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Kenalog-10 (Triamcinolone Acetonide Intra-Articular) - Summary

 
 



KENALOG-10 SUMMARY

Kenalog®-10 Injection (triamcinolone acetonide injectable suspension, USP) is triamcinolone acetonide, a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intralesional and intra-articular injection. THIS FORMULATION IS SUITABLE FOR INTRA-ARTICULAR AND INTRALESIONAL USE ONLY. Each mL of the sterile aqueous suspension provides 10 mg triamcinolone acetonide, with sodium chloride for isotonicity, 0.9% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and 0.04% polysorbate 80; sodium hydroxide or hydrochloric acid may have been added to adjust pH between 5.0 and 7.5. At the time of manufacture, the air in the container is replaced by nitrogen.

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, or 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).


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NEWS HIGHLIGHTS

Published Studies Related to Kenalog-10 (Triamcinolone Intra-Articular)

Gait patterns after intraarticular treatment of patients with osteoarthritis of the knee--hyaluronan versus triamcinolone: a prospective, randomized, doubleblind, monocentric study. [2009.04.16]
OBJECTIVE: Evaluation of gait performance and muscle activity patterns as well as clinical efficacy and safety after single intraarticular injection with hyaluronan compared with triamcinolone in patients with knee osteoarthritis... CONCLUSION: Single application of high-viscosity hyaluronan shows superior range of motion and pain reduction as well as improvement in clinical results. Even if there was a lack of significant differences compared to triamcinolone, this therapy classified as safe and effective in the short follow up.

Intramuscular botulinum toxin-A reduces hemiplegic shoulder pain: a randomized, double-blind, comparative study versus intraarticular triamcinolone acetonide. [2008.01]
BACKGROUND AND PURPOSE: Shoulder pain is frequent after stroke and interferes with the rehabilitative process and outcome. However, treatments used for hemiplegic shoulder pain are limited and largely ineffective. This prospective, randomized, double-blind controlled study was conducted to compare the efficacies of botulinum toxin type A (BoNT-A) and triamcinolone acetonide (TA) on hemiplegic shoulder pain and their effects on arm function in patients with stroke... CONCLUSIONS: Results from this study suggest that injection of BoNT-A into selected muscles of the shoulder girdle might provide more pain relief and ROM improvement than intraarticular steroid in patients with hemiplegic shoulder pain. A larger clinical trial needs to be undertaken to confirm the benefits of this approach.

A randomized controlled trial of intra-articular triamcinolone and/or physiotherapy in shoulder capsulitis. [2005.04]
OBJECTIVE: To assess the effectiveness of intra-articular triamcinolone injection and physiotherapy singly or combined in the treatment of adhesive capsulitis of the shoulder... CONCLUSION: Corticosteroid injection is effective in improving shoulder-related disability, and physiotherapy is effective in improving the range of movement in external rotation 6 weeks after treatment.

Treatment of de Quervain disease with triamcinolone injection with or without nimesulide. A randomized, double-blind, placebo-controlled trial. [2004.12]
BACKGROUND: There is uncertainty as to whether supplemental oral nonsteroidal anti-inflammatory medication improves the effectiveness of steroid injections in the treatment of de Quervain disease. We tested the hypothesis that there are no significant differences in the success rates when this condition is treated with triamcinolone injection with or without supplemental oral nimesulide... CONCLUSIONS: Supplemental oral administration of the nonsteroidal anti-inflammatory drug nimesulide does not improve the effectiveness of a single injection of triamcinolone acetonide in the treatment of de Quervain disease. Patients with crepitation in the first dorsal compartment during thumb extension or abduction are at increased risk for recurrence of this disease. LEVEL OF EVIDENCE: Therapeutic study, Level I-1b (randomized controlled trial [no significant difference but narrow confidence intervals]).

Triamcinolone acetonide and hexacetonide intra-articular treatment of symmetrical joints in juvenile idiopathic arthritis: a double-blind trial. [2004.10]
CONCLUSION: Even when TA is given at higher doses, TH is more effective and should be considered the drug of choice for intra-articular treatment of JIA.

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Clinical Trials Related to Kenalog-10 (Triamcinolone Intra-Articular)

Intralesional Steroids in the Treatment of Alopecia Areata [Recruiting]
Alopecia areata is a common form of hair loss which reportedly occurs in up to 1. 7% of the population at some time in their life. Alopecia areata is apparently triggered when the individual's own immune system attacks hair follicles on the scalp or body resulting in hair loss ranging from single patches on the scalp (patch type alopecia areata) to loss of every hair on the scalp and body (alopecia universalis). Currently, there are limited treatment options for alopecia areata and unfortunately, the treatments utilized have never been rigorously tested in a placebo controlled trial. Triamcinolone (Kenalog) is a steroid solution that has been used as treatment for alopecia areata for over 50 years. It is administered via injection into the scalp and appears to have some efficacy for patients with mild to moderate alopecia areata. We currently do not have objective data on the frequency of occurrence of successful regrowth, the duration of response or the incidence of side effects. In addition, there is disagreement between clinicians regarding the dose of intralesional triamcinolone (IL TAC) that is considered most effective. This study aims to determine the frequency of response to treatment with 3 concentrations of IL TAC, 2. 5mg/ml, 5mg/ml or 10mg/ml as well as the duration of response and incidence of side effects compared to treatment with placebo (sterile saline solution). After the 1st 6 months non or partial responders may be treated for 6 months with open label triamcinolone at the dose deemed appropriate by the investigator. We will also perform skin biopsies of the scalp and draw blood at selected time points in order to examine the immunohistochemical/pathological response in scalp hair follicles and the systemic circulation to treatment with IL TAC for alopecia areata.

