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Duloxetine 60 mg Capsule, Delayed Release, 30-count

by Proficient Rx LP · 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-358-30)

NDC 71205-0358-30

🏷️ FDA NDC (as labeled) 71205-358-30 billing pads the product segment with a zero

This package

Contains30-count Pack sizes3 compare ↓

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

Also comes in: 60 capsules 71205-0358-60 90 capsules 71205-0358-90

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) 71205-358-30

Product NDC 71205-358

11-digit billing NDC 71205035830

NCPDP billing unit EA — each (per item)

RxCUI 596934

UNII 9044SC542W

UPC 0371205358303

Application # ANDA208706

SPL Set ID e36a6919-568a-4d4a-9920-7a7fe4f3441c

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 2017-03-16

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 71205-358-30 — 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 → 71205-0358-30. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

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

Pharmacologic class Serotonin and Norepinephrine Reuptake Inhibitor

Drug family (ATC) Other antidepressants

How it works Norepinephrine Uptake Inhibitors, Serotonin Uptake Inhibitors

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerProficient Rx LP

Application holderAJANTA PHARMA LTD

FDA applicationANDA208706 (ANDA)

Labeler code71205

First marketedMar 2017

Product typeHuman Prescription Drug

Portfolio1,729 products on file

🔎 All NDCs from Proficient Rx LP

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

📖 What it is MedlinePlus · NLM

Duloxetine is used to treat depression and generalized anxiety disorder (GAD; excessive worry and tension that disrupts daily life). Duloxetine is also used to pain associated with diabetic neuropathy (damage to nerves that can develop in people who have diabetes) and fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep). It is also used to treat ongoing bone or muscle pain. Duloxetine is in a class of medications called selective serotonin and norepinephrine reuptake inhibitors (SNRIs). It work...

Read the full MedlinePlus article ↗

📗 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 White / Blue

ShapeCapsule

ImprintDLX60;ap

Size19 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
UNII 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
UNII 8PJ61P6TS3
Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
UNII NX76LV5T8J
A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
UNII 8Z96QXD6UM
Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

Where does this data come from?

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

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

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

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$0.3495	$10.49 / 30 capsules

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 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	—
Duloxetine 60 mg 00228-2892-03	Actavis	30 capsules	$0.135	AB	Availability likely	—
Duloxetine 60 mg 27241-0099-03	Ajanta	30 capsules	$0.135	AB	Availability likely	—
Duloxetine 60 mg 43547-0381-03	Solco	30 capsules	$0.135	AB	Availability likely	—
Duloxetine Delayed-Release 60 mg 51991-0748-10	Breckenridge	1000 capsules	$0.135	AB	Availability likely	—
Duloxetine 60 mg 68001-0596-04	BluePoint	30 capsules	$0.135	AB	Availability likely	—
Duloxetine 60 mg 68180-0296-03	Lupin	1000 capsules	$0.135	AB	Availability likely	—
Duloxetine 60 mg 82009-0032-10	Quallent	1000 capsules	$0.135	AB	Availability likely	—
Duloxetine 60 mg 82009-0173-10	Quallent	1000 capsules	$0.135	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 67877-0265-01	Ascend	100 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 mgthis 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

🏛️

2017

On the market since

Mar 2017

📍

2026

Currently FDA-listed

9 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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
71205-0358-30 You're viewing this	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-358-30)	2019-11-14	Active
71205-0358-60	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-358-60)	2019-11-14	Active
71205-0358-90	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-358-90)	2019-11-14	Active

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

Pack size FAQ

What quantity is in NDC 71205-0358-30?

NDC 71205-0358-30 is a 30-count package — 30 capsule, delayed release in 1 bottle.

What is the difference between NDC 71205-0358-30 and NDC 71205-0358-60?

Both are Duloxetine 60 mg Capsule, Delayed Release — the drug itself is identical. NDC 71205-0358-30 is the 30-count package, while NDC 71205-0358-60 is the 60 capsules package.

