Schedule H

Oral, Inhalation (MDI, DPI, Nebuliser), Parenteral (IV, SC)

• Inhaler (MDI): 100 mcg/actuation

• Dry Powder Inhaler (DPI): 200 mcg/dose (Rotacaps, Accuhaler)

• Nebuliser solution: 5 mg/mL respules; 2.5 mg/2.5 mL unit dose vials

• Tablets: 2 mg, 4 mg

• Oral syrup: 2 mg/5 mL

• Injection (IV/SC): 500 mcg/mL (as sulphate)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Acute Bronchospasm (Asthma Exacerbation, COPD Exacerbation)

Inhalation is the preferred route for rapid bronchodilation with fewer systemic effects.

Route Starting Dose Titration Usual Maintenance Dose Maximum Dose Clinical Notes

MDI (100 mcg/puff) 2 puffs (200 mcg) May repeat every 20 min × 3 doses in acute attack 1–2 puffs every 4–6 hours PRN 8–12 puffs/day Use spacer device for optimal lung deposition

Nebulised 2.5 mg in 3 mL NS May repeat every 20 min × 3 doses in acute setting 2.5–5 mg every 4–6 hours 40 mg/day (divided doses) Continuous nebulisation in severe cases under monitoring

SC Injection 250 mcg May repeat after 4 hours 250–500 mcg every 4–6 hours 500 mcg every 4 hours Reserve for situations where inhalation not feasible

IV Infusion 5 mcg/min Increase by 1–2 mcg/min every 15–30 min 3–20 mcg/min 20 mcg/min ICU setting only; continuous cardiac monitoring mandatory

1. Chronic Asthma — Reliever Therapy

• Starting dose: 1–2 puffs (100–200 mcg) MDI/DPI as needed

• Titration: Not applicable (PRN use)

• Usual maintenance dose: 1–2 puffs up to four times daily when required

• Maximum dose: Should not exceed 8 puffs/day regularly; frequent use indicates need for controller therapy escalation

Clinical Note: Use alongside inhaled corticosteroids (ICS) as per GINA/Indian Asthma Guidelines. Sole reliance on SABA without ICS is associated with increased mortality risk.

1. Exercise-Induced Bronchospasm (EIB) — Prophylaxis

• Starting dose: 200 mcg (2 puffs MDI) 10–15 minutes before exercise

• Titration: Not applicable

• Usual maintenance dose: 200 mcg pre-exercise

• Maximum dose: 200 mcg per occasion; if frequent EIB, consider adding LABA or optimising ICS

1. Hyperkalaemia (Adjunctive — Temporary Intracellular Potassium Shift)

ICU/Emergency setting only

• Starting dose: 10 mg nebulised over 10–15 minutes

• Titration: May repeat 10 mg dose if K+ remains elevated

• Usual maintenance dose: 10–20 mg nebulised

• Maximum dose: 20 mg single dose

Clinical Note: Always combine with insulin-dextrose therapy. Effect is temporary (shifts K+ intracellularly). Monitor serum potassium and ECG continuously. Expect K+ reduction of 0.5–1 mEq/L within 30 minutes.

Secondary Indications — Adults (Off-label)

Tocolysis in Preterm Labour

Parameter Details

Indication Acute tocolysis for preterm labour (24–34 weeks gestation)

Route IV infusion

Starting dose 10 mcg/min

Titration Increase by 5 mcg/min every 10 minutes based on uterine response

Usual range 10–45 mcg/min

Maximum dose 80 mcg/min

Duration Up to 48 hours to allow corticosteroid effect for fetal lung maturity

Label status OFF-LABEL

Specialist only Yes — Obstetrics specialist supervision mandatory

Evidence basis AIIMS Obstetrics protocols; Indian specialist practice. Nifedipine or atosiban preferred as first-line in current practice due to better safety profile

