Home › NDC Lookup › Ingredients › Venlafaxine Hydrochloride › 63187-0420-30
💊image loading
(from DailyMed)

Venlafaxine Hydrochloride 150 mg Capsule, Extended Release, 30-count — NDC 63187-420-30 (Billing 63187-0420-30)

by Proficient Rx LP · 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

This is a package of 30 capsules of Venlafaxine Hydrochloride 150 mg Capsule, Extended Release from Proficient Rx LP, marketed since Jul 2010 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 63187-0420-30
🏷️ FDA NDC (as labeled) 63187-420-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.2146/unit — full pricing hub ↓
Main listing for product 63187-420 · Also comes in: 60 capsules 63187-420-60 90 capsules 63187-420-90
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63187-420-30
Product NDC 63187-420
11-digit billing NDC 63187042030
NCPDP billing unit EA — each (per item)
RxCUI 313581
UNII 7D7RX5A8MO
UPC 0363187420307
Application # ANDA076565
SPL Set ID 613658d3-7eb5-4822-961f-f4c6f6b2a2c1
Established class (EPC) Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of action Norepinephrine Uptake Inhibitors; Serotonin Uptake Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-07-01
Route ORAL
Dosage form CAPSULE, EXTENDED RELEASE
Substance VENLAFAXINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 58180090107050
GPI class Venlafaxine HCl ER
GCN Seq No 046405
GCN 16818
HICL code 008847
Ingredient (HICL) Venlafaxine Hcl
HIC1 code H
Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)
HIC2 code H7
Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 1)
HIC3 code H7C
Therapeutic class — specific (HIC3) Serotonin-Norepinephrine Reuptake-Inhib (Snris)
AHFS code 28:16.04.16
AHFS class Sel.serotonin,Norepi Reuptake Inhibitor
FDB label name VENLAFAXINE HCL ER 150 MG CAP
FDB brand name Venlafaxine Hcl Er
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 046405
  • GCN: 16818
  • GPI-14 (Medi-Span): 58180090107050
  • HICL (First Databank): 008847
  • AHFS class code: 28:16.04.16
  • RxCUI (RxNorm): 313581
Why two NDCs? The FDA registers this code as 63187-420-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63187-0420-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Serotonin and Norepinephrine Reuptake Inhibitor class.

Pharmacologic class Serotonin and Norepinephrine Reuptake Inhibitor
Drug family (ATC) Other antidepressants
How it works Norepinephrine Uptake Inhibitors, Serotonin Uptake Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name VENLAFAXINE HCL ER 150 MG CAP Ingredient Venlafaxine Hcl
📗 Our plain-language guide HelloPharmacist
  • It treats major depressive disorder. Depending on the product, it is also used for social anxiety disorder, generalized anxiety disorder and panic disorder. Your pharmacist can con...
  • Take extended-release forms once a day with food, at about the same time each day. Swallow tablets and capsules whole. A capsule can be opened onto applesauce if swallowing is hard...
  • Nausea, sleepiness, dry mouth, sweating, constipation and loss of appetite are common. Some people have sexual side effects. Call your doctor if side effects are severe or don’t ea...
  • Please don’t stop suddenly. Stopping or cutting the dose quickly can cause dizziness, nausea, anxiety, insomnia and electric-shock feelings. Your prescriber will lower the dose gra...
📖 Read our full Venlafaxine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Venlafaxine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Venlafaxine nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2146 $6.44 / 30 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63187-0420-30 You're viewing this Main listing 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE 2015-03-02 — Active
63187-0420-60 63187-420-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE 2015-03-02 — Active
63187-0420-90 63187-420-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE 2015-03-02 — Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 capsule, extended release in 1 bottle.
How does this package differ from NDC 63187-0420-60?
Both are Venlafaxine Hydrochloride 150 mg Capsule, Extended Release — the drug itself is identical. This page's package is the 30-count one, while NDC 63187-0420-60 is the 60 capsules package.
What NDC number is used to bill for this package of Venlafaxine Hydrochloride 150 mg Capsule, Extended Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Venlafaxine Hydrochloride 150 mg 00093-7386-05 Teva 500 capsules $0.119 AB Availability likely —
Venlafaxine Hydrochloride 150 mg 00904-7489-61 Major 1 capsule $0.119 AB Availability likely —
Venlafaxine Hydrochloride 150 mg 42806-0603-05 Epic 500 capsules $0.119 AB Availability likely —
venlafaxine hydrochloride 150 mg 43598-0002-05 Dr.Reddys 500 capsules $0.119 AB Availability likely —
Venlafaxine Hydrochloride 150 mg 50268-0875-15 AvPAK 1 capsule $0.119 AB Availability likely —
Venlafaxine Hydrochloride 150 mg 65862-0697-01 Aurobindo 100 capsules $0.119 — Availability likely —
Venlafaxine Hydrochloride 150 mg 68084-0713-01 American 1 capsule $0.119 AB Availability likely —
Venlafaxine Hydrochloride 150 mg 70010-0186-03 Granules 30 capsules $0.119 AB Availability likely —
Venlafaxine Hydrochloride 150 mg 70710-1700-00 Zydus 1000 capsules $0.119 AB Availability likely —
Venlafaxine Hydrochloride 150 mg 72603-0749-01 NorthStar 90 capsules $0.119 AB Availability likely —
Venlafaxine Hydrochloride 150 mg 82009-0058-05 QUALLENT 500 capsules $0.119 AB Availability likely —
Venlafaxine hydrochloride 150 mg 33342-0196-07 Macleods 30 capsules $0.139 AB FDA listed —
Effexor XR 150 mg 58151-0127-77 Viatris 90 capsules $21.622 AB Availability likely —
Effexor XR 150 mg 00008-0836-21 Wyeth 30 capsules $21.625 AB Discontinued —
Venlafaxine Hydrochloride 150 mg 00615-8510-39 NCS 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 10135-0827-10 Marlex 1000 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 31722-0004-01 Camber 10 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 42291-0899-30 AvKARE 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 46708-0794-30 Alembic 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 50090-2519-00 A-S 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 50090-5890-00 A-S 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 50090-6896-00 A-S 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 50090-7323-00 A-S 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 50090-7324-00 A-S 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 50090-7942-00 A-S 30 capsules — AB FDA listed —
venlafaxine hydrochloride 150 mg 55111-0455-01 Dr.Reddy's 100 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 62332-0794-30 Alembic 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mgthis 63187-0420-30 Proficient 30 capsules — AB FDA listed —
venlafaxine hydrochloride 150 mg 65841-0753-06 Zydus 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 67046-1656-03 Coupler 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 68071-3727-09 NuCare 90 capsules — AB FDA listed —
venlafaxine hydrochloride 150 mg 68071-4442-09 NuCare 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 68071-5020-09 NuCare 90 capsules — AB FDA listed —
venlafaxine hydrochloride 150 mg 68382-0036-06 Zydus 30 capsules — AB FDA listed —
venlafaxine hydrochloride 150 mg 68788-6806-01 Preferred 100 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 68788-8072-03 Preferred 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 68788-8752-03 Preferred 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 68788-8774-01 Preferred 100 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 70518-2259-00 REMEDYREPACK 90 capsules — AB Discontinued —
Venlafaxine Hydrochloride 150 mg 70518-4154-00 REMEDYREPACK 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 70771-1838-00 Zydus 1000 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 71335-1642-01 Bryant 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 71335-1812-01 Bryant 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 71335-2495-01 Bryant 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 71335-2992-01 Bryant 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 71785-1008-00 Annora 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 72888-0181-30 Advagen 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 76420-0632-01 Asclemed 100 capsules — AB FDA listed —
Venlafaxine HCL ER 150 mg 80425-0194-02 Advanced 60 capsules — AB FDA listed —
Venlafaxine hydrochloride ER 150 mg 80425-0297-01 Advanced 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 82804-0038-30 Proficient 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 150 mg 24658-0127-05 PURACAP 500 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2010
On the market since
Jul 2010
📍
2026
Currently FDA-listed
16 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerProficient Rx LP
Application holderTEVA PHARMACEUTICALS USA INC
FDA applicationANDA076565 (ANDA)
Labeler code63187
First marketedJul 2010
Product typeHuman Prescription Drug
Portfolio1,729 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔒 Drug Abuse and Dependence 🔒 Controlled Substance 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 190 words ▾

Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of venlafaxine hydrochloride extended-release capsules or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.

Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.

Venlafaxine hydrochloride extended-release capsules are not approved for use in pediatric patients (see WARNINGS, Clinical Worsening and Suicide Risk; PRECAUTIONS , Information for Patients; and PRECAUTIONS , Pediatric Use).

🎯 Indications and Usage ~3 min read ▾

INDICATIONS AND USAGE Major Depressive Disorder Venlafaxine Hydrochloride Extended-Release Capsules USP are indicated for the treatment of major depressive disorder. The efficacy of Venlafaxine Hydrochloride Extended-Release Capsules USP in the treatment of major depressive disorder was established in 8 and 12 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials ). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.

The efficacy of Venlafaxine Hydrochloride Tablets USP (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4 week controlled trial (see Clinical Trials ). The safety and efficacy of Venlafaxine Hydrochloride Extended-Release Capsules USP in hospitalized depressed patients have not been adequately studied. The efficacy of Venlafaxine Hydrochloride Extended-Release Capsules USP in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial.

The efficacy of Venlafaxine Hydrochloride Tablets USP (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials ). Nevertheless, the physician who elects to use Venlafaxine Hydrochloride Tablets USP/Venlafaxine Hydrochloride Extended-Release Capsules USP for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ).

Panic Disorder Venlafaxine Hydrochloride Extended-Release Capsules USP are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. Panic disorder (DSM-IV) is characterized by recurrent, unexpected panic attacks, i.e., a discrete period of intense fear or discomfort, in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: 1) palpitations, pounding heart, or accelerated heart rate; 2) sweating; 3) trembling or shaking; 4) sensations of shortness of breath or smothering; 5) feeling of choking; 6) chest pain or discomfort; 7) nausea or abdominal distress; 8) feeling dizzy, unsteady, lightheaded, or faint; 9) derealization (feelings of unreality) or depersonalization (being detached from oneself); 10) fear of losing control; 11) fear of dying; 12) paresthesias (numbness or tingling sensations); 13) chills or hot flushes.

The efficacy of Venlafaxine Hydrochloride Extended-Release Capsules USP in the treatment of panic disorder was established in two 12 week placebo-controlled trials in adult outpatients with panic disorder (DSM-IV). The efficacy of Venlafaxine Hydrochloride Extended-Release Capsules USP in prolonging time to relapse in panic d… [Excerpted — this section continues on DailyMed.]

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION Venlafaxine hydrochloride extended-release capsules should be administered in a single dose with food either in the morning or in the evening at approximately the same time each day. Each capsule should be swallowed whole with fluid and not divided, crushed, chewed, or placed in water, or it may be administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of applesauce. This drug/food mixture should be swallowed immediately without chewing and followed with a glass of water to ensure complete swallowing of the pellets.

Initial Treatment Major Depressive Disorder For most patients, the recommended starting dose for venlafaxine hydrochloride extended-release capsules is 75 mg/day, administered in a single dose. In the clinical trials establishing the efficacy of venlafaxine hydrochloride extended-release capsules in moderately depressed outpatients, the initial dose of venlafaxine was 75 mg/day. For some patients, it may be desirable to start at 37.5 mg/day for 4 to 7 days, to allow new patients to adjust to the medication before increasing to 75 mg/day.