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

Bill NDC 71205-0358-30 — the 11-digit billing format is 71205035830. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 71205-358-30, 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: 71205-0358-30, written without dashes as 71205035830. 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 71205-0358-30, the first segment (71205) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0358) 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.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 2 other package presentations of this same product, including 60 capsules (71205-0358-60), 90 capsules (71205-0358-90). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 148 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 )] . • 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 102 words ▾

1 INDICATIONS AND USAGE Duloxetine delayed-release capsules are indicated for the treatment of: • Major Depressive Disorder [see Clinical Studies ( 14.1 )] . • Generalized Anxiety Disorder [see Clinical Studies ( 14.2 )] . • Diabetic Peripheral Neuropathy [see Clinical Studies ( 14.3 )] . • Chronic Musculoskeletal Pain [see Clinical Studies ( 14.5 )] . Duloxetine delayed-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: • Major Depressive Disorder (MDD) ( 1 ) • Generalized Anxiety Disorder (GAD) ( 1 ) • Diabetic Peripheral Neuropathic Pain (DPNP) ( 1 ) • Chronic Musculoskeletal Pain ( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Swallow duloxetine delayed-release capsules whole. Do not chew or crush. Do not open the capsule and sprinkle its contents on food or mix with liquids.

All of these might affect the enteric coating. Duloxetine delayed-release capsules can be given without regard to meals. 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. • Take duloxetine delayed-release capsules once daily, with or without food. Swallow duloxetine delayed-release capsules whole; do not crush or chew, do not open capsule.

Take a missed dose as soon as it is remembered. Do not take two doses of duloxetine delayed-release capsules at the same time. ( 2 ) Indication Starting Dose Target Dose Maximum Dose MDD ( 2.1 ) 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 ( 2.2 ) Adults 60 mg/day 60 mg/day (once daily) 120 mg/day Elderly 30 mg/day 60 mg/day (once daily) 120 mg/day Children and Adolescents (7 to 17 years of age) 30 mg/day 30 to 60 mg/day (once daily) 120 mg/day DPNP ( 2.3 ) 60 mg/day 60 mg/day (once daily) 60 mg/day Chronic Musculoskeletal Pain ( 2.5 ) 30 mg/day 60 mg/day (once daily) 60 mg/day • Some patients may benefit from starting at 30 mg once daily ( 2 ) • There is no evidence that doses greater than 60 mg/day confers additional benefit, while some adverse reactions were observed to be dose-dependent ( 2 ) • Discontinuing duloxetine delayed-release capsules: Gradually reduce dosage to avoid discontinuation symptoms ( 2.7 , 5.7 ) • 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 <30 mL/min ( 5.14 )

2.1Dosage for Treatment of Major Depressive Disorder Administer duloxetine delayed-release capsules at a total dose of 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 the medication 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.

The safety of doses above 120 mg/day has not been adequately evaluated. Periodically reassess to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies ( 14.1 )] .

2.2Dosage for Treatment of Generalized Anxiety Disorder Adults - For most patients, initiate duloxetine delayed-release 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 the medication before increasing to 60 mg once daily. While a 120 mg once daily dose 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 dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The safety of doses above 120 mg once daily has not been adequately evaluated. Periodically reassess to determine the continued need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies ( 14.2 )].

Elderly - Initiate duloxetine delayed-release capsules at a dose of 30 mg once daily for 2 weeks before considering an increase to the target dose of 60 mg. 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. Safety of doses above 120 mg once d…

💊 Dosage Forms and Strengths 65 words ▾

3 DOSAGE FORMS AND STRENGTHS Duloxetine delayed-release capsules are available as: 20 mg white and blue capsules imprinted with “ap DLX20” 30 mg blue and blue capsules imprinted with “ap DLX30” 40 mg pink and blue capsules imprinted with “ap DLX40” 60 mg white and blue capsules imprinted with “ap DLX60” 20 mg, 30 mg, 40 mg and 60 mg delayed-release capsules ( 3 )

⛔ Contraindications 176 words ▾

4 CONTRAINDICATIONS Monoamine Oxidase Inhibitors (MAOIs) - 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 also 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 )]. • Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with duloxetine or within 5 days of stopping treatment with duloxetine.

Do not use duloxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start duloxetine in a patient who is being treated with linezolid or intravenous methylene blue ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with duloxetine. Duloxetine should be discontinued in patients who develop jaundice or other evidence of clinically significant liver dysfunction and should not be resumed unless another cause can be established. Duloxetine should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease ( 5.2 ) • Orthostatic Hypotension, Falls and Syncope: Cases have been reported with duloxetine therapy ( 5.3 ) • Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including with duloxetine, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St.

John’s Wort). If such symptoms occur, discontinue duloxetine and initiate supportive treatment. If concomitant use of duloxetine with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases ( 5.4 ) • Abnormal Bleeding: Duloxetine may increase the risk of bleeding events.

