Schedule H

Inhalation

• Inhalation solution (soft mist inhaler): 2.5 mcg per actuation (Respimat® device)

Note: Each therapeutic dose comprises 2 actuations delivering 5 mcg total.

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Chronic Obstructive Pulmonary Disease (COPD) — Maintenance Bronchodilation

Parameter Details

Starting dose 5 mcg inhaled once daily (2 puffs of 2.5 mcg each)

Titration Not applicable — fixed-dose regimen

Usual maintenance dose 5 mcg once daily

Maximum dose 5 mcg once daily

Clinical Notes:

• NOT indicated for relief of acute bronchospasm — ensure patient has rescue SABA (salbutamol) prescription

• Administer at the same time each day for consistent bronchodilation

• Onset of action: approximately 5 minutes; duration: 24 hours

• May be used as add-on to LAMA (tiotropium) in patients with persistent symptoms

• LABA/LAMA fixed-dose combination (olodaterol + tiotropium) available for patients requiring dual bronchodilation

• Suitable for GOLD Group B–D patients as per COPD management guidelines

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Remarks

Asthma-COPD overlap (ACO) — OFF-LABEL 5 mcg once daily (as part of triple therapy with ICS and LAMA) Long-term Specialist only (Pulmonologist); LABA monotherapy contraindicated in asthma — must be combined with ICS; limited Indian data

⚠️ LABA monotherapy is CONTRAINDICATED in asthma without concurrent ICS — increases risk of asthma-related death.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Not applicable — Olodaterol is NOT approved for use in children or adolescents.

Secondary Indications — Paediatric (Off-label)

Not applicable — No evidence supporting safe off-label use in paediatric population.

⚠️ NOT RECOMMENDED below 18 years of age. Safety and efficacy not established in paediatric population. No Indian paediatric data available.

No dose adjustment required in dialysis-dependent patients — systemic exposure is low with inhaled route.

• Hypersensitivity to olodaterol or any formulation component (benzalkonium chloride, disodium edetate)

• Monotherapy for asthma (without concurrent ICS) — risk of asthma-related death

• Acute bronchospasm or status asthmaticus — not a rescue medication

• Acutely deteriorating COPD

• Cardiovascular disorders — ischaemic heart disease, cardiac arrhythmias, hypertrophic obstructive cardiomyopathy, uncontrolled hypertension

• QT prolongation risk — pre-existing long QT syndrome or concurrent QT-prolonging medications

• Hyperthyroidism

• Seizure disorders — beta-agonists may lower seizure threshold

• Diabetes mellitus — beta-agonists may cause transient hyperglycaemia; monitor blood glucose

• Hypokalaemia risk — especially with concurrent diuretics, corticosteroids, or xanthines

• Phaeochromocytoma

• Concurrent use of other LABAs — avoid therapeutic duplication

• Patients with deteriorating disease — increasing SABA use may indicate worsening control

Parameter Details

Safety Category Limited human data; animal studies show beta-agonist class effects (fetal toxicity at high doses)

Preferred alternatives LAMA (tiotropium) monotherapy; ICS/LABA combinations with more safety data (budesonide/formoterol)

When to use Only if potential benefit justifies potential risk to fetus; avoid near term if possible

Monitoring Uterine activity if used near term (beta-agonists may inhibit labour); fetal heart rate monitoring

Parameter Details

Compatibility Likely compatible — low systemic absorption with inhalation route

Drug levels in milk Expected to be negligible due to minimal systemic exposure

Preferred alternatives Tiotropium (LAMA); salmeterol or formoterol may be considered (more historical data)

Infant monitoring Irritability, poor feeding, tremor, tachycardia (unlikely with inhaled route)

Parameter Recommendation

Starting dose Standard adult dose (5 mcg once daily) — no age-based adjustment

Titration Not applicable — fixed-dose regimen

Special considerations Increased susceptibility to cardiovascular effects (tachycardia, arrhythmias); monitor heart rate and rhythm

Additional risks Falls risk if tremor or palpitations occur; ensure adequate hydration; assess for drug interactions with cardiac medications

Drug Mechanism Clinical Effect Recommendation

Other LABAs (salmeterol, formoterol, indacaterol, vilanterol) Additive beta-adrenergic stimulation Increased risk of cardiovascular adverse effects (tachycardia, arrhythmias, hypertension) Avoid concurrent use — therapeutic duplication

