Excess dosage or too-frequent administration of injections into the same site may cause local subcutaneous atrophy. If this occurs, recovery may take several months due to the long-term effect of the drug.
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-FPO HEXACETONIDE is contraindicated in the case of:
- active tuberculosis
- herpes simplex keratitis,
- acute psychoses,
systemic mycoses and parasitoses (strongyloid infections).
The use of solvents containing methylparaben, propylparaben, phenol, etc. should be avoided, since they may cause precipitation of the steroid.
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.
Immune system disorders
Very rare: anaphylaxis-type reactions
Not known: exacerbation or masking of infections
Endocrine disorders
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
Psychiatric disorders
Not known: insomnia; exacerbation of existing psychiatric symptoms; depression (sometimes severe); euphoria; mood swings; psychotic symptoms
Nervous system disorders
Rare: vertigo
Not known: increased intracranial pressure with papilloedema (pseudotumor cerebri) usually after treatment; headache
Eye disorders
)
Cardiac disorders
Not known: cardiac failure; arrhythmias
Vascular disorders
Very rare: thromboembolism
Not known: hypertension
Gastrointestinal disorders
Not known: peptic ulcers with possibility of subsequent perforation and haemorrhage; pancreatitis
Skin and subcutaneous tissue disorders
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
Musculoskeletal and connective tissue disorders
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
Renal and urinary disorders
Not known: negative nitrogen balance owing to protein catabolism
General disorders and administration site conditions
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.
Paediatric population
Glucocorticoids may induce growth suppression in children.
Reporting of suspected adverse reactions
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.
Triamcinolone-FPO hexacetonide is a potent teratogen in many animals. For example cleft palate has been reported in mice, rats, rabbits, and hamsters. CNS anomalies and cranial malformations have been observed in monkeys following gestational exposure. To date, however, no signs of teratogenicity of corticosteroids have been observed in humans.
Environmental Risk Assessment (ERA)
The environmental risk assessment has been performed according to European standards. From these results it is assumed that the medicinal product is unlikely to represent a risk for the environment following the recommended use in patients.
Triamcinolone-FPO HEXACETONIDE is indicated for intraarticular, intrasynovial or periarticular use in adults and adolescents for the symptomatic treatment of subacute and chronic inflammatory joint diseases including:
- Rheumatoid arthritis
- Juvenile Idiopathic Arthritis (JIA)
- Osteoarthritis and post-traumatic arthritis
- Synovitis, tendinitis, bursitis and epicondylitis
Triamcinolone-FPO HEXACETONIDE may also be used for the intraarticular use in children aged 3 - 12 years with Juvenile Idiopathic Arthritis (see Posology below).
Pharmacotherapeutic group: Corticosteroids for systemic use, glucocorticoids
ATC code: H02AB08
Mechanism of action
The mode of action of glucocorticoids is not fully known, but local injections are thought to have an anti-inflammatory effect.
Pharmacodynamic effects
Triamcinolone-FPO HEXACETONIDE is a synthetic glucocorticoid with pronounced anti-inflammatory activity. The product is a microcrystalline water suspension with a depot effect.
The anti-inflammatory potency of Triamcinolone-FPO on a milligram by milligram comparison is approximately five times that of hydrocortisone. Triaminolone has practically no mineralocorticoid effect, so no sodium retention occurs.
Paediatric population
The efficacy and safety of Triamcinolone-FPO hexacetonide in children and adolescents are based on the well-researched effects of glucocorticoids, which are the same in children and adults. Published studies and current therapeutic guidelines for treatment of Juvenile Idiopathic Arthritis (JIA) indicate efficacy and safety in children and adolescents for the treatment of JIA.
The hexacetonide ester is almost insoluble in water, so dissolution is slow and the effect in the tissue of the injection site lasts for a long time, from a few weeks to several months. Generally, the onset of effect after Triamcinolone-FPO HEXACETONIDE administration occurs after 24 hours and normally lasts for 4 to 6 weeks.
