KENALOG-10 10 mg/mL

TRIAMCINOLONE ACETONIDE · INJECTION, SUSPENSION · E.R. Squibb & Sons, L.L.C.

No Recall HistoryCurrently in Shortage

Plain English

KENALOG-10 is a injection, suspension containing triamcinolone acetonide at 10 mg/mL, taken intra-articular. Manufactured by E.R. Squibb & Sons, L.L.C..

Key Facts

Brand Name: KENALOG-10
Generic Name: TRIAMCINOLONE ACETONIDE
NDC Code (Product): 0003-0494
Manufacturer: E.R. Squibb & Sons, L.L.C.
Strength: 10 mg/mL
Dosage Form: INJECTION, SUSPENSION
Route: INTRA-ARTICULAR, INTRALESIONAL
Marketing Status
Application #: NDA012041
Drug Class: Corticosteroid [EPC]
Marketing Start: 06/01/2009

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective3,581 reports

off label use2,666 reports

pruritus2,302 reports

rash2,260 reports

pain1,997 reports

fatigue1,884 reports

nausea1,804 reports

product use in unapproved indication1,602 reports

vomiting1,556 reports

diarrhoea1,540 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE The intra-articular or soft tissue administration of Kenalog-10 Injection (triamcinolone acetonide injectable suspension, USP) 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. The intralesional administration of Kenalog-10 Injection is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques; necrobiosis lipoidica diabeticorum. Kenalog-10 Injection may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).

Dosage & Administration

DOSAGE AND ADMINISTRATION General NOTE: CONTAINS BENZYL ALCOHOL (see PRECAUTIONS ). 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. In pediatric patients, the initial dose of triamcinolone may vary depending on the specific dis…

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 ta…

Contraindications

CONTRAINDICATIONS Kenalog-10 Injection 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.

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. Antidia…

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 melli…

Frequently Asked Questions

What is KENALOG-10 used for?

KENALOG-10 contains TRIAMCINOLONE ACETONIDE. It is a injection, suspension taken intra-articular. Consult your doctor for specific uses.

Is KENALOG-10 a controlled substance?

KENALOG-10 is not classified as a controlled substance by the DEA.

What is the generic name for KENALOG-10?

The generic name for KENALOG-10 is TRIAMCINOLONE ACETONIDE. There are 12 other brand versions of TRIAMCINOLONE ACETONIDE.

What is the NDC code for KENALOG-10 10 mg/mL?

The NDC (National Drug Code) for KENALOG-10 10 mg/mL is 0003-0494, listed by E.R. Squibb & Sons, L.L.C..

Product NDC

0003-0494

Package NDC

0003-0494-20

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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