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Venlafaxine Hydrochloride 150 mg Capsule, Extended Release, 500-count

by Preferred Pharmaceuticals, Inc. · 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8072-6)

NDC 68788-8072-06

🏷️ FDA NDC (as labeled) 68788-8072-6 billing pads the package segment with a zero

This package

Contains500-count Pack sizes3 compare ↓

Also priced by: Part D plans $0.2146/unit — full pricing hub ↓

Also comes in: 30 capsules 68788-8072-03 60 capsules 68788-8072-09

Rx only Generic On market Non-controlled

🗂️ Data synced 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 Dr. Brian Staiger, PharmD

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

🆔 Identity & classification

FDA NDC (as labeled) 68788-8072-6

Product NDC 68788-8072

11-digit billing NDC 68788807206

NCPDP billing unit EA — each (per item)

RxCUI 313581

UNII 7D7RX5A8MO

Application # ANDA212277

SPL Set ID b18d726e-cdb2-4c80-a49d-330cddee17e9

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 2021-08-27

Route ORAL

Dosage form CAPSULE, EXTENDED RELEASE

Substance VENLAFAXINE HYDROCHLORIDE

GPI-14 58180090107050

GPI class Venlafaxine HCl ER

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 68788-8072-6 — a 5-4-1 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 package segment → 68788-8072-06. 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.

🏭 Manufacturer & labeler

LabelerPreferred Pharmaceuticals, Inc.

Application holderANNORA PHARMA PRIVATE LTD

FDA applicationANDA212277 (ANDA)

Labeler code68788

First marketedAug 2021

Product typeHuman Prescription Drug

Portfolio178 products on file

🔎 All NDCs from Preferred Pharmaceuticals, Inc.

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.

🩺 Clinical

📖 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

Venlafaxine treats major depressive disorder in all its forms. Depending on which formulation you're prescribed, it can also treat generalized anxiety disorder, social anxiety diso...
Most people don't feel a full benefit right away — it typically takes several weeks before you notice a meaningful improvement in mood or anxiety. Blood levels stabilize within abo...
How long does it take for venlafaxine to start working?
The most common side effects are nausea, dry mouth, sweating, drowsiness or insomnia, dizziness, and decreased appetite — and many of these tend to improve after the first couple o...

📖 Read our full Venlafaxine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Nutrient depletion considerations

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

SODIUM Moderate Depletion

🧪 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.

💊 What it looks like

Color Orange / White

ShapeCapsule

ImprintV;11

Size21 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 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 EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue 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 R75537T0T4
Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
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 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 O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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.

13 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.

💲 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 system	Per each	Per 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	$107.30 / 500 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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Venlafaxine Hydrochloride 150 mg 00093-7386-05	Teva	500 capsules	$0.116	AB	Availability likely	—
Venlafaxine Hydrochloride 150 mg 00904-7489-61	Major	1 capsule	$0.116	AB	Availability likely	—
Venlafaxine Hydrochloride 150 mg 42806-0603-05	Epic	500 capsules	$0.116	AB	Availability likely	—
venlafaxine hydrochloride 150 mg 43598-0002-05	Dr.Reddys	500 capsules	$0.116	AB	Availability likely	—
Venlafaxine Hydrochloride 150 mg 50268-0875-15	AvPAK	1 capsule	$0.116	AB	Availability likely	—
Venlafaxine Hydrochloride 150 mg 65862-0697-01	Aurobindo	100 capsules	$0.116	—	Availability likely	—
Venlafaxine Hydrochloride 150 mg 68084-0713-01	American	1 capsule	$0.116	AB	Availability likely	—
Venlafaxine Hydrochloride 150 mg 70010-0186-03	Granules	30 capsules	$0.116	AB	Availability likely	—
Venlafaxine Hydrochloride 150 mg 70710-1700-00	Zydus	1000 capsules	$0.116	AB	Availability likely	—
Venlafaxine Hydrochloride 150 mg 82009-0058-05	QUALLENT	500 capsules	$0.116	AB	Availability likely	—
Venlafaxine hydrochloride 150 mg 33342-0196-07	Macleods	30 capsules	$0.139	AB	FDA listed	—
Effexor XR 150 mg 00008-0836-21	Wyeth	30 capsules	$21.625	AB	Discontinued	—
Effexor XR 150 mg 58151-0127-77	Viatris	90 capsules	$21.625	AB	Availability likely	—
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 mg 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 mgthis 68788-8072-06	Preferred	500 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 72603-0749-01	NorthStar	90 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