While the relationship between dose and antidepressant response for venlafaxine hydrochloride extended-release capsules has not been adequately explored, patients not responding to the initial 75 mg/day dose may benefit from dose increases to a maximum of approximately 225 mg/day. Dose increases should be in increments of up to 75 mg/day, as needed, and should be made at intervals of not less than 4 days, since steady state plasma levels of venlafaxine and its major metabolites are achieved in most patients by day 4.

In the clinical trials establishing efficacy, upward titration was permitted at intervals of 2 weeks or more; the average doses were about 140 to 180 mg/day (see CLINICAL PHARMACOLOGY , Clinical Trials ). It should be noted that, while the maximum recommended dose for moderately depressed outpatients is also 225 mg/day for venlafaxine hydrochloride tablets (immediate release), more severely depressed inpatients in one study of the development program for that product responded to a mean dose of 350 mg/day (range of 150 to 375 mg/day).

Whether or not higher doses of venlafaxine hydrochloride extended-release capsules are needed for more severely depressed patients is unknown; however, the experience with venlafaxine hydrochloride extended-release capsule doses higher than 225 mg/day is very limited (see PRECAUTIONS , General , Use in Patients With Concomitant Illness ). Panic Disorder It is recommended that initial single doses of 37.5 mg/day of venlafaxine hydrochloride extended-release capsules be used for 7 days. In clinical trials establishing the efficacy of venlafaxine hydrochloride extended-release capsules in outpatients with panic disorder, initial doses of 37.5 mg/day for 7 days were followed by doses of 75 mg/day and subsequent weekly dose increases of 75 mg/day to a maximum dose of 225 mg/day.

Although a dose-response relationship for effectiveness in patients with panic disorder was not clearly established in fixed-dose studies, certain patients not responding to 75 mg/day may benefit from dose increases to a maximum of approximately 225 mg/day. Dose increases should be in increments of up to 75 mg/day, as needed, and should be made at intervals of not less than 7 days (see PRECAUTIONS , Use in Patients With Concomitant Illness ). Switching Patients From Venlafaxine Hydrochloride Tablets Depressed patients who are currently being treated at a therapeutic dose with venlafaxine hydrochloride tablets (immediate release) may be switched to venlafaxine hydrochloride extended-release capsules at the nearest equivalent dose (mg/day), e.g., 37.5 mg venlafaxine two-times-a-day to 75 mg venlafaxine hydrochloride extended-release capsules once daily.

However, individual dosage adjustments may be necessary. Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 108 words ▾

CONTRAINDICATIONS Hypersensitivity to venlafaxine hydrochloride or to any excipients in the formulation. The use of MAOIs intended to treat psychiatric disorders with venlafaxine hydrochloride or within 7 days of stopping treatment with venlafaxine hydrochloride is contraindicated because of an increased risk of serotonin syndrome. The use of venlafaxine hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION ).

Starting venlafaxine hydrochloride in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION ).

⚠️ Warnings ~3 min read ▾

WARNINGS Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.

There has been a long standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders.

Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4400 patients. The pooled analyses of placebo-controlled trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients.

There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications.

These risk differences (drug-placebo difference in the number of cases of suicidality per 1000 patients treated) are provided in Table 1 . Table Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1000 Patients Treated Increases Compared to Placebo < 18 14 additional cases 18 to 24 5 additional cases Decreases Compared to Placebo 25 to 64 1 fewer case ≥ 65 6 fewer cases No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the number was not sufficient to reach any conclusion about drug effect on suicide.

It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.

Consideration should be given to chang… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS The information included in the Adverse Findings Observed in Short-Term, Placebo-Controlled Studies With Venlafaxine Hydrochloride Extended-Release Capsules subsection is based on data from a pool of three 8 and 12 week controlled clinical trials in major depressive disorder (includes two U.S. trials and one European trial), and on data up to 12 weeks from a pool of four controlled clinical trials in panic disorder. Information on additional adverse events associated with venlafaxine hydrochloride extended-release capsules in the entire development program for the formulation and with venlafaxine hydrochloride tablets (immediate release) is included in the Other Adverse Events Observed During the Premarketing Evaluation of Venlafaxine Hydrochloride Tablets and Venlafaxine Hydrochloride Extended-Release Capsules subsection (see also WARNINGS and PRECAUTIONS ).

Adverse Findings Observed in Short-Term, Placebo-Controlled Studies With Venlafaxine Hydrochloride Extended-Release Capsules Adverse Events Associated With Discontinuation of Treatment Approximately 11% of the 357 patients who received venlafaxine hydrochloride extended-release capsules in placebo-controlled clinical trials for major depressive disorder discontinued treatment due to an adverse experience, compared with 6% of the 285 placebo-treated patients in those studies. Approximately 7% of the 1,001 patients who received venlafaxine hydrochloride extended-release capsules in placebo-controlled clinical trials for panic disorder discontinued treatment due to an adverse experience, compared with 6% of the 662 placebo-treated patients in those studies.

The most common events leading to discontinuation and considered to be drug-related (i.e., leading to discontinuation in at least 1% of the venlafaxine hydrochloride extended-release capsule-treated patients at a rate at least twice that of placebo) are shown in Table 6 . Table 5: Common Adverse Events Leading to Discontinuation of Treatment in Placebo-Controlled Trials Two of the major depressive disorder studies were flexible dose and one was fixed dose. Two of the panic disorder studies were flexible dose and two were fixed dose.

Percentage of Patients Discontinuing Due to Adverse Event Adverse Event Major Depressive Disorder Indication In U.S. placebo-controlled trials for major depressive disorder, the following were also common events leading to discontinuation and were considered to be drug-related for venlafaxine hydrochloride extended-release capsule-treated patients (% venlafaxine hydrochloride extended-release capsules [n = 192], % Placebo [n = 202]): hypertension (1%, < 1%); diarrhea (1%, 0%); paresthesia (1%, 0%); tremor (1%, 0%); abnormal vision, mostly blurred vision (1%, 0%); and abnormal, mostly delayed, ejaculation (1%, 0%).

