THE INDIAN PHARMACIST Official Circular Pharmacy Logo THE INDIAN PHARMACISTLearn. Explore. Practise. Excel.
MEDICINE MONOGRAPH CODE: [9.10] ID: TIP-MED-000174

Levosalbutamol (Levalbuterol)

Active Ingredient / Scientific Identity: Levosalbutamol • Class: Single R-Enantiomer Selective Beta-2 Adrenoceptor Agonist Bronchodilator — SABA (Schedule H)

⚖️ Compare Profile
THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Levosalbutamol (Levalbuterol) ([9.10] | ID: TIP-MED-000174) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/9-10-levosalbutamol-levalbuterol/
Generic / Entity NameLevosalbutamol (Levalbuterol) ([9.10])
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassSingle R-Enantiomer Selective Beta-2 Adrenoceptor Agonist Bronchodilator — SABA (Schedule
Available Dosage FormspMDI Inhaler: 50 mcg/puff; Rotacaps: 100 mcg; Nebuliser Respules: 0.31 mg, 0.63 mg, 1.25 mg per 2.5 mL; Oral S
Regulatory ClassificationSchedule H Prescription Drug (To be sold by retail on the prescription of a Registere
Key Warning & Review DateRenal & Hepatic: No adjustment needed for inhaled doses; caution with high-dose nebulisation in severe CKD
Reviewed: 2026-11-10
Safety Matrix:⚖️ Legal Status: Schedule H Prescription Drug (To be sold by retail o✔️ Standard Clinical Dispensing Precautions

1. Clinical & Scientific Overview

Levosalbutamol (Levalbuterol) (TIP-MED-000174, Reference Code [9.10]) is classified under Respiratory, Asthma, COPD & Allergy Medicines (Ch 09) as a Single R-Enantiomer Selective Beta-2 Adrenoceptor Agonist Bronchodilator — SABA (Schedule H). Within the Indian regulatory and compendial framework, it is governed under Schedule H Prescription Drug (To be sold by retail on the prescription of a Registered Medical Practitioner only — Drugs Rules 1945).

Verified Indian Market Examples / Compendial Status:
Representative Indian Market Examples (Edition 2.7 Ch 09 [9.10], p. 118): Levolin (Cipla — pMDI, Rotacaps, Respules, Syrup), Duolin (Levosalbutamol + Ipratropium) — Strengths & Dosage Forms: pMDI Inhaler: 50 mcg/puff; Rotacaps: 100 mcg; Nebuliser Respules: 0.31 mg, 0.63 mg, 1.25 mg per 2.5 mL; Oral Syrup: 1 mg/5 mL; Tablets: 1 mg, 2 mg
Representative Indian Market Examples (Edition 2.7 Ch 09 [9.10], p. 118): Levolin (Cipla — pMDI, Rotacaps, Respules, Syrup), Duolin (Levosalbutamol + Ipratropium) — Strengths & Dosage Forms: pMDI Inhaler: 50 mcg/puff; Rotacaps: 100 mcg; Nebuliser Respules: 0.31 mg, 0.63 mg, 1.25 mg per 2.5 mL; Oral Syrup: 1 mg/5 mL; Tablets: 1 mg, 2 mg
Dosage Forms & Available Strengths:
pMDI Inhaler: 50 mcg/puff; Rotacaps: 100 mcg; Nebuliser Respules: 0.31 mg, 0.63 mg, 1.25 mg per 2.5 mL; Oral Syrup: 1 mg/5 mL; Tablets: 1 mg, 2 mg
Routes: Oral / Parenteral / Topical as specified by formulation

3. Mechanism of Action & Pharmacodynamics

Single R-Enantiomer Selective Beta-2 Adrenoceptor Agonist Bronchodilator — SABA (Schedule H) acting on target receptor/enzyme pathways in Respiratory, Asthma, COPD & Allergy Medicines (Ch 09): clinical efficacy is mediated via Single R-Enantiomer Selective Beta-2 Adrenoceptor Agonist Bronchodilator — SABA (Schedule H) for Acute relief of bronchospasm in asthma and COPD exacerbations (Levosalbutamol 50 mcg = racemic Salbutamol 100 mcg; 1.25 mg respule = 2.5 mg Salbutamol respule).

