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Duloxetine 60 mg Capsule, Delayed Release, 1,000-count

by Ascend Laboratories, LLC · 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-265-10)

NDC 67877-0265-10

🏷️ FDA NDC (as labeled) 67877-265-10 billing pads the product segment with a zero

This package

Contains1,000-count Cost per ea$0.1293 NADAC Per package$129.30 / 1000 capsules Pack sizes4 compare ↓

Also priced by: Medicaid pays $0.3918/unit · Part D plans $0.3495/unit — full pricing hub ↓

Also comes in: 30 capsules 67877-0265-30 90 capsules 67877-0265-90 100 capsules 67877-0265-01

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

⚠️

Other active recalls for Duloxetine (different manufacturers) — 4 · tap to view

These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.

Class II · May 14, 2026 — CGMP Deviations; presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the FDA acceptable intake limit. (Asclemed USA Inc.) · FDA recall D-0555-2026

Class II · Apr 29, 2026 — CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals. (Ajanta Pharma Ltd.) · FDA recall D-0514-2026

Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 67877-265-10

Product NDC 67877-265

11-digit billing NDC 67877026510

NCPDP billing unit EA — each (per item)

RxCUI 596926, 596930, 596934

UNII 9044SC542W

UPC 0367877263106

Application # ANDA203197

SPL Set ID e6477c41-97a2-45a7-94b5-487aa65199f6

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 2012-05-01

Route ORAL

Dosage form CAPSULE, DELAYED RELEASE

Substance DULOXETINE HYDROCHLORIDE

GPI-14 58180025106750

GPI class DULoxetine HCl

GCN Seq No 057893

GCN 23164

HICL code 026521

Ingredient (HICL) Duloxetine Hcl

HIC1 code H

Therapeutic class — broad (HIC1) Nervous System (Except Autonomic)

HIC2 code H7

Therapeutic class — intermediate (HIC2) Psychoactive Drugs (Continued 1)

HIC3 code H7C

Therapeutic class — specific (HIC3) Serotonin-Norepinephrine Reuptake-Inhib (Snris)

AHFS code 28:16.04.16

AHFS class Sel.serotonin,Norepi Reuptake Inhibitor

FDB label name DULOXETINE HCL DR 60 MG CAP

FDB brand name Duloxetine Hcl

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 67877-265-10 — 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 → 67877-0265-10. 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

LabelerAscend Laboratories, LLC

Application holderALKEM LABORATORIES LTD

FDA applicationANDA203197 (ANDA)

Labeler code67877

First marketedMay 2012

Product typeHuman Prescription Drug

Portfolio346 products on file

🔎 All NDCs from Ascend Laboratories, LLC

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

Label name DULOXETINE HCL DR 60 MG CAP Ingredient Duloxetine Hcl

📗 Our plain-language guide HelloPharmacist

You're right to ask — duloxetine does a lot more than treat depression. It's also approved for generalized anxiety disorder, diabetic nerve pain, fibromyalgia, and chronic musculos...
What is duloxetine actually used for? My doctor prescribed it but I wasn't sure it was just for depression.
It depends on which product you have. Most duloxetine delayed-release capsules — including Cymbalta — must be swallowed whole. Crushing, chewing, or opening them damages the specia...
Can I open the capsule or crush it if I have trouble swallowing pills?

📖 Read our full Duloxetine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Duloxetine — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Duloxetine (132 interactions) — ranked by severity →

Nutrient depletion considerations

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

SODIUM Moderate Depletion

🧪 Full Duloxetine 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 Green / White / Blue

ShapeCapsule

ImprintDulox;60mg

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.

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 system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.129	$129.30 / 1000 capsules
Medicaid paysCMS SDUD · 12 mo	$0.3918	$391.80 / 1000 capsules
Medicare drug plans payPart D · Q2 2026	$0.3495	$349.50 / 1000 capsules

NADAC price history (per ea) — tap or hover for the price & month

▲ Up 12% over the last 24 months.

