Triamcinolone Acetonide 40 mg/mL Injection, Suspension
Other active recalls for Triamcinolone Acetonide (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Triamcinolone Acetonide — tap one for details:
Triamcinolone Acetonide may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
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UNII LKG8494WBH
Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
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UNII K679OBS311
Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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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.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
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?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $6.328 | $31.64 / 5 ml |
| Medicaid paysCMS SDUD · 12 mo | $10.32 | $51.60 / 5 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J3301 | $0.996 / J3301 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Triamcinolone Acetonide 40 mg/mL 55150-0385-01 | Eugia | 1 vial | $3.294 | AB | FDA listed | save 48% |
| Triamcinolone Acetonide 40 mg/mL 25021-0054-01 | Sagent | 25 vials | $4.838 | AB | Availability likely | save 24% |
| Triamcinolone Acetonide 40 mg/mL 00143-9387-25 | Hikma | 25 vials | $4.838 | AB | Availability likely | save 24% |
| Triamcinolone Acetonide 40 mg/mL 00703-0245-01 | Teva | 1 vial | $4.869 | AB | Availability likely | save 23% |
| Triamcinolone Acetonide 400 mg/10mL 16714-0150-01 | NorthStar | 1 vial | $4.869 | AB | Availability likely | save 23% |
| Triamcinolone Acetonide 400 mg/10mL 67457-0623-10 | Mylan | 1 vial | $4.869 | AB | Discontinued | save 23% |
| Triamcinolone Acetonide 400 mg/10mL 70121-1169-01 | Amneal | 1 vial | $4.869 | AB | Availability likely | save 23% |
| Triamcinolone Acetonide 400 mg/10mL 70121-1653-01 | Amneal | 1 vial | $4.869 | AB | Availability likely | save 23% |
| Triamcinolone Acetonide 400 mg/10mL 70121-1655-01 | Amneal | 1 vial | $4.869 | AB | Availability likely | save 23% |
| Triamcinolone Acetonide 40 mg/mL 81298-5783-03 | Long | 1 vial | $4.869 | AB | Availability likely | save 23% |
| Triamcinolone Acetonide 40 mg/mLthis 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 | +5% |
| Triamcinolone Acetonide 40 mg/mL 67457-0621-02 | Mylan | 1 vial | $6.990 | AB | Discontinued | +10% |
| Triamcinolone Acetonide 40 mg/mL 70121-1657-01 | Amneal | 1 vial | $6.990 | AB | Availability likely | +10% |
| Triamcinolone Acetonide 40 mg/mL 70121-1049-02 | Amneal | 1 vial | $6.990 | AB | Availability likely | +10% |
| Triamcinolone Acetonide 40 mg/mL 70121-1651-01 | Amneal | 1 vial | $6.990 | AB | Availability likely | +10% |
| Triamcinolone Acetonide 40 mg/mL 16714-0130-01 | NorthStar | 1 vial | $6.990 | AB | Availability likely | +10% |
| Triamcinolone Acetonide 40 mg/mL 00703-0241-01 | Teva | 1 vial | $6.990 | AB | Availability likely | +10% |
| Kenalog-40 40 mg/mL 00003-0293-05 | E.R. | 1 vial | $9.001 | AB | Availability likely | +42% |
| 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/mL 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 | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00703-0243-01 You're viewing this | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-0243-01) / 5 mL in 1 VIAL, MULTI-DOSE | 2019-08-29 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE 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 ▾
DOSAGE AND ADMINISTRATION 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 mg/kg/day to 1.6 mg/kg/day in 3 or 4 divided doses (3.2 mg/m 2 bsa/day to 48 mg/m 2 bsa/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 injectab…
⛔ Contraindications ▾
CONTRAINDICATIONS 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 ▾
WARNINGS 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 wit…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS (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. To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
Drug Interactions Aminoglutethimide: Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression. Amphotericin B injection and potassium-depleting agents: When corticosteroids are administered concomitantly with potassium-depleting agents ( i.e. , amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.
