Aristocort (Triamcinolone Diacetate)

ARISTOCORT® Parenteral

Stiefel/Glades

Triamcinolone Diacetate

Corticosteroid

Indications And Clinical Uses: Intralesional Injection: For intralesional or sublesional use in local therapy of various skin diseases, e.g. psoriasis, alopecia areata, neurodermatitis, atopic dermatitis, acne, synovial and sebaceous cysts, pruritus ani, contact and nummular dermatoses. Not for i.v. use.

Forte Parenteral: For i.m., intrasynovial or intra-articular injection. Not for i.v. use. May be used in the treatment of asthma, allergies, ulcerative colitis, collagen diseases, and various dermatoses including psoriasis, contact dermatitis and urticaria. Also in the treatment of rheumatoid arthritis, bursitis, fibromyositis, peritendinitis, intermittent hydrarthrosis, epicondylitis, and related conditions, and may be used in any accessible joint except the intervertebrals.

Contra-Indications: See Aristospan. Local contraindications for the use of intrarectal steroids, include obstruction, abscess, perforation, peritonitis, extensive fistulas and sinus tracts. It must be remembered that infected joints should not be injected with corticosteroids.

Precautions: See Aristospan. Strict asepsis should be observed since exacerbation of symptoms of flare-up from septic joint have been reported in the literature following intra-articular administration. Should this condition develop it should receive early and adequate treatment. Unstable joints should not be injected. X-ray follow up is suggested in selected cases to detect deterioration. During rectal administration, caution should be exercised in patients with severe ulcerative disease because these individuals are predisposed to perforation of the bowel wall.

Adverse Reactions: See Aristospan. Rare cases of anaphylactoid reactions have been reported following parenteral triamcinolone therapy. Appropriate precautions are advised. Flushing of the face may occur but it is not considered serious. In contrast to euphoria seen with other glucocorticoids, a mild depression may occur. Occasional patients manifest reversible weakness or atrophy of the quadriceps or gastrocnemius muscle groups when on large doses. The development of myopathy has been demonstrated by electromyographic abnormalities and biopsy findings. The effect may be reversed by discontinuation of the drug.

A “side effect” sometimes observed with intralesional or sublesional or i.m. use is a local loss of tissue substance or depression of the treated area called “atrophy” by some physicians. In this condition the injected site appears thinned out and is shiny. In certain conditions, keloids for example, atrophy and sloughing of tissue may be a desirable “complication”. Administration of smaller amounts of the drug should lessen this effect. Changes in pigmentation and a papule at the injection site may occur. Injection given too deeply or in doses greater than 75 mg per week may lead to systemic manifestations.

For the first few hours following intrasynovial or intra-articular injection there may be local discomfort in the joint but this is usually rapidly followed by effective relief of pain and improvement of local function.

Dosage And Administration: Parenteral-Intralesional: Intra-articular or intrasynovial, 5 to 40 mg. Intralesional, from 5 mg divided over several locations in small lesions up to 50 mg total in large psoriatic plaques. May also be used to replace or supplement oral therapy. In general, a single parenteral dose 4 to 7 times the oral daily dose may be expected to control the patient from 4 to 7 days up to 3 to 4 weeks.

Forte Parenteral: I.M.: 40 mg once a week. Single doses over 80 mg are seldom indicated. Intra-articular and intrasynovial, 5 to 40 mg every 1 to 8 weeks.

Availability And Storage: Parenteral-Intralesional: Each mL contains: triamcinolone diacetate 25 mg suspended in a vehicle of polysorbate 80 USP 0.2%, polyethylene glycol 4 000 USP 3%, sodium chloride 0.85%, benzyl alcohol 0.9%, water for injection q.s. to 100%, hydrochloric acid to pH 6. Vials of 5 mL.

Forte Parenteral: Each mL contains: triamcinolone diacetate 40 mg suspended in a vehicle of polysorbate 80 USP 0.2%, polyethylene glycol 4 000 USP 3%, sodium chloride 0.85%, benzyl alcohol 0.9%, water for injection q.s. to 100%, hydrochloric acid to pH 6. Vials of 5 mL. Boxes of 5.

ARISTOCORT® Parenteral Stiefel/Glades Triamcinolone Diacetate Corticosteroid

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