Schedule H

Oral

• Extended-Release Tablets: 50 mg, 100 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Major Depressive Disorder (MDD) — Adults

Used as monotherapy for moderate to severe depression.

Step Dose

Starting dose 50 mg once daily (morning, with or without food)

Titration Usually not required; may increase after 4–6 weeks if inadequate response

Usual maintenance dose 50 mg once daily

Maximum dose 100 mg once daily

Key Clinical Notes:

• Higher doses (100 mg) may benefit partial responders but carry increased adverse effect risk

• Initial clinical response typically observed within 1–2 weeks; full therapeutic effect by 4–6 weeks

• Swallow tablets whole; do not crush, chew, or dissolve

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Notes Evidence Basis

Generalized Anxiety Disorder (GAD) Start 50 mg OD; may increase to 100 mg OD 6–12 weeks initial; maintenance based on response OFF-LABEL; Specialist only Meta-analyses; extrapolation from venlafaxine data; used in Indian psychiatric practice

Vasomotor symptoms (menopausal hot flashes) 50 mg once daily 4–12 weeks OFF-LABEL; Specialist only; for patients where HRT is contraindicated RCTs supporting non-hormonal management; international practice guidelines

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Not applicable — No approved paediatric indications in India.

Secondary Indications — Paediatric (Off-label)

Not applicable — No established off-label paediatric uses with adequate safety data.

Safety Statement:

• Not recommended for individuals below 18 years

• Use only under specialist psychiatric supervision if absolutely necessary

• No established safety data or approved indications in Indian paediatric guidelines

• Increased risk of suicidality reported in adolescents with antidepressants

ESRD / on dialysis Use with caution; prolonged half-life; dose as for eGFR <30; not significantly removed by dialysis

• Known hypersensitivity to desvenlafaxine or venlafaxine

• Concurrent use with monoamine oxidase inhibitors (MAOIs)

• Use within 14 days of stopping an MAOI

• Initiation of MAOI within 7 days of stopping desvenlafaxine

• Uncontrolled narrow-angle glaucoma

• History of seizure disorder (may lower seizure threshold)

• Bipolar disorder (risk of mania/hypomania induction — use with mood stabiliser)

• Bleeding disorders or concurrent use of NSAIDs, antiplatelets, anticoagulants

• Pre-existing hypertension or cardiovascular disease (may elevate blood pressure)

• Risk of hyponatraemia (particularly elderly, patients on diuretics, SIADH risk)

• Anatomically narrow angles (mydriatic effect may precipitate angle-closure)

• Hepatic impairment (moderate–severe)

• Renal impairment (dose adjustment required)

• Risk of withdrawal symptoms on abrupt cessation — gradual taper advised

Parameter Recommendation

Risk category Use only if potential benefit justifies risk to fetus

Preferred alternatives SSRIs (sertraline preferred in Indian obstetric psychiatry)

When may be used Continuation may be considered if patient stable; specialist psychiatric and obstetric input recommended

Monitoring Neonatal adaptation syndrome (respiratory distress, feeding difficulties, irritability); risk of persistent pulmonary hypertension of newborn (PPHN) with third trimester exposure

Parameter Recommendation

Compatibility Not recommended; limited safety data in breastfeeding

Preferred alternatives Sertraline or nortriptyline (better Indian clinical experience)

Expected levels in milk Low to moderate; desvenlafaxine is excreted in breast milk

Infant monitoring Sedation, somnolence, poor feeding, weight gain, irritability

• Recommended starting dose: 25–50 mg once daily

• Titration: Slower than in younger adults

• Special risks:

• Hyponatraemia (especially with concurrent diuretics)

• Blood pressure elevation

• Falls and orthostatic hypotension

• SIADH

• Renal consideration: Reduced renal clearance — adjust dose based on creatinine clearance

• Monitoring: Baseline and periodic serum sodium; regular BP monitoring

Interacting Drug(s) Effect / Mechanism Action

MAO inhibitors (phenelzine, tranylcypromine, linezolid, methylene blue, selegiline) Risk of serotonin syndrome (hyperthermia, rigidity, myoclonus, autonomic instability) Contraindicated — maintain 14-day washout

Other serotonergic agents (SSRIs, SNRIs, triptans, tramadol, fentanyl, lithium, buspirone) Additive serotonergic effect → serotonin syndrome Avoid combination or use with extreme caution; monitor closely