Antibiotics: Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance. Anticholinesterases: Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy.
Anticoagulants, oral: Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics: Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.
Antitubercular drugs: Serum concentrations of isoniazid may be decreased. Cholestyramine: Cholestyramine may increase the clearance of corticosteroids. Cyclosporine: Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently.
Convulsions have been reported with this concurrent use. CYP3A4 inhibitors: Triamcinolone acetonide is a substrate of CYP3A4. Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects.
Coadministration of other strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin, cobicistat-containing products) with triamcinolone acetonide injectable suspension may cause increased plasma concentration of triamcinolone leading to adverse reactions (see ADVERSE REACTIONS ). During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving triamcinolone acetonide and strong CYP3A4 inhibitors (e.g., ritonavir) (see WARNINGS, Endocrine and PRECAUTIONS, Endocrine ).
Consider the benefit-risk of concomitant use and monitor for systemic corticosteroid side effects. Digitalis glycosides: Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, including oral contraceptives: Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect.
Hepatic enzyme inducers (e.g., barbiturates, phenytoin, carbamazepine, rifampin): Drugs which induce hepatic microsomal drug metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Nonsteroidal anti-inflammatory drugs (NSAIDs): Concomitant use of aspirin (or other nonsteroidal anti-inflammatory drugs) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.
The clearance of salicylates may be increased with concurrent use of corticosteroids. Skin tests: Corticosteroids may suppress reactions to skin tests. Vaccines: Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response.
Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS : Immunos…
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women.
Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
🧒 Pediatric Use ▾
Pediatric Use This product contains benzyl alcohol as a preservative. Benzyl alcohol, a component of this product, has been associated with serious adverse events and death, particularly in pediatric patients. The “gasping syndrome” (characterized by central nervous system depression, metabolic acidosis, gasping respirations, and high levels of benzyl alcohol and its metabolites found in the blood and urine) has been associated with benzyl alcohol dosages >99 mg/kg/day in neonates and low-birth-weight neonates.
Additional symptoms may include gradual neurological deterioration, seizures, intracranial hemorrhage, hematologic abnormalities, skin breakdown, hepatic and renal failure, hypotension, bradycardia, and cardiovascular collapse. Although normal therapeutic doses of this product deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome,” the minimum amount of benzyl alcohol at which toxicity may occur is not known. Premature and low-birth-weight infants, as well as patients receiving high dosages, may be more likely to develop toxicity.
Practitioners administering this and other medications containing benzyl alcohol should consider the combined daily metabolic load of benzyl alcohol from all sources. The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (>2 years of age), and aggressive lymphomas and leukemias (>1 month of age).
Other indications for pediatric use of corticosteroids, e.g. , severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations. The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis.
Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity. This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of HPA axis suppression ( i.e. , cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function.
The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives. In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.
🧓 Geriatric Use ▾
Geriatric Use No overall differences in safety or effectiveness were observed between elderly 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.
🆘 Overdosage ▾
OVERDOSAGE 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 ▾
CLINICAL PHARMACOLOGY 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 ▾
HOW SUPPLIED 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 40 mg per mL 1 mL single-dose vial One vial per carton NDC 0703-0241-01 200 mg per 5 mL (40 mg per mL) 5 mL multiple-dose vial One vial per carton NDC 0703-0243-01 400 mg per 10 mL (40 mg per mL) 10 mL multiple-dose vial One vial per carton NDC 0703-0245-01 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 Rev. A 7/2024
📋 Description ▾
DESCRIPTION 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: C 24 H 31 FO 6 M.W. 434.51 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. structural formula
💬 Information for Patients ▾
Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision, to advise any medical attendants that they are taking corticosteroids, and to seek medical advice at once should they develop fever or other signs of infection. Persons who are on corticosteroids should be warned to avoid exposure to chicken pox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.