🏛️

2021

On the market since

Aug 2021

📍

2026

Currently FDA-listed

5 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for VENLAFAXINE HYDROCHLORIDE — the ingredient across all brands.

Top reported reactions

Nausea9,124

Fatigue8,208

Headache7,507

Dizziness6,594

Depression6,359

Anxiety6,176

Pain5,572

Age at onset

Neonate605

Infant45

Child25

Adolescent200

Adult10,846

Elderly4,452

Reporter sex

Serious outcomes

Hospitalization41,900

Death13,165

Life-threatening7,253

Disabling4,781

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
68788-8072-03	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8072-3)	2021-08-27	Active
68788-8072-06 You're viewing this	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8072-6)	2021-08-27	Active
68788-8072-09	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68788-8072-9)	2021-08-27	Active

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

Pack size FAQ

What quantity is in NDC 68788-8072-06?

NDC 68788-8072-06 is a 500-count package — 500 capsule, extended release in 1 bottle.

What is the difference between NDC 68788-8072-06 and NDC 68788-8072-03?

Both are Venlafaxine Hydrochloride 150 mg Capsule, Extended Release — the drug itself is identical. NDC 68788-8072-06 is the 500-count package, while NDC 68788-8072-03 is the 30 capsules package.

What NDC number is used to bill for this package of Venlafaxine Hydrochloride 150 mg Capsule, Extended Release?

Bill NDC 68788-8072-06 — the 11-digit billing format is 68788807206. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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	✓ Available
Inactive ingredients (structured)	✓ 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 FDA registers it as 68788-8072-6, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68788-8072-06, written without dashes as 68788807206. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 68788-8072-06, the first segment (68788) is the labeler code FDA assigned to Preferred Pharmaceuticals, Inc.; the middle segment (8072) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) identifies this exact package size and type. Together they name one specific package of one specific product.

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 Preferred Pharmaceuticals, Inc.. 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 30 capsules (68788-8072-03), 60 capsules (68788-8072-09). 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?

Preferred Pharmaceuticals, Inc. 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients

🚨 Boxed Warning 65 words ▾

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( )] . Venlafaxine hydrochloride extended-release capsules are not approved for use in pediatric patients [see Use in Specific Populations ( )].

Highlight

🎯 Indications and Usage 101 words ▾

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

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Indication Starting Dose TargetDose Maximum Dose MDD (2.2) 37.5 to 75 mg/day 75 mg/day 225 mg/day GAD (2.3) 37.5 to 75 mg/day 75 mg/day 225 mg/day SAD (2.4) 75 mg/day 75 mg/day 75 mg/day PD (2.5) 37.5 mg/day 75 mg/day 225mg/day • Take once daily with food. Capsules should be taken whole; do not divide, crush, chew, or dissolve ( ). • When discontinuing treatment, reduce the dose gradually ( , ). • 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 ( ). • 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% ( ).

2.1General Administration Information Administer venlafaxine hydrochloride extended-release capsules as a single dose with food, either in the morning or in the evening at approximately the same time each day [see Clinical Pharmacology ( )] . Swallow capsules whole with fluid. Do not divide, crush, chew, or place in water.

The capsule may also 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).

2.2Major Depressive Disorder For most patients, the recommended starting dose for venlafaxine hydrochloride extended-release capsules are 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. In the clinical studies establishing efficacy, upward titration was permitted at intervals of 2 weeks or more.

2.3Generalized Anxiety Disorder For most patients, the recommended starting dose for venlafaxine hydrochloride extended-release capsules are 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.

2.4Social 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.

