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venlafaxine hydrochloride 75 mg Capsule, Extended Release, 100-count — NDC 55111-0454-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

venlafaxine hydrochloride 75 mg Capsule, Extended Release, 100-count — NDC 55111-454-01 (Billing 55111-0454-01)

by Dr.Reddy's Laboratories Ltd. · 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

This is a package of 100 capsules of venlafaxine hydrochloride 75 mg Capsule, Extended Release from Dr.Reddy's Laboratories Ltd., marketed since Jun 2011 and currently FDA-listed. It is the main listing for this product, which comes in 6 package sizes.

NDC 55111-0454-01
🏷️ FDA NDC (as labeled) 55111-454-01 billing pads the product segment with a zero
This package
Contains100-count Pack sizes6 compare ↓
Also priced by: Part D plans $0.2146/unit — full pricing hub ↓
Main listing for product 55111-454 · Also comes in: 10 capsules 55111-454-78 30 capsules 55111-454-30 60 capsules 55111-454-60 90 capsules 55111-454-90 500 capsules 55111-454-05
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) 55111-454-01
Product NDC 55111-454
11-digit billing NDC 55111045401
RxCUI 313581, 313583, 313585
UNII 7D7RX5A8MO
Application # ANDA078421
SPL Set ID 7027be98-61d6-a986-c9df-60ceef5f7ff0
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 2011-06-01
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

GCN Seq No 046404
GCN 16817
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 75 MG CAP
FDB brand name Venlafaxine Hcl Er
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 046404
  • GCN: 16817
  • HICL (First Databank): 008847
  • AHFS class code: 28:16.04.16
  • RxCUI (RxNorm): 313581
Why two NDCs? The FDA registers this code as 55111-454-01 — 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 → 55111-0454-01. 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 75 MG CAP Ingredient Venlafaxine Hcl
📖 What it is MedlinePlus · NLM

Venlafaxine is used to treat depression, generalized anxiety disorder (GAD; excessive worrying that is difficult to control), social anxiety disorder (extreme fear of interacting with others or performing in front of others that interferes with normal life), and panic disorder (sudden, unexpected attacks of extreme fear and worry about these attacks). Venlafaxine is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). It works by increasing the amounts of serotonin and norepinephrine, natural substances in the brain that help maintain mental bala...

Read the full MedlinePlus article ↗
📗 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 $21.46 / 100 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
55111-0454-01 You're viewing this Main listing 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE 2011-06-01 — Active
55111-0454-05 55111-454-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE 2011-06-01 — Active
55111-0454-30 55111-454-30 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE 2011-06-01 — Active
55111-0454-60 55111-454-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE 2011-06-01 — Active
55111-0454-78 55111-454-78 10 BLISTER PACK in 1 CARTON / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK 2011-06-01 — Active
55111-0454-90 55111-454-90 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE 2011-06-01 — Active

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 capsule, extended release in 1 bottle.
How does this package differ from NDC 55111-0454-30?
Both are venlafaxine hydrochloride 75 mg Capsule, Extended Release — the drug itself is identical. This page's package is the 100-count one, while NDC 55111-0454-30 is the 30 capsules package.
What NDC number is used to bill for this package of venlafaxine hydrochloride 75 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 75 mg 00093-7385-05 Teva 500 capsules $0.080 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 00904-7488-61 Major 1 capsule $0.080 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 42806-0602-09 Epic 90 capsules $0.080 AB Availability likely —
venlafaxine hydrochloride 75 mg 43598-0001-10 Dr.Reddys 1000 capsules $0.080 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 50268-0874-15 AvPAK 1 capsule $0.080 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 62332-0793-30 Alembic 30 capsules $0.080 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 65862-0528-01 Aurobindo 100 capsules $0.080 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 68084-0709-01 American 1 capsule $0.080 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 70010-0185-03 Granules 30 capsules $0.080 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 70710-1699-00 Zydus 1000 capsules $0.080 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 72603-0748-01 NorthStar 90 capsules $0.080 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 82009-0057-10 QUALLENT 1000 capsules $0.080 AB Availability likely —
Venlafaxine hydrochloride 75 mg 33342-0195-07 Macleods 30 capsules $0.100 AB FDA listed —
Effexor XR 75 mg 58151-0126-77 Viatris 90 capsules $19.820 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 00615-8509-39 NCS 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 10135-0826-10 Marlex 1000 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 31722-0003-01 Camber 10 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 42291-0898-30 AvKARE 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 42708-0054-30 QPharma, 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 42708-0194-30 QPharma, 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 46708-0793-30 Alembic 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 50090-2180-00 A-S 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 50090-6214-00 A-S 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 50090-6517-00 A-S 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 50090-6599-00 A-S 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 50090-7317-00 A-S 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 50090-7319-00 A-S 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 50090-7941-00 A-S 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 51655-0849-26 Northwind 90 capsules — AB FDA listed —
venlafaxine hydrochloride 75 mgthis 55111-0454-01 Dr.Reddy's 100 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 55154-0197-00 Cardinal 1 capsule — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 63187-0177-30 Proficient 30 capsules — AB FDA listed —
venlafaxine hydrochloride 75 mg 65841-0752-06 Zydus 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 67046-0390-03 Coupler 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 68071-3653-09 NuCare 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 68071-3886-03 NuCare 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 68071-4897-03 NuCare 30 capsules — AB FDA listed —
venlafaxine hydrochloride 75 mg 68382-0035-06 Zydus 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 68788-8068-03 Preferred 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 68788-8140-03 Preferred 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 68788-8694-03 Preferred 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 68788-8837-03 Preferred 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 70518-2107-00 REMEDYREPACK 30 capsules — AB Discontinued —
Venlafaxine Hydrochloride 75 mg 70518-4151-00 REMEDYREPACK 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 70518-4280-00 REMEDYREPACK 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 70518-4632-00 REMEDYREPACK 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 70771-1837-00 Zydus 1000 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 71205-0369-30 Proficient 30 capsules — AB FDA listed —
venlafaxine hydrochloride 75 mg 71335-1338-01 Bryant 90 capsules — AB Discontinued —
Venlafaxine Hydrochloride 75 mg 71335-1868-01 Bryant 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 71335-1993-01 Bryant 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 71335-2421-01 Bryant 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 71335-2971-01 Bryant 90 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 71785-1007-00 Annora 30 capsules — AB FDA listed —
Venlafaxine HCL ER 75 mg 72189-0414-60 Direct_Rx 60 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 72888-0180-30 Advagen 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 76420-0631-01 Asclemed 100 capsules — AB FDA listed —
Venlafaxine hydrochloride ER 75 mg 80425-0296-01 Advanced 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 80425-0396-01 Advanced 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 80425-0470-01 Advanced 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 80425-0471-01 Advanced 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 80425-0472-01 Advanced 30 capsules — AB FDA listed —
Venlafaxine Hydrochloride 75 mg 24658-0126-10 PURACAP 1000 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