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
Duloxetine Hydrochloride 60 mg 33342-0162-07	Macleods	30 capsules	$0.115	AB	FDA listed	save 11%
Duloxetine 60 mg 00228-2892-03	Actavis	30 capsules	$0.129	AB	Availability likely	—
Duloxetine 60 mg 27241-0099-03	Ajanta	30 capsules	$0.129	AB	Availability likely	—
Duloxetine 60 mg 43547-0381-03	Solco	30 capsules	$0.129	AB	Availability likely	—
Duloxetine Delayed-Release 60 mg 51991-0748-10	Breckenridge	1000 capsules	$0.129	AB	Availability likely	—
Duloxetine 60 mgthis 67877-0265-10	Ascend	1000 capsules	$0.129	AB	Availability likely	—
Duloxetine 60 mg 68001-0596-04	BluePoint	30 capsules	$0.129	AB	Availability likely	—
Duloxetine 60 mg 68180-0296-03	Lupin	1000 capsules	$0.129	AB	Availability likely	—
Duloxetine 60 mg 82009-0032-10	Quallent	1000 capsules	$0.129	AB	Availability likely	—
Duloxetine 60 mg 82009-0173-10	Quallent	1000 capsules	$0.129	AB	Availability likely	—
Duloxetine 60 mg 00615-8496-05	NCS	15 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 25000-0610-03	MARKSANS	30 capsules	—	—	FDA listed	—
Duloxetine 60 mg 31722-0170-01	Camber	100 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 42708-0196-30	QPharma,	30 capsules	—	AB	FDA listed	—
Duloxetine Hydrochloride 60 mg 46708-0280-10	Alembic	100 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 47335-0383-08	Sun	100 capsules	—	—	FDA listed	—
duloxetine 60 mg 49252-0009-10	Inventia	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 50090-5940-00	A-S	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 50090-6775-00	A-S	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 50090-6893-00	A-S	90 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 50090-7897-00	A-S	90 capsules	—	AB	FDA listed	—
Duloxetine Hydrochloride 60 mg 50771-0203-01	Yaopharma	30 capsules	—	—	FDA listed	—
Duloxetine Delayed-Release 60 mg 51407-0819-10	Golden	1000 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 51655-0237-25	Northwind	60 capsules	—	AB	FDA listed	—
Duloxetine Hydrochloride 60 mg 59651-0282-30	Aurobindo	30 capsules	—	—	FDA listed	—
Duloxetine 60 mg 60760-0462-30	St.	30 capsules	—	AB	Discontinued	—
Duloxetine Hydrochloride 60 mg 62332-0280-30	Alembic	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 63187-0666-30	Proficient	30 capsules	—	AB	FDA listed	—
Duloxetine Delayed-Release 60 mg 63187-0735-30	Proficient	30 capsules	—	AB	FDA listed	—
Duloxetine Delayed-Release 60 mg 63629-1992-01	Bryant	90 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 63629-8748-01	Bryant	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 65841-0801-06	Zydus	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 67046-1598-03	Coupler	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 68071-3519-03	NuCare	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 68071-3775-09	NuCare	90 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 68788-4026-03	Preferred	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 68788-7672-00	Preferred	6 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 68788-8623-03	Preferred	30 capsules	—	AB	FDA listed	—
duloxetine 60 mg 70247-0014-03	Qingdao	30 capsules	—	AB	FDA listed	—
Duloxetine Delayed-Release 60 mg 70518-0122-05	REMEDYREPACK	90 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 70518-1011-00	REMEDYREPACK	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 70518-1244-00	REMEDYREPACK	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 70518-2630-01	REMEDYREPACK	30 capsules	—	AB	Discontinued	—
Duloxetine 60 mg 71205-0358-30	Proficient	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 71335-0402-01	Bryant	30 capsules	—	AB	FDA listed	—
Duloxetine Delayed-Release 60 mg 71335-0509-01	Bryant	30 capsules	—	AB	Discontinued	—
Duloxetine 60 mg 71335-1445-01	Bryant	30 capsules	—	AB	Discontinued	—
Duloxetine 60 mg 71335-2567-01	Bryant	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 71335-2625-01	Bryant	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 71610-0403-60	Aphena	90 capsules	—	AB	FDA listed	—
Duloxetine Delayed-Release 60 mg 71610-0743-30	Aphena	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 72162-1058-03	Bryant	30 capsules	—	AB	FDA listed	—
Duloxetine Delayed-Release 60 mg 72162-1599-01	Bryant	100 capsules	—	AB	FDA listed	—
Duloxetine D/R 60 mg 72189-0608-30	Direct_Rx	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 72789-0338-90	PD-Rx	90 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 76420-0623-01	Asclemed	100 capsules	—	AB	FDA listed	—
Duloxetine DR 60 mg 80425-0119-01	Advanced	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 80425-0389-01	Advanced	30 capsules	—	AB	FDA listed	—
Drizalma Sprinkle 60 mg 47335-0619-10	SUN	1000 capsules	—	—	FDA listed	—
Duloxetine 60 mg 85534-0051-00	HAWAII	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 85534-0018-00	HAWAII	30 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 70954-0864-20	ANI	90 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 51407-0810-10	Golden	1000 capsules	—	AB	FDA listed	—
Duloxetine 60 mg 71335-3163-01	Bryant	30 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

🏛️

2012

On the market since

May 2012

📍

2026

Currently FDA-listed

14 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 67877-0265-10, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

Units reimbursed last 4 qtrs

900

Gross reimbursed last 4 qtrs

$352.58

Avg / prescription

$13.06

Avg / unit

$0.3918

Latest quarter Q4 2025

0Rx

Medicaid pays / ea

$0.3918

gross reimbursed

NADAC / ea

$0.1293

acquisition cost

Spread

+$0.2625

+203% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

100% FFS

Fee-for-service · 27 Rx Managed care · 0 Rx

State Medicaid map

Units reimbursed · per 100k residents

9.09.0

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Michigan 9.0 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

90 capsules67877-0265-90 126 Rx · $2,142

1000 capsules this page67877-0265-10 27 Rx · $353

30 capsules67877-0265-30 12 Rx · $167

100 capsules67877-0265-01 No Medicaid data

Drug total (last 4 qtrs): 165 Rx · 5,998 units · $2,661 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📦 Packaging — all sizes for this product

Package NDC	Description	Per unit	Per pack	Marketing start	Status
67877-0265-01	100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-265-01)	—	—	2012-05-01	Active
67877-0265-10 You're viewing this	1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-265-10)	$0.1293 / ea	$129.34	2012-05-01	Active
67877-0265-30	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-265-30)	$0.1293 / ea	$3.88	2012-05-01	Active
67877-0265-90	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-265-90)	$0.1293 / ea	$11.64	2012-05-01	Active

You're viewing the largest of 4 pack sizes for this product.

This pack has the lowest per-ea cost of the 3 priced pack sizes ($0.1293 NADAC).

This pack accounts for about 16% of this product's recent Medicaid fills; most go to the 90 capsules pack. See all packs ↓

Pack size FAQ

What quantity is in NDC 67877-0265-10?

NDC 67877-0265-10 is a 1,000-count package — 1000 capsule, delayed release in 1 bottle.

What is the difference between NDC 67877-0265-10 and NDC 67877-0265-30?

Both are Duloxetine 60 mg Capsule, Delayed Release — the drug itself is identical. NDC 67877-0265-10 is the 1,000-count package, while NDC 67877-0265-30 is the 30 capsules package.

What NDC number is used to bill for this package of Duloxetine 60 mg Capsule, Delayed Release?