2.5Panic Disorder The recommended starting dose is 37.5 mg per day of venlafaxine hydrochloride extended-release capsules for 7 days. Patients not responding to 75 mg per day may benefit from dose increases to a maximum of approximately 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 7 days.

2.6Screen for Bipolar Disorder Prior to Starting Venlafaxine Hydrochloride Extended-Release Capsules Prior to initiating treatment with venlafaxine hydrochloride extended-release capsules, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions ( )].

2.7Switching Patients from Venlafaxine Hydrochloride Tablets Patients with depression who are currently being treated with venlafaxine hydrochloride tablets may be switched to venlafaxine hydrochloride extended-release capsules at the nearest equivalent dose (mg per day), e.g., 37.5 mg venlafa…

💊 Dosage Forms and Strengths 148 words ▾

3 DOSAGE FORMS AND STRENGTHS Venlafaxine hydrochloride extended-release capsules USP are available in the following strengths: • 37.5 mg capsules (white to off white colored, round to oval shaped pellets filled in size '3' hard Gelatin capsules with grey opaque cap imprinted with 'V' in black color, white opaque body imprinted with '9' in black color.) • 75 mg capsules (white to off white colored, round to oval shaped pellets filled in size '1' hard Gelatin capsules with peach opaque cap imprinted with 'V' in black color, white opaque body imprinted with '10' in black color.) • 150 mg capsules (white to off white colored, round to oval shaped pellets filled in size '0' hard Gelatin capsules with orange opaque cap imprinted with 'V' in black color, white opaque body imprinted with '11' in black color.) • Extended-release capsules: 37.5 mg, 75 mg, and 150 mg ( ).

⛔ Contraindications 109 words ▾

4 CONTRAINDICATIONS Venlafaxine hydrochloride extended-release capsules are contraindicated in patients: • with known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation [see Adverse Reactions ( )]. • taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of the risk of serotonin syndrome [see Dosage and Administration ( ), Warnings and Precautions ( ), and Drug Interactions ( )]. • Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate, or any excipients in the venlafaxine hydrochloride extended-release capsules formulation ( ). • Concomitant use of monoaminoxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI ( , , ).

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue venlafaxine hydrochloride extended-release capsules and serotonergic agents and initiate supportive treatment ( , , ). • Elevated Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment ( ). • Increased Risk of Bleeding: Concomitant use of aspirin, NSAIDs, other antiplatelet drugs, warfarin, and other anticoagulants may increase risk ( ). • Angle-Closure Glaucoma: Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles, treated with antidepressants ( ). • Activation of Mania or Hypomania: Screen patients for bipolar disorder ( ). • Discontinuation Syndrome: Taper dose and monitor for discontinuation symptoms ( ). • Seizures: Can occur.

Use cautiously in patients with seizure disorder ( ). • Hyponatremia: Can occur in association with SIADH ( ). • Interstitial Lung Disease and Eosinophilic Pneumonia: Can occur ( ). • Sexual Dysfunction: Venlafaxine hydrochloride extended-release capsules may cause symptoms of sexual dysfunction ( ).

5.1Suicidal Thoughts and Behaviors in Adolescents and Young Adults In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients and 4,500 pediatric patients, the incidence of suicidal thoughts and behaviors in antidepressant-treated patients age 24 years and younger was greater than in placebo-treated patients. There was considerable variation in risk of suicidal thoughts and behaviors among drugs, but there was an increased risk identified in young patients for most drugs studied.

There were differences in absolute risk of suicidal thoughts and behaviors across the different indications, with the highest incidence in patients with MDD. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1,000 patients treated are provided in Table 1. Table 1: Risk Differences of the Number of Patients of Suicidal Thoughts and Behaviors in the Pooled Placebo-Controlled Trials of Antidepressants in Pediatric* and Adult Patients AgeRange Drug-PlaceboDifference in Number of Patients of Suicidal Thoughts and Behaviors per 1,000 Patients Treated Increases Compared to Placebo <18 years old 14 additional patients 18 to 24 years old 5 additional patients Decreases Compared to Placebo 25 to 64 years old 1 fewer patient ≥ 65 years old 6 fewer patients * Venlafaxine hydrochloride extended-release capsules are not approved in pediatric patients.