🏛️
2011
On the market since
Jun 2011
📍
2026
Currently FDA-listed
15 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.

What it looks like

Color Gray / Pink / Orange
ShapeCapsule
ImprintRDY;455
Size23 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 905HNO1SIH
    A synthetic polymer made from methacrylate compounds that forms a film coating on tablets or capsules. It helps control how quickly the medicine dissolves and releases its active ingredient in the digestive system.
  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII C9H2L21V7U
    A fat derived from coconut or palm oil containing shorter fatty acid chains. It serves as a solvent and carrier to help dissolve or suspend active ingredients, improving absorption and stability in liquid formulations.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII 7CV7WJK4UI
    Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

15 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerDr.Reddy's Laboratories Ltd.
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA078421 (ANDA)
Labeler code55111
First marketedJun 2011
Product typeHuman Prescription Drug
Portfolio6 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 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🔬 Clinical Studies 🔒 Drug Abuse and Dependence 🧪 Nonclinical Toxicology 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 183 words ▾

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS A n tidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions ( 5.1 )]. In patients of all ages who are started on antidepressant therapy monitor closely for clinical worsening and emergence of suicidal thoughts and behaviors.

Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1 ) and Patient Counseling Information ( 17 ) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants ( 5.1) • Monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 ) • Venlafaxine hydrochloride extended-release capsules are not approved for use in pediatric patients ( 8.4)

🎯 Indications and Usage 164 words ▾

1 INDICATIONS AND USAGE Venlafaxine hydrochloride extended-release capsules are serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of: • Major Depressive Disorder (MDD) • Generalized Anxiety Disorder (GAD) • Social Anxiety Disorder (SAD) • Panic Disorder (PD)

1.1Major Depressive Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (MDD). Efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials.

1.2Generalized Anxiety Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of generalized anxiety disorder (GAD). Efficacy was established in two 8-week and two 26-week placebo-controlled trials.

1.3Social Anxiety Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Social Anxiety Disorder (SAD), also known as social phobia. Efficacy was established in four 12-week and one 26-week, placebo-controlled trials.

1.4Panic Disorder Venlafaxine hydrochloride extended-release capsules are indicated for the treatment of Panic Disorder (PD), with or without agoraphobia. Efficacy was established in two 12-week placebo-controlled trials.

⏱️ Dosage and Administration ~3 min read ▾

2 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 [see Clinical Pharmacology ( 12.3) ]. 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 (spheroids).

Indication Starting Dose Target Dose Maximum Dose MDD (2.1) 37.5 to75 mg/day 75 mg/day 225 mg/day GAD (2.2) 37.5 to75 mg/day 75 mg/day 225 mg/day SAD (2.3) 75 mg/day 75 mg/day 75 mg/day PD (2.4) 37.5 mg/day 75 mg/day 225 mg/day • Take once daily with food ( 2 ). Capsules should be taken whole; do not divide, crush, chew, or dissolve ( 2 ). • When discontinuing treatment, reduce the dose gradually ( 2.8 , 5.7 ). • Renal impairment: reduce the total daily dose by 25% to 50% in patients with renal impairment. Reduce the total daily dose by 50% or more in patients undergoing dialysis or with severe renal impairment ( 2.6 ). • Hepatic impairment: reduce the daily dose by 50% in patients with mild to moderate hepatic impairment.

