Venlafaxine

Selected ER capsules: adult MDD, GAD, social anxiety and panic disorder. Selected IR tablets: MDD. Selected ER tablets: MDD and social anxiety. Pediatric safety/effectiveness is not established.

IR MDD: start 75 mg/day in 2–3 divided doses with food; titrate by ≤75 mg at intervals ≥4 days, generally to 225 mg/day. Certain severely depressed patients, including inpatients, may require up to 375 mg/day generally in 3 doses. Selected ER tablets: MDD 75 mg/day (optional 37.5 mg for 4–7 days), maximum approximately 225; social anxiety 75 mg/day.

ER capsules: reduce 25–50% at CrCl 30–89 mL/min; reduce ≥50% below 30 or on hemodialysis. Selected IR label: reduce 25% for mild/moderate renal impairment; 50% on hemodialysis. ER tablet label: renal reduction 25–50%; dialysis 50%. Mild/moderate hepatic impairment generally requires 50% reduction; severe disease/cirrhosis may require more. Individualize to exact label and response.

ER products once daily with food; swallow whole. Selected capsules may be opened onto applesauce using the entire contents, swallowed immediately unchewed and followed by water; do not apply this to tablets. Prescriber-directed IR-to-ER switching uses nearest equivalent daily dose with adjustment. Taper individually; some patients need months. Allow ≥14 days after an antidepressant MAOI before venlafaxine and ≥7 days after venlafaxine before an MAOI.

Selected ER capsule label: venlafaxine, desvenlafaxine or excipient hypersensitivity; MAOI combinations or prohibited washout periods. Do not start during linezolid or IV methylene blue. Exact IR/ER-tablet wording differs; review the selected product before urgent reversible-MAOI therapy.

Antidepressants increase short-term suicidal-thought/behavior risk in pediatric and young-adult patients. Closely monitor all treated patients, especially early and around dose changes. Venlafaxine is not approved for pediatric use.

Common effects include nausea, sleepiness, dry mouth, sweating, appetite loss, constipation and sexual dysfunction. Serious postmarketing allergy, arrhythmia and skin/blood/liver disorders are reported. Overdose can cause seizures, ECG changes, impaired consciousness and death; urgent poison-center/emergency care is needed and no specific antidote is known.

• MAOIs are contraindicated; other serotonergic drugs increase serotonin-syndrome risk and require observation.
• NSAIDs, aspirin, antiplatelets and anticoagulants increase bleeding risk; monitor warfarin indices during initiation, titration and stopping.
• ER capsule label: consider reducing venlafaxine with CYP3A inhibitors; consider reducing interacting CYP2D6-substrate doses.
• IR/ER-tablet labels advise caution with cimetidine in older/hepatic/BP-risk patients and with metoprolol, haloperidol and other relevant psychotropics; consult exact interaction text.
• Avoid alcohol and do not combine with weight-loss agents such as phentermine without review; combination is not recommended.

Urine immunoassays may falsely identify PCP or amphetamines, including for days after stopping. Confirmatory testing distinguishes venlafaxine.

Current ER-capsule evidence has not identified a major-birth-defect signal, but limitations remain. Mid/late pregnancy may increase preeclampsia risk; near-delivery exposure may increase postpartum hemorrhage and neonatal adaptation complications. Balance untreated illness risks and monitor exposed neonates. Venlafaxine/ODV enter milk; current capsule PI individualizes breastfeeding benefit/risk. Older IR/ER-tablet labels advise choosing nursing or medicine continuation after assessment.

Pediatric efficacy is not established; studies showed appetite/weight/growth and BP/lipid concerns. Older adults face greater hyponatremia risk. No age-only adjustment is required, but organ impairment and sensitivity may lower the dose.

Venlafaxine and active ODV inhibit neuronal serotonin/norepinephrine reuptake. The full therapeutic mechanism is not established.

Metabolism

Hepatic; CYP2D6 forms active O-desmethylvenlafaxine (ODV).

Capsule-label half-lives

Venlafaxine approximately 5 hours; ODV 11 hours.

ER-tablet study

Apparent half-lives approximately 10.7 / 12.5 hours under fed conditions.

Elimination

Predominantly urinary metabolites; renal/hepatic disease reduces clearance.

• Screen bipolar history; monitor suicidality/clinical worsening early and after dose changes.
• Check BP before and regularly during treatment; assess pulse/cardiovascular context.
• Assess sodium when at risk/symptomatic, bleeding, sexual function and appetite/weight.
• Review renal/hepatic function for dosing; consider lipids with continued treatment.
• Monitor during taper; urgent assessment for severe neurologic, eye, allergy or lung symptoms.

Do not abruptly stop or alter the dose. Take the correct formulation with food. Avoid alcohol/driving until effects are known; review OTC/herbal medicines. Seek urgent help for suicidal thoughts, serotonin symptoms, severe allergy or eye pain. Read the Medication Guide; inert ER shells/pellets may appear in stool.

Appearance

Opaque light-grey cap and flesh body.

Imprint

YH / 129 in black ink.

Distributor

Epic Pharma, LLC.

Example NDC

42806-602-30 · 30 capsules.

U.S. status

Prescription; not a controlled substance.

Selected IR tablets

25, 37.5, 50, 75 and 100 mg.

Selected ER capsules

37.5, 75 and 150 mg.

Selected ER-tablet repack

75 mg; underlying description includes 37.5/75/150/225 mg product family.

Brand context

Effexor XR; exact current product/availability must be verified.

Selected products: 20–25°C, excursions 15–30°C. IR tablets protect from light/moisture; ER tablets protect from moisture/humidity; keep ER capsules dry. Keep out of children’s reach and preserve Medication Guide.