Triamcinolone-FPO hexacetonide is hydrolysed by human serum in vitro (43% hydrolysed after 24 hours), but following intra-articular injection, the substance does not disperse in situ.
This product contains a potent glucocorticoid and so should be used with caution in patients suffering from the following conditions:
- cardiac insufficiency, acute coronary artery disease,
- hypertension,
- thrombophlebitis, thromboembolism
- myasthenia gravis,
- osteoporosis,
- gastric ulcer, diverticulitis, ulcerative colitis, recent intestinal anastomosis,
- exanthematous diseases,
- psychosis,
- Cushing's syndrome,
- diabetes mellitus,
- hypothyroidism,
- renal insufficiency, acute glomerulonephritis, chronic nephritis,
- cirrhosis,
- infections that cannot be treated with antibiotics,
- metastatic carcinoma.
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-FPO 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.
Co-administration of Triamcinolone-FPO 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.
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.
Paediatric population
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 Syndromeâ€, 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-FPO HEXACETONIDE contains sorbitol. Patients with very rare hereditary problems of fructose intolerance should not take this medicine.
Triamcinolone-FPO HEXACETONIDE has no or negligible influence on the ability to drive and use machines.
Posology
Intraarticular injection (dosage for adults and adolescents) for all indications
The dose 2-20 mg is determined individually according to the size of the joint and the amount of articular fluid. Large joints (e.g. hip, knee, shoulder) generally require 10-20 mg (0.5-1 ml), medium-sized joints 5-10 mg (0.25-0.5 ml), and smaller joints 2-6 mg (0.1-0.3 ml). If there is a lot of articular fluid, it can be aspirated prior to administration of the drug. The next dose and the number of injections depend on the progress of the clinical condition. Because Triamcinolone-FPO HEXACETONIDE is long-acting, administration of injections into individual joints more frequently than at 3-4 week intervals is not recommended. Accumulation of the drug at the injection site must be avoided, because it may cause atrophy.
Dosage for intraarticular use in children aged 3 - 12 years with Juvenile Idiopathic Arthritis
The dosage regime for Triamcinolone-FPO hexacetonide intraarticular injection for JIA in children is 1 mg/kg for large joints (knees, hips, and shoulders) and 0.5 mg/kg for smaller joints (ankles, wrists, and elbows). For the hands and feet, 1-2 mg/joint for metacarpophalangeal/metatarsophalangeal (MCP/MTP) joints, and 0.6-1 mg/joint for proximal interphalangeal (PIP) joints may be used.
Periarticular injection (dosage for adults and adolescents only)
Bursitis/Epicondylitis: Generally 10-20 mg (0.5-1 ml) depending on the size of the bursa and the severity of the disease. In the majority of cases a single treatment is sufficient.
Synovitis/Tendinitis: Generally 10-20 mg (0.5-1 ml). The need for additional injections should be determined on the basis of response to treatment.
Method of administration
Asepsis must be observed in the use of this product. The vial should be shaken carefully before use to ensure suspension. The injection site should be sterilised using the same technique as with lumbar puncture.
At each treatment session, an injection may be given into two joints at the most. Do not administer in unstable joints.
This formulation is intended for intraarticular, periarticular and intrasynovial use, and must not be used for intravenous, intraocular, epidural or intrathecal use.
Precautions to be taken before handling or administering the medicinal product
Triamcinolone-FPO HEXACETONIDE ampoules must be inspected for discolouration of the contents prior to administration.
Shake gently before use.
If necessary, Triamcinolone-FPO HEXACETONIDE may be mixed with 1% or 2% lidocaine hydrochloride or other similar local anaesthetics. Triamcinolone-FPO HEXACETONIDE should be drawn into the syringe before drawing in the anaesthetic to prevent contamination of Triamcinolone-FPO HEXACETONIDE. The syringe should then be shaken gently, and the resulting solution used immediately thereafter.