In patients with severe hepatic impairment or hepatic cirrhosis, it may be necessary to reduce the dose by more than 50% ( 2.6 ).

2.1Major Depressive Disorder For most patients, the recommended starting dose for venlafaxine hydrochloride extended-release capsules is 75 mg per day, administered in a single dose. For some patients, it may be desirable to start at 37.5 mg per day for 4 to 7 days to allow new patients to adjust to the medication before increasing to 75 mg per day. Patients not responding to the initial 75 mg per day dose may benefit from dose increases to a maximum of 225 mg per day.

Dose increases should be in increments of up to 75 mg per 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 [see Clinical Pharmacology ( 12.3) ]. In the clinical studies establishing efficacy, upward titration was permitted at intervals of 2 weeks or more. It should be noted that, while the maximum recommended dose for moderately depressed outpatients is also 225 mg per day for venlafaxine hydrochloride (immediate-release), more severely depressed inpatients in one study of the development program for that product responded to a mean dose of 350 mg per day (range of 150 to 375 mg per 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 capsules doses higher than 225 mg per day is very limited.

2.2Generalized Anxiety Disorder For most patients, the recommended starting dose for venlafaxine hydrochloride extended-release capsules is 75 mg per day, administered in a single dose. For some patients, it may be desirable to start at 37.5 mg per day for 4 to 7 days to allow new patients to adjust to the medication before increasing to 75 mg per day. Patients not responding to the initial 75 mg per day dose may benefit from dose increases to a maximum of 225 mg per day.

Dose increases should be in increments of up to 75 mg per 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 [see Clinical Pharmacology ( 12.3) ].

2.3Social Anxiety Disorder (Social Phobia) The recommended dose is 75 mg per day, administered in a single dose. There was no evidence that higher doses confer any additional benefit.

2.4Panic Disorder The recommended starting dose is 37.5 mg per day of… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 167 words ▾

3 DOSAGE FORMS AND STRENGTHS Venlafaxine hydrochloride extended-release capsules are available in the following strengths: 37.5 mg capsules (white to off-white, coated mini tablets filled in size “3” hard gelatin capsule shells with opaque gray colored cap and opaque pink colored body, imprinted “RDY” on cap and “453”on body with black ink) 75 mg capsules (white to off-white, coated mini tablets filled in size “2” hard gelatin capsule shells with opaque pink colored cap and opaque pink colored body, imprinted “RDY” on cap and “454”on body with black ink) 150 mg capsules (white to off-white, coated mini tablets filled in size “Oel” hard gelatin capsule shells with opaque Swedish orange colored cap and opaque Swedish orange colored body, imprinted “RDY” on cap and “455”on body with white ink) • Venlafaxine hydrochloride extended-release capsules are available as 37.5 mg, 75 mg and 150 mg strengths ( 3 ). • Each capsule contains venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg or 150 mg of venlafaxine ( 3 ).

⛔ Contraindications 217 words ▾

4 CONTRAINDICATIONS Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate, or any excipients in the venlafaxine hydrochloride extended-release capsules formulation ( 4.1). Do not use with an MAOI or within 14 days of stopping an MAOI. Allow 7 days after stopping venlafaxine hydrochloride extended-release capsules before starting an MAOI, because of the risk of serotonin syndrome ( 4.2 , 5.2 , 7.3 ).

4.1H ypersensitivity Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation

4.2Concomitant Use with Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs (intended to treat psychiatric disorders) concomitantly with venlafaxine hydrochloride extended-release capsules or within 7 days of discontinuing treatment with venlafaxine hydrochloride extended-release capsules are contraindicated because of an increased risk of serotonin syndrome. The use of venlafaxine hydrochloride extended-release capsules within 14 days of discontinuing treatment with an MAOI (intended to treat psychiatric disorders) is also contraindicated [see Dosage and Administration ( 2.9 ), Warnings and Precautions ( 5.2 ), and Drug Interactions ( 7.2 )].

Starting venlafaxine hydrochloride extended-release capsules in a patient who is being treated with an MAOI such as linezolid or intravenous methylene blue is also contraindicated, because of an increased risk of serotonin syndrome [see Dosage and Administration ( 2.9 ), Warnings and Precautions ( 5.2 ), and Drug Interactions ( 7.3 )].

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Clinical Worsening/Suicide Risk: Monitor for clinical worsening and suicide risk ( 5.1 ). Serotonin Syndrome: Risk increases with concomitant use of other serotonergic drugs. Discontinue venlafaxine hydrochloride extended-release capsules and initiate supportive treatment if serotonin syndrome occurs ( 4.2 , 5.2 , 7.3 ).

Elevations in Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment ( 5.3). Abnormal Bleeding: Venlafaxine hydrochloride extended-release capsules may increase risk of bleeding events.

