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MEDICINE MONOGRAPH CODE: [9.12]-C90 ID: TIP-MED-000360

Beclomethasone + Formoterol / Levosalbutamol [FDC]

Active Ingredient / Scientific Identity: Beclomethasone + Formoterol / Levosalbutamol [FDC] • Class: Inhaled Corticosteroid (ICS) Prodrug Activated by Pulmonary Esterases (Schedule H | NLEM 2022)

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THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Beclomethasone + Formoterol / Levosalbutamol [FDC] ([9.12]-C90 | ID: TIP-MED-000360) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/9-12-c90-beclomethasone-formoterol-levosalbutamol-fdc/
Generic / Entity NameBeclomethasone + Formoterol / Levosalbutamol [FDC] ([9.12]-C90)
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassInhaled Corticosteroid (ICS) Prodrug Activated by Pulmonary Esterases (Schedule H | NLEM 2
Available Dosage FormspMDI Inhaler: 50 mcg, 100 mcg, 200 mcg, 250 mcg per puff; Rotacaps: 100 mcg, 200 mcg, 400 mcg
Regulatory ClassificationSchedule H Prescription Drug (To be sold by retail on the prescription of a Registere
Key Warning & Review DateRenal & Hepatic: Minimal impact; preferred ICS in patients on potent CYP3A4 inhibitors
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

Beclomethasone + Formoterol / Levosalbutamol [FDC] (TIP-MED-000360, Reference Code [9.12]-C90) is classified under Respiratory, Asthma, COPD & Allergy Medicines (Ch 09) as a Inhaled Corticosteroid (ICS) Prodrug Activated by Pulmonary Esterases (Schedule H | NLEM 2022). 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:
Co-indexed constituent under primary monograph [9.12] (Beclomethasone Dipropionate (Alone & in Formoterol / Levosalbutamol Inhalers)). Representative Indian Market Examples (Edition 2.7 Ch 09 [9.12], p. 119): Beclate Inhaler / Rotacaps (Cipla), Becoride; FDCs: Fullform (Formoterol 6 mcg + Beclomethasone 100/200 mcg), Aerocort (Levosalbutamol + Beclomethasone) — Strengths & Dosage Forms: pMDI Inhaler: 50 mcg, 100 mcg, 200 mcg, 250 mcg per puff; Rotacaps: 100 mcg, 200 mcg, 400 mcg
Co-indexed constituent under primary monograph [9.12] (Beclomethasone Dipropionate (Alone & in Formoterol / Levosalbutamol Inhalers)). Representative Indian Market Examples (Edition 2.7 Ch 09 [9.12], p. 119): Beclate Inhaler / Rotacaps (Cipla), Becoride; FDCs: Fullform (Formoterol 6 mcg + Beclomethasone 100/200 mcg), Aerocort (Levosalbutamol + Beclomethasone) — Strengths & Dosage Forms: pMDI Inhaler: 50 mcg, 100 mcg, 200 mcg, 250 mcg per puff; Rotacaps: 100 mcg, 200 mcg, 400 mcg
Dosage Forms & Available Strengths:
pMDI Inhaler: 50 mcg, 100 mcg, 200 mcg, 250 mcg per puff; Rotacaps: 100 mcg, 200 mcg, 400 mcg
Routes: Oral / Parenteral / Topical per formulation

3. Mechanism of Action & Pharmacodynamics

Inhaled Corticosteroid (ICS) Prodrug Activated by Pulmonary Esterases (Schedule H | NLEM 2022) acting on target receptor/enzyme pathways in Respiratory, Asthma, COPD & Allergy Medicines (Ch 09): clinical efficacy is mediated via Inhaled Corticosteroid (ICS) Prodrug Activated by Pulmonary Esterases (Schedule H | NLEM 2022) for Maintenance anti-inflammatory controller therapy for persistent bronchial asthma across all severity steps (and in ultrafine Formoterol+Beclomethasone MART regimen).

4. Therapeutic Indications & Evidence-Supported Uses

  • Maintenance anti-inflammatory controller therapy for persistent bronchial asthma across all severity steps (and in ultrafine Formoterol+Beclomethasone MART regimen)

🇮🇳 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: Adults (Standard Particle pMDI/DPI): Low dose: 200–500 mcg/day; Medium: >500–1000 mcg/day; High: >1000 mcg/day in 2 divided doses (Ultrafine HFA pMDI requires ~50% lower microgram dose!)

Administration & Meal Timing: Inhale via pMDI with valved spacer; ALWAYS rinse mouth, gargle, and spit out water after every inhalation | Morning & Evening (12-hourly BD)

6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment

Absorption & Disposition:
Follows class pharmacokinetic profile detailed in parent monograph [9.12].
Metabolism & Biotransformation:
Renal & Hepatic: Minimal impact; preferred ICS in patients on potent CYP3A4 inhibitors
Elimination & Renal Adjustment:
Renal & Hepatic: Minimal impact; preferred ICS in patients on potent CYP3A4 inhibitors
Hepatic Impairment Considerations:
Renal & Hepatic: Minimal impact; preferred ICS in patients on potent CYP3A4 inhibitors

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • Not for rapid relief of acute bronchospasm (unless formulated with fast-acting Formoterol or SABA). Caution in active/quiescent pulmonary tuberculosis

Key Clinical Precautions: Renal & Hepatic: Minimal impact; preferred ICS in patients on potent CYP3A4 inhibitors

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • Oropharyngeal candidiasis (oral thrush), hoarseness/dysphonia, cough upon inhalation (prevented by using a spacer!)
  • Adrenal suppression, decreased bone mineral density, cataracts/glaucoma on chronic high doses (>1000 mcg/day)
Serious / Dose-Limiting Adverse Effects:

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

    • KEY PHARMACOKINETIC ADVANTAGE OVER FLUTICASONE/BUDESONIDE: Beclomethasone dipropionate is hydrolysed to active 17-BMP by ubiquitous esterases rather than relying solely on CYP3A4 — therefore it is the PREFERRED inhaled corticosteroid in patients taking Ritonavir, Cobicistat, or Itraconazole!

    10. Clinical Monitoring, Patient Counselling & Storage

    Clinical & Laboratory Monitoring: Monitor clinical parameters per parent monograph [9.12].

    Pharmacist Patient Counselling Points:

    • Patient Counselling Checklist: Attach a spacer chamber to your Beclate inhaler (reduces throat deposition by 70% and doubles lung delivery!) and always rinse, gargle, and spit water after every use
    • Meal & Clock Timing Instruction: Inhale via pMDI with valved spacer; ALWAYS rinse mouth, gargle, and spit out water after every inhalation (Morning & Evening (12-hourly BD))
    • Missed Dose Protocol: Inhale as soon as remembered; never stop ICS controller abruptly when feeling well
    • Geriatric Dispensing Pearl: Ensure older adults can actuate pMDI or provide a valved spacer

    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, 100 mcg, 200 mcg, 250 mcg per puff; Rotacaps: 100 mcg, 200 mcg, 400 mcg

    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 Pharmacopoeia (IP 2022) • NFI • CDSCO

    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: VERIFIED_EDUCATIONAL_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.

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    Educational Reference Notice: This printout from THE INDIAN PHARMACIST (https://theindianpharmacist.com/medicine/9-12-c90-beclomethasone-formoterol-levosalbutamol-fdc/, 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.