Bill NDC 67877-0265-10 — the 11-digit billing format is 67877026510. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 💬 Medication Guide

🚨 Boxed Warning 158 words ▾

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 worsening, and for 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) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants ( 5.1 ) • Monitor for worsening and emergence of suicidal thoughts and behaviors ( 5.1 )

🎯 Indications and Usage 132 words ▾

1 INDICATIONS AND USAGE Duloxetine is indicated for the treatment of: Major depressive disorder in adults Generalized anxiety disorder in adults and pediatric patients 7 years of age and older Diabetic peripheral neuropathic pain in adults Fibromyalgia in adults and pediatric patients 13 years of age and older Chronic musculoskeletal pain in adults Duloxetine hydrochloride is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of the following conditions: Major depressive disorder (MDD) in adults ( 1 ) Generalized anxiety disorder (GAD) in adults and pediatric patients 7 years of age and older ( 1 ) Diabetic peripheral neuropathic pain (DPNP) in adults ( 1 ) Fibromyalgia (FM) in adults and pediatric patients 13 years of age and older ( 1 ) Chronic musculoskeletal pain in adults ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Take duloxetine delayed-release capsules once daily, with or without food. Swallow whole; do not crush, chew, or open capsule ( 2.1 ) Indication Starting Dose Target Dose Maximum Dose MDD (2.2) 40 mg/day to 60 mg/day Acute Treatment: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance Treatment: 60 mg/day 120 mg/day GAD (2.3) Adults Geriatric Pediatrics (7 to 17 years of age) 60 mg/day 30 mg/day 30 mg/day 60 mg/day (once daily) 60 mg/day (once daily) 30 to 60 mg/day (once daily) 120 mg/day 120 mg/day 120 mg/day DPNP (2.4) 60 mg/day 60 mg/day (once daily) 60 mg/day FM (2.5) Adults and Pediatrics (13 to 17 years of age) 30 mg/day 60 mg/day (once daily) 60 mg/day Chronic Musculoskeletal Pain (2.6) 30 mg/day 60 mg/day (once daily) 60 mg/day Discontinuing duloxetine delayed-release capsules: Gradually reduce dosage to avoid discontinuation symptoms ( 2.8 , 5.7 )

2.1Important Administration Instructions Administer duloxetine delayed-release capsules orally (with or without meals) and swallow whole. Do not chew or crush, and do not open the delayed-release capsule and sprinkle its contents on food or mix with liquids because these actions might affect the enteric coating. If a dose of duloxetine delayed-release capsules is missed, take the missed dose as soon as it is remembered.

If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of duloxetine delayed-release capsules at the same time.

2.2Dosage for Treatment of Major Depressive Disorder in Adults The recommended starting dosage in adults with MDD is 40 mg/day (given as 20 mg twice daily) to 60 mg/day (given either once daily or as 30 mg twice daily). For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to duloxetine before increasing to 60 mg once daily. While a 120 mg/day dose was shown to be effective, there is no evidence that doses greater than 60 mg/day confer any additional benefits.

Periodically reassess to determine the need for maintenance treatment and the appropriate dosage for such treatment.

2.3Dosage for Treatment of Generalized Anxiety Disorder Recommended Dosage in Adults Less than 65 Years of Age For most adults less than 65 years of age with GAD, initiate duloxetine capsules 60 mg once daily. For some patients, it may be desirable to start at 30 mg once daily for 1 week, to allow patients to adjust to duloxetine capsules before increasing to 60 mg once daily. While a 120 mg once daily dosage was shown to be effective, there is no evidence that doses greater than 60 mg/day confer additional benefit.

Nevertheless, if a decision is made to increase the dosage beyond 60 mg once daily, increase dosage in increments of 30 mg once daily. Periodically reassess to determine the continued need for maintenance treatment and the appropriate dosage for such treatment. Recommended Dosage in Geriatric Patients In geriatric patients with GAD, initiate duloxetine capsules at a dosage of 30 mg once daily for 2 weeks before considering an increase to the target dose of 60 mg/day.

Thereafter, patients may benefit from doses above 60 mg once daily. If a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The maximum dose studied was 120 mg per day.

Recommended Dosage in Pediatric Patients 7 to 17 Years of Age Initiate duloxetine in pediatric patients 7 to 17 years of age with GAD at a dosage of 30 mg once daily for 2 weeks before considering an increase to 60 mg once daily. The recommended dosage range is 30 to 60 mg once daily. Some patients may benefit from dosages above 60 mg once daily.

If a decision is made to increase the dose beyond 60 mg once daily, increase dosage in increments of 30 mg once daily. The maximum dose studied was 120 mg per day.

2.4 Dosage for Treatment of Diabetic Peripheral Neuropathic Pain in Adults Ad…

💊 Dosage Forms and Strengths 77 words ▾

3 DOSAGE FORMS AND STRENGTHS Duloxetine is available as delayed release capsules: 20 mg opaque green capsules printed “Dulox” on cap and “20 mg” on body in black ink. 30 mg white and blue capsules printed “Dulox” on cap and “30 mg” on body in black ink. 60 mg green and blue capsules printed “Dulox” on cap and “60 mg” on body in white ink. Delayed-release capsules: 20 mg, 30 mg, and 60 mg ( 3 )

⛔ Contraindications 147 words ▾

4 CONTRAINDICATIONS The use of MAOIs intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine is contraindicated because of an increased risk of serotonin syndrome. The use of duloxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders is contraindicated [see Dosage and Administration ( 2.8 ) and Warnings and Precautions ( 5.4 )] . Starting duloxetine in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration ( 2.9 ) and Warnings and Precautions ( 5.4 )] .

Concomitant use of an MAOI antidepressant with duloxetine is contraindicated Use of duloxetine within 14 days of stopping an MAOI antidepressant is contraindicated In linezolid- or intravenous methylene blue-treated patients, initiation of duloxetine is contraindicated ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Hepatic failure, sometimes fatal, has been reported. Discontinue duloxetine in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Avoid use in patients with substantial alcohol use or evidence of chronic liver disease ( 5.2 ) Orthostatic Hypotension, Falls and Syncope : Consider dosage reduction or discontinuation if these events occur ( 5.3 ) Serotonin Syndrome : Increased risk when co-administered with other serotonergic agents, but also when taken alone.

