: Prefer Respimat for elderly patients or those with poor inspiratory flow; DPI requires forceful inhalation for adequate drug deposition.

1. Technique is critical: Always verify inhaler technique at every visit — incorrect use is a common cause of treatment failure.

1. Not for rescue: Tiotropium is strictly preventive/maintenance therapy; never prescribe for acute symptom relief.

1. Eye protection: Advise patients to avoid spraying toward eyes, especially with Respimat — can precipitate acute glaucoma.

1. Asthma positioning: In asthma, tiotropium is a Step 4/5 add-on only when ICS + LABA are insufficient; never use as monotherapy.

1. Anticholinergic burden: Screen for concomitant anticholinergic medications in elderly to prevent cumulative toxicity.

COPD; asthma; LAMA; bronchodilator; inhalation; Respimat; long-acting; anticholinergic; renal-caution; NLEM India

RxIndia v1.0 — 19 Jun 2025

• CDSCO (Form 45 and product inserts)

• Indian Pharmacopoeia / National Formulary of India (IP/NFI) 2021

• National List of Essential Medicines (NLEM) 2022

• API Textbook of Medicine

• ICMR COPD Management Guidelines

• Indian Chest Society Expert Guidelines

• AIIMS Formulary and Clinical Protocols

• Select RCTs/meta-analyses (for off-label bronchiectasis and paediatric asthma use)