Caution patients about the risk of bleeding associated with the concomitant use of venlafaxine hydrochloride extended-release and NSAIDs, aspirin, or other drugs that affect coagulation ( 5.4 ). Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.5 ).

Activation of Mania/Hypomania: Use cautiously in patients with bipolar disorder. Caution patients about the risk of activation of mania/hypomania ( 5.6 ).

5.1Su i c i d a l Thoughts and Behaviors in Children, Adolescents, and Young Adults 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 studies 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 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 studies in children and adolescents with MDD, Obsessive Compulsive Disorder (OCD), or other psychiatric disorders included a total of 24 short-term studies of 9 antidepressant drugs in over 4,400 patients. The pooled analyses of placebo-controlled studies in adults with MDD or other psychiatric disorders included a total of 295 short-term studies (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 versus 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 1,000 patients treated) are provided in Table 1.

Table 1: Difference in the Number of Cases of Suicidality per 1,000 Patients Treated versus Placebo A ge Range Increases Compared to Placebo < 18 14 additional cases 18 to 24 5 additional cases D ecreases Compared to Placebo 25 to 64 1 fewer case ≥ 65 6 fewer cases No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, 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… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: • Hypersensitivity [see Contraindications ( 4.1) ] • Suicidal Thoughts and Behaviors in Children, Adolescents, and Adults [see Warnings and Precautions ( 5.1 )] • Serotonin Syndrome [see Warnings and Precautions (5.2 ) ] • Elevations in Blood Pressure [see Warnings and Precautions ( 5.3) ] • Abnormal Bleeding [see Warnings and Precautions ( 5.4 ) ] • Angle Closure Glaucoma [see Warnings and Precautions ( 5.5) ] • Activation of Mania/Hypomania [see Warnings and Precautions ( 5.6) ] • Discontinuation Syndrome [see Warnings and Precautions ( 5.7) ] • Seizure [see Warnings and Precautions ( 5.8 )] • Hyponatremia [see Warnings and Precautions ( 5.9) ] • Weight and Height changes in Pediatric Patients [see Warnings and Precautions ( 5.10 )] • Appetite Changes in Pediatric Patients [see Warnings and Precautions ( 5.11 )] • Interstitial Lung Disease and Eosinophilic Pneumonia [see Warnings and Precautions ( 5.12 )] Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo): nausea, somnolence, dry mouth, sweating, abnormal ejaculation, anorexia, constipation, erectile dysfunction, and libido decreased ( 6.1 ).

To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Most Common Adverse Reactions The most commonly observed adverse reactions in the clinical study database in venlafaxine extended-release capsules treated patients in MDD, GAD, SAD, and PD (incidence ≥ 5% and at least twice the rate of placebo) were: nausea (30.0%), somnolence (15.3%), dry mouth (14.8%), sweating (11.4%), abnormal ejaculation (9.9%), anorexia (9.8%), constipation (9.3%), impotence (5.3%) and decreased libido (5.1%).

Adverse Reactions Reported as Reasons for Discontinuation of Treatment Combined across short-term, placebo-controlled premarketing studies for all indications, 12% of the 3,558 patients who received venlafaxine hydrochloride extended-release capsules (37.5-225 mg) discontinued treatment due to an adverse experience, compared with 4% of the 2,197 placebo-treated patients in those studies. The most common adverse reactions leading to discontinuation in ≥ 1% of the venlafaxine hydrochloride extended-release capsules treated patients in the short-term studies (up to 12 weeks) across indications are shown in Table 7.

Table 7: Incidence (%) of Patients Reporting Adverse Reactions Leading to Discontinuation in Placebo-controlled Clinical Studies (up to 12 Weeks Duration) Body System Adverse Reaction Venlafaxine Hydrochloride Extended-Release Capsules n = 3,558 Placebo n = 2,197 Body as a whole Asthenia 1.7

0.5Headache 1.5

0.8Digestive system Nausea 4.3

0.4Nervous system Dizziness 2.2

0.8Insomnia 2.1

0.6Somnolence 1.7

0.3Skin and appendages 1.5

0.6 Sweating 1

0.2Common Adverse Reactions in Placebo-controlled Studies The number of patients receiving multiple doses of venlafaxine hydrochloride extended-release capsuels during the premarketing assessment for each approved indication is shown in Table 8. The conditions and duration of exposure to venlafaxine in all development programs varied greatly, and included (in overlapping categories) open and double-blind studies, uncontrolled and controlled studies, inpatient (venlafaxine hydrochloride only) and outpatient studies, fixed-dose, and titration studies.

T able 8: Patients Receiving Venlafaxine Hydrochloride Extended-Release Capsules in Premarketing Clinical Studies Indication Venlafaxine Hydrochloride Extended-Release Capsules MDD 705 a GAD 1,381 SAD 819 PD 1,314 a In additi… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS · Serotonergic Drugs (e.g., MAOIs, triptans, SSRIs, other SNRIs, linezolid, lithium, tramadol, or St. John’s wort): Potential for serotonin syndrome. Careful patient observation is advised ( 4.2 , 5.2 , 7.3 ).