Panic Disorder Indication Venlafaxine Hydrochloride Extended-Release Capsules Placebo Venlafaxine Hydrochloride Extended-Release Capsules Placebo n = 357 n = 285 n = 1001 n = 662 Body as a Whole Asthenia -- -- 1% 0% Headache -- -- -- -- Digestive System Nausea 4% < 1% 2% < 1% Anorexia 1% < 1% -- -- Dry Mouth 1% 0% -- -- Vomiting -- -- -- -- Nervous System Dizziness 2% 1% -- -- Insomnia 1% < 1% 1% < 1% Somnolence 2% < 1% -- -- Nervousness -- -- -- -- Tremor -- -- -- -- Skin Sweating -- -- -- -- Urogenital System Impotence Incidence is based on the number of men (venlafaxine hydrochloride extended-release capsules = 454, placebo = 357). -- -- -- -- Adverse Events Occurring at an Incidence of 2% or More Among Venlafaxine Hydrochloride Extended-Release Capsule-Treated Patients Tables 7 and 10 enumerate the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred during acute therapy of major depressive disorder (up to 12 weeks; dose range of 75 to 225 mg/day), and of panic disorder (up to 12 weeks; dose range of 37.5 to 225 mg/day), respectively, in 2% or more of patients treated with venlafaxine hydrochloride extended-release capsul… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

Drug Interactions As with all drugs, the potential for interaction by a variety of mechanisms is a possibility. Alcohol A single dose of ethanol (0.5 g/kg) had no effect on the pharmacokinetics of venlafaxine or O-desmethylvenlafaxine (ODV) when venlafaxine was administered at 150 mg/day in 15 healthy male subjects. Additionally, administration of venlafaxine in a stable regimen did not exaggerate the psychomotor and psychometric effects induced by ethanol in these same subjects when they were not receiving venlafaxine.

Cimetidine Concomitant administration of cimetidine and venlafaxine in a steady-state study for both drugs resulted in inhibition of first-pass metabolism of venlafaxine in 18 healthy subjects. The oral clearance of venlafaxine was reduced by about 43%, and the exposure (AUC) and maximum concentration (C max ) of the drug were increased by about 60%. However, coadministration of cimetidine had no apparent effect on the pharmacokinetics of ODV, which is present in much greater quantity in the circulation than venlafaxine.

The overall pharmacological activity of venlafaxine plus ODV is expected to increase only slightly, and no dosage adjustment should be necessary for most normal adults. However, for patients with preexisting hypertension, and for elderly patients or patients with hepatic dysfunction, the interaction associated with the concomitant use of venlafaxine and cimetidine is not known and potentially could be more pronounced. Therefore, caution is advised with such patients.

Diazepam Under steady-state conditions for venlafaxine administered at 150 mg/day, a single 10 mg dose of diazepam did not appear to affect the pharmacokinetics of either venlafaxine or ODV in 18 healthy male subjects. Venlafaxine also did not have any effect on the pharmacokinetics of diazepam or its active metabolite, desmethyldiazepam, or affect the psychomotor and psychometric effects induced by diazepam. Haloperidol Venlafaxine administered under steady-state conditions at 150 mg/day in 24 healthy subjects decreased total oral-dose clearance (Cl/F) of a single 2 mg dose of haloperidol by 42%, which resulted in a 70% increase in haloperidol AUC.

In addition, the haloperidol C max increased 88% when coadministered with venlafaxine, but the haloperidol elimination half-life (t 1/2 ) was unchanged. The mechanism explaining this finding is unknown. Lithium The steady-state pharmacokinetics of venlafaxine administered at 150 mg/day were not affected when a single 600 mg oral dose of lithium was administered to 12 healthy male subjects.

ODV also was unaffected. Venlafaxine had no effect on the pharmacokinetics of lithium (see also CNS-Active Drugs , below). Drugs Highly Bound to Plasma Proteins Venlafaxine is not highly bound to plasma proteins; therefore, administration of venlafaxine hydrochloride extended-release capsules to a patient taking another drug that is highly protein bound should not cause increased free concentrations of the other drug.

Drugs That Interfere With Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin) Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are coadministered with warfarin.

Patients receiving warfarin therapy should be carefully monitored when venlafaxine hydrochloride extended-release capsules are initiated or discontinued. Drugs That Inhibit Cytochrome P450 Isoenzymes CYP2D6 Inhibitors In vitro and in vivo studies indicate that venlafaxine is metabolized to its active metabolite, ODV, by CYP2D6, the isoenzyme that is responsible for the genetic polymorphism seen… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

Pregnancy Teratogenic Effects Pregnancy Category C Venlafaxine did not cause malformations in offspring of rats or rabbits given doses up to 2.5 times (rat) or 4 times (rabbit) the maximum recommended human daily dose on a mg/m 2 basis. However, in rats, there was a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation, when dosing began during pregnancy and continued until weaning. The cause of these deaths is not known.

These effects occurred at 2.5 times (mg/m 2 ) the maximum human daily dose. The no effect dose for rat pup mortality was 0.25 times the human dose on a mg/m 2 basis. There are no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nonteratogenic Effects Neonates exposed to venlafaxine hydrochloride extended-release capsules, other SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), or SSRIs (Selective Serotonin Reuptake Inhibitors), late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery.

Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome (see PRECAUTIONS , Drug Interactions , CNS-Active Drugs ).

When treating a pregnant woman with venlafaxine hydrochloride extended-release capsules during the third trimester, the physician should carefully consider the potential risks and benefits of treatment (see DOSAGE AND ADMINISTRATION ).

🧒 Pediatric Use ~1 min read ▾

Pediatric Use Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS , Clinical Worsening and Suicide Risk ). Two placebo-controlled trials in 766 pediatric patients with MDD have been conducted with venlafaxine hydrochloride extended-release capsules, and the data were not sufficient to support a claim for use in pediatric patients. Anyone considering the use of venlafaxine hydrochloride extended-release capsules in a child or adolescent must balance the potential risks with the clinical need.

