HomeNDC LookupIngredientsTriamcinolone Acetonide › 80425-0262-01
Triamcinolone acetonide 40 mg/mL Injection, Suspension — NDC 80425-0262-01 package photo

Triamcinolone acetonide 40 mg/mL Injection, Suspension

by Advanced Rx Pharmacy of Tennessee, LLC · 1 VIAL, MULTI-DOSE in 1 CARTON (80425-0262-1) / 5 mL in 1 VIAL, MULTI-DOSE
NDC 80425-0262-01
🏷️ FDA NDC (as labeled) 80425-0262-1 billing pads the package segment with a zero
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 →
⚠️
Other active recalls for Triamcinolone Acetonide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Sep 28, 2023 — Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial. The piece of glass appears to be roughly 1 cm x 0.5 cm inside the vial. (Eugia US LLC) · FDA recall D-0041-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 80425-0262-1
Product NDC 80425-0262
11-digit billing NDC 80425026201
NCPDP billing unit ML — per mL (volume)
RxCUI 1085754
UNII F446C597KA
Application # ANDA209852
SPL Set ID f4c077f2-2609-2235-e053-2995a90a1b57
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-02-15
Route INTRA-ARTICULAR, INTRAMUSCULAR
Dosage form INJECTION, SUSPENSION
Substance TRIAMCINOLONE ACETONIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 80425-0262-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 80425-0262-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids for local oral treatment, Corticosteroids, Corticosteroids, moderately potent (group II)
How it works Corticosteroid Hormone Receptor Agonists
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

LabelerAdvanced Rx Pharmacy of Tennessee, LLC
Application holderTEVA PHARMACEUTICALS USA INC
FDA applicationANDA209852 (ANDA)
Labeler code80425
First marketedFeb 2023
Product typeHuman Prescription Drug
Portfolio254 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Triamcinolone is used to reduce inflammation (swelling, heat, redness, and pain) and to treat allergic reactions, low amounts of corticosteroids produced by the body, and immune system conditions. Triamcinolone is in a class of medications called corticosteroids. It works by changing the response of the immune system or to replace steroids that are normally produced by the body.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Yes, intra-articular triamcinolone is specifically approved to give short-term relief for knee arthritis, gout flares, bursitis, and similar joint conditions. The extended-release...
  • I'm getting a triamcinolone injection in my knee. Will it actually help, and how long does it last?
  • That's a really important thing to flag with your doctor before your injection or prescription. Triamcinolone can raise blood sugar — even in people whose diabetes is well-controll...
  • I have diabetes. Should I be worried about using triamcinolone?
📖 Read our full Triamcinolone guide →
8
Nutrient depletion considerations

