Schedule H

Oral

Formulation Type Available Strengths

Immediate-release tablets (IR) 37.5 mg, 75 mg, 150 mg

Extended-release tablets/capsules (ER/XR) 37.5 mg, 75 mg, 150 mg, 225 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Major Depressive Disorder (MDD) — Adults

Parameter IR Formulation ER Formulation

Starting dose 75 mg/day in 2–3 divided doses 75 mg once daily

Titration Increase by 75 mg/day every 4–7 days Increase by 75 mg/day every 4–7 days

Usual maintenance dose 150–225 mg/day in divided doses 150–225 mg once daily

Maximum dose 375 mg/day 225 mg/day

Clinical notes:

• ER formulation preferred for better tolerability and once-daily adherence

• Therapeutic response typically observed within 2–4 weeks

• Take with food to reduce gastrointestinal side effects

1. Generalised Anxiety Disorder (GAD) — Adults

Parameter Recommendation

Starting dose 75 mg/day (ER formulation)

Titration Increase by 75 mg/day every 7–10 days based on response

Usual maintenance dose 75–225 mg/day

Maximum dose 225 mg/day

Clinical notes:

• Use lowest effective dose to minimise initial activation or worsening of anxiety

• Response assessment recommended at 4–8 weeks

• ER formulation strongly preferred

1. Panic Disorder — Adults

Parameter Recommendation

Starting dose 37.5 mg/day (ER formulation) for 7 days

Titration Increase to 75 mg/day after 1 week; then by 75 mg/day increments every 7–10 days

Usual maintenance dose 75–225 mg/day

Maximum dose 225 mg/day

Clinical notes:

• Start low to avoid initial panic exacerbation

• Full therapeutic benefit may take 8–12 weeks

• Concurrent short-term benzodiazepine may be considered during initiation (specialist decision)

1. Social Anxiety Disorder (SAD) — Adults

Parameter Recommendation

Starting dose 75 mg/day (ER formulation)

Titration Not routinely required

Usual maintenance dose 75 mg/day

Maximum dose 75 mg/day

Clinical notes:

• Higher doses have not consistently shown added benefit in SAD

• Evaluate response at 8–12 weeks before considering alternatives

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes Evidence

Neuropathic pain (e.g., diabetic neuropathy) Starting: 37.5 mg/day; Titration: Increase to 150–225 mg/day Monitor over 4–6 weeks OFF-LABEL; Specialist only Meta-analyses; Indian specialist practice

Migraine prophylaxis Starting: 37.5 mg/day; Maintenance: 75–150 mg/day Minimum 3 months trial OFF-LABEL; Specialist only International RCTs

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Not applicable. Venlafaxine has no approved paediatric indications in India.

Secondary Indications — Paediatric (Off-label)

Indication Age Dose Notes Evidence

Depression or Anxiety ≥12 years Starting: 37.5 mg once daily (ER preferred) OFF-LABEL; Specialist only International RCTs; limited Indian data

Titration: Increase by 37.5 mg/day every 1–2 weeks Monitor for suicidality, mood changes

Maintenance: 75–150 mg/day

Maximum: 225 mg/day

Safety Monitoring in Paediatrics:

• Close monitoring for suicidal ideation and behavioural changes (especially first 1–2 months)

• Regular BP monitoring

• Weight and growth assessment at each visit

Important statements:

• Not recommended below 12 years of age except in exceptional situations under tertiary psychiatric care

• Use requires child psychiatrist supervision

• Black box warning regarding increased suicidality in adolescents applies

• Known hypersensitivity to venlafaxine or desvenlafaxine

• Concurrent use with MAO inhibitors — contraindicated during treatment and for at least 14 days after stopping MAOI; wait at least 7 days after stopping venlafaxine before starting MAOI

• Concurrent use with linezolid or intravenous methylene blue (MAOI activity)

• Uncontrolled narrow-angle glaucoma

• Hypertension — dose-dependent BP elevation; pre-existing hypertension requires close monitoring

• History of seizure disorder — may lower seizure threshold

• Bipolar disorder — risk of manic or hypomanic switch

• Risk of SIADH and hyponatraemia — particularly in elderly patients

• Angle-closure glaucoma — mydriasis may precipitate acute attack

• Discontinuation syndrome — taper gradually; avoid abrupt cessation

• Bleeding risk — especially with concurrent antiplatelet/anticoagulant/NSAID use

• Suicidal ideation — monitor closely, especially in young adults during early treatment

Parameter Recommendation

Overall safety Limited human data; potential risk — use only if benefit clearly outweighs risk

Preferred alternative Sertraline (more safety data in pregnancy)

When may be used Only if essential; shared decision with psychiatrist and obstetrician; avoid in first trimester if possible

What to monitor Fetal growth; neonatal withdrawal symptoms (respiratory distress, feeding difficulties, irritability, tremor)

Parameter Recommendation

Compatibility Compatible with breastfeeding; relatively low levels in breast milk