Although no studies have been designed to primarily assess venlafaxine hydrochloride extended-release capsules’ impact on the growth, development, and maturation of children and adolescents, the studies that have been done suggest that venlafaxine hydrochloride extended-release capsules may adversely affect weight and height (see PRECAUTIONS , General , Changes in Height and Changes in Weight ). Should the decision be made to treat a pediatric patient with venlafaxine hydrochloride extended-release capsules, regular monitoring of weight and height is recommended during treatment, particularly if it is to be continued long term.

The safety of venlafaxine hydrochloride extended-release capsule treatment for pediatric patients has not been systematically assessed for chronic treatment longer than six months in duration. In the studies conducted in pediatric patients (ages 6 to 17), the occurrence of blood pressure and cholesterol increases considered to be clinically relevant in pediatric patients was similar to that observed in adult patients. Consequently, the precautions for adults apply to pediatric patients (see WARNINGS , Sustained Hypertension and PRECAUTIONS , General , Serum Cholesterol Elevation ).

🧓 Geriatric Use 196 words ▾

Geriatric Use Approximately 4% (14/357) and 2% (16/1001) of venlafaxine hydrochloride extended-release capsule-treated patients in placebo-controlled premarketing major depressive disorder and panic disorder trials, respectively, were 65 years of age or over. Of 2,897 venlafaxine hydrochloride tablet-treated (immediate release) patients in premarketing phase major depressive disorder studies, 12% (357) were 65 years of age or over. No overall differences in effectiveness or safety were observed between geriatric patients and younger patients, and other reported clinical experience generally has not identified differences in response between the elderly and younger patients.

However, greater sensitivity of some older individuals cannot be ruled out. SSRIs and SNRIs, including venlafaxine hydrochloride extended-release capsules have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event (see PRECAUTIONS , Hyponatremia ). The pharmacokinetics of venlafaxine and ODV are not substantially altered in the elderly (see CLINICAL PHARMACOLOGY ).

No dose adjustment is recommended for the elderly on the basis of age alone, although other clinical circumstances, some of which may be more common in the elderly, such as renal or hepatic impairment, may warrant a dose reduction (see DOSAGE AND ADMINISTRATION ).

🆘 Overdosage ~3 min read ▾

OVERDOSAGE Human Experience Among the patients included in the premarketing evaluation of venlafaxine hydrochloride extended-release capsules, there were 2 reports of acute overdosage with venlafaxine hydrochloride extended-release capsules in major depressive disorder trials, either alone or in combination with other drugs. One patient took a combination of 6 g of venlafaxine hydrochloride extended-release capsules and 2.5 mg of lorazepam. This patient was hospitalized, treated symptomatically, and recovered without any untoward effects.

The other patient took 2.85 g of venlafaxine hydrochloride extended-release capsules. This patient reported paresthesia of all four limbs but recovered without sequelae. There were 2 reports of acute overdose with venlafaxine hydrochloride extended-release capsules in panic disorder trials.

One patient took 0.675 g of venlafaxine hydrochloride extended-release capsules once, and the other patient took 0.45 g of venlafaxine hydrochloride extended-release capsules for 2 days. No signs or symptoms were associated with either overdose, and no actions were taken to treat them. Among the patients included in the premarketing evaluation with venlafaxine hydrochloride tablets (immediate release), there were 14 reports of acute overdose with venlafaxine, either alone or in combination with other drugs and/or alcohol.

The majority of the reports involved ingestion in which the total dose of venlafaxine taken was estimated to be no more than several-fold higher than the usual therapeutic dose. The 3 patients who took the highest doses were estimated to have ingested approximately 6.75 g, 2.75 g, and 2.5 g. The resultant peak plasma levels of venlafaxine for the latter 2 patients were 6.24 and 2.35 mcg/mL, respectively, and the peak plasma levels of O-desmethylvenlafaxine were 3.37 and 1.30 mcg/mL, respectively.

Plasma venlafaxine levels were not obtained for the patient who ingested 6.75 g of venlafaxine. All 14 patients recovered without sequelae. Most patients reported no symptoms.

Among the remaining patients, somnolence was the most commonly reported symptom. The patient who ingested 2.75 g of venlafaxine was observed to have 2 generalized convulsions and a prolongation of QT c to 500 msec, compared with 405 msec at baseline. Mild sinus tachycardia was reported in 2 of the other patients.

In postmarketing experience, overdose with venlafaxine has occurred predominantly in combination with alcohol and/or other drugs. The most commonly reported events in overdosage include tachycardia, changes in level of consciousness (ranging from somnolence to coma), mydriasis, seizures, and vomiting. Electrocardiogram changes (e.g., prolongation of QT interval, bundle branch block, QRS prolongation), ventricular tachycardia, bradycardia, hypotension, rhabdomyolysis, vertigo, liver necrosis, serotonin syndrome, and death have been reported.

Published retrospective studies report that venlafaxine overdosage may be associated with an increased risk of fatal outcomes compared to that observed with SSRI antidepressant products, but lower than that for tricyclic antidepressants. Epidemiological studies have shown that venlafaxine-treated patients have a higher preexisting burden of suicide risk factors than SSRI-treated patients. The extent to which the finding of an increased risk of fatal outcomes can be attributed to the toxicity of venlafaxine in overdosage as opposed to some characteristic(s) of venlafaxine-treated patients is not clear.

Prescriptions for venlafaxine hydrochloride extended-release capsules should be written for the smallest quantity of capsules consistent with good patient management, in order to reduce the risk of overdose. Management of Overdosage Treatment should consist of those general measures employed in the management of overdosage with any antidepressant. Ensure an adequate airway, oxygenation, and ventilation.