Triamcinolone Acetonide may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

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

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Triamcinolone Acetonide 40 mg/mL 55150-0385-01 Eugia 1 vial $3.294 AB FDA listed
Triamcinolone Acetonide 40 mg/mL 25021-0054-01 Sagent 25 vials $4.838 AB Availability likely
Triamcinolone Acetonide 40 mg/mL 00143-9387-25 Hikma 25 vials $4.838 AB Availability likely
Triamcinolone Acetonide 40 mg/mL 00703-0245-01 Teva 1 vial $4.869 AB Availability likely
Triamcinolone Acetonide 400 mg/10mL 16714-0150-01 NorthStar 1 vial $4.869 AB Availability likely
Triamcinolone Acetonide 400 mg/10mL 67457-0623-10 Mylan 1 vial $4.869 AB Discontinued
Triamcinolone Acetonide 400 mg/10mL 70121-1169-01 Amneal 1 vial $4.869 AB Availability likely
Triamcinolone Acetonide 400 mg/10mL 70121-1653-01 Amneal 1 vial $4.869 AB Availability likely
Triamcinolone Acetonide 400 mg/10mL 70121-1655-01 Amneal 1 vial $4.869 AB Availability likely
Triamcinolone Acetonide 40 mg/mL 81298-5783-03 Long 1 vial $4.869 AB Availability likely
Triamcinolone Acetonide 40 mg/mL 00703-0243-01 Teva 1 vial $6.328 AB Availability likely
Triamcinolone Acetonide 200 mg/5mL 16714-0140-01 NorthStar 1 vial $6.328 AB Availability likely
Triamcinolone Acetonide 200 mg/5mL 43598-0694-11 Dr. 1 vial $6.328 AB Availability likely
Triamcinolone Acetonide 200 mg/5mL 67457-0622-05 Mylan 1 vial $6.328 AB Discontinued
Triamcinolone Acetonide 200 mg/5mL 70121-1168-01 Amneal 1 vial $6.328 AB Availability likely
Triamcinolone Acetonide 200 mg/5mL 70121-1652-01 Amneal 1 vial $6.328 AB Availability likely
Triamcinolone Acetonide 200 mg/5mL 70121-1654-01 Amneal 1 vial $6.328 AB Availability likely
Triamcinolone Acetonide 40 mg/mL 81298-5785-03 Long 1 vial $6.328 AB Availability likely
Triamcinolone Acetonide 40 mg/mL 55150-0384-01 Eugia 1 vial $6.671 AB FDA listed
Triamcinolone Acetonide 40 mg/mL 67457-0621-02 Mylan 1 vial $6.990 AB Discontinued
Triamcinolone Acetonide 40 mg/mL 70121-1657-01 Amneal 1 vial $6.990 AB Availability likely
Triamcinolone Acetonide 40 mg/mL 70121-1049-02 Amneal 1 vial $6.990 AB Availability likely
Triamcinolone Acetonide 40 mg/mL 70121-1651-01 Amneal 1 vial $6.990 AB Availability likely
Triamcinolone Acetonide 40 mg/mL 16714-0130-01 NorthStar 1 vial $6.990 AB Availability likely
Triamcinolone Acetonide 40 mg/mL 00703-0241-01 Teva 1 vial $6.990 AB Availability likely
Kenalog-40 40 mg/mL 00003-0293-05 E.R. 1 vial $9.001 AB Availability likely
Triamcinolone Acetonide 400 mg/10mL 43598-0695-11 Dr. 1 vial AB FDA listed
Triamcinolone Acetonide 200 mg/5mL 46708-0090-05 Alembic 1 vial AB FDA listed
Triamcinolone Acetonide 400 mg/10mL 46708-0091-10 Alembic 1 vial AB FDA listed
Kenalog-40 40 mg/mL 50090-0256-00 A-S 1 vial AB FDA listed
Kenalog-40 40 mg/mL 50090-0819-00 A-S 1 vial AB FDA listed
Triamcinolone Acetonide 200 mg/5mL 62332-0090-05 Alembic 1 vial AB FDA listed
Triamcinolone Acetonide 400 mg/10mL 62332-0091-10 Alembic 1 vial AB FDA listed
Kenalog-40 40 mg/mL 63187-0661-01 Proficient 1 vial AB FDA listed
Triamcinolone Acetonide 400 mg/10mL 70518-4582-00 REMEDYREPACK 1 vial AB FDA listed
Triamcinolone Acetonide 400 mg/10mL 76420-0016-10 ASCLEMED 1 vial AB FDA listed
Kenalog-40 40 mg/mL 76420-0085-01 Asclemed 1 ml AB FDA listed
Triamcinolone acetonide 40 mg/mLthis 80425-0262-01 Advanced 1 vial AB FDA listed
Triamcinolone Acetonide 400 mg/10mL 85766-0016-10 Sportpharm 1 vial AB FDA listed
Triamcinolone Acetonide 200 mg/5mL 85766-0134-05 Sportpharm 1 vial AB FDA listed
Triamcinolone Acetonide 400 mg/10mL 85766-0194-10 Sportpharm 1 vial AB FDA listed
Triamcinolone Acetonide 200 mg/5mL 85766-0206-05 Sportpharm 1 vial AB FDA listed
Triamcinolone Acetonide 200 mg/5mL 87063-0077-05 ASCLEMED 1 vial AB FDA listed
Triamcinolone Acetonide 40 mg/mL 71205-0451-01 Proficient 1 vial AB FDA listed
Triloan SUIK 40 mg/mL 76420-0220-01 Asclemed 1 vial FDA listed
Triloan II SUIK 40 mg/mL 76420-0222-01 Asclemed 2 vials FDA listed
Kenalog-40 40 mg/mL 50090-2360-00 A-S 1 vial AB FDA listed
Triamcinolone Acetonide 40 mg/mL 46708-0812-01 Alembic 1 vial AB FDA listed
Triamcinolone Acetonide 40 mg/mL 43598-0677-11 Dr. 1 vial AB FDA listed
Triamcinolone Acetonide 40 mg/mL 62332-0812-01 Alembic 1 vial 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

🏛️
2023
On the market since
Feb 2023
📍
2026
Currently FDA-listed
3 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Triamcinolone Acetonide — the program that covers self-administered drugs. 22 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Triamcinolone Acetonide. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$17.79M
Claims incl. refills
1.7M
Beneficiaries
1.4M
Spend / beneficiary
$13.01
Spend / claim
$10.45
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

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

Top reported reactions

Pruritus2,650
Rash2,534
Pain2,232
Fatigue2,133
Nausea2,043
Headache1,916
Condition Aggravated1,747

