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MEDICINE MONOGRAPH CODE: [11.18] ID: TIP-MED-000222

Venlafaxine Hydrochloride & Desvenlafaxine Succinate

Active Ingredient / Scientific Identity: Venlafaxine Hydrochloride & Desvenlafaxine Succinate • Class: Serotonin–Noradrenaline Reuptake Inhibitors (SNRIs)

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Generic / Entity NameVenlafaxine Hydrochloride & Desvenlafaxine Succinate ([11.18])
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassSerotonin–Noradrenaline Reuptake Inhibitors (SNRIs)
Available Dosage FormsVenlafaxine Extended-Release (ER/XR) Capsules/Tablets: 37.5 mg, 75 mg, 150 mg. Desvenlafaxine Extended-Release
Regulatory ClassificationSchedule H Prescription Drug (To be sold by retail on the prescription of a Registere
Key Warning & Review DateRenal: Reduce dose by 25–50% if CrCl <30 mL/min (50 mg alternate days for Desvenlafaxine if CrCl <30). Hepatic: Reduce
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

Venlafaxine Hydrochloride & Desvenlafaxine Succinate (TIP-MED-000222, Reference Code [11.18]) is classified under CNS & Psychiatric Medicines (Ch 11) as a Serotonin–Noradrenaline Reuptake Inhibitors (SNRIs). 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 11 [11.18], p. 148): Venlafaxine ER: Veniz-XR (Sun — 37.5 mg, 75 mg, 150 mg), Venlor-XR (Cipla), Ventab-XL (Intas); Desvenlafaxine ER: D-Veniz (Sun — 50 mg, 100 mg), Desven (Intas), Nexvenla — Strengths & Dosage Forms: Venlafaxine Extended-Release (ER/XR) Capsules/Tablets: 37.5 mg, 75 mg, 150 mg. Desvenlafaxine Extended-Release Tablets: 50 mg, 100 mg.
Representative Indian Market Examples (Edition 2.7 Ch 11 [11.18], p. 148): Venlafaxine ER: Veniz-XR (Sun — 37.5 mg, 75 mg, 150 mg), Venlor-XR (Cipla), Ventab-XL (Intas); Desvenlafaxine ER: D-Veniz (Sun — 50 mg, 100 mg), Desven (Intas), Nexvenla — Strengths & Dosage Forms: Venlafaxine Extended-Release (ER/XR) Capsules/Tablets: 37.5 mg, 75 mg, 150 mg. Desvenlafaxine Extended-Release Tablets: 50 mg, 100 mg.
Dosage Forms & Available Strengths:
Venlafaxine Extended-Release (ER/XR) Capsules/Tablets: 37.5 mg, 75 mg, 150 mg. Desvenlafaxine Extended-Release Tablets: 50 mg, 100 mg.
Routes: Oral / Parenteral / Topical as specified by formulation

3. Mechanism of Action & Pharmacodynamics

Dual presynaptic inhibition of serotonin (SERT) and noradrenaline (NET) reuptake; Desvenlafaxine (O-desmethylvenlafaxine) is the active metabolite bypassing CYP2D6.

4. Therapeutic Indications & Evidence-Supported Uses

  • Major depressive disorder (MDD), generalised anxiety disorder (GAD), panic disorder, social anxiety disorder, diabetic peripheral neuropathic pain, and vasomotor menopausal symptoms

🇮🇳 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: Venlafaxine ER: Start 37.5–75 mg PO OD with food; titrate to 75–225 mg OD. Desvenlafaxine ER: 50 mg PO OD (max 100 mg OD).

Administration & Meal Timing: Take Venlafaxine ER WITH food at the same time each morning to reduce nausea; swallow ER capsules/tablets whole (never crush or chew). | Once daily in the morning with breakfast.

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: Reduce dose by 25–50% if CrCl <30 mL/min (50 mg alternate days for Desvenlafaxine if CrCl <30). Hepatic: Reduce Venlafaxine dose by 50% in Child-Pugh B/C.
Elimination & Renal Adjustment:
Renal: Reduce dose by 25–50% if CrCl <30 mL/min (50 mg alternate days for Desvenlafaxine if CrCl <30). Hepatic: Reduce Venlafaxine dose by 50% in Child-Pugh B/C.
Hepatic Impairment Considerations:
Renal: Reduce dose by 25–50% if CrCl <30 mL/min (50 mg alternate days for Desvenlafaxine if CrCl <30). Hepatic: Reduce Venlafaxine dose by 50% in Child-Pugh B/C.

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • DOSE-DEPENDENT HYPERTENSION & SEVERE DISCONTINUATION SYNDROME: Noradrenergic tone increases blood pressure above 150 mg/day (control hypertension before starting). Short half-life (~5h for Venlafaxine) causes severe 'brain zaps', dizziness, and rebound anxiety within 24h of a missed dose.

Key Clinical Precautions: Renal: Reduce dose by 25–50% if CrCl <30 mL/min (50 mg alternate days for Desvenlafaxine if CrCl <30). Hepatic: Reduce Venlafaxine dose by 50% in Child-Pugh B/C.

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • Nausea, dry mouth, diaphoresis (sweating), insomnia or somnolence, constipation, sexual dysfunction, dose-related diastolic BP elevation.
  • Serotonin syndrome, sustained hypertension, hyponatraemia (SIADH in elderly), angle-closure glaucoma (mydriasis), suicidality in young adults (<25 yr).
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

  • CONTRAINDICATED with MAOIs and Linezolid (14-day washout)
  • Additive serotonin syndrome with Tramadol, Tapentadol, Triptans, or Lithium; increased GI bleed risk with NSAIDs/Antiplatelets

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: Swallow XR capsules/tablets whole (insoluble ghost shell in stool is normal for matrix tablets); never miss a single day's dose (causes electric-shock sensations/dizziness); check blood pressure regularly.
  • Meal & Clock Timing Instruction: Take Venlafaxine ER WITH food at the same time each morning to reduce nausea; swallow ER capsules/tablets whole (never crush or chew). (Once daily in the morning with breakfast.)
  • 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 (Standard Psychiatric OPD SNRI) | Compendia: NFI 7th Ed 2026 / 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: Venlafaxine Extended-Release (ER/XR) Capsules/Tablets: 37.5 mg, 75 mg, 150 mg. Desvenlafaxine Extended-Release Tablets: 50 mg, 100 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 11 [11.18] (p. 148)

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.