Monitor cardiac rhythm and vital signs. General supportive and symptomatic meas… [Excerpted — this section continues on DailyMed.]

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Pharmacodynamics The mechanism of the antidepressant action of venlafaxine in humans is believed to be associated with its potentiation of neurotransmitter activity in the CNS. Preclinical studies have shown that venlafaxine and its active metabolite, O-desmethylvenlafaxine (ODV), are potent inhibitors of neuronal serotonin and norepinephrine reuptake and weak inhibitors of dopamine reuptake. Venlafaxine and ODV have no significant affinity for muscarinic cholinergic, H 1 -histaminergic, or α 1 -adrenergic receptors in vitro .

Pharmacologic activity at these receptors is hypothesized to be associated with the various anticholinergic, sedative, and cardiovascular effects seen with other psychotropic drugs. Venlafaxine and ODV do not possess monoamine oxidase (MAO) inhibitory activity. Pharmacokinetics Steady-state concentrations of venlafaxine and ODV in plasma are attained within 3 days of oral multiple dose therapy.

Venlafaxine and ODV exhibited linear kinetics over the dose range of 75 to 450 mg/day. Mean ± SD steady-state plasma clearance of venlafaxine and ODV is 1.3 ± 0.6 and 0.4 ±

0.2L/h/kg, respectively; apparent elimination half-life is 5 ± 2 and 11 ± 2 hours, respectively; and apparent (steady-state) volume of distribution is 7.5 ± 3.7 and 5.7 ±

1.8L/kg, respectively. Venlafaxine and ODV are minimally bound at therapeutic concentrations to plasma proteins (27% and 30%, respectively). Absorption Venlafaxine is well absorbed and extensively metabolized in the liver.

O-desmethylvenlafaxine (ODV) is the only major active metabolite. On the basis of mass balance studies, at least 92% of a single oral dose of venlafaxine is absorbed. The absolute bioavailability of venlafaxine is about 45%.

Administration of venlafaxine hydrochloride extended-release capsules (150 mg q24 hours) generally resulted in lower C max (150 ng/mL for venlafaxine and 260 ng/mL for ODV) and later T max (5.5 hours for venlafaxine and 9 hours for ODV) than for venlafaxine hydrochloride tablets (immediate release) [C max 's for immediate release 75 mg q12 hours were 225 ng/mL for venlafaxine and 290 ng/mL for ODV; T max 's were 2 hours for venlafaxine and 3 hours for ODV]. When equal daily doses of venlafaxine were administered as either an immediate release tablet or the extended-release capsule, the exposure to both venlafaxine and ODV was similar for the two treatments, and the fluctuation in plasma concentrations was slightly lower with the venlafaxine hydrochloride extended-release capsule.

Venlafaxine hydrochloride extended-release capsules, therefore, provide a slower rate of absorption, but the same extent of absorption compared with the immediate release tablet. Food did not affect the bioavailability of venlafaxine or its active metabolite, ODV. Time of administration (AM vs PM) did not affect the pharmacokinetics of venlafaxine and ODV from the 75 mg venlafaxine hydrochloride extended-release capsule.

Metabolism and Excretion Following absorption, venlafaxine undergoes extensive presystemic metabolism in the liver, primarily to ODV, but also to N-desmethylvenlafaxine, N,O-didesmethylvenlafaxine, and other minor metabolites. In vitro studies indicate that the formation of ODV is catalyzed by CYP2D6; this has been confirmed in a clinical study showing that patients with low CYP2D6 levels ("poor metabolizers") had increased levels of venlafaxine and reduced levels of ODV compared to people with normal CYP2D6 ("extensive metabolizers").

The differences between the CYP2D6 poor and extensive metabolizers, however, are not expected to be clinically important because the sum of venlafaxine and ODV is similar in the two groups and venlafaxine and ODV are pharmacologically approximately equiactive and equipotent. Approximately 87% of a venlafaxine dose is recovered in the urine within 48 hours as unchanged venlafaxine (5%), unconjugated ODV (29%), conjugated ODV (26%), or other minor inactive metabolites (27%). Renal elimination… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 116 words ▾

HOW SUPPLIED Venlafaxine Hydrochloride Extended-Release Capsules USP are available as follows: 150 mg - light-orange opaque cap/light-orange opaque body with “93” and “7386” on both body and cap. They are available in bottles of 30, 60 and 90. Store at 20 o to 25 o C (68 o to 77 o F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Israel By: TEVA PHARMACEUTICAL IND.

LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Repackaged by: PROFICIENT RX LP Thousand Oaks, CA 91320 Rev. H 7/2014

📋 Description 205 words ▾

DESCRIPTION Venlafaxine Hydrochloride Extended-Release Capsules USP for oral administration contain venlafaxine hydrochloride, USP a structurally novel antidepressant. It is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α-[(dimethylamino)methyl]- p -methoxybenzyl] cyclohexanol hydrochloride. The structural formula is shown below.

C 17 H 27 NO 2 •HCl M.W. 313.87 Venlafaxine hydrochloride, USP is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of

0.2M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Venlafaxine Hydrochloride Extended-Release Capsules USP are formulated as an extended-release capsule for once-a-day oral administration.

Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride, USP equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of black iron oxide, dibutyl sebacate, ethylcellulose, gelatin, polyethylene glycol, povidone, propylene glycol, shellac, sugar spheres (which contain sucrose and corn starch), sunset yellow FCF FD&C yellow 6, talc, and titanium dioxide.

The 37.5 mg capsules also contain D&C yellow 10 and potassium hydroxide, the 75 mg capsules also contain D&C yellow 10 and may contain potassium hydroxide, and the 150 mg capsules also contain potassium hydroxide. Structural formula for venlafaxing hydrochloride

💬 Information for Patients ~3 min read ▾

Information for Patients Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with venlafaxine hydrochloride extended-release capsules and should counsel them in its appropriate use. A patient Medication Guide about “ Antidepressant Medicines, Depression and Other Serious Mental Illness, and Suicidal Thoughts or Actions ” is available for venlafaxine hydrochloride extended-release capsules. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents.

Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document. Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking venlafaxine hydrochloride extended-release capsules.

Clinical Worsening and Suicide Risk Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt.

Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication. Interference With Cognitive and Motor Performance Clinical studies were performed to examine the effects of venlafaxine on behavioral performance of healthy individuals.

The results revealed no clinically significant impairment of psychomotor, cognitive, or complex behavior performance. However, since any psychoactive drug may impair judgment, thinking, or motor skills, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain that venlafaxine therapy does not adversely affect their ability to engage in such activities. Concomitant Medication Patients should be advised to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, including herbal preparations and nutritional supplements, since there is a potential for interactions.

Patients should be cautioned about the risk of serotonin syndrome with the concomitant use of venlafaxine hydrochloride extended-release capsules and triptans, tramadol, tryptophan supplements or other serotonergic agents (see CONTRAINDICATIONS and WARNINGS , Serotonin Syndrome and PRECAUTIONS , Drug Interactions , CNS-Active Drugs , Serotonergic Drugs ). Patients should be advised that taking venlafaxine hydrochloride extended-release capsules can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle closure glaucoma.

Preexisting glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible.

Patients should be cautioned about the concomitant use of venlafaxine hydrochloride extended-release capsules and NSAIDs,… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Venlafaxine (ven la fax een) Hydrochloride Extended-Release Capsules USP Read the Medication Guide that comes with venlafaxine hydrochloride extended-release capsules before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment.

Talk with your healthcare provider if there is something you do not understand or want to learn more about. What is the most important information I should know about venlafaxine hydrochloride extended-release capsules? Venlafaxine hydrochloride extended-release capsules and other antidepressant medicines may cause serious side effects, including: 1.

Suicidal thoughts or actions: • Venlafaxine hydrochloride extended-release capsules and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed. • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. • Watch for these changes and call your healthcare provider right away if you notice: o New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. o Pay particular attention to such changes when venlafaxine hydrochloride extended-release capsules are started or when the dose is changed.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you: • attempts to commit suicide • acting on dangerous impulses • acting aggressive or violent • thoughts about suicide or dying • new or worse depression • new or worse anxiety or panic attacks • feeling agitated, restless, angry or irritable • trouble sleeping • an increase in activity or talking more than what is normal for you • other unusual changes in behavior or mood • Visual Problems ● eye pain ● changes in vision ● swelling or redness in or around the eye Only some people are at risk for these problems.

You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Venlafaxine hydrochloride extended-release capsules may be associated with these serious side effects: 2.

Serotonin Syndrome. This condition can be life-threatening and may include: • agitation, hallucinations, coma or other changes in mental status • coordination problems or muscle twitching (overactive reflexes) • racing heartbeat, high or low blood pressure • sweating or fever • nausea, vomiting, or diarrhea • muscle rigidity 3. Changes in blood pressure.

Venlafaxine hydrochloride extended-release capsules may: • increase your blood pressure. Control high blood pressure before starting treatment and monitor blood pressure regularly 4. Enlarged pupils (mydriasis).

5. Anxiety and insomnia. 6.

Changes in appetite or weight. 7. Manic/hypomanic episodes: • greatly increased energy • severe trouble sleeping • racing thoughts • reckless behavior • unusually grand ideas • excessive happiness or irritability • talking more or faster than usual 8.

Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include: • headache • weakness or feeling unsteady • confusion, problems concentrating or thinking or memory problems 9.

Seizures or convulsions. 10. Abnormal bleeding : Venlafaxine hydrochloride extended-release capsules and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin ® , Jantoven ® ), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen),… [Excerpted — this section continues on DailyMed.]

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Discontinuation of Treatment With Venlafaxine Hydrochloride Extended-Release Capsules Discontinuation symptoms have been systematically evaluated in patients taking venlafaxine, to include retrospective surveys of trials in major depressive disorder. Abrupt discontinuation or dose reduction of venlafaxine at various doses has been found to be associated with the appearance of new symptoms, the frequency of which increased with increased dose level and with longer duration of treatment. Reported symptoms include agitation, anorexia, anxiety, confusion, impaired coordination and balance, diarrhea, dizziness, dry mouth, dysphoric mood, fasciculation, fatigue, flu-like symptoms, headaches, hypomania, insomnia, nausea, nervousness, nightmares, sensory disturbances (including shock-like electrical sensations), somnolence, sweating, tremor, vertigo, and vomiting.

During marketing of venlafaxine hydrochloride extended-release capsules, other SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), and SSRIs (Selective Serotonin Reuptake Inhibitors), there have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures.

While these events are generally self-limiting, there have been reports of serious discontinuation symptoms. Patients should be monitored for these symptoms when discontinuing treatment with venlafaxine hydrochloride extended-release capsules. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible.

If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate (see DOSAGE AND ADMINISTRATION ). Insomnia and Nervousness Treatment-emergent insomnia and nervousness were more commonly reported for patients treated with venlafaxine hydrochloride extended-release capsules than with placebo in pooled analyses of short-term major depressive disorder and panic disorder studies as shown in Table 5 .

Table 4: Incidence of Insomnia and Nervousness in Placebo-Controlled Major Depressive Disorder and Panic Disorder Trials Major Depressive Disorder Panic Disorder Venlafaxine Hydrochloride Extended-Release Capsules Placebo Venlafaxine Hydrochloride Extended-Release Capsules Placebo Symptom n = 357 n = 285 n = 1001 n = 662 Insomnia 17% 11% 17% 9% Nervousness 10% 5% 4% 6% Insomnia and nervousness each led to drug discontinuation in 0.9% of the patients treated with venlafaxine hydrochloride extended-release capsules in major depressive disorder studies.