Reporter sex

31,697 reports
Male · 34%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization6,577
Death3,076
Disabling2,415
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4,201 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
80425-0262-01 You're viewing this 1 VIAL, MULTI-DOSE in 1 CARTON (80425-0262-1) / 5 mL in 1 VIAL, MULTI-DOSE 2023-02-15 Active

🧭 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 80425-0262-1, 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: 80425-0262-01, written without dashes as 80425026201. 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 80425-0262-01, the first segment (80425) is the labeler code FDA assigned to Advanced Rx Pharmacy of Tennessee, LLC; the middle segment (0262) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Advanced Rx Pharmacy of Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Advanced Rx Pharmacy of Tennessee, LLC 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.
🎯 Indications and Usage ~2 min read

Intramuscular Where oral therapy is not feasible, injectable corticosteroid therapy, including triamcinolone acetonide injectable suspension is indicated for intramuscular use as follows: Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).

Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.

Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy.

Ophthalmic diseases: Sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.

Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. Intra-Articular The intra-articular or soft tissue administration of triamcinolone acetonide injectable suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.

⏱️ Dosage and Administration ~3 min read

General NOTE: CONTAINS BENZYL ALCOHOL (see PRECAUTIONS). The initial dose of triamcinolone acetonide injectable suspension may vary from 2.5 mg to 100 mg per day depending on the specific disease entity being treated (see DOSAGE section below). However, in certain overwhelming, acute, life-threatening situations, administration in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages.

IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment.

In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. Dosage SYSTEMIC The suggested initial dose is 60 mg, injected deeply into the gluteal muscle.

Atrophy of subcutaneous fat may occur if the injection is not properly given. Dosage is usually adjusted within the range of 40 mg to 80 mg, depending upon patient response and duration of relief. However, some patients may be well controlled on doses as low as 20 mg or less.

Hay fever or pollen asthma: Patients with hay fever or pollen asthma who are not responding to pollen administration and other conventional therapy may obtain a remission of symptoms lasting throughout the pollen season after a single injection of 40 mg to 100 mg. In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of triamcinolone for a week followed by 64 mg every other day for one month are recommended (see PRECAUTIONS: NEURO-PSYCHIATRIC). In pediatric patients, the initial dose of triamcinolone may vary depending on the specific disease entity being treated.

The range of initial doses is 0.11 to 1.6 mg/kg/day in 3 or 4 divided doses (3.2 to 48 mg/m2bsa/day). For the purpose of comparison, the following is the equivalent milligram dosage of the various glucocorticoids: Cortisone, 25 Triamcinolone, 4 Hydrocortisone, 20 Paramethasone, 2 Prednisolone, 5 Betamethasone,

0.75 Prednisone, 5 Dexamethasone,

0.75Methylprednisolone, 4 These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered. LOCAL Intra-articular administration: A single local injection of triamcinolone acetonide is frequently sufficient, but several injections may be needed for adequate relief of symptoms.

Initial dose: 2.5 mg to 5 mg for smaller joints and from 5 mg to 15 mg for larger joints, depending on the specific disease entity being treated. For adults, doses up to 10 mg for smaller areas and up to 40 mg for larger areas have usually been sufficient. Single injections into several joints, up to a total of 80 mg, have been given.

Administration GENERAL STRICT ASEPTIC TECHNIQUE IS MANDATORY. The vial should be shaken before use to ensure a uniform suspension. Prior to withdrawal, the suspension should be inspected for clumping or granular appearance (agglomeration).

An agglomerated product results from exposure to freezing temperatures and should not be used. After withdrawal, triamcinolone acetonide injectable suspension should be injected without delay to preven…

Contraindications 29 words

Triamcinolone acetonide injectable suspension is contraindicated in patients who are hypersensitive to any components of this product (see WARNINGS: GENERAL). Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.

⚠️ Warnings and Cautions ~2 min read

Serious Neurologic Adverse Reactions with Epidural Administration Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids (see WARNINGS: NEUROLOGIC). Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy.

The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use. General Exposure to excessive amounts of benzyl alcohol has been associated with toxicity (hypotension, metabolic acidosis), particularly in neonates, and an increased incidence of kernicterus, particularly in small preterm infants. There have been rare reports of deaths, primarily in preterm infants, associated with exposure to excessive amounts of benzyl alcohol.

The amount of benzyl alcohol from medications is usually considered negligible compared to that received in flush solutions containing benzyl alcohol. Administration of high dosages of medications containing this preservative must take into account the total amount of benzyl alcohol administered. The amount of benzyl alcohol at which toxicity may occur is not known.