7.1Central Nervous System (CNS)-Active Drugs The risk of using venlafaxine in combination with other CNS-active drugs has not been systematically evaluated. Consequently, caution is advised when venlafaxine hydrochloride extended-release capsules are taken in combination with other CNS-active drugs.

7.2Monoamine Oxidase Inhibitors Adverse reactions, some of which were serious, have been reported in patients who have recently been discontinued from an MAOI and started on antidepressants with pharmacological properties similar to venlafaxine hydrochloride extended-release capsules (SNRIs or SSRIs), or who have recently had SNRI or SSRI therapy discontinued prior to initiation of an MAOI [see Dosage and Administration ( 2.9 ),Contraindications ( 4.2) and Warnings and Precautions ( 5.2) ].

7.3Serotonergic Drugs Based on the mechanism of action of venlafaxine hydrochloride extended-release capsules and the potential for serotonin syndrome, caution is advised when venlafaxine hydrochloride extended-release capsules are coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as triptans, SSRIs, other SNRIs, linezolid (an antibiotic which is a reversible non-selective MAOI), lithium, tramadol, or St. John’s wort. If concomitant treatment with venlafaxine hydrochloride extended-release capsules and these drugs is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.

The concomitant use of venlafaxine hydrochloride extended-release capsules with tryptophan supplements are not recommended [see Dosage and Administration (2.9 ), Contraindications ( 4.2 ),and Warnings and Precautions ( 5.2 )].

7.4Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin) Serotonin release by platelets plays an important role in hemostasis. The use of psychotropic drugs that interfere with serotonin reuptake is associated with the occurrence of upper gastrointestinal bleeding and concurrent use of an NSAID or aspirin may potentiate this risk of bleeding [see Warnings and Precautions ( 5.4) ]. 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.

7.5Weight Loss Agents The safety and efficacy of venlafaxine therapy in combination with weight loss agents, including phentermine, have not been established. Coadministration of venlafaxine hydrochloride extended-release capsules and weight loss agents are not recommended. Venlafaxine extended-release capsules are not indicated for weight loss alone or in combination with other products.

7.6Effects of Other Drugs on venlafaxine extended-release F i gure 1: Effect of interacting drugs on the pharmacokinetics of venlafaxine and active metabolite O-desmethylvenlafaxine (ODV). Abbreviations: ODV, O-desmethylvenlafaxine; AUC, area under the curve; Cmax, peak plasma concentrations; EM’s, extensive metabolizers; PM’s, poor metabolizers * No dose adjustment on co-administration with CYP2D6 inhibitors (Fig 3 and Metabolism Section 12.3 )

7.7Effects of Venlafaxine extended-release on Other Drugs F i gure 2: Effect of venlafaxine on the pharmacokinetics interacting drugs and their active metabolites. Abbreviations: AUC, area under the curve; Cmax, peak plasma concentrations; OH, hydroxyl * Data for 2-OH desipramine were not plotted to enhance clarity; the fold change and 90% CI for Cmax and AUC of 2-OH desipramine were 6.6 (5.5, 7.9) and 4.4 (3.8, 5.0), respectively. N o te: *: Administration of venlafaxine in a stable regimen did not… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm ( 8.1 ). Nursing Mothers: Discontinue drug or nursing, taking into consideration importance of drug to mother ( 8.3)

8.1Pregnancy 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/m2 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/m2) the maximum human daily dose. The no effect dose for rat pup mortality was 0.25 times the human dose on a mg/m2 basis. In reproductive developmental studies in rats and rabbits with O-desmethylvenlafaxine (ODV), the major human metabolite of venlafaxine, evidence of teratogenicity was not observed at exposure margins of 13 in rats and 0.3 in rabbits.

There are no adequate and well-controlled studies in pregnant women. Venlafaxine hydrochloride extended-release capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Non-teratogenic Effects Neonates exposed to venlafaxine hydrochloride extended-release capsules, other SNRIs, or SSRIs, 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 Warnings and Precautions ( 5.2) and Drug Interactions ( 7.3) ]. 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.

8.2Labor and Delivery The effect of venlafaxine on labor and delivery in humans is unknown.

8.3Nursing 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.

8.4Pediatric Use Two placebo-controlled trials in 766 pediatric patients with MDD and two placebo-controlled trials in 793 pediatric patients with GAD 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 [s ee Boxed Warning, Warnings and Precautions ( 5.1, 5.10, 5.11)and Adverse Reactions ( 6.4 )].

Although no studies have been designed to primarily assess venlafaxine hydrochloride extended-release capsules’s 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 Warnings and Precautions (5.10) ]. Should the decision be made to treat a pediatric patient with venlaf… [Excerpted — this section continues on DailyMed.]