Caution: Contraindicated in maternal cardiac disease, preeclampsia, eclampsia, significant antepartum haemorrhage. Monitor maternal HR, BP, fluid balance, serum glucose, and potassium. Risk of pulmonary oedema with IV use.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

1. Acute Asthma / Acute Bronchospasm

Age Group MDI with Spacer Nebulised Oral (Syrup/Tablet)

<2 years Not routinely preferred; if used: 1 puff (100 mcg) with spacer + mask, may repeat every 20 min × 3 in acute setting 0.15 mg/kg/dose (min 1.25 mg, max 2.5 mg) every 4–6 hours Not routinely recommended

2–5 years 1 puff (100 mcg) up to every 4 hours; in acute attack: 2–4 puffs every 20 min × 3 2.5 mg every 4–6 hours Syrup: 1–2 mg (0.1–0.15 mg/kg) TID

6–11 years 1–2 puffs every 4–6 hours PRN; in acute: 4–6 puffs every 20 min × 3 2.5–5 mg every 4–6 hours Tablet: 2 mg TID

≥12 years Adult dosing applies 2.5–5 mg every 4–6 hours Tablet: 2–4 mg TID

Dosing structure:

• Starting dose: As per age table above

• Titration: In acute exacerbation, may give every 20 minutes for up to 3 doses, then every 1–4 hours as needed

• Usual maintenance dose: PRN use only; 1–2 puffs every 4–6 hours

• Maximum dose: Nebulised — 10 mg/dose in severe acute asthma under monitoring; Oral — 24 mg/day

Clinical Note: MDI with spacer (and face mask in children <4 years) is as effective as nebulisation and preferred in non-severe exacerbations. Ensure proper technique training.

1. Exercise-Induced Bronchospasm Prophylaxis (Age ≥6 years)

• Starting dose: 100–200 mcg MDI 15 minutes before exercise

• Titration: Not applicable

• Usual maintenance dose: 200 mcg pre-exercise

• Maximum dose: 200 mcg per occasion

Secondary Indications — Paediatrics (Off-label)

Hyperkalaemia in Paediatric ICU

Parameter Details

Indication Acute hyperkalaemia — adjunctive treatment

Route Nebulised

Dose 2.5 mg (<25 kg) to 5 mg (≥25 kg) nebulised

Frequency May repeat once after 30 minutes

Label status OFF-LABEL

Specialist only Yes — PICU setting only

Evidence basis Extrapolated from adult data; used in AIIMS PICU protocols

Monitoring: Continuous ECG, serum potassium every 1–2 hours. Always use with insulin-dextrose.

Viral-Induced Wheeze / Bronchiolitis (Age <2 years)

Parameter Details

Indication Acute viral wheeze in infants

Route Nebulised or MDI with spacer

Dose 2.5 mg nebulised or 2 puffs MDI as therapeutic trial

Duration Single trial; continue only if objective improvement observed

Label status OFF-LABEL — Routine use not recommended in bronchiolitis (IAP guidelines)

Specialist only Yes

Evidence basis Variable response; IAP guidelines note limited evidence of benefit in RSV bronchiolitis

Age Restriction Statement:

Not recommended in children below 2 years of age except under specialist supervision due to limited efficacy data and increased risk of paradoxical bronchospasm. Inhaled route strongly preferred over oral in all age groups.

Safety Monitoring in Children:

• Heart rate (tachycardia common)

• Serum potassium if high-dose or prolonged nebulisation

• Tremor, irritability

• Oxygen saturation response

60 No adjustment

30–60 No adjustment

15–30 No adjustment; monitor for hypokalaemia

<15 or dialysis No adjustment; use with caution; monitor potassium

Note: Salbutamol is not significantly renally excreted. However, patients with severe CKD may be more susceptible to hypokalaemia and cardiovascular effects. Use lowest effective dose.