Non-selective beta-blockers (propranolol, carvedilol, labetalol) Pharmacological antagonism Loss of bronchodilator efficacy; risk of severe bronchospasm Avoid; if beta-blocker essential, use cardioselective agent (bisoprolol, metoprolol)

MAO inhibitors Reduced catecholamine metabolism Enhanced sympathomimetic effects — hypertension, tachycardia Avoid combination; if unavoidable, close cardiovascular monitoring

Tricyclic antidepressants (amitriptyline, imipramine) Reduced catecholamine uptake Potentiated cardiovascular effects of beta-agonists Avoid combination or monitor closely for cardiac adverse effects

QT-prolonging drugs (amiodarone, sotalol, haloperidol, ondansetron, fluoroquinolones) Additive QT prolongation Risk of torsades de pointes Avoid combination if possible; ECG monitoring if concurrent use unavoidable

Drug Interaction Recommendation

Loop diuretics (furosemide, torsemide) Additive hypokalaemia Monitor serum potassium; correct deficiency promptly

Thiazide diuretics (hydrochlorothiazide) Additive hypokalaemia Monitor serum potassium

Systemic corticosteroids (prednisolone, dexamethasone) May potentiate hypokalaemia Monitor potassium during concurrent use

Xanthine derivatives (theophylline, aminophylline) Additive beta-agonist effects; hypokalaemia risk Monitor for tremor, tachycardia, hypokalaemia

Antidiabetic agents Beta-agonists may cause transient hyperglycaemia Monitor blood glucose; dose adjustment may be needed

Digoxin Hypokalaemia may increase digoxin toxicity risk Monitor potassium; watch for signs of digoxin toxicity

• Nasopharyngitis

• Upper respiratory tract infection

• Cough

• Dizziness

• Back pain

• Arthralgia

• Diarrhoea

• Insomnia

• Tachycardia (dose-related)

• Headache

• Paradoxical bronchospasm — discontinue immediately; treat with rescue SABA; consider alternative therapy

• Cardiac arrhythmias — tachycardia, atrial fibrillation, ventricular ectopy; may require discontinuation

• QT prolongation — rare; ECG monitoring if risk factors present

• Severe hypokalaemia — particularly with concurrent diuretics or corticosteroids; may cause muscle weakness, arrhythmias

• Anaphylaxis/angioedema — rare hypersensitivity reaction; discontinue immediately and manage appropriately

• Worsening of COPD — paradoxical deterioration may indicate need for therapy reassessment

Phase Parameters

Baseline Spirometry (FEV₁, FVC); cardiac history and examination; serum potassium (if on diuretics); blood glucose (diabetics); ECG (if cardiac risk factors)

After initiation (4–8 weeks) Symptom control assessment (CAT score, mMRC dyspnoea grade); heart rate; adverse effects

Long-term Annual spirometry; exacerbation frequency monitoring; periodic potassium (if polypharmacy); reassess inhaler technique

Monotherapy:

• Striverdi® Respimat (Boehringer Ingelheim)

Fixed-Dose Combinations:

Note: Not included in NLEM 2022; not NPPA price-controlled; available only through private market.

• Once-daily dosing: Administer at the same time each day — consistent timing improves bronchodilation and patient compliance

• Not for rescue: Olodaterol is maintenance therapy only — always ensure patient has SABA (salbutamol) for acute symptom relief

• Device technique critical: Respimat soft mist inhaler requires specific technique — device priming before first use and proper hand-breath coordination; counsel patient thoroughly

• LAMA combination: In patients inadequately controlled on single bronchodilator, LABA/LAMA combination (olodaterol + tiotropium) provides additive bronchodilation and reduces exacerbation risk

• Asthma contraindication: NEVER use LABA monotherapy in asthma — associated with increased risk of asthma-related death; always combine with ICS if treating asthma component

• Comparison with other LABAs: Olodaterol has similar efficacy to indacaterol and formoterol; choice depends on device preference, cost, and availability of FDC options

COPD; LABA; long-acting beta-agonist; inhaled bronchodilator; once-daily; Respimat; tiotropium combination; asthma-contraindicated; maintenance therapy; Schedule H; India

RxIndia v1.0 — 12 Apr 2025

• CDSCO approved product information

• Indian Pharmacopoeia 2022

• API Textbook of Medicine — COPD Management

• GOLD Guidelines (India-adapted — NCCP/ICMR)

• AIIMS Respiratory Medicine Protocols

• Boehringer Ingelheim India product insert — Striverdi Respimat

• Goodman & Gilman's The Pharmacological Basis of Therapeutics