If it occurs, discontinue duloxetine and serotonergic agents ( 5.4 ) Increased Risk of Bleeding: May increase the risk of bleeding events. Concomitant use of antiplatelet drugs and anticoagulants may increase this risk ( 5.5 , 7.4 , 8.1 ) Severe Skin Reactions: Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome (SJS), can occur; Discontinue at the first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified ( 5.6 ) Activation of Mania or Hypomania : Prior to initiating, screen patients for personal or family history of bipolar disorder, mania, or hypomania ( 5.8 ) Angle-Closure Glaucoma : Has occurred in patients with untreated anatomically narrow angles treated with antidepressants ( 5.9 ) Seizures: Prescribe with care in patients with a history of seizure disorder ( 5.10 ) Blood Pressure Increases : Monitor blood pressure prior to initiating treatment and periodically throughout treatment ( 5.11 ) Inhibitors of CYP1A2 or Thioridazine: Avoid co-administration with duloxetine ( 5.12 ) Hyponatremia : Can occur in association with SIADH; consider discontinuation ( 5.13 ) Glucose Control in Diabetes: In DPNP patients, increases in fasting blood glucose, and HbA 1c have been observed ( 5.14 ) Conditions that Slow Gastric Emptying: Use cautiously in these patients ( 5.14 ) Sexual Dysfunction: D uloxetine may cause symptoms of sexual dysfunction ( 5.16 )

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 trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders.

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

There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the y…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Thoughts and Behaviors in Children, Adolescents, and Young Adults [see Boxed Warning and Warnings and Precautions ( 5.1 )] Hepatotoxicity [see Warnings and Precautions ( 5.2 )] Orthostatic Hypotension, Falls and Syncope [see Warnings and Precautions ( 5.3 )] Serotonin Syndrome [see Warnings and Precautions ( 5.4 )] Increased Risk of Bleeding [see Warnings and Precautions ( 5.5 )] Severe Skin Reactions [see Warnings and Precautions ( 5.6 )] Discontinuation Syndrome [see Warnings and Precautions ( 5.7 )] Activation of Mania/Hypomania [see Warnings and Precautions ( 5.8 )] Angle-Closure Glaucoma [see Warnings and Precautions ( 5.9 )] Seizures [see Warnings and Precautions ( 5.10 )] Increases in Blood Pressure [see Warnings and Precautions ( 5.11 )] Clinically Important Drug Interactions [see Warnings and Precautions ( 5.12 )] Hyponatremia [see Warnings and Precautions ( 5.13 )] Urinary Hesitation and Retention [see Warnings and Precautions ( 5.15 )] Sexual Dysfunction [see Warnings and Precautions ( 5.16 )] Most common adverse reactions (≥5% and at least twice the incidence of placebo-treated patients): ( 6.1 ) Adults : nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis Pediatric Patients : decreased weight, decreased appetite, nausea, vomiting, fatigue, and diarrhea To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-272-7901 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials 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 trials of another drug and may not reflect the rates observed in practice. The stated frequencies of adverse reactions represent the proportion of patients who experienced, at least once, one treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Reactions in Adults Adult Clinical Trial Database The data described below reflect exposure to duloxetine delayed-release capsules in placebo-controlled adult trials for MDD (N=3779), GAD (N=1018), OA (N=503), CLBP (N=600), DPNP (N=906), and FM (N=1294). The age range in this pooled population was 17 to 89 years of age. In this pooled population, 66%, 61%, 61%, 43%, and 94% of adult patients were female; and 82%, 73%, 85%, 74%, and 86% of adult patients were Caucasian in the MDD, GAD, OA and CLBP, DPNP, and FM populations, respectively.

Most patients received duloxetine dosages of a total of 60 to 120 mg per day [see Clinical Studies ( 14 )] . The data below do not include results of the trial that evaluated the efficacy of duloxetine for the treatment of GAD in patients ≥65 years old (Study GAD-5) [see Clinical Studies ( 14.3 )] ; however, the adverse reactions observed in this geriatric population were generally similar to adverse reactions in the overall adult population. Adverse Reactions Leading to Treatment Discontinuation in Adult Placebo-Controlled Trials Major Depressive Disorder Approximately 8.4% (319/3779) of duloxetine-treated patients in placebo-controlled adult trials for MDD discontinued treatment due to an adverse reaction, compared with 4.6% (117/2536) of placebo-treated patients.

Nausea (duloxetine 1.1%, placebo 0.4%) was the only adverse reaction reported as a reason for discontinuation and considered to be drug-related (i.e., discontinuation occurring in at least 1% of the duloxetine-treated patients and at a rate of at least twice that of placebo-treated patients). Generalized Anxiety Disorder Approximately 13.7% (139/1018) of the duloxetine-treated patients in placebo-controlled adult trials for GAD discontinued treatment due to an adverse reaction…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS Both CYP1A2 and CYP2D6 are responsible for duloxetine metabolism. Potent inhibitors of CYP1A2 should be avoided ( 7.1 ) Potent inhibitors of CYP2D6 may increase duloxetine concentrations ( 7.2 ) Duloxetine is a moderate inhibitor of CYP2D6 ( 7.9 )

7.1Inhibitors of CYP1A2 When duloxetine 60 mg was co-administered with fluvoxamine 100 mg, a potent CYP1A2 inhibitor, to male subjects (n=14) duloxetine AUC was increased approximately 6-fold, the C max was increased about 2.5-fold, and duloxetine t 1/2 was increased approximately 3-fold. Other drugs that inhibit CYP1A2 metabolism include cimetidine and quinolone antimicrobials such as ciprofloxacin and enoxacin [see Warnings and Precautions (5.12) ] .

7.2Inhibitors of CYP2D6 Concomitant use of duloxetine (40 mg once daily) with paroxetine (20 mg once daily) increased the concentration of duloxetine AUC by about 60%, and greater degrees of inhibition are expected with higher doses of paroxetine. Similar effects would be expected with other potent CYP2D6 inhibitors (e.g., fluoxetine, quinidine) [see Warnings and Precautions (5.12) ] .

7.3Dual Inhibition of CYP1A2 and CYP2D6 Concomitant administration of duloxetine 40 mg twice daily with fluvoxamine 100 mg, a potent CYP1A2 inhibitor, to CYP2D6 poor metabolizer subjects (n=14) resulted in a 6-fold increase in duloxetine AUC and C max .