If the patient requires more than the recommended dosages or other medications containing this preservative, the practitioner must consider the daily metabolic load of benzyl alcohol from these combined sources (see PRECAUTIONS: PEDIATRIC USE). Rare instances of anaphylaxis have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS). Cases of serious anaphylaxis, including death, have been reported in individuals receiving triamcinolone acetonide injection, regardless of the route of administration.

Because triamcinolone acetonide injectable suspension is a suspension, it should not be administered intravenously. Unless a deep intramuscular injection is given, local atrophy is likely to occur. (For recommendations on injection techniques, see DOSAGE AND ADMINISTRATION.) Due to the significantly higher incidence of local atrophy when the material is injected into the deltoid area, this injection site should be avoided in favor of the gluteal area.

Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during, and after the stressful situation. Triamcinolone acetonide injectable suspension is a long-acting preparation, and is not suitable for use in acute stress situations. To avoid drug-induced adrenal insufficiency, supportive dosage may be required in times of stress (such as trauma, surgery, or severe illness) both during treatment with triamcinolone acetonide injectable suspension and for a year afterwards.

Results from one multicenter, randomized, placebo-controlled study with methylprednisolone hemisuccinate, an intravenous corticosteroid, showed an increase in early (at 2 weeks) and late (at 6 months) mortality in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment. High doses of systemic corticosteroids, including triamcinolone acetonide injectable suspension, should not be used for the treatment of traumatic brain injury. Cardio-Renal Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.

These effects are less likely to occur with the synthetic derivatives except when they are used in large doses. Dietary salt restriction and potassium supplementation may be necessary (see PRECAUTIONS). All corticosteroids increase calcium excretion.

Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great cauti…

🤒 Adverse Reactions ~2 min read

(listed alphabetically under each subsection) The following adverse reactions may be associated with corticosteroid therapy: Allergic reactions: Anaphylaxis including death, angioedema. Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS), pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.

Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, lupus erythematosus-like lesions, purpura, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria. Endocrine: Decreased carbohydrate and glucose tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, postmenopausal vaginal hemorrhage, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients.

Fluid and electrolyte disturbances: Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention. Gastrointestinal: Abdominal distention, bowel/bladder dysfunction (after intrathecal administration [see WARNINGS: NEUROLOGIC]), elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis.

Metabolic: Negative nitrogen balance due to protein catabolism. Musculoskeletal: Aseptic necrosis of femoral and humeral heads, calcinosis (following intra-articular or intralesional use), Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, post injection flare (following intra-articular use), steroid myopathy, tendon rupture, vertebral compression fractures. Neurologic/Psychiatric: Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychiatric disorders, vertigo.

Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration. Spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke (including brainstem) have been reported after epidural administration of corticosteroids (see WARNINGS: SERIOUS NEUROLOGIC ADVERSE REACTIONS WITH EPIDURAL ADMINISTRATION and WARNINGS: NEUROLOGIC). Ophthalmic: Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections.

Other: Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain.

🆘 Overdosage 40 words

Treatment of acute overdosage is by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced.

🧬 Clinical Pharmacology 126 words

Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract. Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Synthetic analogs such as triamcinolone are primarily used for their anti-inflammatory effects in disorders of many organ systems.

Triamcinolone acetonide injectable suspension has an extended duration of effect which may be sustained over a period of several weeks. Studies indicate that following a single intramuscular dose of 60 mg to 100 mg of triamcinolone acetonide, adrenal suppression occurs within 24 to 48 hours and then gradually returns to normal, usually in 30 to 40 days. This finding correlates closely with the extended duration of therapeutic action achieved with the drug.

📦 How Supplied / Storage and Handling 108 words

Triamcinolone acetonide injectable suspension USP is a sterile, isotonic, nonpyrogenic white parenteral suspension supplied in vials providing 40 mg triamcinolone acetonide per mL. Strength Vial Size Carton NDC Number 200 mg per 5 mL (40 mg per mL) 5 mL multiple-dose vial One vial per carton NDC: 80425-0262-01 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]; protect from temperatures below 20°C (68°F). Store vial in carton to protect from light.

Store vial upright. Manufactured In Croatia By: Pliva Hrvatska d.o.o. Zagreb, Croatia Manufactured For: Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454 Distributed by: Advanced Rx Pharmacy of Tennessee, LLC Iss. 8/2018

📋 Description 135 words

Triamcinolone acetonide injectable suspension USP is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION.

Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, USP with 0.65% sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and 0.042% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen.

The chemical name for triamcinolone acetonide is 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is: Triamcinolone acetonide, USP occurs as a white powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol. Description

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