It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with MDD that antidepressants delay the recurrence of depression and that depression itself is a risk factor for suicidal thoughts and behaviors. Monitor all antidepressant-treated patients for any indication for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy, and at times of dosage changes.

Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing venlafaxine hydrochloride extended-release capsules, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.

5.2Serotonin Syndrome Serotonin-norepinephrine reuptake inhibitors (SNRIs), including venlafaxine hydrochloride extended-release capsules, can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs (including triptans, tric…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: • Hypersensitivity [see Contraindications ( )] • Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions ( )] • Serotonin Syndrome [see Warnings and Precautions ( )] • Elevated Blood Pressure [see Warnings and Precautions ( )] • Increased Risk of Bleeding [see Warnings and Precautions ( )] • Angle-Closure Glaucoma [see Warnings and Precautions ( )] • Activation of Mania/Hypomania [see Warnings and Precautions ( )] • Discontinuation Syndrome [see Warnings and Precautions ( )] • Seizure [see Warnings and Precautions ( )] • Hyponatremia [see Warnings and Precautions ( )] • Weight and Height Changes in Pediatric Patients [see Warnings and Precautions ( )] • Appetite Changes in Pediatric Patients [see Warnings and Precautions ( )] • Interstitial Lung Disease and Eosinophilic Pneumonia [see Warnings and Precautions ( )] • Sexual Dysfunction [see Warnings and Precautions ( )] Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo): nausea, somnolence, dry mouth, sweating, abnormal ejaculation, anorexia, constipation, impotence (men), and libido decreased ( ).

To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Most Common Adverse Reactions The most commonly observed adverse reactions in the clinical study database in venlafaxine hydrochloride extended-release capsules treated patients in MDD, GAD, SAD, and PD (incidence ≥5% and at least twice the rate of placebo) were: nausea (30%), 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 to 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) BodySystem 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 capsules 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.

Table 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…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS

7.1Drugs Having Clinically Important Interactions with Venlafaxine Hydrochloride Extended-Release Capsules Table 15: Clinically Important Drug Interactions with Venlafaxine Hydrochloride Extended-Release Capsules Monoamine Oxidase Inhibitors (MAOI) Clinical Impact The concomitant use of SNRIs, including venlafaxine hydrochloride extended-release capsules, with MAOIs increases the risk of serotonin syndrome. Intervention Concomitant use of venlafaxine hydrochloride extended-release capsules are contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration ( ), Contraindications( ) and Warnings and Precautions ( )].

Other Serotonergic Drugs Clinical Impact Concomitant use of venlafaxine hydrochloride extended-release capsules with other serotonergic drugs (including other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St. John's Wort) increases the risk of serotonin syndrome. Intervention Monitor for symptoms of serotonin syndrome when venlafaxine hydrochloride extended-release capsules are used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems.

If serotonin syndrome occurs, consider discontinuation of venlafaxine hydrochloride extended-release capsules and/or concomitant serotonergic drugs [see Dosage and Administration ( ) and Warnings and Precautions ( )]. Drugs that Interfere with Hemostasis Clinical Impact Concomitant use of venlafaxine hydrochloride extended-release capsules with an antiplatelet or anticoagulant drug may potentiate the risk of bleeding. This may be due to the effect of venlafaxine hydrochloride extended-release capsules on the release of serotonin by platelets.

Intervention Closely monitor for bleeding for patients receiving an antiplatelet or anticoagulant drug when venlafaxine hydrochloride extended-release capsules are initiated or discontinued [see Warnings and Precautions ( )] . Effect of CYP3A Inhibitors Clinical Impact Concomitant use of a CYP3A inhibitor increases the C max and AUC of venlafaxine and O-desmethylvenlafaxine (ODV) [see Clinical Pharmacology ( )] , which may increase the risk of toxicity of venlafaxine hydrochloride extended-release capsules. Intervention Consider reducing the dose of venlafaxine hydrochloride extended-release capsules.