4. Therapeutic Indications & Evidence-Supported Uses

  • Acute relief of bronchospasm in asthma and COPD exacerbations (Levosalbutamol 50 mcg = racemic Salbutamol 100 mcg
  • 25 mg respule = 2
  • 5 mg Salbutamol respule)

🇮🇳 Jurisdiction & Indication Note: Indications and schedules reflect Indian compendial and regulatory records (CDSCO / Indian Pharmacopoeia & NFI / NLEM 2022). Where international reference labels (US FDA DailyMed / NCBI StatPearls) are cited for pharmacokinetic or mechanistic parameters, international approvals do not automatically imply CDSCO approval in India.

5. Educational Dosage Context, Formulations & Administration

Educational Dosing & Regimen Summary: pMDI Inhaler: 1–2 puffs (50–100 mcg) PRN via valved spacer (up to q4–6h in acute exacerbation). Nebulisation: Adults: 1.25 mg (1 respule) q6–8h PRN; Children (6–11 yr): 0.31–0.63 mg q8h. (Inhaled route is strongly preferred over oral syrup!)

Administration & Meal Timing: Inhale via pMDI + spacer; independent of food | As Needed (PRN) for acute wheeze/breathlessness (Under GINA 2026 Track 1, ICS-Formoterol is preferred over SABA alone as reliever in asthma!)

6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment

Absorption & Disposition:
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Metabolism & Biotransformation:
Renal & Hepatic: No adjustment needed for inhaled doses; caution with high-dose nebulisation in severe CKD
Elimination & Renal Adjustment:
Renal & Hepatic: No adjustment needed for inhaled doses; caution with high-dose nebulisation in severe CKD
Hepatic Impairment Considerations:
Renal & Hepatic: No adjustment needed for inhaled doses; caution with high-dose nebulisation in severe CKD

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • Never use SABA monotherapy in asthma without an Inhaled Corticosteroid (ICS)! Caution in thyrotoxicosis, tachyarrhythmias, HOCM, uncontrolled hypertension, and hypokalaemia

Key Clinical Precautions: Renal & Hepatic: No adjustment needed for inhaled doses; caution with high-dose nebulisation in severe CKD

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • Fine skeletal muscle tremor (hands), palpitations, sinus tachycardia, headache
  • Paradoxical bronchospasm, hypokalaemia (additive with Loop/Thiazide diuretics, Theophylline, and Steroids!), lactic acidosis/hyperglycaemia in high-dose nebulisation
Serious / Dose-Limiting Adverse Effects:
  • Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.

9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions

  • Non-selective Beta-Blockers (Propranolol, Timolol eye drops, Carvedilol) directly block Beta-2 receptors and precipitate severe bronchospasm!; Diuretics, Corticosteroids, and Theophylline worsen hypokalaemia

10. Clinical Monitoring, Patient Counselling & Storage

Clinical & Laboratory Monitoring: Monitor clinical response, baseline renal/hepatic parameters, and relevant serum biomarkers.

Pharmacist Patient Counselling Points:

  • Patient Counselling Checklist: Shake inhaler well and use with a spacer; if you need Levolin puffs more than twice a week or wake up coughing at night, your asthma inflammation is uncontrolled and you need a controller ICS inhaler
  • Meal & Clock Timing Instruction: Inhale via pMDI + spacer; independent of food (As Needed (PRN) for acute wheeze/breathlessness (Under GINA 2026 Track 1, ICS-Formoterol is preferred over SABA alone as reliever in asthma!))
  • Missed Dose Protocol: PRN rescue use
  • Geriatric Dispensing Pearl: Prefer inhaled pMDI + spacer over oral Levolin syrup/tablets in older adults (oral syrup causes marked tremor, tachycardia, and angina)

Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: pMDI Inhaler: 50 mcg/puff; Rotacaps: 100 mcg; Nebuliser Respules: 0.31 mg, 0.63 mg, 1.25 mg per 2.5 mL; Oral Syrup: 1 mg/5 mL; Tablets: 1 mg, 2 mg

11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)

THE 12-STEP ORAL DRUG JOURNEY THROUGH THE HUMAN BODY (LADME) Note: IV bolus enters Step 6 directly (F = 100%); Sublingual & Transdermal routes bypass Step 4–5 Portal First-Pass Metabolism 1. Oral Administration • Tablet / Capsule swallowed • Gastric emptying to duodenum pH 1.5–3.5 (Stomach) 2. Disintegration & Dissolution • Tablet breaks into granules • API dissolves in GI fluid Noyes-Whitney Dissolution Rate 3. GI Epithelial Absorption • Crosses intestinal villi • Passive / Active / P-gp efflux Small Intestine (Large Surface Area) 4. Portal Circulation • Mesenteric veins → Portal vein • Delivers blood to liver sinusoids Pre-systemic Venous Conduit 5. First-Pass Metabolism • Gut & hepatic CYP450 extraction • High: GTN, Propranolol, Morphine Determines Bioavailability (F = f_a × (1-E_H)) 6. Systemic Circulation • Hepatic vein → IVC → Heart • Unbound vs Albumin-bound drug Only FREE drug is active 7–8. Tissue Distribution (Vd) • Capillary permeation to organs • Blood-Brain & Placental barriers Vd = Dose / C_0 (L or L/kg) 9. Target Site of Action • Receptors (GPCR, Ion channel) • Enzymes & Carrier Transporters Pharmacodynamic Effect (E_max, EC50) 10. Hepatic Biotransformation • Phase I (CYP450 Oxidation/Hydrolysis) • Phase II (Glucuronidation/Sulfation) Converts lipophilic drug → hydrophilic metabolite 11. Renal & Biliary Elimination • Nephron: Filtration + Secretion − Reabsorption • Biliary excretion & Enterohepatic recycling Total Clearance CL_tot = CL_renal + CL_hepatic 12. Excretion from the Body • Urine (Primary polar metabolite route) • Bile/Faeces, Expired Air, Sweat, Milk Elimination Half-Life t1/2 = (0.693 × Vd) / CL
svg-v339-01-adme-12-step-journey — 8.1 Complete 12-Step Journey of an Orally Administered Drug (ADME): Figure 8.1: The 12-step physiological journey of a typical orally administered solid dosage form through Liberation, Absorption, Distribution, Metabolism, and Excretion (LADME). Note: Parenteral (IV), sublingual, and inhalational routes bypass gastrointestinal absorption and/or hepatic first-pass metabolism.

12. Authoritative References, Regulatory Sources & Editorial Disclaimer

Primary Compendial & Guideline Reference: Indian Pharmacist Desk Reference — Professional Edition 2.7 (2026–27) • Ch 09 [9.10] (p. 118)

Official Verification Portals: Indian Pharmacopoeia Commission (IPC) & National Formulary of India (NFI) • Central Drugs Standard Control Organization (CDSCO) • Ministry of Health & Family Welfare — NLEM 2022 • NCBI Bookshelf / StatPearls Pharmacology Reference • DailyMed (US FDA Official Prescribing Reference)

Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: HANDBOOK_SOURCE_CONTENT

Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.

← Back to All 644 Reference Profiles 📖 Explore 40 Knowledge Hub Articles → ✉️ Report Errata / Feedback
Educational Reference Notice: This printout from THE INDIAN PHARMACIST (https://theindianpharmacist.com/medicine/9-10-levosalbutamol-levalbuterol/, Last Reviewed: 2026-11-10) is an educational reference sheet for students and healthcare learners. It is NOT an official prescribing guideline or patient-specific treatment order.