Preferred alternative Sertraline

Drug levels in milk Low

Infant monitoring Feeding pattern, sedation, irritability, weight gain

Parameter Recommendation

Starting dose 37.5 mg once daily

Titration Slow titration — every 2–4 weeks

Special risks Hyponatraemia (SIADH), orthostatic hypotension, falls, reduced renal reserve

Additional considerations Prefer ER formulation; monitor BP, electrolytes (sodium) more frequently; assess renal function before initiation

Interacting Drug Effect / Risk Recommendation

MAO inhibitors (phenelzine, selegiline, tranylcypromine) Serotonin syndrome — potentially fatal Contraindicated

Linezolid, IV methylene blue MAOI activity — serotonin syndrome risk Contraindicated

Strong CYP2D6 inhibitors (fluoxetine, paroxetine, quinidine) Increased venlafaxine levels Reduce venlafaxine dose; monitor for toxicity

Other serotonergic drugs (SSRIs, triptans, tramadol, fentanyl, lithium) Serotonin syndrome risk Avoid or use with extreme caution; close monitoring

Anticoagulants/antiplatelets (warfarin, aspirin, clopidogrel) Increased bleeding risk Monitor INR closely; watch for bleeding

Interacting Drug Effect / Risk Recommendation

Antihypertensives Venlafaxine-induced BP elevation may reduce efficacy Monitor BP regularly; adjust antihypertensive dose if needed

Carbamazepine CYP3A4 induction — reduced venlafaxine efficacy May need higher venlafaxine dose; monitor response

Ketoconazole, itraconazole CYP3A4 inhibition — increased venlafaxine concentration Monitor for adverse effects; consider dose reduction

Rifampicin and other TB drugs CYP induction — reduced venlafaxine efficacy May require dose adjustment; monitor response

Alcohol Additive CNS depression Advise avoidance or minimisation

NSAIDs Increased GI bleeding risk Use with gastroprotection if necessary

Metoprolol CYP2D6 substrate — venlafaxine may increase metoprolol levels Monitor for bradycardia, hypotension

• Nausea (most common, often transient)

• Headache

• Dizziness

• Dry mouth

• Insomnia or somnolence

• Increased sweating (hyperhidrosis)

• Constipation

• Loss of appetite

• Sexual dysfunction (decreased libido, anorgasmia, erectile dysfunction)

• Elevated blood pressure (dose-related)

Adverse Effect Notes

Serotonin syndrome Agitation, hyperthermia, tremor, clonus, autonomic instability — discontinue immediately; requires urgent care

Hypertensive crisis Especially at doses >225 mg/day — monitor BP; discontinue if severe

Seizures Particularly at high doses or in predisposed patients

SIADH / Hyponatraemia Especially in elderly — monitor sodium; discontinue if symptomatic

Discontinuation syndrome Dizziness, paraesthesia, irritability, insomnia, electric shock sensations — taper gradually

Acute angle-closure glaucoma Due to mydriatic effect — urgent ophthalmology referral if eye pain, visual changes

Suicidal ideation Especially in young adults — close monitoring in first 1–2 months

Hepatotoxicity Rare; monitor if symptoms of liver dysfunction appear

Long-term BP quarterly; renal and liver function annually; sodium periodically in elderly; weight and mental status at each visit

• Venlor / Venlor XR (Cipla)

• Veniz / Veniz XR (Sun Pharma)

• Venfax / Venfax XR (Intas)

• Venjoy (Torrent)

• Ventab XR (Macleods)

• Effexor XR (Pfizer — limited availability, imported)

Notes:

• Prices vary by brand and procurement source

• Not listed under NLEM 2022 — not price-controlled under NPPA

• ER formulations generally more expensive but preferred for tolerability

1. Prefer ER formulation: Better tolerated, once-daily dosing improves adherence, fewer GI side effects compared to IR

1. Taper gradually: Never stop abruptly — reduce dose by 25–50% weekly over 2–4 weeks to avoid discontinuation syndrome

1. BP monitoring essential: Check BP before initiation, at each dose increment, and quarterly during maintenance — particularly important at doses ≥150 mg/day

1. Morning dosing preferred: May cause insomnia or activation; advise taking in the morning

1. Avoid in uncontrolled hypertension: If hypertension develops or worsens, consider dose reduction or alternative agent

1. Bipolar precaution: Avoid as monotherapy in bipolar disorder — risk of manic switch; use only with mood stabiliser if essential

venlafaxine; SNRI; depression; anxiety; panic-disorder; social-anxiety; neuropathic-pain; hypertension-risk; ER-preferred; renal-adjustment; serotonin-syndrome; psychiatry

RxIndia v1.0 — 10 Apr 2025

• CDSCO-approved prescribing information

• Indian Pharmacopoeia

• National Formulary of India (NFI)

• API Textbook of Medicine

• AIIMS Delhi Psychopharmacology Protocols

• Indian Psychiatric Society clinical guidelines

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Cochrane Reviews (for off-label neuropathic pain indication — annotated as off-label)

• WHO Essential Medicines List (supportive reference for ER venlafaxine)