• Known hypersensitivity to salbutamol or any excipient in formulation

• Uncontrolled severe cardiac arrhythmias (tachyarrhythmias)

• Hypertrophic obstructive cardiomyopathy

• Concurrent use with non-selective beta-blockers (e.g., propranolol, carvedilol) — antagonises bronchodilator effect

• Tocolysis-specific: Maternal cardiac disease, eclampsia, severe preeclampsia, intrauterine infection, intrauterine fetal death, antepartum haemorrhage requiring immediate delivery

• Cardiovascular disease (ischaemic heart disease, heart failure, arrhythmias) — increased risk of tachycardia, palpitations

• Hypertension — may cause transient BP elevation

• Diabetes mellitus — may elevate blood glucose; monitor in diabetic patients on high-dose or IV therapy

• Hyperthyroidism — may exacerbate cardiovascular effects

• Seizure disorders — potential CNS stimulation at high doses

• Hypokalaemia or concurrent use of potassium-lowering drugs

• Phaeochromocytoma (theoretical concern)

• Paradoxical bronchospasm — discontinue immediately if worsening wheeze after inhalation

• Frequent SABA use (>2 days/week) — indicates poor asthma control; reassess controller therapy

Parameter Details

Overall safety Considered relatively safe; one of the most commonly used bronchodilators in pregnant women with asthma

Risk category US legacy Category C (crosses placenta; no controlled human studies showing teratogenicity)

Indian practice First-line reliever for asthma in pregnancy per IAP/FOGSI guidelines

When to use Inhaled route for asthma management — benefit clearly outweighs theoretical risk

Preferred alternatives None required for inhaled use; salbutamol is standard of care

Monitoring Maternal: heart rate, blood pressure. Fetal: heart rate monitoring if high-dose or IV use

Tocolysis caution IV use associated with maternal tachycardia, hypotension, pulmonary oedema, hypokalaemia. Nifedipine preferred as first-line tocolytic in current Indian practice

Key Point: Uncontrolled asthma poses greater risk

Parameter Recommendation

Compatibility Compatible with breastfeeding

Drug levels in milk Low; clinically insignificant amounts excreted

Preferred alternatives None needed; salbutamol is standard for breastfeeding mothers with asthma

Infant monitoring Observe for irritability, feeding difficulties, or tremor if high maternal doses used

Parameter Recommendation

Starting dose Lower end of adult dosing range (100 mcg MDI; 2.5 mg nebulised)

Titration Slower; assess cardiovascular tolerance before dose increase

Specific risks Tachycardia, palpitations, arrhythmias (especially in underlying IHD or AF); hypokalaemia; tremor more pronounced

Additional caution Use lowest effective dose; monitor potassium if on diuretics; avoid oral formulations if possible

Drug Interaction Recommendation

Non-selective beta-blockers (propranolol, carvedilol, nadolol) Antagonise bronchodilatory effect; may precipitate severe bronchospasm AVOID combination. Use cardioselective beta-blockers (bisoprolol, metoprolol) with caution if essential

MAO inhibitors Potentiation of cardiovascular effects; risk of hypertensive crisis Avoid salbutamol within 14 days of MAO inhibitor use

Tricyclic antidepressants Enhanced cardiovascular effects; risk of arrhythmias Use with caution; monitor heart rate and blood pressure

Digoxin Hypokalaemia induced by salbutamol may increase digoxin toxicity Monitor serum potassium and digoxin levels

Drug Interaction Recommendation

Loop diuretics (furosemide) Additive hypokalaemia Monitor serum potassium; correct deficits

Thiazide diuretics Additive hypokalaemia Monitor serum potassium

Systemic corticosteroids Additive hypokalaemia, especially with high doses Monitor potassium in prolonged use

Theophylline/Aminophylline Additive tachycardia, tremor, CNS stimulation Use together with monitoring; dose adjustment rarely needed

Antidiabetic agents (insulin, sulphonylureas) Salbutamol may cause hyperglycaemia, reducing efficacy Monitor blood glucose; may need temporary dose adjustment