CYP2D6 Substrates Clinical Impact Concomitant use of venlafaxine hydrochloride extended-release capsules increases C max and AUC of a CYP2D6 substrate, which may increase the risk of toxicity of the CYP2D6 substrate [see Clinical Pharmacology ( )]. Intervention Consider reduction in dose of concomitant CYP2D6 substrates.

7.2Other Drug Interactions with Venlafaxine Hydrochloride Extended-Release Capsules Central Nervous System (CNS)-Active Drugs The risk of using venlafaxine concomitantly with other CNS-active drugs (including alcohol) has not been systematically evaluated. Consequently, caution is advised when venlafaxine hydrochloride extended-release capsules are taken concomitantly in combination with other CNS-active drugs. Weight Loss Agents Concomitant use of venlafaxine hydrochloride extended-release capsules and weight loss agents is not recommended.

The safety and efficacy of venlafaxine therapy in combination with weight loss agents, including phentermine, have not been established. Venlafaxine hydrochloride extended-release capsules are not indicated for weight loss alone or in combination with other products. Laboratory Test Interference False-positive urine immunoassay screening tests for phencyclidine (PCP) and amphetamine have been reported in patients taking venlafaxine due to lack of specificity of the screening tests.

False-positive test results may be expected for several days following discontinuation of venlafaxine therapy. Confirmatory tests, such as gas chromatography/mass spectrometry, will distinguish venlafaxine from PCP and amphet…

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Third trimester use may increase risk for symptoms of poor neonatal adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate ( ).

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including venlafaxine hydrochloride extended-release capsules, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. Risk Summary Based on data from published observational studies, exposure to SNRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions ( ) and Clinical Considerations] .

Available data from published epidemiologic studies on venlafaxine use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse fetal outcomes (see Data). Available data from observational studies with venlafaxine have identified a potential increased risk for preeclampsia when used during mid to late pregnancy; exposure to SNRIs near delivery may increase the risk for postpartum hemorrhage (see Clinical Considerations).There are risks associated with untreated depression in pregnancy and poor neonatal adaptation in newborns with exposure to SNRIs, including venlafaxine hydrochloride extended-release capsules, during pregnancy (see Clinical Considerations).

In animal studies, there was no evidence of malformations or fetotoxicity following administration of venlafaxine during organogenesis at doses up to 2.5 times (rat) or 4 times (rabbit) the maximum recommended human daily dose on a mg/m 2basis. Postnatal mortality and decreased pup weights were observed following venlafaxine administration to pregnant rats during gestation and lactation at 2.5 times (mg/m 2) the maximum human daily dose. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants.

This finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depression who were euthymic and taking antidepressants at the beginning of pregnancy. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Maternal Adverse Reactions Exposure to venlafaxine hydrochloride extended-release capsules in mid to late pregnancy may increase the risk for preeclampsia, and exposure to venlafaxine hydrochloride extended-release capsules in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.4)].

Fetal/Neonatal Adverse Reactions Neonates exposed to SNRIs 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, tremors, jitteriness, irritability, and constant crying.

These findin…

🤰 Pregnancy ~2 min read ▾

These findings are consistent with either a direct toxic effect of 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 ( )] .…

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Safety and effectiveness of venlafaxine hydrochloride extended-release capsules in pediatric patients have not been established. 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 use in pediatric patients. In the studies conducted in pediatric patients ages 6 to 17 years, the occurrence of blood pressure and cholesterol increases was considered to be clinically relevant in pediatric patients and was similar to that observed in adult patients [see Warnings and Precautions ( ) , Adverse Reactions ( )] .

The following adverse reactions were also observed in pediatric patients: abdominal pain, agitation, dyspepsia, ecchymosis, epistaxis, and myalgia. 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 Warnings and Precautions ( , )] . Decreased appetite and weight loss were observed in placebo-controlled studies of pediatric patients 6 to 17 years.

In pediatric clinical studies, the adverse reaction, suicidal ideation, was observed. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning, Warnings and Precautions ( )] .

