Source: Health Products and Food Branch (CA) Revision Year: 2020
Trispan is contraindicated in:
Trispan must not be administered intravenously, intraocularly, epidurally or intrathecally.
Trispan should not be used to alleviate joint pain arising from infectious states such as gonococcal or tubercular arthritis.
This product contains a potent glucocorticoid, and even though systemic adverse effects are unusual when glucocorticoids are given as an intra-articular injection triamcinolone hexacetonide should be used with caution in patients suffering from the following conditions:
Inadvertent injection into the soft tissues around the joint may lead to an increased incidence of systemic effects, as may peri-articular injections. As with all local injections, care should be taken to avoid entering a blood vessel. Adverse reactions may be minimised by using the lowest effective dose for a minimum duration of time. Frequent patient review is required to titrate the dose appropriately against disease activity (refer to DOSAGE AND ADMINISTRATION).
No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis.
Glucocorticoids may increase the risk for thromboembolic events.
Adrenal cortical atrophy develops during prolonged corticosteroid therapy and may persist for years after stopping treatment. Withdrawal of corticosteroids after prolonged therapy must, therefore, always be gradual to avoid acute adrenal insufficiency and should be tapered off over weeks or months according to the dose and duration of treatment. During prolonged therapy any intercurrent illness, trauma, or surgical procedure may require a temporary increase in dosage. If corticosteroids have been stopped following prolonged therapy they may need to be reintroduced temporarily.
Patients should not be vaccinated or immunized with live vaccines while they are under treatment with moderate or high dose corticosteroids for longer than 2 weeks treatment, since a possible lack of an antibody response may predispose to medical, and particularly neurological, complications. Intraarticular and periarticular corticosteroid use, or steroids given for less than 2 weeks, or in a long-term regular dosage of 10 mg daily, are not considered a contraindication to use of live vaccines.
Caution should be used in the event of exposure to chickenpox, measles or other communicable diseases, since the course of specific viral diseases such as chickenpox and measles may be particularly severe in patients treated with glucocorticoids. At particular risk are immunocompromised (immunosuppressed) children and individuals with no history of chickenpox or measles infection. If such individuals should come into contact with people infected with chickenpox or measles during treatment with Trispan, prophylactic treatment should be considered as appropriate.
Trispan is a corticosteroid product which may increase calcium excretion, and predispose patients to osteoporosis.
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. Severe joint destruction with necrosis of bone may occur if repeated intra-articular injections are given over a long period of time.
Sterile technique is necessary to prevent infections or contamination. Appropriate examination of any joint fluid present is necessary to exclude a septic process. 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, antimicrobial therapy should be instituted immediately.
Patients should be advised not to overuse treated joints in which symptomatic benefit has been obtained as long as the inflammatory process remains active.
Ophthalmic complications during prolonged corticosteroid therapy have been observed. These include posterior subcapsular cataract, central serous chorioretinopathy, glaucoma and possible damage to optic nerves, and enhancement of secondary ocular infections due to fungi or virus.
Psychiatric disorders may be seen with corticosteroid treatment, including sleep disorders, depression, euphoria, mood swings, psychotic disorders and personality disorders. Existing emotional instability or psychotic disorder may be aggravated by corticosteroids.
Trispan contains sorbitol. Patients with very rare hereditary problems of fructose intolerance should not take this medicine.
Corticosteroid therapy may cause menstrual disorders and amenorrhea in premenopausal women, and vaginal bleeding in postmenopausal women.
Steroids may increase or decrease motility and number of spermatozoa in some patients.
Triamcinolone crosses the placenta. Corticosteroids have been shown to be teratogenic in many species when given at doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. Long-term use of corticosteroids in humans and animals has led to a decrease in weight of the placenta and the newborn.
There are no adequate and well-controlled studies in pregnant women. Trispan should be used during pregnancy only if the potential benefit to the mother clearly outweighs the risk to the fetus. Infants born to mothers who have received corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
Triamcinolone hexacetonide is excreted in human milk, but is not likely to have any effect on the child at therapeutic doses. Caution must be observed with the long-term use of large doses.