Anticoagulants (warfarin, heparin), antiplatelets (aspirin, clopidogrel) Increased bleeding risk via platelet dysfunction Avoid if possible; monitor for bleeding

Interacting Drug(s) Effect / Mechanism Action

Strong CYP3A4 inhibitors (ketoconazole, itraconazole, fluconazole) Increased desvenlafaxine plasma levels Monitor for adverse effects

CYP3A4 inducers (carbamazepine, phenytoin, rifampicin) Reduced desvenlafaxine efficacy Consider dose adjustment; monitor response

Antihypertensives May blunt antihypertensive response or cause additive hypotension Monitor blood pressure

Alcohol Additive CNS depression Advise avoidance

NSAIDs Increased bleeding risk Use with caution; monitor

CYP2D6 substrates (tamoxifen, codeine, metoprolol) Mild CYP2D6 inhibition; may increase substrate exposure Monitor; clinical significance usually low

• Nausea (most common, usually transient)

• Dizziness

• Dry mouth

• Hyperhidrosis (excessive sweating)

• Constipation

• Headache

• Insomnia or somnolence

• Fatigue

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

• Decreased appetite

Adverse Effect Clinical Notes

Serotonin syndrome Medical emergency; discontinue immediately; supportive care

Hyponatraemia / SIADH Particularly in elderly; presents as confusion, seizures; check sodium

Seizures Dose-related or in predisposed patients

Angle-closure glaucoma Due to mydriatic effect; ophthalmology referral if eye pain/visual changes

Suicidal ideation Especially in young adults (18–24 years); close monitoring during initiation and dose changes

Severe hypertension Sustained BP elevation; monitor and manage

Hepatotoxicity Rare; monitor LFTs if symptoms suggest

Severe skin reactions Rare; discontinue if suspected

Phase Parameters

Baseline Blood pressure; renal function (serum creatinine, eGFR); hepatic function (LFTs); serum sodium (especially elderly); psychiatric assessment including suicidality

After initiation (1–2 weeks) Blood pressure; mental status; emergence of suicidal ideation; tolerability

Short-term (4–6 weeks) Clinical response assessment; adverse effects; blood pressure

Long-term (ongoing) Blood pressure every 3–6 months; serum sodium (elderly or symptomatic); renal function annually; periodic reassessment of need for continued therapy

Brand Name Manufacturer

D-Veniz® Sun Pharma

Desval ER® Intas Pharmaceuticals

Dvenexa® Zydus Cadila

Faxito® Cipla

Desven® Mankind Pharma

Note: Extended-release preparations are standard; fixed-dose combinations are uncommon.

Strength Approximate Price (per tablet)

• Not listed under NLEM / NPPA price control

• Widely available in private pharmacy sector

• Not typically available through government supply

1. Differentiate from venlafaxine: Desvenlafaxine is the active metabolite of venlafaxine with more predictable pharmacokinetics and fewer CYP450 interactions — preferred in patients on multiple medications.

1. Taper to discontinue: Never stop abruptly — reduce dose gradually over 1–2 weeks minimum to prevent discontinuation syndrome (dizziness, nausea, anxiety, irritability, sensory disturbances).

1. Blood pressure monitoring is essential: BP elevation is dose-dependent; pre-existing hypertension must be controlled before initiation.

1. Flat dose-response curve: Most patients respond to 50 mg; increasing to 100 mg adds adverse effects with limited additional efficacy benefit.

1. Hyponatraemia awareness: Particularly in elderly patients on diuretics — check sodium if confusion, lethargy, or seizures develop.

1. Swallow whole: Extended-release tablets must not be crushed, chewed, or split.

desvenlafaxine; SNRI; antidepressant; major depressive disorder; psychiatry; serotonin syndrome; renal-adjustment; withdrawal-syndrome; not-first-line-pregnancy; India

RxIndia v1.0 — 10 Jan 2025

• CDSCO approved product inserts

• National Formulary of India (NFI) 2021

• Indian Pharmacopoeia 2018

• API Textbook of Medicine, 11th edition

• AIIMS Psychiatry Standard Operating Procedures

• Indian Psychiatric Society practice consensus documents

• Published RCTs and meta-analyses (for off-label indications: GAD, vasomotor symptoms)