🧓 Geriatric Use ~1 min read ▾

8.5Geriatric Use The percentage of patients in clinical studies for venlafaxine hydrochloride extended-release capsules for MDD, GAD, SAD, and PD who were 65 years of age or older are shown in Table 16. Table 16: Percentage (and Number of Patients Studied) of Patients 65 Years of Age and Older by Indication a Indication Venlafaxine Hydrochloride Extended-Release Capsules MDD 4 (14/357) GAD 6 (77/1,381) SAD 1 (10/819) PD 2 (16/1,001) a In addition, in the premarketing assessment of venlafaxine hydrochloride (immediate-release), 12% (357/2,897) of patients were ≥ 65 years of age.

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 Warnings and Precautions ( )] .

The pharmacokinetics of venlafaxine and ODV are not substantially altered in the elderly [see Clinical Pharmacology ( )] (see Figure 1). 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 ~2 min read ▾

10 OVERDOSAGE Human 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. Management of Overdosage No specific antidotes for venlafaxine hydrochloride extended-release capsules are known. In managing overdosage, consider the possibility of multiple drug involvement.

Consider contacting a Poison Center (1-800-222-1222) or a medical toxicologist for overdosage management recommendations for venlafaxine hydrochloride extended-release capsules.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of venlafaxine in the treatment of MDD, GAD, SAD, and PD is unclear, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of their reuptake.

12.2Pharmacodynamics In vitro studies have demonstrated that venlafaxine and its active metabolite, O-desmethylvenlafaxine (ODV), are potent and selective 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. Cardiac Electrophysiology The effect of venlafaxine on the QT interval was evaluated in a randomized, double-blind, placebo- and positive-controlled three-period crossover thorough QT study in 54 healthy adult subjects. No significant QT prolongation effect of venlafaxine at 450 mg (2 times the maximum recommended dosage) was detected.

12.3Pharmacokinetics Venlafaxine and ODV steady-state concentrations are reached within 3 days. Venlafaxine and ODV exhibited linear kinetics over the dosage range of 75 to 450 mg per day (0.33 to 2 times the maximum recommended dosage). Time of administration (AM versus PM) did not affect the pharmacokinetics of venlafaxine and ODV from the 75 mg venlafaxine hydrochloride extended-release capsules.

Absorption Venlafaxine is well absorbed. 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 C max and later T max values than for venlafaxine hydrochloride administered twice daily (Table 17). 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 provides a slower rate of absorption, but the same extent of absorption compared with the immediate-release tablet. Table 17: Comparison of C max and T max Values for Venlafaxine and ODV Following Oral Administration of Venlafaxine Hydrochloride Extended-Release Capsules and Venlafaxine Hydrochloride (Immediate-Release) Venlafaxine ODV C max (ng/mL) T max (h) C max (ng/mL) T max (h) Venlafaxine Hydrochloride Extended-Release Capsules (150 mg once daily) 150 5.5 260 9 Venlafaxine Hydrochloride tablets (75 mg twice daily) 225 2 290 3 Effect of Food Food did not affect the bioavailability of venlafaxine or its active metabolite, ODV.

Distribution Venlafaxine is 27% and ODV is 30% bound to plasma proteins. The apparent volume of distribution at steady-state is 7.5 ±

3.7L/kg for venlafaxine and 5.7 ±

1.8L/kg for ODV. Elimination Mean ± SD plasma apparent clearance at steady-state is 1.3 ±

0.6L/h/kg for venlafaxine and 0.4 ±

0.2L/h/kg for ODV. The apparent elimination half-life is 5 ± 2 hours for venlafaxine and 11 ± 2 hours for ODV. Metabolism 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 r…

🧬 Mechanism of Action 44 words ▾

📦 How Supplied / Storage and Handling 84 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING • Venlafaxine hydrochloride extended-release capsules USP, 150 mg are white to off white colored, round to oval shaped pellets filled in size '0' hard Gelatin capsules with orange opaque cap imprinted with 'V' in black color, white opaque body imprinted with '11' in black color. Bottle of 30 capsules NDC 68788-8072-3 Bottle of 60 capsules NDC 68788-8072-6 Bottle of 90 capsules NDC 68788-8072-9 Store at controlled room temperature, 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]

📋 Description 170 words ▾

11 DESCRIPTION Venlafaxine hydrochloride extended-release capsule USP is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a serotonin and norepinephrine reuptake inhibitor (SNRI). Venlafaxine is designated Cyclohexanol,1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]-, 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 313.9.