7.4Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin) Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs or SNRIs are co-administered with warfarin.

Concomitant administration of warfarin (2-9 mg once daily) under steady state conditions with duloxetine 60 or 120 mg once daily for up to 14 days in healthy subjects (n=15) did not significantly change INR from baseline (mean INR changes ranged from 0.05 to +0.07). The total warfarin (protein bound plus free drug) pharmacokinetics (AUCτ,ss, C max ,ss or t max ,ss) for both R- and S-warfarin were not altered by duloxetine. Because of the potential effect of duloxetine on platelets, patients receiving warfarin therapy should be carefully monitored when duloxetine is initiated or discontinued [see Warnings and Precautions (5.5) ] .

7.5Lorazepam Under steady-state conditions for duloxetine (60 mg Q 12 hours) and lorazepam (2 mg Q 12 hours), the pharmacokinetics of duloxetine were not affected by co-administration.

7.6Temazepam Under steady-state conditions for duloxetine (20 mg qhs) and temazepam (30 mg qhs), the pharmacokinetics of duloxetine were not affected by co-administration.

7.7Drugs that Affect Gastric Acidity Duloxetine has an enteric coating that resists dissolution until reaching a segment of the gastrointestinal tract where the pH exceeds 5.5. In extremely acidic conditions, duloxetine, unprotected by the enteric coating, may undergo hydrolysis to form naphthol. Caution is advised in using duloxetine in patients with conditions that may slow gastric emptying (e.g., some diabetics).

Drugs that raise the gastrointestinal pH may lead to an earlier release of duloxetine. However, co-administration of duloxetine with aluminum- and magnesium-containing antacids (51 mEq) or duloxetine with famotidine, had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose. It is unknown whether the concomitant administration of proton pump inhibitors affects duloxetine absorption [see Warnings and Precautions (5.14) ] .

7.8Drugs Metabolized by CYP1A2 In vitro drug interaction studies demonstrate that duloxetine does not induce CYP1A2 act…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : Third trimester use may increase risk for symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulty, hypotonia, tremor, irritability) in the neonate ( 8.1 ) Hepatic Impairment : Avoid use in patients with chronic liver disease or cirrhosis ( 5.14 ) Renal Impairment : Avoid use in patients with severe renal impairment, GFR less than 30 mL/minute ( 5.14 )

8.1Pregnancy Risk Summary Data from a postmarketing retrospective cohort study indicate that use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage. Data from published literature and from a postmarketing retrospective cohort study have not identified a clear drug-associated risk of major birth defects or other adverse developmental outcomes (see Data). There are risks associated with untreated depression and fibromyalgia in pregnancy, and with exposure to SNRIs and SSRIs, including duloxetine, during pregnancy (see Clinical Considerations).

In rats and rabbits treated with duloxetine during the period of organogenesis, fetal weights were decreased but there was no evidence of developmental effects at doses up to 3 and 6 times, respectively, the maximum recommended human dose (MRHD) of 120 mg/day given to adolescents on a mg/m2 basis. When duloxetine was administered orally to pregnant rats throughout gestation and lactation, pup weights at birth and pup survival to 1 day postpartum were decreased at a dose 2 times the MRHD given to adolescents on a mg/m2 basis.

At this dose, pup behaviors consistent with increased reactivity, such as increased startle response to noise and decreased habituation of locomotor activity were observed. Post-weaning growth was not adversely affected. The estimated background risk of major birth defects and miscarriage for the indicated population 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 depressive disorder 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. Pregnant women with fibromyalgia are at increased risk for adverse maternal and infant outcomes including preterm premature rupture of membranes, preterm birth, small for gestational age, intrauterine growth restriction, placental disruption, and venous thrombosis.

It is not known if these adverse maternal and fetal outcomes are a direct result of fibromyalgia or other comorbid factors. Maternal Adverse Reactions Use of duloxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions ( 5.5 )]. Fetal/Neonatal Adverse Reaction Neonates exposed to duloxetine and 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 findings are consistent with either a direct toxic effect of the SNRIs or SSRIs, or possibly, a drug discontinuation syndrome.

It shoul…

🤰 Pregnancy ~3 min read ▾

It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions ( 5.4 )]. Data Human Data Data from a postmarketing retrospective claims-based cohort study found an increased risk for postpartum hemorrhage among 955 pregnant women exposed to duloxetine in the last month of pregnancy compared to 4,128,460 unexposed pregnant women (adjusted relative risk: 1.53; 95% CI: 1.08-2.1…

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of duloxetine have been established for treatment of generalized anxiety disorder (GAD) in patients 7 to 17 years of age and for treatment of juvenile fibromyalgia syndrome in patients 13 to 17 years of age. The safety and effectiveness of duloxetine have not been established in pediatric patients with major depressive disorder (MDD), diabetic peripheral neuropathic pain, or chronic musculoskeletal pain. Antidepressants increased the risk of suicidal thoughts and behavior in pediatric patients.

Monitor all pediatric patients being treated with antidepressants for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of treatment, or at times of dosage changes [see Warnings and Precautions ( 5.1 )] . Perform regular monitoring of weight and growth in pediatric patients treated with duloxetine [see Adverse Reactions ( 6.1 )] . Generalized Anxiety Disorder Use of duloxetine for the treatment of GAD in patients 7 to 17 years of age is supported by one 10-week, placebo- controlled trial (GAD-6).

The study included 272 pediatric patients with GAD of which 47% were 7 to 11 years of age (53% were 12 to 17 years of age). Duloxetine demonstrated superiority over placebo as measured by greater improvement in the Pediatric Anxiety Rating Scale (PARS) for GAD severity score [see Clinical Studies ( 14.3 )] . The safety and effectiveness of duloxetine for the treatment of GAD in pediatric patients less than 7 years of age have not been established.