Patients should be cautioned about the risk of bleeding associated with the concomitant use of duloxetine and NSAIDs, aspirin, or other drugs that affect coagulation ( 5.5 , 7.4 ) • Severe Skin Reactions: Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome (SJS), can occur with duloxetine. Duloxetine should be discontinued 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 ) • Discontinuation: May result in symptoms, including dizziness, headache, nausea, diarrhea, paresthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue ( 5.7 ) • Activation of mania or hypomania has occurred ( 5.8 ) • Angle-Closure Glaucoma: 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: Monitor blood pressure prior to initiating treatment and periodically throughout treatment ( 5.11 ) • Inhibitors of CYP1A2 or Thioridazine: Should not administer with duloxetine ( 5.12 ) • Hyponatremia: Cases of hyponatremia have been reported ( 5.13 ) • Glucose Control in Diabetes: In diabetic peripheral neuropathic pain patients, small 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 ) • Urinary Hesitation and Retention ( 5.15 )

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 to 24) with major depressive disorder (MDD) and other psychiatric disorders.

Short-term studies did not show an increase in the risk of suici…

🤒 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 )] • Abnormal Bleeding [see Warnings and Precautions ( 5.5 )] • Severe Skin Reactions [see Warnings and Precautions ( 5.6 )] • Discontinuation of Treatment with Duloxetine Delayed-Release Capsules [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 )] • Effect on 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 )] • Most common adverse reactions (≥5% and at least twice the incidence of placebo patients): nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis ( 6.3 ).

To report SUSPECTED ADVERSE REACTIONS, contact Ajanta Pharma USA Inc. at 1-855-664-7744 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trial Data Sources 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 individuals who experienced, at least once, a 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.

Reactions reported during the studies were not necessarily caused by the therapy, and the frequencies do not reflect investigator impression (assessment) of causality. Adults — The data described below reflect exposure to duloxetine delayed-release capsules in placebo-controlled trials for MDD (N=3779), GAD (N=1018), OA (N=503), CLBP (N=600), DPNP (N=906), and another indication (N=1294). The population studied was 17 to 89 years of age; 65.7%, 60.8%, 60.6%, 42.9%, and 94.4% female; and 81.8%, 72.6%, 85.3%, 74.0% and 85.7% Caucasian for MDD, GAD, OA and CLBP, DPNP, and another indication, respectively.

Most patients received doses of a total of 60 to 120 mg per day [see Clinical Studies ( 14 )]. The data below do not include results of the trial examining the efficacy of duloxetine delayed-release capsules in patients ≥ 65 years old for the treatment of generalized anxiety disorder; however, the adverse reactions observed in this geriatric sample were generally similar to adverse reactions in the overall adult population. Children and Adolescents — The data described below reflect exposure to duloxetine delayed-release capsules in pediatric, 10-week, placebo-controlled trials for MDD (N=341) and GAD (N=135).

The population studied (N=476) was 7 to 17 years of age with 42.4% children age 7 to 11 years of age, 50.6% female, and 68.6% white. Patients received 30-120 mg per day during placebo-controlled acute treatment studies. Additional data come from the overall total of 822 pediatric patients (age 7 to 17 years of age) with 41.7% children age 7 to 11 years of age and 51.8% female exposed to duloxetine delayed-release capsules in MDD and GAD clinical trials up to 36-weeks in length, in which most patients received 30-120 mg per day.

6.2Adverse Reactions Reported as Reasons for Discontinuation of Treatment in Adult Placebo-Controlled Trials Major Depressive Disorder — Approximately 8.4% (31…

🔄 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 to 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 (AUC T,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 i…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Pregnancy: Based on animal data may cause fetal harm ( 8.1 ) • Nursing Mothers: Exercise caution when administered to a nursing woman ( 8.3 )

8.1Pregnancy Pregnancy Category C Risk Summary — There are no adequate and well-controlled studies of duloxetine administration in pregnant women. In animal studies with duloxetine, fetal weights were decreased but there was no evidence of teratogenicity in pregnant rats and rabbits at oral doses administered during the period of organogenesis up to 4 and 7 times the maximum recommended human dose (MRHD) of 120 mg/day, respectively. 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.