The structural formula is shown as follows: Venlafaxine hydrochloride USP is a white or almost white powder, freely soluble in methanol and water, soluble in anhydrous ethanol and slightly soluble or practically insoluble in acetone. 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 ethyl cellulose, hypromellose, sugar spheres and talc. The capsule shells have the following inactive ingredients: iron oxide yellow, iron oxide red, iron oxide black, gelatin and titanium dioxide. The printing Ink contains shellac, strong ammonia solution, black iron oxide and potassium hydroxide.

Meets USP Dissolution Test-10. venlafaxinestructure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dose is adjusted up or down, and instruct them to report such symptoms to the healthcare provider [see Boxed Warning and Warnings and Precautions ( )]. Concomitant Medication Instruct patients not to take venlafaxine hydrochloride extended-release capsules with an MAOI or within 14 days of stopping an MAOI [see Contraindications ( )].

Serotonin Syndrome Caution patients about the risk of serotonin syndrome, particularly with the concomitant use of venlafaxine hydrochloride extended-release capsules with other serotonergic drugs including triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, St. John’s Wort, and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid). Instruct patients to contact their healthcare provider or report to the emergency room if they experience signs or symptoms of serotonin syndrome [see Warnings and Precautions ( ) and Drug Interactions ( )].

Elevated Blood Pressure Advise patients that they should have regular monitoring of blood pressure when taking venlafaxine hydrochloride extended-release capsules [see Warnings and Precautions ( )]. Increased Risk of Bleeding Inform patients about the concomitant use of venlafaxine hydrochloride extended-release capsules with NSAIDs, aspirin, other antiplatelet drugs, warfarin, or other drugs that affect coagulation because the combined use has been associated with an increased risk of bleeding. Advise patients to inform their health care providers if they are taking or planning to take any prescription or over-the-counter medications that increase the risk of bleeding [see Warnings and Precautions ( )].

Activation of Mania/Hypomania Advise patients, their families and caregivers to observe for signs of activation of mania/hypomania and instruct them to report such symptoms to the healthcare provider [see Warnings and Precautions ( )]. Cardiovascular/Cerebrovascular Disease Caution is advised in administering venlafaxine hydrochloride extended-release capsules to patients with cardiovascular, cerebrovascular, or lipid metabolism disorders [see Adverse Reactions ( )]. Serum Cholesterol and Triglyceride Elevation Advise patients that elevations in total cholesterol, LDL and triglycerides may occur and that measurement of serum lipids may be considered [see Adverse Reactions ( )].

Discontinuation Syndrome Advise patients not to abruptly stop taking venlafaxine hydrochloride extended-release capsules without talking first with their healthcare provider. Patients should be aware that discontinuation effects may occur when stopping venlafaxine hydrochloride extended-release capsules and they should monitor for discontinuation symptoms [see Warnings and Precautions ( ) and Adverse Reactions ( )]. Sexual Dysfunction Advise patients that use of venlafaxine hydrochloride extended-release capsules may cause symptoms of sexual dysfunction in both male and female patients.

Inform patients that they should discuss any changes in sexual function and potential management strategies with their healthcare provider [see Warnings and Precautions ( )]. Interference with Cognitive and Motor Performance Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that venlafaxine hydrochloride extended-release capsules therapy does not adversely affect their ability to engage in such activities. Alcohol Advise patients to avoid alcohol while taking venlafaxine hydrochloride extended-release capsules [see Drug Interactions ( )].