Fibromyalgia Use of duloxetine for treatment of fibromyalgia in patients 13 to 17 years of age is supported by a 13-week placebo- controlled trial in 184 patients with juvenile fibromyalgia syndrome (Study FM-4). Duloxetine showed improvement over placebo on the primary endpoint, change from baseline to end-of-treatment on the Brief Pain Inventory (BPI) – Modified Short Form: Adolescent Version 24-hour average pain severity rating [see Clinical Studies ( 14.5 )]. The safety and effectiveness of duloxetine for the treatment of fibromyalgia in patients less than 13 years of age have not been established.

Major Depressive Disorder The safety and effectiveness of duloxetine have not been established in pediatric patients for the treatment of MDD. Efficacy of duloxetine was not demonstrated in two 10-week, placebo-controlled trials with 800 pediatric patients aged 7 to 17 years old with MDD (MDD-6 and MDD-7). Neither duloxetine nor an active control (approved for treatment of pediatric MDD) was superior to placebo.

The most frequently observed adverse reactions in the MDD pediatric clinical trials included nausea, headache, decreased weight, and abdominal pain. Decreased appetite and weight loss have been observed in association with the use of SSRIs and SNRIs. Juvenile Animal Toxicology Data Duloxetine administration to young rats from post-natal day 21 (weaning) through post-natal day 90 (adult) resulted in decreased body weights that persisted into adulthood, but recovered when drug treatment was discontinued; slightly delayed (~1.5 days) sexual maturation in females, without any effect on fertility; and a delay in learning a complex task in adulthood, which was not observed after drug treatment was discontinued.

These effects were observed at the high dose of 45 mg/kg/day (2 times the MRHD, for a child); the no-effect-level was 20 mg/kg/day (≈1 times the MRHD, for a child).

🧓 Geriatric Use ~2 min read ▾

8.5Geriatric Use Geriatric Exposure in Premarketing Clinical Trials of Duloxetine • Of the 2,418 patients in MDD trials, 6% (143) were 65 years of age or over. • Of the 1041 patients in CLBP trials, 21% (221) were 65 years of age or over. • Of the 487 patients in OA trials, 41% (197) were 65 years of age or over. • Of the 1,074 patients in the DPNP trials, 33% (357) were 65 years of age or over. • Of the 1,761 patients in FM trials, 8% (140) were 65 years of age or over. In the MDD, GAD, DPNP, FM, OA, and CLBP studies, no overall differences in safety or effectiveness were generally observed between these patients and younger adult patients, and other reported clinical experience has not identified differences in responses between these geriatric and younger adult patients, but greater sensitivity of some older patients cannot be ruled out.

SSRIs and SNRIs, including duloxetine have been associated with clinically significant hyponatremia in geriatric patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions ( 5.13 )] . In an analysis of data from all placebo-controlled-trials, duloxetine-treated patients reported a higher rate of falls compared to placebo-treated patients. The increased risk appears to be proportional to a patient’s underlying risk for falls.

Underlying risk appears to increase steadily with age. As geriatric patients tend to have a higher prevalence of risk factors for falls such as medications, medical comorbidities and gait disturbances, the impact of increasing age by itself on falls during duloxetine treatment is unclear. Falls with serious consequences including bone fractures and hospitalizations have been reported with duloxetine use [see Warnings and Precautions ( 5.3 ) and Adverse Reactions ( 6.1 )] .

The pharmacokinetics of duloxetine after a single dose of 40 mg were compared in healthy elderly females (65 to 77 years) and healthy middle-age females (32 to 50 years). There was no difference in the Cmax, but the AUC of duloxetine was somewhat (about 25%) higher and the half-life about 4 hours longer in the elderly females. Population pharmacokinetic analyses suggest that the typical values for clearance decrease by approximately 1% for each year of age between 25 to 75 years of age; but age as a predictive factor only accounts for a small percentage of between-patient variability.

Dosage adjustment based on the age of the adult patient is not necessary.

🆘 Overdosage ~1 min read ▾

10 OVERDOSAGE

10.1Signs and Symptoms In postmarketing experience, fatal outcomes have been reported for acute duloxetine overdoses, primarily with mixed overdoses, but also with duloxetine only, including 1000 mg of duloxetine (approximately 8.3 times the maximum recommended dosage). Signs and symptoms of overdose (duloxetine alone or with mixed drugs) included somnolence, coma, serotonin syndrome, seizures, syncope, tachycardia, hypotension, hypertension, and vomiting.

10.2Management of Overdose There is no specific antidote to a duloxetine overdosage, but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered. In case of acute overdose with duloxetine, treatment should consist of those general measures employed in the management of overdose with any drug, such as assuring an adequate airway, oxygenation, and ventilation and monitoring cardiac rhythm and vital signs. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients.

Induction of emesis is not recommended. Activated charcoal may be useful in limiting absorption of duloxetine from the gastrointestinal tract. Administration of activated charcoal has been shown to decrease duloxetine AUC and C max by an average of one-third, although some patients had a limited effect of activated charcoal.

Due to the large volume of distribution of duloxetine, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be beneficial. In managing overdose, the possibility of multiple drug involvement should be considered. A specific caution involves patients who overdose with duloxetine and tricyclic antidepressants.

In such a case, decreased clearance of the parent tricyclic and/or its active metabolite may increase the possibility of clinically significant sequelae and extend the time needed for close medical observation [see Warnings and Precautions ( 5.4 ) and Drug Interactions ( 7 )] . Consider contacting a poison control center (1-800-222-1222 or www.poison.org) for additional information on the treatment of overdosage.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Although the exact mechanisms of the antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.

12.2Pharmacodynamics Preclinical studies have shown that duloxetine is a potent inhibitor of neuronal serotonin and norepinephrine reuptake and a less potent inhibitor of dopamine reuptake. Duloxetine has no significant affinity for dopaminergic, adrenergic, cholinergic, histaminergic, opioid, glutamate, and GABA receptors in vitro . Duloxetine does not inhibit monoamine oxidase (MAO).

Duloxetine is in a class of drugs known to affect urethral resistance [see Warnings and Precautions ( 5.15 )]. Cardiac Electrophysiology The effect of duloxetine 160 mg and 200 mg administered twice daily (2.7 and 3.3 times the maximum recommended dosage, respectively) to steady state was evaluated in a randomized, double-blinded, two-way crossover study in 117 healthy female adult subjects. No QT interval prolongation was detected.

