1. Clinical & Scientific Overview
Bupropion Hydrochloride SR/XL IP (TIP-MED-000410, Reference Code [11.21]-CMP140) is classified under
CNS & Psychiatric Medicines (Ch 11) as a Noradrenergic and Specific Serotonergic Antidepressant (NaSSA; Central Alpha-2 Antagonist).
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).
Co-indexed per approved Author Decision DEC-12 (Option 12A; from HTML [11.15]). NDRI antidepressant & smoking-cessation aid (Bupron-SR/XL 150/300 mg); lowers seizure threshold and inhibits CYP2D6.
Standard approved strengths (refer to comparative context)
3. Mechanism of Action & Pharmacodynamics
Co-indexed per approved Author Decision DEC-12 (Option 12A; from HTML [11.15]). NDRI antidepressant & smoking-cessation aid (Bupron-SR/XL 150/300 mg); lowers seizure threshold and inhibits CYP2D6.
4. Therapeutic Indications & Evidence-Supported Uses
- Major depressive disorder (especially with severe insomnia, anxiety, weight loss, or chemotherapy/GI nausea)
🇮🇳 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: Co-indexed per approved Author Decision DEC-12 (Option 12A; from HTML [11.15]). NDRI antidepressant & smoking-cessation aid (Bupron-SR/XL 150/300 mg); lowers seizure threshold and inhibits CYP2D6.
Administration & Meal Timing: See Administration & Counselling below. | Standard clinical schedule per indication.
6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment
Comparative pharmacokinetic profile co-indexed under [11.21].
Renal: eGFR 15-30 mL/min: Clearance reduced by 30%; eGFR <15 mL/min: Clearance reduced by 50%; titrate cautiously. • Hepatic: Mild-to-moderate hepatic impairment: Clearance reduced by ~30%; use lower maintenance dose.
Renal: eGFR 15-30 mL/min: Clearance reduced by 30%; eGFR <15 mL/min: Clearance reduced by 50%; titrate cautiously. • Hepatic: Mild-to-moderate hepatic impairment: Clearance reduced by ~30%; use lower maintenance dose.
Renal: eGFR 15-30 mL/min: Clearance reduced by 30%; eGFR <15 mL/min: Clearance reduced by 50%; titrate cautiously. • Hepatic: Mild-to-moderate hepatic impairment: Clearance reduced by ~30%; use lower maintenance dose.
7. Contraindications, Precautions & High-Risk Warnings
- Contraindications: Concomitant MAOIs or Linezolid (within 14 days). • Precautions: Paradoxical dose-sedation relationship: lower doses (7.5-15 mg) are MORE sedating than higher doses (30-45 mg) because H1 antihistamine effect predominates at low doses while activating noradrenergic release offsets sedation at >=30 mg.
Key Clinical Precautions: Renal: eGFR 15-30 mL/min: Clearance reduced by 30%; eGFR <15 mL/min: Clearance reduced by 50%; titrate cautiously. • Hepatic: Mild-to-moderate hepatic impairment: Clearance reduced by ~30%; use lower maintenance dose.
8. Adverse Effects Profile
- Marked somnolence, increased appetite, weight gain, dry mouth, dizziness.
- Rare reversible agranulocytosis/neutropenia (presents as fever/sore throat), hypertriglyceridaemia, QT prolongation.
9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions
- Alcohol / Benzodiazepines -> additive sedation; CYP3A4 inhibitors (Ketoconazole) -> increase levels; Phenytoin / Carbamazepine -> reduce mirtazapine levels by 50%
10. Clinical Monitoring, Patient Counselling & Storage
Clinical & Laboratory Monitoring: Monitor clinical parameters per parent class monograph [11.21].
Pharmacist Patient Counselling Points:
- Patient Counselling Checklist: Take at bedtime; low doses cause strong sleepiness; report any unexplained fever, sore throat, or mouth ulcers immediately.
- Meal & Clock Timing Instruction: See Administration & Counselling below. (Standard clinical schedule per indication.)
- Missed Dose Protocol: Take as soon as remembered unless close to next scheduled dose; never double the dose.
- Geriatric Dispensing Pearl: Schedule: Schedule H | NLEM 2022: Non-NLEM | Compendia: IP 2026 / NFI 7th Ed 2026 / CDSCO Schedule H / BNF 90th Ed
Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Film-Coated Tablet / Orally Disintegrating Tablet (ODT): 7.5 mg, 15 mg, 30 mg, 45 mg.
11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)
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.
13. Related Reference Monographs, Educational Guides & Visual Concept
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