1. Clinical & Scientific Overview
Acebrophylline & Doxofylline (TIP-MED-000178, Reference Code [9.14]) is classified under
Respiratory, Asthma, COPD & Allergy Medicines (Ch 09) as a Airway Muco-Regulator / Surfactant Stimulator & Novelly Substituted Xanthine Bronchodilator (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).
Representative Indian Market Examples (Edition 2.7 Ch 09 [9.14], p. 120): Acebrophylline: AB Phylline / AB Phylline SR (Sun), Macphylline (Macleods), Ascoril AB. Doxofylline: Doxolin (Zydus), Doxovent (Glenmark), Synasma (Ranbaxy) — Strengths & Dosage Forms: Acebrophylline Capsules: 100 mg IR (BD); SR Tablets: 200 mg (OD); Syrup: 50 mg/5mL. Doxofylline Tablets: 400 mg IR (BD), 650 mg SR (OD); Syrup: 100 mg/5mL
Acebrophylline Capsules: 100 mg IR (BD); SR Tablets: 200 mg (OD); Syrup: 50 mg/5mL. Doxofylline Tablets: 400 mg IR (BD), 650 mg SR (OD); Syrup: 100 mg/5mL
3. Mechanism of Action & Pharmacodynamics
Airway Muco-Regulator / Surfactant Stimulator & Novelly Substituted Xanthine Bronchodilator (Schedule H) acting on target receptor/enzyme pathways in Respiratory, Asthma, COPD & Allergy Medicines (Ch 09): clinical efficacy is mediated via Airway Muco-Regulator / Surfactant Stimulator & Novelly Substituted Xanthine Bronchodilator (Schedule H) for Add-on maintenance therapy for COPD and chronic bronchitis with tenacious mucus hypersecretion (Doxofylline has minimal adenosine A1/A2 receptor affinity and a wider therapeutic window than conventional Theophylline!).
4. Therapeutic Indications & Evidence-Supported Uses
- Add-on maintenance therapy for COPD and chronic bronchitis with tenacious mucus hypersecretion (Doxofylline has minimal adenosine A1/A2 receptor affinity and a wider therapeutic window than conventional Theophylline!)
🇮🇳 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: Acebrophylline: 100 mg IR PO BD after meals, or 200 mg SR PO OD after dinner. Doxofylline: 400 mg PO BD (200 mg BD in frail elderly), or 650 mg SR OD
Administration & Meal Timing: Take WITH or after meals to minimise epigastric discomfort; swallow SR tablets whole | Morning & Evening after meals (BD) or Evening after dinner (200 mg / 650 mg SR OD)
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Renal & Hepatic: Reduce dose (Doxofylline 200 mg BD or Acebrophylline 100 mg OD) in significant hepatic cirrhosis, congestive heart failure, or severe renal impairment
Renal & Hepatic: Reduce dose (Doxofylline 200 mg BD or Acebrophylline 100 mg OD) in significant hepatic cirrhosis, congestive heart failure, or severe renal impairment
Renal & Hepatic: Reduce dose (Doxofylline 200 mg BD or Acebrophylline 100 mg OD) in significant hepatic cirrhosis, congestive heart failure, or severe renal impairment
7. Contraindications, Precautions & High-Risk Warnings
- Contraindicated in acute myocardial infarction, severe hypotension, uncontrolled tachyarrhythmias, active peptic ulcer, severe renal/hepatic failure, and lactation. NEVER combine Acebrophylline, Doxofylline, and Theophylline/Deriphyllin together!
Key Clinical Precautions: Renal & Hepatic: Reduce dose (Doxofylline 200 mg BD or Acebrophylline 100 mg OD) in significant hepatic cirrhosis, congestive heart failure, or severe renal impairment
8. Adverse Effects Profile
- Mild epigastric pain, nausea, headache, dizziness, occasional palpitations or insomnia (significantly lower incidence of tachyarrhythmias, seizures, and gastric hyperacidity on Doxofylline compared with Theophylline!)
- Supraventricular tachycardia, severe vomiting, hypokalaemia, or seizures in massive overdose
- Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Unlike Theophylline, Doxofylline has minimal CYP1A2 inhibition interactions with Ciprofloxacin or Clarithromycin, though caution is still advised with ephedrine/high-dose SABA, caffeine excess, Allopurinol, and Cimetidine
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: Take after food; verify patient is NOT also taking Deriphyllin or Unicontin (Theophylline); cut back on strong coffee/tea if you feel shaky or have a fast heartbeat
- Meal & Clock Timing Instruction: Take WITH or after meals to minimise epigastric discomfort; swallow SR tablets whole (Morning & Evening after meals (BD) or Evening after dinner (200 mg / 650 mg SR OD))
- Missed Dose Protocol: Take after next meal if remembered; never double dose
- Geriatric Dispensing Pearl: Doxofylline (200–400 mg BD) is much safer than Theophylline in older COPD patients because it avoids narrow-therapeutic-index arrhythmias and Ciprofloxacin interactions
Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Acebrophylline Capsules: 100 mg IR (BD); SR Tablets: 200 mg (OD); Syrup: 50 mg/5mL. Doxofylline Tablets: 400 mg IR (BD), 650 mg SR (OD); Syrup: 100 mg/5mL
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
12. Authoritative References, Regulatory Sources & Editorial Disclaimer
Primary Compendial & Guideline Reference: Indian Pharmacist Desk Reference — Professional Edition 2.7 (2026–27) • Ch 09 [9.14] (p. 120)
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.
13. Related Reference Monographs, Educational Guides & Visual Concept
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