Early Treatment for Acute ACL Tear [Active, not recruiting]
This research study is the first of its kind and will allow health care professionals and researchers to answer many questions about the reasons why anterior cruciate ligament (ACL) injury leads to knee pain and disability and osteoarthritis. We also hope that this study will be the beginning of new, more powerful and safer drugs to help patients with ACL injuries heal sooner and return to sports or daily activities pain free. Study participants will be recruited from the University of Kentucky and Vanderbilt University. The purpose of this research is to gather information on how safe and effective Kenalog« is in alleviating knee pain following ACL rupture.

A Pilot Study of Peribulbar Triamcinolone Acetonide for Diabetic Macular Edema [Completed]
The study involves the enrollment of patients over 18 years of age with diabetic macular edema involving the center of the macula who have not already been given maximal laser treatment. Patients with one study eye will be randomly assigned (stratified by prior laser) with equal probability to one of five treatment groups: 1. Focal laser photocoagulation (modified ETDRS technique) 2. Posterior peribulbar injection of 40 mg triamcinolone (Kenalog) 3. Anterior peribulbar injection of 20 mg triamcinolone 4. Posterior peribulbar injection of 40 mg triamcinolone followed after one month by laser 5. Anterior peribulbar injection of 20 mg triamcinolone followed after one month by laser For patients with two study eyes (both eyes eligible at the time of randomization), the right eye (stratified by prior laser) will be randomly assigned with equal probabilities to one of the five treatment groups listed above. If the right eye was assigned to laser only, then the left eye will be assigned to one of the four triamcinolone groups above with equal probability (stratified by prior laser). If the right eye was assigned to receive triamcinolone, then the left eye will receive laser only. Triamcinolone acetonide will be the corticosteroid utilized in this study. The triamcinolone acetonide preparation to be used is Kenalog. Kenalog is manufactured by Bristol Myers Squibb and is approved by the Food and Drug Administration for intramuscular use for a variety of indications. Peribulbar injections of Kenalog have been used for a wide variety of ocular conditions, particularly uveitis and post-cataract extraction cystoid macular edema, for many years. Two different triamcinolone regimens will be assessed in the study: 40 mg injected posteriorly and 20 mg injected anteriorly. There is no indication of which treatment regimen will be better. Although the injection behind the eye is more common than the injection near the front of the eye, the injection near the front of the eye has less risk of injuring the eye. However, it is possible that the injection near the front of the eye may increase eye pressure more frequently. Little is known about which of the two injections decreases macular edema and improves vision more often. Patients enrolled into the study will be followed for three years and will have study visits 1 month, 2 months, 4 months, 8 months and annually after receiving their assigned study treatment. For the first 8 months of the study, patients should only be retreated with their randomized treatment. However, if the patient's visual acuity has decreased by 15 letters or more, then any treatment may be given at the investigator's discretion. After completion of the 8-month visit, treatment is at investigator discretion. The primary objective of this study is to obtain estimates of efficacy and safety outcomes for each of the treatment groups. These estimates will provide a basis for the sample size estimation and hypothesis generation in a phase III trial.

Relationship to Dose of Triamcinolone Acetonide and Methylyprednisolone to Improvement in Subacromial Bursitis [Recruiting]
It is currently unknown whether or not the improvement in pain and function related to a "steroid shot" for shoulder pain due to subacromial bursitis is important. This study seeks to determine whether 20 mg or 40 mg of either triamcinolone or methylprednisolone significantly affect improvement in shoulder pain 6 weeks after injection.

Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain [Not yet recruiting]
The goal of this study is to compare the effectiveness of two different medications used in intravaginal trigger point injections (injections into extremely painful areas of a muscle) to treat chronic pelvic pain. The study compares onabotulinumtoxinA (BOTOX«) (a drug prepared from the bacterial toxin botulin which temporarily paralyzes muscles) to Kenalog (a synthetic corticosteroid used as an anti-inflammatory agent).

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Reports of Suspected Kenalog-10 (Triamcinolone Intra-Articular) Side Effects

Incorrect Route of Drug Administration (2)Medication Error (2)Headache (1)Drug Administration Error (1)Eye Disorder (1)Rash (1)Paraesthesia (1)Flushing (1)Injection Site Atrophy (1)Muscle Disorder (1)


Page last updated: 2009-10-20

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