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VENLAFAXINE HYDROCHLORIDE 75 mg Capsule, Extended Release, 30-count

by DIRECT RX · 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (61919-222-30)
NDC 61919-0222-30
🏷️ FDA NDC (as labeled) 61919-222-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also comes in: 60 capsules 61919-0222-60
Rx only Generic Discontinued Non-controlled ⚠ Listing certification expired
🗂️ Data synced Jul 14, 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

⚠️
Excluded from the active FDA NDC Directory. This product’s FDA listing certification lapsed (the firm did not recertify), so it was excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 61919-222-30
Product NDC 61919-222
11-digit billing NDC 61919022230
NCPDP billing unit EA — each (per item)
Application # ANDA090174
SPL Set ID b4481d2d-e26f-49b7-be15-947092cde49c
Established class (EPC) Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Listing certification expired (certified through Dec 2024)
Route ORAL
Dosage form CAPSULE, EXTENDED RELEASE
Substance VENLAFAXINE HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 61919-222-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 61919-0222-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerDIRECT RX
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA090174 (ANDA)
Labeler code61919
Product typeHuman Prescription Drug
Portfolio204 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.

🩺 Clinical

📗 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 →

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.

🧪 Inactive Ingredients / Excipients

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

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

Inactive ingredient FAQ

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

💲 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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 60 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Venlafaxine Hydrochloride 75 mg 00093-7385-05 Teva 500 capsules $0.079 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 00904-7488-61 Major 1 capsule $0.079 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 42806-0602-09 Epic 90 capsules $0.079 AB Availability likely —
venlafaxine hydrochloride 75 mg 43598-0001-10 Dr.Reddys 1000 capsules $0.079 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 50268-0874-15 AvPAK 1 capsule $0.079 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 62332-0793-30 Alembic 30 capsules $0.079 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 65862-0528-01 Aurobindo 100 capsules $0.079 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 68084-0709-01 American 1 capsule $0.079 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 70010-0185-03 Granules 30 capsules $0.079 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 70710-1699-00 Zydus 1000 capsules $0.079 AB Availability likely —
Venlafaxine Hydrochloride 75 mg 82009-0057-10 QUALLENT 1000 capsules $0.079 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 $19.836 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 mg 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 72603-0748-01 NorthStar 90 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 mgthis 61919-0222-30 DIRECT 30 capsules — AB Discontinued —
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

📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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

0 reports

Serious outcomes

Hospitalization41,900
Death13,165
Life-threatening7,253
Disabling4,781
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 9,286 3,377
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 NDCDescription Marketing startStatus
61919-0222-30 You're viewing this 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (61919-222-30) 2020-08-12 Listing certification expired
61919-0222-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (61919-222-60) 2014-01-01 Listing certification expired

You're viewing the smallest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 61919-0222-30?
NDC 61919-0222-30 is a 30-count package — 30 capsule, extended release in 1 bottle.
What is the difference between NDC 61919-0222-30 and NDC 61919-0222-60?
Both are VENLAFAXINE HYDROCHLORIDE 75 mg Capsule, Extended Release — the drug itself is identical. NDC 61919-0222-30 is the 30-count package, while NDC 61919-0222-60 is the 60 capsules package.
What NDC number is used to bill for this package of VENLAFAXINE HYDROCHLORIDE 75 mg Capsule, Extended Release?
Bill NDC 61919-0222-30 — the 11-digit billing format is 61919022230. 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 No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 61919-222-30, 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: 61919-0222-30, written without dashes as 61919022230. 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 61919-0222-30, the first segment (61919) is the labeler code FDA assigned to DIRECT RX; the middle segment (0222) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 60 capsules (61919-0222-60). 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?
DIRECT RX 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 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning 117 words ▾

BOXED WARNING SECTION WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants 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)].

🎯 Indications and Usage 103 words ▾

INDICATIONS & USAGE SECTION

1.1Major Depressive Disorder Venlafaxine hydrochloride extended-release capsules, USP 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.

1.3Social Anxiety Disorder Venlafaxine hydrochloride extended-release capsules, USP 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, USP 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 ▾

DOSAGE & ADMINISTRATION SECTION 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).

2.1Major 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, 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 tablets, 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.

2.3Social 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 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.

