KENACORT-A

What it is

Kenacort-A 40 is a sterile triamcinolone acetonide suspension containing 40 mg in 1 mL, supplied as an injection ampoule for intramuscular and intra-articular or intrasynovial use. It is not for intravenous, intradermal or intraocular use. Kenacort-A 40 provides a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action.

Approved indications

— Allergic diseases, dermatoses, or generalised rheumatoid arthritis and other connective tissue disorders (intramuscular administration for systemic corticosteroid therapy). — Synovitis of osteoarthritis; rheumatoid arthritis; acute and subacute bursitis; acute gouty arthritis; epicondylitis; acute nonspecific tenosynovitis; post-traumatic osteoarthritis (intra-articular or intrasynovial administration, and for injections into tendon sheaths, as adjunctive therapy for short-term administration).

Dosing overview

The initial dose of Kenacort-A 40 Injection may vary from 2.5 to 60 mg per day depending on the specific disease entity being treated. For systemic use, the suggested initial dose for adults and children over 12 years of age is 60 mg, injected deeply into the gluteal muscle. Dosage is usually adjusted within the range of 40 to 80 mg, depending upon patient response and duration of relief, although some patients may be well controlled on dosage as low as 20 mg or less. For children from 6 to 12 years of age, the suggested initial dose is 40 mg, although dosage depends on the severity of symptoms than on age or weight. For intra-articular or intrasynovial use, the initial dose may vary from 2.5 to 5 mg for smaller joints and from 5 to 15 mg for larger joints. For adults, doses up to 10 mg for smaller areas and up to 40 mg for larger areas have usually been sufficient to alleviate symptoms, and single injections into several joints for multiple locus involvement, up to a total of 80 mg have been given without undue reactions.

Key safety warnings

Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localise infection when corticosteroids are used. In addition, patients who are on immunosuppressant drugs including corticosteroids are more susceptible to infections than those not taking these drugs. Chickenpox and measles can have a more serious or even fatal course in patients on corticosteroids. In such children, or adults receiving corticosteroids who have had these diseases, particular care should be taken to avoid exposure. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chickenpox or herpes zoster develops, treatment with antiviral agents may be considered. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Corticosteroid therapy has been associated with central serous chorioretinopathy, which may lead to retinal detachment. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes. This product contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with serious adverse events and death, particularly in paediatric patients. The gasping syndrome has been associated with benzyl alcohol. 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.

Contraindications

Corticosteroids are contraindicated in patients with systemic infections. Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. Kenacort-A 40 Injection is also contraindicated in patients with a sensitivity to the active or inactive ingredients.

Regulatory history

Kenacort-A 40 was first listed on the ARTG on 29 September 1995.