ARISTOSPAN®
Stiefel/Glades
Triamcinolone Hexacetonide
Glucocorticoid
Action And Clinical Pharmacology: The hexacetonide ester of triamcinolone is relatively insoluble (0.0002% at 25°C in water). When injected intra-articularly it can be expected to be absorbed slowly from the injection site. The pharmacological action of triamcinolone hexacetonide is less intense and more prolonged, but qualitatively the same as triamcinolone acetonide. Triamcinolone hexacetonide’s activity is ascribable to the slow release of triamcinolone acetonide through hydrolysis. Following this reaction, the pharmacology is identical to that of the parent compound, triamcinolone acetonide. tag_IndicationsIndications
Indications And Clinical Uses: Adjunctive therapy for short-term administration in synovitis of osteoarthritis, acute and subacute bursitis, epicondylitis, post-traumatic osteoarthritis, rheumatoid arthritis, acute gouty arthritis, acute nonspecific tenosynovitis.
Since triamcinolone hexacetonide has low solubility, if a more immediate therapeutic effect is desired, then a more soluble corticosteroid should be administered locally or systemically.
Contra-Indications: Systemic fungal infection.
Manufacturers’ Warnings In Clinical States: Should not be given i.v.
Active, latent or questionably healed turberculosis, ocular herpes simplex and acute psychosis are considered to be conditions which require caution when glucocorticoid therapy is utilized.
Pregnancy: In pregnancy, particularly during the first trimester, steroids should be considered only when the benefits outweigh the risks involved, since fetal abnormalities have been observed in experimental animals.
Steroids should be used with caution in cases of psychic disturbances, in acute glomerulonephritis, active or latent peptic ulcer, myasthenia gravis, osteoporosis, fresh intestinal anastomoses, diverticulitis, thrombophlebitis, diabetes mellitus, hyperthyroidism, acute coronary artery disease, hyper-tension, limited cardiac reserve or systemic infections including exanthematous diseases.
Caution regarding vaccination against smallpox and other immunization procedures is advised.
Ophthalmic complications during prolonged corticosteroid therapy have been observed. These include posterior subcapsular cataract, glaucoma and possible damage to optic nerves and enhancement of secondary ocular infections due to fungi or virus.
Calcium excretion is increased during corticosteroid therapy.
Patients should be advised to inform subsequent physicians of the prior use of corticosteroids.
Appropriate examination of any joint fluid present is necessary to avoid a septic process.
Precautions: See Aristocort monograph.
The prolonged and repeated use of glucocorticoids in weight bearing joints may result in further joint degeneration. This may be related to increased use of still diseased joints following relief of pain and other symptoms, or it may be due to inhibition by corticosteroids of protein synthesis in articular cartilage. It is inadvisable to inject unstable joints; repeated injections may, in some cases, result in instability of the joint.
Inadvertent injection into the soft tissues around the joint may lead to an increased incidence of systemic effect. As with all intra-articular injections, take care to avoid entering a blood vessel.
A marked increase in pain, accompanied by local swelling, further restriction of joint motion, fever and malaise occurring after intra-articular injection is suggestive of septic arthritis. If this complication appears and the diagnosis of sepsis is confirmed, institute antimicrobial therapy immediately and continue for at least 7 to 10 days after clinical evidence of infection has disappeared.
Avoid over distension of the joint capsule and deposition of the steroid along the needle track.
Advise patients not to overuse treated joints in which symptomatic benefit has been obtained as long as the inflammatory process remains active.
Adverse Reactions: Systemic effects have occurred infrequently with triamcinolone hexacetonide, but, nevertheless, the patient should be observed for the following:
Specific triamcinolone effects: Certain systemic effects may occur that do not occur or may occur less frequently with other corticosteroids. These include:
A depression of appetite, in contrast to voracious appetite ordinarily encountered with other glucocorticoids.
Most common corticosteroids may cause euphoria whereas triamcinolone may cause a mood depression.
Common glucocorticoids cause sodium retention and edema, but triamcinolone may produce a mild early diuresis, making edema uncommon.
A myopathy with muscle weakness involving the muscles of the thighs, pelvis and lower back may occur more frequently with triamcinolone than with other corticosteroids.
Calcium excretion is increased during corticosteroid therapy.
Since systemic absorption may occasionally occur with intra-articular administration, watch patients closely for adverse reactions which may be associated with any corticosteroid therapy (see Aristocort monograph).
Intra-articular corticosteroid administration may produce an exacerbation of symptoms or “flare-up” following injection. Local atrophy, Charcot-like arthropathy, burning, flushing, pain and swelling may occur. Blindness associated with therapy around the face and head have been reported following intra-articular corticosteroid administration.
Dosage And Administration: Not for i.v. use. Strict aseptic administration technique is mandatory. Topical ethyl chloride spray may be used locally before injection.
Before each use gently agitate the vial to achieve a uniform suspension. A small bore needle (25 to 26 gauge) may be used for administration.
Average intra-articular dose is 2 to 20 mg. Dosage is dependent on the size of the joint to be injected, the degree of inflammation and the amount of fluid present. In general, large joints (such as knee, hip, shoulder) require 10 to 20 mg. For small joints (such as interphalangeal, metacarpophalangeal) 2 to 6 mg may be employed. When the amount of synovial fluid is increased, aspiration may be performed before administering Aristospan. Subsequent dosage and frequency of injections can best be judged by clinical response.
The usual frequency of injection into a single joint is every 3 or 4 weeks, and injection more frequently than that is generally not advisable. To avoid possible joint destruction from repeated use of intra-articular corticosteroids, injection should be as infrequent as possible, consistent with adequate patient care. Avoid deposition of drug along the needle path, which might produce atrophy.
Availability And Storage: Each mL of suspension contains: micronized triamcinolone hexacetonide 20 mg, polysorbate 80 USP 0.4% w/v, sorbitol solution USP 50% v/v and water for injection q.s. Preserved with benzyl alcohol 0.9% w/v. Tartrazine-free. Vials of 1 and 5 mL.
ARISTOSPAN® Stiefel/Glades Triamcinolone Hexacetonide Glucocorticoid
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