2.5Switching Patients from Venlafaxine Hydrochloride Tablets Depressed patients who are currently being treated at a therapeutic dose 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 venlafaxine twice a day to 75 mg venlafaxine hydrochloride extended-release capsules once daily. However, individual dosage adjustments may be necessary.

2.6Specific Populations Patients with Hepatic Impairment The total daily dose should be reduced by 50% in patients with mild (Child-Pugh=5 to 6) to moderate (Child-Pugh=7 to 9) hepatic impairment. In patients with severe hepatic impairment (Child-Pugh=10 to 15) or hepatic cirrhosis, it may be necessary to reduce the dose by 50% or more [See Use in Specific Populations (8.7)]. Patients with Renal Impairment The total daily dose should be reduced by 25% to 50% in patients with mild (CLcr= 60 to 89 mL/min) or moderate (CLcr= 30 to 59 mL/min) renal impairment.

In patients undergoing hemodialysis or with severe renal impairment (CLcr < 30 mL/min), the total daily dose should be reduced by 50% or more. Because there was much individual variability in clearance between patients with renal impairment, individualization of dosage may be desirable in some pat…

💊 Dosage Forms and Strengths 140 words ▾

DOSAGE FORMS & STRENGTHS SECTION Venlafaxine Hydrochloride Extended-release Capsules, USP are available in the following strengths: Venlafaxine Hydrochloride Extended-release Capsules USP, 37.5 mg are white to off-white free flowing pellets filled in size '3' hard gelatin capsules with grey colored cap printed with "ZA-35" in black ink & white body printed with "37.5 mg" in black ink. Venlafaxine Hydrochloride Extended-release Capsules USP, 75 mg are white to off-white free flowing pellets filled in size '1' hard gelatin capsules with peach colored cap printed with "ZA-36" in black ink & white body printed with "75 mg" in black ink.

Venlafaxine Hydrochloride Extended-release Capsules USP, 150 mg are white to off-white free flowing pellets filled in size '0' hard gelatin capsules with dark orange colored cap printed with "ZA-37" in black ink & white body printed with "150 mg" in black ink.

⛔ Contraindications 145 words ▾

CONTRAINDICATIONS SECTION

4.1Hypersensitivity 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 ▾

WARNINGS AND PRECAUTIONS SECTION

5.1Suicidal 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 1Difference in the Number of Cases of Suicidality per 1,000 Patients Treated versus Placebo Age Range Increases Compared to Placebo < 18 14 additional cases 18 to 24 5 additional cases Decreases Compared to Placebo 25 to 64 1 fewer case ≥ 65 6 fewer cases No suicides occurred in any of the pediatric 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 evidence from placebo-controlled maintenance studies in adults with depression that the use of antidepressants can delay the recurrence of depression. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for MDD, as well as for other indications, both psychiatric and nonpsychiatric.

Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.…

🤒 Adverse Reactions ~3 min read ▾

ADVERSE REACTIONS SECTION 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 andPrecautions ( 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 ) ] Renal Impairment [see Warnings and Precautions ( 2.6 ) ] Hepatic Impairment [see Warnings and Precautions ( 2.6 ) ] 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 )]

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 hydrochloride extended-release capsules treated patients in MDD, 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 7Incidence (%) 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 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 tablets only) and outpatient studies, fixed-dose, and titration studies.

Table 8Patients Receiving Venlafaxine Hydrochloride Extended-release Capsules in Premarketing Clinical Studies aIn addition, in the premarketing assessment of venlafaxine hydrochloride tablets, multiple doses were administered to 2,897 patients in studies for MDD. Indication Venlafaxine Hydrochloride Extended-release Capsules MDD 705a SAD 819 PD 1,314 The incidences of common adverse reactions (those that occurred in ≥ 2% of venlafaxine hydrochloride extended-release ca…

🔄 Drug Interactions ~2 min read ▾

DRUG INTERACTIONS SECTION

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 is 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 is not recommended. Venlafaxine hydrochloride extended-release capsules are not indicated for weight loss alone or in combination with other products.