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. Duloxetine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Clinical Considerations Fetal/Neonatal Adverse Reaction — Neonates exposed during pregnancy to serotonin - norepinephrine reuptake inhibitors (SNRIs) or selective serotonin reuptake inhibitors (SSRIs) have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding which 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 the SNRIs or SSRIs, 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 ( 5.4 )] . Data Animal Data — In animal reproduction studies, duloxetine has been shown to have adverse effects on embryo/fetal and postnatal development.

When duloxetine was administered orally to pregnant rats and rabbits during the period of organogenesis, there was no evidence of teratogenicity at doses up to 45 mg/kg/day (4 times the maximum recommended human dose (MRHD) of 120 mg/day on a mg/m 2 basis, in rat; 7 times the MRHD in rabbit). However, fetal weights were decreased at this dose, with a no-effect dose of 10 mg/kg/day approximately equal to the MRHD in rats; 2 times the MRHD in rabbits). When duloxetine was administered orally to pregnant rats throughout gestation and lactation, the survival of pups to 1 day postpartum and pup body weights at birth and during the lactation period were decreased at a dose of 30 mg/kg/day (2 times the MRHD); the no-effect dose was 10 mg/kg/day.

Furthermore, behaviors consistent with increased reactivity, such as increased startle response to noise and decreased habituation of locomotor activity, were observed in pups following maternal exposure to 30 mg/kg/day. Post-weaning growth and reproductive performance of the progeny were not affected adversely by maternal duloxetine treatment.

8.3Nursing Mothers Risk Summary Duloxetine is present in human milk. In a published study, lactating women who were weaning their infants were given duloxetine. At steady state, the concentration of duloxetine in breast milk was approximately 25% that of maternal plasma.

The estimated daily infant dose was approximately 0.14% of the maternal dose. The developmental and health benefits of human milk feeding should be considered along with the mother’s clinical need for duloxetine and any potential adverse effects on the milk-fed child from the drug or from the underlying maternal condition. Exercise caution when duloxetine is administered to a nursing woman.

Data The disposition of duloxetine was studied in 6 lactating women who were at…

🤰 Pregnancy ~2 min read ▾

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Generalized Anxiety Disorder — In pediatric patients aged 7 to 17 years, efficacy was demonstrated in one 10 week, placebo-controlled trial. The study included 272 pediatric patients with GAD of which 47% were 7 to 11 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 ( 14.2 )].

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

The safety and effectiveness in pediatric patients less than 7 years of age have not been established. The most frequently observed adverse reactions in the 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.

Perform regular monitoring of weight and growth in children and adolescents treated with an SNRI such as duloxetine [see Adverse Reactions ( 6.11 )]. Use of duloxetine in a child or adolescent must balance the potential risks with the clinical need [see Boxed Warning and Warnings and Precautions ( 5.1 )]. Animal 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 Of the 2,418 patients in premarketing clinical studies of duloxetine for MDD, 5.9% (143) were 65 years of age or over. Of the 1041 patients in CLBP premarketing studies, 21.2% (221) were 65 years of age or over. Of the 487 patients in OA premarketing studies, 40.5% (197) were 65 years of age or over.

Of the 1,074 patients in the DPNP premarketing studies, 33% (357) were 65 years of age or over. In the MDD, GAD, DPNP, OA, CLBP, and other studies, no overall differences in safety or effectiveness were generally observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. SSRIs and SNRIs, including duloxetine have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [seeWarnings and Precautions ( 5.13 )] .

In an analysis of data from all placebo-controlled-trials, patients treated with duloxetine reported a higher rate of falls compared to patients treated with placebo. The increased risk appears to be proportional to a patient’s underlying risk for falls. Underlying risk appears to increase steadily with age.

As elderly 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 treatment with duloxetine is unclear. Falls with serious consequences including bone fractures and hospitalizations have been reported [see Warnings and Precautions ( 5.3 ) and Adverse Reactions ( 6.10 )] . 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 patient is not necessary.

🆘 Overdosage ~2 min read ▾

10 OVERDOSAGE

10.1Signs and Symptoms In postmarketing experience, fatal outcomes have been reported for acute overdoses, primarily with mixed overdoses, but also with duloxetine only, at doses as low as 1000 mg. 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 duloxetine but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered. In case of acute overdose, treatment should consist of those general measures employed in the management of overdose with any drug. An adequate airway, oxygenation, and ventilation should be assured, and cardiac rhythm and vital signs should be monitored.