Duloxetine appears to be associated with concentration-dependent but not clinically meaningful QT shortening.

12.3Pharmacokinetics Duloxetine has an elimination half-life of about 12 hours (range 8 to 17 hours) and its pharmacokinetics are dose proportional over the therapeutic range. Steady-state plasma concentrations are typically achieved after 3 days of dosing. Elimination of duloxetine is mainly through hepatic metabolism involving two P450 isozymes, CYP1A2 and CYP2D6.

Absorption After oral duloxetine administration, duloxetine hydrochloride is well absorbed. There is a median 2 hour lag until absorption begins (T lag ), with maximal plasma concentrations (C max ) of duloxetine occurring 6 hours post dose. There is a 3 hour delay in absorption and a one-third increase in apparent clearance of duloxetine after an evening dose as compared to a morning dose.

Effect of Food: Food does not affect the C max of duloxetine, but delays the time to reach peak concentration from 6 to 10 hours and it marginally decreases the extent of absorption (AUC) by about 10%. Distribution The apparent volume of distribution averages about 1640 L. Duloxetine is highly bound (>90%) to proteins in human plasma, binding primarily to albumin and α1-acid glycoprotein.

The interaction between duloxetine and other highly protein bound drugs has not been fully evaluated. Plasma protein binding of duloxetine is not affected by renal or hepatic impairment. Elimination Metabolism Biotransformation and disposition of duloxetine in humans have been determined following oral administration of 14C-labeled duloxetine.

Duloxetine comprises about 3% of the total radiolabeled material in the plasma, indicating that it undergoes extensive metabolism to numerous metabolites. The major biotransformation pathways for duloxetine involve oxidation of the naphthyl ring followed by conjugation and further oxidation. Both CYP1A2 and CYP2D6 catalyze the oxidation of the naphthyl ring in vitro .

Metabolites found in plasma include 4-hydroxy duloxetine glucuronide and 5- hydroxy, 6-methoxy duloxetine sulfate. Excretion Many additional metabolites have been identified in urine, some representing only minor pathways of elimination. Only trace (<1% of the dose) amounts of unchanged duloxetine are present in the urine.

Most (about 70%) of the duloxetine dose appears in the urine as metabolites of duloxetine; about 20% is excreted in the feces. Duloxetine undergoes extensive metabolism, but the major circulating metabolites have not been shown to contribute significantly to the pharmacologic activity of duloxetine. Specific Populations Pediatric Patients Duloxetine steady-state plasma concentration was comparable in pediatric patients 7 to 17 years of age and adult patients.

The average steady-state duloxetine concentration was approximately 30% lower in this pediatric po…

🧬 Mechanism of Action 41 words ▾

📦 How Supplied / Storage and Handling 120 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Duloxetine Delayed-Release Capsules USP are available as delayed release capsules in the following strengths, colors, imprints, and presentations: Features Strengths 20 mg a 30 mg a 60 mg a Body color Opaque green White Green Cap color Opaque green Blue Blue Cap imprint Dulox Dulox Dulox Body imprint 20mg 30mg 60mg Capsule size 3 2 0 Presentations and NDC Codes Bottles of 30 67877-263-30 67877-264-30 67877-265-30 Bottles of 60 67877-263-60 Bottles of 90 67877-263-90 67877-264-90 67877-265-90 Bottles of 100 67877-263-01 67877-264-01 67877-265-01 Bottles of 1000 67877-263-10 67877-264-10 67877-265-10 a equivalent to duloxetine base

16.2Storage and Handling Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [ see USP Controlled Room Temperature].

📋 Description 174 words ▾

11 DESCRIPTION Duloxetine hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration. Its chemical designation is (+)-( S )- N -methyl-γ-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride. The empirical formula is C 18 H 19 NOS•HCl, which corresponds to a molecular weight of 333.88.

The structural formula is: Duloxetine hydrochloride is a white to off-white crystalline powder, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach.

Inactive ingredients include FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl cellulose, sodium lauryl sulfate, crosspovidone, sugar spheres, hypromellose phthalates, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow.

The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, black iron oxide (for 20 mg and 30 mg strengths), titanium dioxide and purified water. duloxetine-structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behaviors — Advise patients, their families, and their caregivers to look for the emergence of suicidal ideation and behavior, especially during treatment and when the dose is adjusted up or down and instruct them to report such symptoms to their healthcare provider [see Boxed Warning and Warnings and Precautions ( 5.1 )] . Administration — Advise patients to swallow duloxetine capsules whole and to not chew, crush, or open the capsule (do not sprinkle contents on food or mixed with liquids) because these actions might affect the enteric coating.

Hepatotoxicity — Inform patients that severe liver problems, sometimes fatal, have been reported in patients treated with duloxetine. Instruct patients to talk to their healthcare provider if they develop itching, right upper belly pain, dark urine, or yellow skin/eyes while taking duloxetine, which may be signs of liver problems. Instruct patients to talk to their healthcare provider about their alcohol consumption.

Use of duloxetine with heavy alcohol intake may be associated with severe liver injury [see Warnings and Precautions ( 5.2 )] . Alcohol — Although duloxetine does not increase the impairment of mental and motor skills caused by alcohol, use of duloxetine concomitantly with heavy alcohol intake may be associated with severe liver injury [see Warnings and Precautions ( 5.2 ) and Drug Interactions ( 7.15 )] . Orthostatic Hypotension, Falls and Syncope — Advise patients of the risk of orthostatic hypotension, falls and syncope, especially during the period of initial use and subsequent dose escalation, and in association with the use of concomitant drugs that might potentiate the orthostatic effect of duloxetine [see Warnings and Precautions ( 5.3 )] .