7.6Effects of Other Drugs on Venlafaxine Hydrochloride Extended-release Capsules Figure 1: Effect of interacting drugs on the pharmacokinetics of venlafaxine and active metabolite Venlafaxine hydrochloride extended-release capsules, USP 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 coadministration with CYP2D6 inhibitors (Fig 3 and Metabolism Section 12.3)

7.7Effects of Venlafaxine Hydrochloride Extended-release Capsules on Other Drugs Figure 2: Effect of venlafaxine on the pharmacokinetics interacting drugs and their active metabolites. Venlafaxine hydrochloride extended-release capsules, USP 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), respectively. Note: *: Administration of venlafaxine in a stable regimen did not exaggerate the psychomotor and psychometric effects induced by ethanol in these…

👥 Use in Specific Populations ~3 min read ▾

USE IN SPECIFIC POPULATIONS SECTION

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 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 [see 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 capsule'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 venlafaxine hydrochloride extended-release capsules, regular monitoring of weight and height is recommended during treatment, particularly if treatment is to be continued long-term [see Warnings and Precautions ( 5.10 , 5.11 )]. The sa…

🆘 Overdosage ~2 min read ▾

OVERDOSAGE SECTION

10.1Human Experience During the premarketing evaluations of venlafaxine hydrochloride extended-release capsules (for MDD, SAD, and PD) and venlafaxine hydrochloride tablets (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 tablets 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 ▾

CLINICAL PHARMACOLOGY SECTION

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, H1-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 tablets 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 16Comparison of Cmax and Tmax Values for Venlafaxine and ODV Following OralAdministration of Venlafaxine Hydrochloride Extended-release Capsules and Venlafaxine Hydrochloride Tablets Venlafaxine ODV Cmax (ng/mL) Tmax (h) Cmax (ng/mL) Tmax (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 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 compared to people with normal CY…

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

HOW SUPPLIED SECTION Venlafaxine Hydrochloride Extended-release Capsules USP, 37.5 mg are white to off-white free flowing pellets filled in size '3' hard gelatin capsules with grey colored cap printed with "ZA-35" in black ink & white body printed with "37.5 mg" in black ink and are supplied as follows: NDC 68382-034-06 in bottle of 30 capsules NDC 68382-034-16 in bottle of 90 capsules NDC 68382-034-01 in bottle of 100 capsules NDC 68382-034-05 in bottle of 500 capsules NDC 68382-034-10 in bottle of 1000 capsules Venlafaxine Hydrochloride Extended-release Capsules USP, 75 mg are white to off-white free flowing pellets filled in size '1' hard gelatin capsules with peach colored cap printed with "ZA-36" in black ink & white body printed with "75 mg" in black ink and are supplied as follows: NDC 68382-035-06 in bottle of 30 capsules NDC 68382-035-16 in bottle of 90 capsules NDC 68382-035-01 in bottle of 100 capsules NDC 68382-035-05 in bottle of 500 capsules NDC 68382-035-10 in bottle of 1000 capsules Venlafaxine Hydrochloride Extended-release Capsules USP, 150 mg are white to off-white free flowing pellets filled in size '0' hard gelatin capsules with dark orange colored cap printed with "ZA-37" in black ink & white body printed with "150 mg" in black ink and are supplied as follows: NDC 68382-036-06 in bottle of 30 capsules NDC 68382-036-16 in bottle of 90 capsules NDC 68382-036-01 in bottle of 100 capsules NDC 68382-036-05 in bottle of 500 capsules NDC 68382-036-10 in bottle of 1000 capsules Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container.

📋 Description 195 words ▾

DESCRIPTION SECTION 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 (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the molecular formula of C17H27NO2 HCl. Its molecular weight is 313.86.

The structural formula is shown as follows: Venlafaxine hydrochloride, USP is a white to off-white crystalline powder; soluble in methanol and in water. Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent.

Venlafaxine hydrochloride extended-release capsules, USP intended for oral administration contains 37.5 mg, 75 mg and 150 mg of venlafaxine. In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, cetostearyl alcohol, gelatin, hypromellose, microcrystalline cellulose, polyacrylate dispersion, sodium lauryl sulfate, talc and titanium dioxide. Additionally each 37.5 mg capsule shell contains black iron oxide and each 75 mg and 150 mg capsule shell contains red iron oxide.

The capsule is printed with black pharmaceutical ink which contains black iron oxide as coloring agent. The product complies with USP dissolution test 7. image description

💬 Information for Patients ~3 min read ▾

INFORMATION FOR PATIENTS SECTION See 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, 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 capsules [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. Preexisting glaucoma is almost always open-angle glaucoma because angle closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle closure glaucoma.

Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prop…

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