Children on prolonged corticosteroid therapy should have their growth and development monitored.
This product contains benzyl alcohol as a preservative. Benzyl alcohol has been linked to severe adverse reactions and death, especially in very young pediatric patients. Exposure to excessive quantities of benzyl alcohol has been linked to toxicity (hypotension, metabolic acidosis, respiratory distress – “Gasping Syndrome”), especially in neonates, and to an increased incidence of kernicterus, mainly in premature infants. Although normal therapeutic doses of Trispan release substantially lower quantities of benzyl alcohol than those associated with “Gasping Syndrome,” the minimum quantity of benzyl alcohol capable of producing toxicity is not known. Premature and low-birth-weight infants, as well as patients taking high doses, are more likely to develop toxicity.
Adverse reactions depend on the dose and the duration of treatment. Systemic adverse reactions are rare, but may occur as a result of repeated periarticular injection. As with other intra-articular steroid treatments, transient adrenocortical suppression has been observed during the first week after injection. This effect is enhanced if corticotropin or oral steroids are used concomitantly.
Administration site conditions: local reactions include sterile abscesses, post-injection erythema, pain, swelling and necrosis at the injection site; excess dosage or too-frequent administration of injections into the same site may cause local subcutaneous atrophy, which, due to the properties of the drug, will only return to normal after several months. As with all glucocorticoids, an exacerbation of symptoms or “flare-up” may occur following injection. Local atrophy, burning, flushing, pain and swelling may occur.
Cardiovascular: cardiac failure; arrhythmias, bradycardia, cardiac arrest, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.
Dermatologic: hyperpigmentation or hypopigmentation, impaired wound healing, thin and fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, purpurea, striae, acneiform eruptions, hives, rash, acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, edema, sterile abscess, striae, suppressed reactions to skin tests, thinning scalp hair, urticaria.
Endocrine: menstrual irregularities, amenorrhoea and postmenopausal vaginal bleeding, hirsutism, development of a Cushingoid state, secondary adrenocortical and pituitary unresponsiveness, particularly during periods of stress (e.g. trauma, surgery or illness), manifestation of latent diabetes mellitus, decreased carbohydrate and glucose tolerance, glycosuria, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetics, suppression of growth in pediatric patients.
Gastrointestinal disorders: peptic ulcers with possibility of subsequent perforation and haemorrhage, pancreatitis, abdominal distention, bowel/bladder dysfunction (after intrathecal administration), elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis.
Immune system disorders: anaphylactoid reactions, anaphylaxis, angioedema, exacerbation or masking of infections.
Metabolic: negative nitrogen balance owing to protein catabolism.
Musculoskeletal: tendon rupture, loss of muscle mass, osteoporosis, aseptic necrosis of the heads of the humerus and femur, spontaneous fractures, Charcot-like arthropathy, calcinosis (following intra-articular or intralesional use), muscle weakness, pathologic fracture of long bones, post-injection flare (following intra-articular use), steroid myopathy, vertebral compression fractures.
Neurologic/Psychiatric: vertigo; increased intracranial pressure with papilloedema (pseudotumor cerebri) usually after treatment; headache, insomnia; exacerbation of existing psychiatric symptoms; depression (sometimes severe); euphoria; mood swings; psychotic symptoms, convulsions, emotional instability, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo. Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration
Ophthalmic: posterior subcapsular cataracts, increased intraocular pressure, glaucoma, blurred vision, exophthalmos, rare instances of blindness associated with periocular injections.
Renal and urinary: Increased calcium excretion.
The drug-drug interactions listed in Table 1 below outline the potential interactions associated with corticosteroid injectable products.
