Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Intrapharm Laboratories Ltd., The Courtyard Barns, Choke Lane, Maidenhead, Berkshire, SL6 6PT, United Kingdom
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
This medicinal product must not be administered to infants born recently or prematurely because it contains benzyl alcohol. It may provoke toxic and anaphylactoid reactions in children under 3 years of age, and so should not be used in infants and children up to 3 years of age.
TRIAMCINOLONE HEXACETONIDE is contraindicated in the case of:
This product contains a potent glucocorticoid and so should be used with caution in patients suffering from the following conditions:
All corticosteroids may increase calcium excretion.
The product must not be administered intravenously, intraocularly, epidurally or intrathecally.
Intra-articular injection should not be carried out in the presence of active infection in or near joints. The preparation should not be used to alleviate joint pain arising from infectious states such as gonococcal or tubercular arthritis.
The load on strained joints in particular should be lightened immediately after the injection to avoid overloading. Repeated injections may damage the joint. Severe joint destruction with necrosis of bone may occur if repeated intra-articular injections are given over a long period of time.
Undesirable effects may be minimised using the lowest effective dose for the minimum period. Frequent patient review is required to titrate the dose appropriately against disease activity (see 4.2).
Adrenal cortical atrophy develops during prolonged 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 carry steroid treatment cards, as appropriate, which give clear guidance on the precautions to be taken to minimise risk and which provide details of prescriber, drug, dosage and the duration of treatment.
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.
If, during treatment, the patient develops serious reactions or acute infections, the treatment must be stopped and appropriate treatment given.
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 chickenpox or measles sufferers during treatment with TRIAMCINOLONE HEXACETONIDE, prophylactic treatment should be considered as appropriate.
Menstrual irregularities may occur and in postmenopausal women vaginal bleeding has been observed. This possibility should be mentioned to female patients but should not deter appropriate investigations as indicated.
Effect on female fertility, see section 4.6.
Co-administration of triamcinolone hexacetonide with CYP3A4 inhibitors is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects. If the potential benefit of co-administration outweighs the increased risk of systemic corticosteroid side-effects, patients should be monitored for these effects (see section 4.5).
Visual disturbance may be reported with systemic and topical corticosteroid use. 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 which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
It is recommended to monitor growth and development of children on prolonged corticosteroid therapy.
This medicinal product must not be administered to infants born recently or prematurely because it contains benzyl alcohol. It may provoke toxic and anaphylactoid reactions in children under 3 years of age.
Benzyl alcohol has been linked to severe adverse reactions and death, especially in paediatric patients. Exposure to excessive quantities of benzyl alcohol has been linked to toxicity (hypotension and metabolic acidosis), especially in neonates, and to an increased incidence of kernicterus, mainly in premature infants. There have been rare cases of death, mainly in premature infants, linked to exposure to excessive quantities of benzyl alcohol.
“Gasping Syndrome” has been linked to benzyl alcohol. Although normal therapeutic doses of this product 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.
TRIAMCINOLONE HEXACETONIDE contains sorbitol. Patients with very rare hereditary problems of fructose intolerance should not take this medicine.
Amphotericin B injection and potassium-depleting agents: Patients should be monitored for additive hypokalaemia.
Anticholinesterases: The effect of anticholinesterase agent may be antagonised.
Anticholinergics (e.g. atropine): Additional increase of intraocular pressure is possible.
Anticoagulants, oral: 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: 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: The reduction in arterial blood pressure may be diminished.
Antituberculosis drugs: Isoniazid serum concentrations may be decreased.
Cyclosporin: When used concomitantly, this substance may produce an increase in both cyclosporin and corticosteroid activity.
Digitalis glycosides: Concomitant administration may increase the likelihood of digitalis toxicity.
Hepatic Enzyme Inducers (e.g. barbiturates, phenytoin, carbamazepine, rifampicin, primidone, aminoglutethimide): 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.
Human growth hormone (somatropin): The growth-promoting effect may be inhibited during long-term therapy with TRIAMCINOLONE HEXACETONIDE.
Hepatic enzyme inhibitors: 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. Co-administration of triamcinolone hexacetonide with CYP 3A inhibitors (including cobicistat-containing products) is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects. If the potential benefit of co-administration outweighs the increased risk of systemic corticosteroid side-effects, patients should be monitored for these effects (see section 4.4).
Non-depolarising muscle relaxants: Corticosteroids may decrease or enhance the neuromuscular blocking action.
Non-steroidal anti-inflammatory agents (NSAIDs): 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: Corticosteroid half-life and concentration may be increased and clearance decreased.
Thyroid drugs: 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: Neurological complications and a diminished antibody response may occur when patients taking corticosteroids are vaccinated (see section 4.4).
Medicines that prolong the QT interval or induce torsade de pointes: Concomitant treatment with TRIAMCINOLONE HEXACETONIDE and class Ia antiarrhythmic agents such as disopyramide, quinidine and procainamide, or other class II antiarrhythmic drugs 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.
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 (e.g. triamcinolone hexacetonide) that may produce a positive result in anti-doping tests.
Interaction studies have only been performed in adults.
Triamcinolone crosses the placenta. Corticosteroids are teratogenic in animal experiments. The significance of this fact for humans is not exactly known, but so far the use of corticosteroids has not been shown to increase the incidence of malformations. Long-term use of corticosteroids in humans and animals has led to a decrease in weight of the placenta and the newborn.
Long-term corticosteroid therapy is also associated with a risk of adrenocortical suppression in the newborn. The product should be used during pregnancy only if the benefit to the mother is clearly greater than the risk to the fetus.
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 in the long-term use of large doses.
Women: Corticosteroid therapy may cause menstrual disorders and amenorrhea.
TRIAMCINOLONE HEXACETONIDE has no or negligible influence on the ability to drive and use machines.
For assessment of adverse reactions (ADRs) following terms regarding frequency are used: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to 1</1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Adverse effects depend on the dose and the duration of treatment. Systemic adverse effects are rare, but may occur as a result of repeated periarticular injection. As with other intraarticular 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.
Very rare: anaphylaxis-type reactions
Not known: exacerbation or masking of infections
Not known: 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); decreased carbohydrate tolerance; manifestation of latent diabetes mellitus
Not known: insomnia; exacerbation of existing psychiatric symptoms; depression (sometimes severe); euphoria; mood swings; psychotic symptoms
Rare: vertigo
Not known: increased intracranial pressure with papilloedema (pseudotumor cerebri) usually after treatment; headache
Not known: posterior subcapsular cataracts; increased intraocular pressure; glaucoma; vision, blurred (see also section 4.4)
Not known: cardiac failure; arrhythmias
Very rare: thromboembolism
Not known: hypertension
Not known: peptic ulcers with possibility of subsequent perforation and haemorrhage; pancreatitis
Very rare: hyperpigmentation or hypopigmentation
Not known: impaired wound healing; thin and fragile skin; petechiae and ecchymoses; facial erythema; increased sweating; purpurea; striae; acneiform eruptions; hives; rash
Very rare: calcinosis; tendon rupture
Not known: loss of muscle mass; osteoporosis; aseptic necrosis of the heads of the humerus and femur; spontaneous fractures; Charcot-like arthropathy
Not known: negative nitrogen balance owing to protein catabolism
Common: Local reactions include sterile abscesses, post-injection erythema, pain, swelling and necrosis at the injection site.
Rare: 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.
Glucocorticoids may induce growth suppression in children.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
The use of solvents containing methylparaben, propylparaben, phenol, etc. should be avoided, since they may cause precipitation of the steroid. This medical product must not be mixed with other medicinal products except those mentioned in section 6.6.
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