Xanthine derivatives Additive cardiac stimulation Monitor for tachyarrhythmias

• Fine tremor (especially hands)

• Palpitations

• Tachycardia

• Headache

• Muscle cramps

• Nervousness/restlessness

• Throat irritation and dry mouth (inhaled forms)

• Transient hypokalaemia

Adverse Effect Clinical Notes

Paradoxical bronchospasm Discontinue immediately; switch to alternative bronchodilator

Severe hypokalaemia Risk of cardiac arrhythmias; especially with high-dose nebulisation or IV use

Cardiac arrhythmias Including atrial fibrillation, ventricular ectopics; monitor ECG in high-risk patients

QTc prolongation Rare; risk increased with hypokalaemia or concurrent QT-prolonging drugs

Lactic acidosis Very rare; reported with high-dose IV infusions

Pulmonary oedema Associated with IV tocolytic use; avoid in cardiac disease

Myocardial ischaemia Risk in patients with underlying coronary artery disease

Phase Parameters

Baseline Heart rate, blood pressure, serum potassium (if high-dose or IV anticipated), blood glucose (diabetics)

During acute management Oxygen saturation, respiratory rate, peak expiratory flow rate, heart rate, ECG (if IV used)

High-dose/IV use Continuous cardiac monitoring, serum potassium every 4–6 hours, blood glucose

Long-term use Frequency of SABA use (>2 days/week indicates poor control); inhaler technique assessment; asthma control parameters

Brand Name Manufacturer Notes

Asthalin Cipla MDI, Rotacaps, Nebuliser solution, Tablets, Syrup

Ventorlin GlaxoSmithKline MDI, Rotacaps, Respules

Salbair Lupin MDI, Nebuliser solution

Salbetol FDC Ltd Tablets, Syrup

Salbutamol (Generic) Various Available across formulations

FDC Products:

• Levolin (Levosalbutamol) — Cipla (R-isomer variant)

Regulatory Note: Listed under NLEM 2022; prices regulated by NPPA for scheduled formulations. Available under government supply programmes.

1. Inhaled route always preferred: Oral and parenteral routes have higher systemic side effects with no added bronchodilator efficacy. Reserve oral forms for patients who cannot use inhalers despite training.

1. Spacer is essential: Always use spacer device with MDI for optimal drug delivery to lower airways, especially in children and elderly. Without spacer, >80% of drug deposits in oropharynx.

1. SABA overuse signals poor control: If patient uses reliever >2 times/week (excluding pre-exercise use), reassess ICS adherence, inhaler technique, and consider stepping up controller therapy.

1. Hyperkalaemia use is adjunctive only: Nebulised salbutamol provides temporary intracellular potassium shift (onset 15–30 min, duration 2–4 hours). Always use with insulin-glucose and arrange definitive therapy.

1. Cardiac caution: In patients with IHD or arrhythmias, use lowest effective dose. Consider ipratropium as alternative or add-on to reduce salbutamol requirement.

1. Combination with ipratropium: In acute severe asthma or COPD exacerbation, adding ipratropium to salbutamol provides additive bronchodilation and is recommended in emergency protocols.

asthma; COPD; bronchodilator; SABA; beta2-agonist; acute-bronchospasm; paediatric-safe; inhaler; nebulisation; hyperkalaemia-adjunct; NLEM-India; Schedule-H

RxIndia v1.0 — 04 May 2025

• CDSCO Drug Database and Product Inserts

• Indian Pharmacopoeia 2022

• National List of Essential Medicines (NLEM) 2022

• National Asthma Control Programme (India)

• AIIMS Treatment Guidelines (Emergency Medicine, Paediatrics)

• API Textbook of Medicine (11th Edition)

• IAP Asthma Guidelines

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• AIIMS Obstetrics Protocols (for tocolysis reference)

• PGI Chandigarh PICU Protocols