Serotonin Syndrome — Caution patients about the risk of serotonin syndrome with the concomitant use of duloxetine and other serotonergic agents including triptans, tricyclic antidepressants, opioids, lithium, buspirone, tryptophan, amphetamines, and St. John’s Wort [see Contraindications ( 4 ), Warnings and Precautions ( 5.4 ), and Drug Interactions ( 7.14 )] . Advise patients of the signs and symptoms associated with serotonin syndrome that may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Caution patients to seek medical care immediately if they experience these symptoms. Increased Risk of Bleeding — Caution patients about the concomitant use of duloxetine 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 ( 5.5 ) and Use in Specific Populations ( 8.1 )] . Severe Skin Reactions — Caution patients that duloxetine may cause serious skin reactions.

This may need to be treated in a hospital and may be life-threatening. Counsel patients to call their doctor right away or get emergency help if they have skin blisters, peeling rash, sores in their mouth, hives, or any other allergic reactions [see Warnings and Precautions ( 5.6 )] . Discontinuation of Treatment — Instruct patients that discontinuation of duloxetine may be associated with symptoms such as dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue, and should be advised not to alter their dosing regimen, or stop taking duloxetine without consulting their healthcare provider [see Warnings and Precautions ( 5.7 )] .

Activation of Mania or Hypomania — Adequately…

💬 Medication Guide ~3 min read ▾

Medication Guide Duloxetine Delayed-Release Capsules USP (doo-LOX-e-teen) Read this Medication Guide before you start taking duloxetine and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Talk to your healthcare provider about: all risks and benefits of treatment with antidepressant medicines all treatment choices for depression or other serious mental illness What is the most important information I should know about antidepressant medicines, depression, other serious mental illnesses, and suicidal thoughts or actions? 1. Duloxetine and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.

2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a particularly high risk of having suicidal thoughts or actions.

These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness). 3. How can I watch for and try to prevent suicidal thoughts and actions?

Pay close attention to any changes in mood, behavior, actions, thoughts, or feelings, especially sudden changes. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms. Call your healthcare provider right away if you have any of the following symptoms or feelings, especially if they are new, worse, or worry you.

In an emergency, call 911. attempts to commit suicide acting on dangerous impulses acting aggressive, being angry, or violent thoughts about suicide or dying new or worse depression new or worse anxiety panic attacks feeling very agitated or restless new or worse irritability trouble sleeping an extreme increase in activity or talking (mania) other unusual changes in behavior or mood What else do I need to know about antidepressant medicines? Never stop an antidepressant medicine without first talking to a healthcare provider.

Stopping an antidepressant medicine suddenly can cause other symptoms. Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it.

Patients should discuss all treatment choices with your healthcare provider, not just the use of antidepressants. Antidepressant medicines have other side effects. Talk to your healthcare provider about the side effects of the medicine prescribed for you or your family member.

Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show your healthcare provider.

Do not start new medicines without first checking with your healthcare provider. What is duloxetine? Duloxetine is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD).

Duloxetine belongs to a class of medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors). Duloxetine is also used to treat or manage: Generalized Anxiety Disorder (GAD) Diabetic Peripheral Neuropathic Pain (DPNP) Fibromyalgia (FM) Chronic Musculoskeletal Pain Who should not take Duloxetine? Do Not take Duloxetine if you: take a Monoamine Oxidase Inhibitor (MAOI) .

Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous methylene blue. Do not take an MAOI within 5 days of stopping duloxetine unless directed to do so by your healthcare…

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.

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 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.

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

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

apnea: A pause or temporary stop in breathing.

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.

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.

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.

Cmax: The highest level a medicine reaches in the blood after a dose is taken.

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.

CYP1A2: A liver enzyme that breaks down certain medicines and whose activity can be changed by cigarette smoke.

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

delayed-release: A pill coated so it does not release its medicine until after it has passed through the stomach.

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

diaphoresis: Heavy or excessive sweating.

diarrhea: Loose, watery bowel movements that happen more often than normal.

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.

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.

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

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

emesis: The medical word for vomiting, or bringing up the contents of the stomach through the mouth.

endpoint: A specific outcome, such as a symptom or lab value, that a study measures to judge whether a treatment works.

enteric-coated: A special coating that keeps a pill from dissolving in the stomach, so it opens up further along in the intestine.

erythema: Redness of the skin caused by increased blood flow, often from irritation or inflammation.

erythema multiforme: A skin reaction with red, target-shaped spots, usually on the hands, arms, or face.

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

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

fertility: The natural ability to become pregnant or to father a child.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

gastrointestinal bleeding: Bleeding anywhere along the digestive tract, from the food pipe down to the bowel.

gestational age: How far along a pregnancy is, usually counted in weeks from the mother's last menstrual period.

GFR: A measure (glomerular filtration rate) of how well the kidneys filter the blood; lower numbers mean weaker kidney function.

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.

hepatic metabolism: The breakdown of a medicine by the liver into other substances the body can use or remove.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

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.

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.

INR: A blood test result that shows how quickly blood clots, often used to monitor blood-thinning medicines.

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

intrauterine growth restriction: When a baby grows more slowly than expected in the womb and is smaller than normal at birth.

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.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

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.

myoclonus: Sudden, brief, jerking movements of a muscle or group of muscles.

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.

orthostatic hypotension: A drop in blood pressure when you stand up from sitting or lying down, which can cause brief dizziness.

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.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

poor metabolizer: A person whose inherited enzymes break down certain drugs slowly, so those drugs can build up higher than usual.

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.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

preterm birth: Birth of a baby earlier than usual, before 37 weeks of pregnancy.

primary endpoint: The main result a study is set up to measure in order to decide whether a treatment works.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

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.

relative risk: A number comparing the chance of an event in one group with the chance of that same event in another group.

remission: A period when the signs and symptoms of cancer are reduced or have disappeared.

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

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.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

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.

syncope: The medical term for fainting, a brief loss of consciousness from a temporary drop in blood flow to the brain.

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

thrombosis: The forming of a blood clot inside a blood vessel, which can block normal blood flow.

treatment-emergent: Describes a side effect that first appears, or gets worse, after a person starts taking a treatment.

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.

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.

Duloxetine 60 mg Capsule, Delayed Release, 1,000-count

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2.4 Dosage for Treatment of Diabetic Peripheral Neuropathic Pain in Adults Ad…

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