Table 1. Established or Potential Drug-Drug Interactions:
| Triamcinolone Hexacetonide | Ref | Clinical comment |
|---|---|---|
| Amphotericin B injection and potassium-depleting agents | T | Patients should be monitored for additive hypokalaemia. |
| Anticholinesterases | T | The effect of anticholinesterase agent may be antagonised. |
| Anticholinergics (e.g. atropine) | T | Additional increase of intraocular pressure is possible. |
| Anticoagulants (oral) | T | Corticosteroids may potentiate or decrease anticoagulant effect. For this reason, patients receiving oral anticoagulants and corticosteroids should be closely monitored |
| Antidiabetics (e.g. sulfonylurea derivatives) and insulin | T | Corticosteroids may increase the levels of glucose in the blood. Diabetic patients should be monitored, especially on instigation and discontinuation of treatment of corticosteroids and if the dosage is changed. |
| Antihypertensives, including diuretics | T | The reduction in arterial blood pressure may be diminished. |
| Antituberculosis drugs | T | Isoniazid serum concentrations may be decreased. |
| Cyclosporine | T | When used concomitantly, this substance may produce an increase in both cyclosporine and corticosteroid activity. |
| Digitalis glycosides | T | Concomitant administration may increase the likelihood of digitalis toxicity. |
| Hepatic Enzyme Inducers (e.g. barbiturates, phenytoin, carbamazepine, rifampicin, primidone, aminoglutethimide) | T | There may be increased metabolic clearance of triamcinolone hexacetonide. Patients should be carefully observed for possible reduced effect of triamcinolone hexacetonide, and the dosage should be adjusted accordingly. |
| Hepatic enzyme inhibitors | T | Protease inhibitors (including ritonavir) or ketoconazole may decrease corticosteroid clearance via CYP3A4 inhibition resulting in increased effects such as Cushing’s syndrome and adrenal suppression. Patients should be monitored for undesirable effects due to triamcinolone and the dose should be adjusted if needed. |
| Human growth hormone (somatropin) | T | The growth-promoting effect may be inhibited during long-term therapy with triamcinolone hexacetonide. |
| Non-depolarising muscle relaxants | T | Corticosteroids may decrease or enhance the neuromuscular blocking action. |
| Non-steroidal antiinflammatory agents (NSAIDs) | T | Corticosteroids may increase the incidence and/or severity of gastrointestinal bleeding and ulceration associated with NSAIDs. Corticosteroids may also reduce serum salicylate levels and therefore decrease their efficacy. Conversely, discontinuing corticosteroids during high-dose salicylate therapy may result in salicylate toxicity. Caution must be exercised during concomitant use of acetylsalicylic acid and corticosteroids in patients with hypoprothrombinaemia. |
| Oestrogens, including oral contraceptives | T | Corticosteroid half-life and concentration may be increased and clearance decreased. |
| Thyroid drugs | T | Metabolic clearance of adrenocorticoids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustments to the dosage of adrenocorticoids. |
| Vaccines | T | Neurological complications and a diminished antibody response may occur when patients taking corticosteroids are vaccinated. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. If possible, routine administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued. |
| Medications that prolong the QT interval or induce torsade de pointes | T | Concomitant treatment with triamcinolone hexacetonide and class Ia antiarrhythmic agents such as disopyramide, quinidine and procainamide, or other class II antiarrhythmic agents such as amiodarone, bepridil and sotalol, is not recommended. Extreme caution is required in cases of concomitant administration with phenothiazines, tricyclic antidepressants, terfenadine and astemizole, vincamine, erythromycin i.v., halofantrine, pentamidine and sultopride. Combination with agents that cause electrolyte disturbances such as hypokalaemia (potassium-depleting diuretics, amphotericin B i.v. and certain laxatives), hypomagnesaemia and severe hypocalcaemia is not recommended. |
Legend: C = Case Study; CT = Clinical Trial; T = Theoretical
Corticosteroids may interfere with the nitroblue tetrazolium test for bacterial infection, producing false-negative results.
Athletes should be informed that this medicinal product contains an ingredient (triamcinolone hexacetonide) that may produce a positive result in anti-doping tests.
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