🆘 Overdosage ~2 min read ▾

10 OVERDOSAGE

10.1Human Experience During the premarketing evaluations of venlafaxine hydrochloride extended-release capsules (for MDD, GAD, SAD, and PD) and venlafaxine hydrochloride (for MDD), there were twenty reports of acute overdosage with venlafaxine hydrochloride (6 and 14 reports in venlafaxine hydrochloride extended-release capsules and venlafaxine hydrochloride patients, respectively), either alone or in combination with other drugs and/or alcohol. Somnolence was the most commonly reported symptom. Among the other reported symptoms were paresthesia of all four limbs, moderate dizziness, nausea, numb hands and feet, and hot-cold spells 5 days after the overdose.

In most cases, no signs or symptoms were associated with overdose. 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. One patient who ingested 2.75 g of venlafaxine was observed to have two generalized convulsions and a prolongation of QTc to 500 msec, compared with 405 msec at baseline.

Mild sinus tachycardia was reported in two of the other patients. Actions taken to treat the overdose included no treatment, hospitalization and symptomatic treatment, and hospitalization plus treatment with activated charcoal. All patients recovered.

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.

10.2Management of Overdosage Consult a Certified Poison Control Center for up-to-date guidance and advice (1-800-222-1222 or www.poison.org). In case of an overdose, provide supportive care, including close medical supervision and monitoring. Treatment should consist of those general measures employed in the management of overdosage with any drug.

Consider the possibility of multiple drug overdose. Ensure an adequate airway, oxygenation, and ventilation. Monitor cardiac rhythm and vital signs.

Provide supportive and symptomatic measures.

🧬 Clinical Pharmacology ~3 min read ▾

12CLINICALPHARMACOLOGY

12.1Mechanism of Action The exact mechanism of the antidepressant action of venlafaxine in humans is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of their reuptake. Non-clinical studies have demonstrated that venlafaxine and its active metabolite, ODV, are potent and selective inhibitors of neuronal serotonin and norepinephrine reuptake and weak inhibitors of dopamine reuptake.

12.2Pharmacodynamics Venlafaxine and ODV have no significant affinity for muscarinic-cholinergic, H 1 -histaminergic, or α1­ 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.

12.3Pharmacokinetics 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 per day. Mean±SD steady-state plasma clearance of venlafaxine and ODV is 1.3±0.6 and 0.4±0.2 L/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±1.8 L/kg, respectively.

Venlafaxine and ODV are minimally bound at therapeutic concentrations to plasma proteins (27% and 30%, respectively). Absorption and Distribution Venlafaxine is well absorbed and extensively metabolized in the liver. ODV is the 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 approximately 45%. Administration of venlafaxine hydrochloride extended-release capsules (150 mg once daily) generally resulted in lower Cmax and later Tmax values than for venlafaxine hydrochloride (immediate release) administered twice daily (Table 16).

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 capsules. Therefore, venlafaxine hydrochloride extended-release capsules provide a slower rate of absorption, but the same extent of absorption compared with the immediate-release tablet. Table 16: Comparison of Cmax and Tmax Values for Venlafaxine and ODV Following Oral Administration of Venlafaxine Hydrochloride Extended-Release Capsules and Venlafaxine Hydrochloride (Immediate Release) V enlafaxine O DV C m a x (ng/mL) T m a x (h) C m a x (ng/mL) T m a x (h) Venlafaxine Hydrochloride Extended-Release Capsules (150 mg once daily) 150 5.5 260 9 Venlafaxine Hydrochloride (75 mg twice daily) 225 2 290 3 Food did not affect the bioavailability of venlafaxine or its active metabolite, ODV.

Time of administration (AM versus PM) did not affect the pharmacokinetics of venlafaxine and ODV from the 75 mg venlafaxine hydrochloride extended-release capsules. 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. Metabolism and Elimination 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 comp… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Venlafaxine hydrochloride extended-release capsules USP are available containing 37.5 mg, 75 mg or 150 mg of venlafaxine. The 37.5 mg capsules are white to off-white, coated mini tablets filled in size “3” hard gelatin capsule shells with opaque gray colored cap and opaque pink colored body, imprinted “RDY” on cap and “453”on body with black ink and are supplied in bottles of 30’s,60’s,90’s,100’s,500’s and unit dose package of 100 (10x10). Bottles of 30 NDC 55111-453-30 Bottles of 60 NDC 55111-453-60 Bottles of 90 NDC 55111-453-90 Bottles of 100 NDC 55111-453-01 Bottles of 500 NDC 55111-453-05 Unit Dose Package of 100(10x10) NDC 55111-453-78 The 75 mg capsules are white to off-white, coated mini tablets filled in size “2” hard gelatin capsule shells with opaque pink colored cap and opaque pink colored body, imprinted “RDY” on cap and “454”on body with black ink and are supplied in bottles of 30’s,60’s,90’s,100’s,500’s and unit dose package of 100 (10x10).