Allergic Reactions Advise patients to notify their healthcare provider if they develop allergic phenomena suc…

Glossary — plain-language definitions of medical terms used in this label:

anticoagulant: A medicine that slows down blood clotting; often called a blood thinner.

antiplatelet: A medicine that makes platelets, the blood cells that start a clot, less likely to clump together.

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

sedative: A substance with a calming effect that can also cause drowsiness.

serotonergic: Acting on serotonin, a chemical messenger involved in mood, sleep, and digestion.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

active metabolite: A substance made when the body breaks down a medicine that still has an effect of its own.

adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

apnea: A pause or temporary stop in breathing.

asthenia: Unusual weakness or lack of physical strength and energy.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

cirrhosis: Long-term scarring of the liver that gradually replaces healthy tissue and reduces how well the liver works.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

cyanosis: A bluish color of the skin, lips, or nails caused by too little oxygen in the blood.

CYP2D6: A liver enzyme that breaks down many medicines; people inherit different versions, so it works faster in some and slower in others.

depression: A lasting low mood with loss of interest that affects everyday life.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

ecchymosis: A bruise; a flat blue or purple mark on the skin where blood has leaked underneath.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

electrocardiogram: A quick, painless test that records the heart's electrical activity to check its rhythm and rate.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

epistaxis: A nosebleed.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

extended-release: A pill or capsule made to release its medicine slowly over many hours, so it can be taken less often; often labeled ER or XR.

glaucoma: An eye condition, often linked to high pressure inside the eye, that can slowly damage vision.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperreflexia: Overactive or exaggerated reflexes, such as an unusually strong knee-jerk response.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypoglycemia: Low blood sugar, when the amount of glucose (sugar) in the blood drops below the normal range.

hypomania: A milder form of mania, with raised energy and mood that is less severe and shorter-lasting than a full manic episode.

hyponatremia: A lower-than-normal level of sodium (salt) in the blood.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

immediate-release: A standard pill or capsule that releases all of its medicine soon after it is swallowed.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

interstitial lung disease: A group of conditions in which the tissue around the lungs' air sacs becomes scarred or inflamed, making breathing harder.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

irritability: Getting annoyed, frustrated, or angry more easily than usual.

lactation: The making and release of milk from a mother's breasts after giving birth.

mania: A period of unusually high energy, racing thoughts, and an excited or irritable mood that is more extreme than normal.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

myalgia: Muscle pain or aching.

mydriasis: Widening of the pupil, the dark center of the eye.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

paresthesia: A tingling, prickling, or "pins and needles" feeling in the skin, often in the hands or feet.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

postpartum: The period of time right after a woman gives birth.

potentiate: To make the effect of one medicine stronger by taking another substance along with it.

Pregnancy Exposure Registry: A study that collects health information from women who took a medicine while pregnant to learn how safe it is.

QT prolongation: A longer-than-normal electrical recovery time between heartbeats, seen on a heart tracing (ECG), which can raise the chance of a dangerous heart rhythm.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

relapse: The return of a cancer after a period of improvement or disappearance.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

rhabdomyolysis: A serious condition where damaged muscle breaks down and releases material into the blood that can harm the kidneys.

seizure: A sudden burst of abnormal electrical activity in the brain that can cause shaking, staring, confusion, or loss of awareness.

serotonin syndrome: A potentially dangerous reaction from too much of the brain chemical serotonin, causing agitation, fast heartbeat, sweating, and muscle twitching.

SIADH: Syndrome of inappropriate antidiuretic hormone: the body makes too much of a water-holding hormone, which lowers the level of sodium (salt) in the blood.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

suicidal ideation: Thoughts about wanting to end your own life, which can range from a passing wish to a detailed plan.

suicidality: A general term covering both thoughts about ending one's own life and actions taken toward it.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

taper: Gradually lowering a dose in steps before stopping, rather than quitting all at once.

titration: Slowly adjusting a medicine's dose up or down in small steps to find the amount that works best with the fewest side effects.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vertigo: A spinning sensation that makes you feel like you or the room around you is moving.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

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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.

Venlafaxine Hydrochloride 150 mg Capsule, Extended Release, 500-count

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