Induction of emesis is not recommended. 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. Activated charcoal may be useful in limiting absorption of duloxetine from the gastrointestinal tract.

Administration of activated charcoal has been shown to decrease AUC and C max by an average of one-third, although some subjects had a limited effect of activated charcoal. Due to the large volume of distribution of this drug, 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 are taking or have recently taken duloxetine and might ingest excessive quantities of a TCA. 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 )] . The physician should consider contacting a poison control center (1-800-222-1222 or www.poison.org) for additional information on the treatment of any overdose.

Telephone numbers for certified poison control centers are listed in the Physicians' Desk Reference (PDR).

🧬 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. If symptoms of urinary hesitation develop during treatment with duloxetine, consideration should be given to the possibility that they might be drug-related.

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 and Distribution — Orally administered 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. 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%.

There is a 3 hour lag in absorption and a one-third increase in apparent clearance of duloxetine after an evening dose as compared to a morning dose. The apparent volume of distribution averages about 1640 L. Duloxetine is highly bound (>90%) to proteins in human plasma, binding primarily to albumin and α 1 -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. Metabolism and Elimination — Biotransformation and disposition of duloxetine in humans have been determined following oral administration of 14 C-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. 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. Children and Adolescents (ages 7 to 17 years) - Duloxetine steady-state plasma concentration was comparable in children (7 to 12 years of age), adolescents (13 to 17 years of age) and adults.

The average steady-state duloxetine concentration was approximately 30% lower in the pediatric population (children and adolescents) relative to the adults. The model-predicted duloxetine steady state plasma concentrations in children and adolescents were mostly within the concentration range observed in adult patients and did not exceed the concentration range in adults.

🧬 Mechanism of Action 41 words ▾

📦 How Supplied / Storage and Handling 85 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Duloxetine delayed-release capsules are available in the following strengths, colors, imprints, and presentations: a equivalent to duloxetine base Features Strengths 60 mg a Body color White Cap color Blue Cap imprint ap Body imprint DLX60 Presentations and NDC Codes Bottles of 30’s pack 71205-358-30 Bottles of 60’s pack 71205-358-60 Bottles of 90’s pack 71205-358-90

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

📋 Description ~1 min read ▾

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

The structural formula is: Duloxetine hydrochloride USP is a white to brownish-white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 22.4, 33.7, 44.9 or 67.3 mg of duloxetine hydrochloride USP equivalent to 20, 30, 40, or 60 mg of duloxetine, respectively. These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach.

Inactive ingredients include sugar spheres, hypromellose, sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate. The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No.

1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate. For 20 mg, 30 mg, 40 mg (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide and purified water.

For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. USP Assay & Organic Impurities test pending. duloxetine-structure

💬 Information for Patients 209 words ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Medication Guide). Advise patients of the following issues and ask them to alert their prescriber if these occur while taking duloxetine delayed-release capsules. Advise families and caregivers of patients to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt.

Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Boxed Warning, and Warnings and Precautions ( 5.1 )] . 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. Advise patients to notify their physician if they: Literature revised 03/2019 Marketed by: Ajanta Pharma USA Inc. Bridgewater, NJ 08807.

Made in INDIA.

💬 Medication Guide ~3 min read ▾

Medication Guide Duloxetine Delayed-Release Capsules (doo lox’ e teen) Read this Medication Guide before you start taking duloxetine delayed-release capsules 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 delayed-release capsules and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.

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?

4. • 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 are duloxetine delayed-release capsules? Duloxetine delayed-release capsules are a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD).

Duloxetine delayed-release capsules belongs to a class of medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors). Duloxetine delayed-release capsules are also used to treat or manage: Who should not take duloxetine delayed-release capsules? Do Not take duloxetine delayed-release capsules if you: People who take duloxetine delayed-release capsules close in time to an MAOI may have a serious problem called Serotonin Syndrome (see “What are the possible side effects of d…

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

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

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

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

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

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

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

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.

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.

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.

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

fetal harm: Injury or damage to a developing baby while it is growing inside the womb.

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

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

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.

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.

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.

peripheral neuropathy: Damage to the nerves outside the brain and spinal cord, often causing numbness, tingling, or pain in the hands and feet.

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.

pregnancy category: An older letter rating (A, B, C, D, or X) once used to describe a medicine's possible risk during pregnancy.

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

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.

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.

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.

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, 30-count

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