Bottles of 30 NDC 55111-454-30 Bottles of 60 NDC 55111-454-60 Bottles of 90 NDC 55111-454-90 Bottles of 100 NDC 55111-454-01 Bottles of 500 NDC 55111-454-05 Unit Dose Package of 100(10x10) NDC 55111-454-78 The 150 mg capsules are white to off-white, coated mini tablets filled in size “Oel” hard gelatin capsule shells with opaque Swedish orange colored cap and opaque Swedish orange colored body, imprinted “RDY” on cap and “455”on body with white ink and are supplied in bottles of 30’s,60’s,90’s,100’s,500’s and unit dose package of 100 (10x10).

Bottles of 30 NDC 55111-455-30 Bottles of 60 NDC 55111-455-60 Bottles of 90 NDC 55111-455-90 Bottles of 100 NDC 55111-455-01 Bottles of 500 NDC 55111-455-05 Unit Dose Package of 100(10x10) NDC 55111-455-78 Storage Store at 20°C - 25°C (68°F - 77°F) [see USP controlled room temperature] The unit of use package is intended to be dispensed as a unit.

📋 Description ~1 min read ▾

11 DESCRIPTION Venlafaxine hydrochloride extended-release capsules USP for once-a-day oral administration contains venlafaxine hydrochloride USP, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C 17 H 27 NO 2 HCl. Its molecular weight is 313.87.

The structural formula is shown as follows. Venlafaxine hydrochloride USP is an off-white to white crystalline powder, soluble in methanol. Venlafaxine hydrochloride extended-release capsules USP are formulated as extended-release capsule for once-a-day oral administration.

Drug release is controlled by diffusion through the coating membrane on the mini-tablets 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 basic butylated methacrylate copolymer, ethyl cellulose, gelatin, medium chain triglycerides, microcrystalline cellulose, povidone, red iron oxide, sodium stearyl fumarate, talc and titanium dioxide.

In addition to the above 37.5 mg consists of black iron oxide and yellow iron oxide. The components of the black imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 37.5 mg and 75 mg are black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution The components of the white imprinting ink used in the venlafaxine hydrochloride extended-release capsules USP, 150 mg are ammonium hydroxide, propylene glycol, simethicone, shellac and titanium dioxide. structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION S ee FDA-approved patient labeling (Medication Guide). Prescribers or other healthcare 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 Illnesses, and Suicidal Thoughts or Actions” is available for venlafaxine hydrochloride extended-release capsules.

The prescriber or healthcare 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 should be asked to alert their prescriber if these occur while taking venlafaxine hydrochloride extended-release capsules. Suicidal Thoughts and Behaviors Advise patients, their families and caregivers to look for the emergence of suicidality, worsening of depression, and other psychiatric symptoms (anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, psychomotor restlessness, hypomania, mania, other unusual changes in behavior), especially early during treatment and when the dose is adjusted up or down.

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 [see Boxed Warning and Warnings and Precautions ( 5.1 ) ]. Concomitant Medication Advise patients taking venlafaxine hydrochloride extended-release capsules not to use concomitantly other products containing venlafaxine or desvenlafaxine.

Healthcare professionals should instruct patients not to take venlafaxine hydrochloride extended-release capsules with an MAOI or within 14 days of stopping an MAOI and to allow 7 days after stopping venlafaxine hydrochloride extended-release capsules before starting an MAOI [see Contraindications ( 4.2 ) ]. Serotonin Syndrome Patients should be cautioned about the risk of serotonin syndrome, with the concomitant use of venlafaxine hydrochloride extended-release capsules and triptans, tramadol, amphetamines, tryptophan supplements, with antipsychotics or other dopamine antagonists, or other serotonergic agents [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7.3 ) ].

Elevated Blood Pressure Advise patients that they should have regular monitoring of blood pressure when taking venlafaxine hydrochloride extended-release [see Warnings and Precautions ( 5.3) ]. Abnormal Bleeding Patients should be cautioned about the concomitant use of venlafaxine hydrochloride extended-release capsules and NSAIDs, aspirin, warfarin, or other drugs that affect coagulation since combined use of psychotropic drugs that interfere with serotonin reuptake and these agents has been associated with an increased risk of bleeding [see Warnings and Precautions ( 5.4 ) ].

Angle-Closure Glaucoma 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. Pre-existing 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… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Medication Guide Venlafaxine Hydrochloride Extended-Release Capsules USP (ven'' la fax' een hye'' droe klor' ide) 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. • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe. • 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… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Major Depressive Disorder The efficacy of venlafaxine hydrochloride extended-release capsules as a treatment for Major Depressive Disorder (MDD) was established in two placebo-controlled, short-term (8 weeks for study 1; 12 weeks for study 2), flexible-dose studies, with doses starting at 75 mg per day and ranging to 225 mg per day in adult outpatients meeting DSM-III-R or DSM-IV criteria for MDD. In moderately depressed outpatients, the initial dose of venlafaxine was 75 mg per day. In both studies, venlafaxine hydrochloride extended-release capsules demonstrated superiority over placebo on the primary efficacy measure defined as change from baseline in the HAM-D-21 total score to the endpoint visit, venlafaxine hydrochloride extended-release capsules also demonstrated superiority over placebo on the key secondary efficacy endpoint, the Clinical Global Impressions (CGI) Severity of Illness scale.