In panic disorder trials, insomnia and nervousness led to drug discontinuation in 1% and 0.1%, respectively, of the patients treated with venlafaxine hydrochloride extended-release capsules up to 12 weeks. Changes in Weight Adult Patients A loss of 5% or more of body weight occurred in 7% of venlafaxine hydrochloride extended-release capsule-treated and 2% of placebo-treated patients in the short-term placebo-controlled major depressive disorder trials. The discontinuation rate for weight loss associated with venlafaxine hydrochloride extended-release capsules was 0.1% in major depressive disorder studies.

In placebo-controlled panic disorder trials, 3% of the venlafaxine hydrochloride extended-release capsule-treated and 2% of the placebo-treated patients sustained a loss of 7% or more of body weight during up to 12 weeks of treatment. None of the patients receiving venlafaxine hydrochloride extended-release capsules in panic disorder studies discontinued for weight loss. The safety and efficacy of venlafaxine therapy in combination w… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 55 words ▾

Nursing Mothers Venlafaxine and ODV have been reported to be excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from venlafaxine hydrochloride extended-release capsules, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🧬 Pharmacokinetics 99 words ▾

Pharmacokinetics Steady-state concentrations of venlafaxine and ODV in plasma are attained within 3 days of oral multiple dose therapy. Venlafaxine and ODV exhibited linear kinetics over the dose range of 75 to 450 mg/day. Mean ± SD steady-state plasma clearance of venlafaxine and ODV is 1.3 ± 0.6 and 0.4 ±

0.2L/h/kg, respectively; apparent elimination half-life is 5 ± 2 and 11 ± 2 hours, respectively; and apparent (steady-state) volume of distribution is 7.5 ± 3.7 and 5.7 ±

1.8L/kg, respectively. Venlafaxine and ODV are minimally bound at therapeutic concentrations to plasma proteins (27% and 30%, respectively).

🧬 Pharmacodynamics 107 words ▾

Pharmacodynamics The mechanism of the antidepressant action of venlafaxine in humans is believed to be associated with its potentiation of neurotransmitter activity in the CNS. Preclinical studies have shown that venlafaxine and its active metabolite, O-desmethylvenlafaxine (ODV), are potent inhibitors of neuronal serotonin and norepinephrine reuptake and weak inhibitors of dopamine reuptake. Venlafaxine and ODV have no significant affinity for muscarinic cholinergic, H 1 -histaminergic, or α 1 -adrenergic receptors in vitro .

Pharmacologic activity at these receptors is hypothesized to be associated with the various anticholinergic, sedative, and cardiovascular effects seen with other psychotropic drugs. Venlafaxine and ODV do not possess monoamine oxidase (MAO) inhibitory activity.

🔒 Drug Abuse and Dependence 171 words ▾

DRUG ABUSE AND DEPENDENCE Controlled Substance Class Venlafaxine hydrochloride extended-release capsules are not a controlled substance. Physical and Psychological Dependence In vitro studies revealed that venlafaxine has virtually no affinity for opiate, benzodiazepine, phencyclidine (PCP), or N-methyl-D-aspartic acid (NMDA) receptors. Venlafaxine was not found to have any significant CNS stimulant activity in rodents.

In primate drug discrimination studies, venlafaxine showed no significant stimulant or depressant abuse liability. Discontinuation effects have been reported in patients receiving venlafaxine (see DOSAGE AND ADMINISTRATION ). While venlafaxine has not been systematically studied in clinical trials for its potential for abuse, there was no indication of drug-seeking behavior in the clinical trials.

However, it is not possible to predict on the basis of premarketing experience the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of venlafaxine (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

🔒 Controlled Substance 12 words ▾

Controlled Substance Class Venlafaxine hydrochloride extended-release capsules are not a controlled substance.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Venlafaxine was given by oral gavage to mice for 18 months at doses up to 120 mg/kg per day, which was 1.7 times the maximum recommended human dose on a mg/m 2 basis. Venlafaxine was also given to rats by oral gavage for 24 months at doses up to 120 mg/kg per day. In rats receiving the 120 mg/kg dose, plasma concentrations of venlafaxine at necropsy were 1 times (male rats) and 6 times (female rats) the plasma concentrations of patients receiving the maximum recommended human dose.

Plasma levels of the O-desmethyl metabolite were lower in rats than in patients receiving the maximum recommended dose. Tumors were not increased by venlafaxine treatment in mice or rats. Mutagenesis Venlafaxine and the major human metabolite, O-desmethylvenlafaxine (ODV), were not mutagenic in the Ames reverse mutation assay in Salmonella bacteria or the Chinese hamster ovary/HGPRT mammalian cell forward gene mutation assay.

Venlafaxine was also not mutagenic or clastogenic in the in vitro BALB/c-3T3 mouse cell transformation assay, the sister chromatid exchange assay in cultured Chinese hamster ovary cells, or in the in vivo chromosomal aberration assay in rat bone marrow. ODV was not clastogenic in the in vitro Chinese hamster ovary cell chromosomal aberration assay, but elicited a clastogenic response in the in vivo chromosomal aberration assay in rat bone marrow. Impairment of Fertility Reproduction and fertility studies of venlafaxine in rats showed no adverse effects on male or female fertility at oral doses of up to 2 times the maximum recommended human dose of 225 mg/day on a mg/m 2 basis.

However, reduced fertility was observed in a study in which male and female rats were treated with O-desmethylvenlafaxine (ODV), the major human metabolite of venlafaxine, prior to and during mating and gestation. This occurred at an ODV exposure (AUC) approximately 2 to 3 times that associated with a human venlafaxine dose of 225 mg/day.

📄 Package Label / Principal Display Panel 4 words ▾

Package/Label Display Panel 63187-420-30

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 60 capsules (63187-0420-60), 90 capsules (63187-0420-90). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 63187-0418-60 · Proficient 63187-0424-60 · Proficient →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.