Examination of gender subsets of the population studied did not reveal any differential responsiveness on the basis of gender. A 4-week study of inpatients meeting DSM-III-R criteria for MDD with melancholia utilizing venlafaxine hydrochloride in a range of 150 to 375 mg per day (divided in a three-times-a-day schedule) demonstrated superiority of venlafaxine hydrochloride over placebo based on the HAM-D-21 total score. The mean dose in completers was 350 mg per day (study 3).

In a longer-term study, adult outpatients with MDD who had responded during an 8-week open-label study on venlafaxine hydrochloride extended-release capsules (75, 150, or 225 mg, once daily every morning) were randomized to continuation of their same venlafaxine hydrochloride extended-release capsules dose or to placebo, for up to 26 weeks of observation for relapse. Response during the open-label phase was defined as a CGI Severity of Illness item score of ≤3 and a HAM-D-21 total score of ≤10 at the day 56 evaluation.

Relapse during the double-blind phase was defined as follows: (1) a reappearance of major depressive disorder as defined by DSM-IV criteria and a CGI Severity of Illness item score of ≥4 (moderately ill), (2) 2 consecutive CGI Severity of Illness item scores of ≥4, or (3) a final CGI Severity of Illness item score of ≥4 for any patient who withdrew from the study for any reason. Patients receiving continued venlafaxine hydrochloride extended-release capsules treatment experienced statistically significantly lower relapse rates over the subsequent 26 weeks compared with those receiving placebo (study 4).

In a second longer term trial, adult outpatients with MDD, recurrent type, who had responded (HAM-D­ 21 total score ≤ 12 at the day 56 evaluation) and continued to be improved [defined as the following criteria being met for days 56 through 180: (1) no HAM-D-21 total score ≥ 20; (2) no more than 2 HAM­ D-21 total scores > 10, and (3) no single CGI Severity of Illness item score ≥ 4 (moderately ill)] during an initial 26 weeks of treatment on venlafaxine hydrochloride [100 to 200 mg per day, on a twice daily schedule] were randomized to continuation of their same venlafaxine hydrochloride dose or to placebo.

The follow-up period to observe patients for relapse, defined as a CGI Severity of Illness item score ≥ 4, was for up to 52 weeks. Patients receiving continued venlafaxine hydrochloride treatment experienced statistically significantly lower relapse rates over the subsequent 52 weeks compared with those receiving placebo (study 5). Table 17: Major Depressive Disorder Studies: Study number Treatment Group Primary Efficacy Measure: HAM-D Score Mean Baseline Score (SD) LS Mean Change from Baseline Placebo Subtracted Difference a (95%CI) Study 1 Venlafaxine Hydrochloride Extended-Release Capsules (75 to 225 mg/day)* 24.5 -11.7 -7.24 -4.45(-6.66,-2.25) Placebo 23.6 - Study 2 Venlafaxine Hydrochloride Extended-Release Capsules (75 to 225mg/day)* 24.5 -15.11 -6.40(-8.45,-4.34) Placebo 24.9 -8.71 Study 3 Venlafaxine Hydrochlori… [Excerpted — this section continues on DailyMed.]

🔒 Drug Abuse and Dependence 173 words ▾

9 DRUG ABUSE AND DEPENDENCE

9.1Controlled Substance Venlafaxine hydrochloride extended-release capsule is not a controlled substance.

9.2Abuse While venlafaxine has not been systematically studied in clinical studies for its potential for abuse, there was no indication of drug-seeking behavior in the clinical studies. 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).

9.3Dependence 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 ( 2.8) ].

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Tumors were not increased by venlafaxine treatment in mice or rats. 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/m2 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 (ODV) were lower in rats than in patients receiving the maximum recommended dose. O-desmethylvenlafaxine (ODV), the major human metabolite of venlafaxine, administered by oral gavage to mice and rats for 2 years did not increase the incidence of tumors in either study.

Mice received ODV at dosages up to 500/300 mg/kg/day (dosage lowered after 45 weeks of dosing). The exposure at the 300 mg/kg/day dose is 9 times that of a human dose of 225 mg/day. Rats received ODV at dosages up to 300 mg/kg/day (males) or 500 mg/kg/day (females).

The exposure at the highest dose is approximately 8 (males) or 11 (females) times that of a human dose of 225 mg/day. Mutagenesis Venlafaxine and the major human metabolite, 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 or in the in vivo chromosomal aberration assay in rats. Impairment of Fertility Reproduction and fertility studies of venlafaxine in rats showed no adverse effects of venlafaxine 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/m2 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.

📄 Recent Major Changes 9 words ▾

Warnings and Precautions, Serotonin Syndrome ( 5.2 ) 1/2017

📄 Package Label / Principal Display Panel 26 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION 37.5 mg Labels Container Label

Carton Label

75 mg Labels Container Label

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150 mg Labels Container Label

Carton Label

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

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