Trispan

Trispan

triamcinolone

Manufacturer:

Stada

Distributor:

HK Medical Supplies
/
Health Express
Full Prescribing Info
Contents
Triamcinolone hexacetonide.
Description
1 ml suspension for injection contains 20 mg triamcinolone hexacetonide.
Excipients with known effect: Contains 9 mg benzyl alcohol per ml.
Contains sorbitol.
Excipients/Inactive Ingredients: 9 mg benzyl alcohol, polysorbate 80, sorbitol, water for injections.
Action
Pharmacotherapeutic group: corticosteroids, glucocorticoids. ATC code: H02A B08.
Pharmacology: Pharmacodynamics: Mechanism of action: Triamcinolone hexacetonide is used on account of its anti-inflammatory properties for the treatment of rheumatic diseases. The action of glucocorticoids is mediated via binding to a specific glucocorticoid receptor, thereby affecting the transcription of various genes.
Pharmacodynamic effects: The active principle of triamcinolone hexacetonide is triamcinolone acetonide. This is not a prodrug of the free triamcinolone alcohol, but rather a substance in its own right, with a significantly greater affinity for its receptor.
Binding affinities of commercially available glucocorticoids to their receptor - relative receptor affinity (Rohdewald et al., 1984). (See table.)

Click on icon to see table/diagram/image

Triamcinolone hexacetonide has a minor systemic glucocorticoid effect, measured as suppression of endogenous cortisol secretion. It possesses only a very slight mineralocorticoid effect.
Clinical efficacy and safety: Study results in the therapeutic indications stated show the benefit of triamcinolone hexacetonide. The pharmacological profile corresponds with the known effects of glucocorticoids. The safety profile is consistent with that of other representatives of the substance group, without any signs of new safety concerns. Thus, Trispan is a medicinal product with good clinical efficacy and acceptable safety.
Paediatric population: The efficacy and safety of triamcinolone hexacetonide in children and adolescents are based on the well-researched effects of glucocorticoids, which are the same in children and adults alike. Published studies demonstrate efficacy and safety in children and adolescents for the treatment of juvenile idiopathic arthritis (JIA).
Pharmacokinetics: Triamcinolone hexacetonide is available as a microcrystalline suspension. The low water solubility of the molecule is due to the tertiary butyl acetate residue at C21. Following release from the crystalline depot, hydrolytic cleavage to triamcinolone acetonide occurs via esterases (tissue enzymes). The plasma levels thus reached are lower and the half­-life longer than with injection of a triamcinolone acetonide preparation.
Paediatric population: The pharmacokinetic properties of triamcinolone hexacetonide have only been studied in adults.
Toxicology: Preclinical safety data: Acute toxicity: Acute toxicity studies on various animal species have revealed no particular sensitivity (see Overdosage).
Chronic toxicity: Chronic toxicity studies have been performed on rats, dogs and monkeys. Depending on the dose, duration of treatment and method of administration, blood count changes, interference with the electrolyte balance, infections and hepatic changes have been recorded in addition to several fatalities.
The observed reduction of the adrenal cortex and lymphatic tissue is directly associated with the glucocorticoid effect. In rats and dogs, an effect on coagulation factors was observed in addition to the previously-mentioned phenomena, as well as a reduction in glycogen levels of the liver, cardiac and skeletal muscle.
Mutagenic and carcinogenic potential: No studies have been conducted to determine mutagenic potential. No long-term animal studies have been conducted to determine carcinogenic potential.
Toxicity to reproduction: The embryotoxic properties of triamcinolone have been studied in three rodent species (rat, mouse, hamster), in rabbits and in three non-human primate species (rhesus, baboon, capuchin). In the rodents and in the rabbit, cleft palates and intrauterine growth impairment occurred, whereby teratogenic effects were induced, e.g. in rats, by doses within the human therapeutic range. In the simian species, disturbances in chondrocranium cartilage formation were observed, leading to skull anomalies (encephalocele) and facial dysmorphia. In addition, malformations of the thymus and intrauterine growth impairment occurred. No experience is available regarding the safety of human use.
Local toxicity (tolerability): In local tolerability studies, dogs were administered a single injection of 100 mg/kg body weight subcutaneously. Minor swelling occurred at the injection site, but this is attributed to the large volume of injection (4.0 ml). Studies on guinea pigs showed that no signs of local reactions are present after a single intradermal injection. In animals receiving intradermal injections twice weekly for 4 weeks, minor histological changes were observed. However, there were no signs of abscess formation and the lesions were classified as non-progressive. In humans, local irritation and signs of intolerability are possible (see Adverse Reactions).
Indications/Uses
lntraarticular Injections: Persistent inflammation in one or several joints after general treatment of chronic inflammatory joint diseases; arthritis in pseudogout/chondrocalcinosis; active osteoarthritis; post-traumatic, non-bacterial arthritis.
Infiltration therapy: Non-bacterial tendovaginitis (only when strictly indicated) and bursitis; periathropathy; insertional tendinopathy; enthesopathy in systemic, inflammatory rheumatic disease.
Sub- and Intralesional Injection: Isolated foci of psoriasis; lichen ruber planus, lichen simplex chronicus (neurodermatitis circumscripta); alopecia areata; chronic discoid lupus erythematosus; keloids.
Dosage/Direction for Use
Posology: Intraarticular Therapy: Intra-articular injections are to be regarded in the same way as open joint surgery and must only be performed under strictly aseptic conditions. In general, a single intra­articular injection of TRISPAN is sufficient for successful symptomatic relief. If another injection is deemed necessary, it should not be given for at least another 3 - 4 weeks, the number of injections per joint should be restricted to 3 - 4. Especially after repeated injection, medical check-ups of the treated joint are indicated.
The dosage depends on the size of the joint and the severity of the findings. The following dosage statements may serve as a guideline: Large joints 10 - 20 mg, medium­-sized joints 5 - 10 mg, small joints 2 - 5 mg triamcinolone hexacetonide.
Paediatric population: In accordance with the German interdisciplinary and evidence-based guideline by the German Society for Paediatric and Adolescent Rheumatology for the treatment of juvenile idiopathic arthritis, administration of 0.5-1 mg/kg BW triamcinolone hexacetonide is recommended for the treatment of large joints. For smaller joints, the dosage should be reduced accordingly.
Sub- and intralesional therapy: The dosage and method of injection are determined by the nature, location and extent of lesions and the clinical picture.
The dose per single injection should not exceed 0.1 mg triamcinolone hexacetonide per cm2 of the skin surface area.
When administered via this route, Trispan should generally be diluted at a ratio of at least 1:1.
Good therapeutic responses are also achieved at a dilution of 1:5.
Paediatric population: No data are available.
Infiltration therapy: The doses depends on the extent and location of the injection site, as well as the severity of symptoms, and can be between 2 and 20 mg triamcinolone hexacetonide.
Trispan is infiltrated into the area of most intense pain or the tendon attachments.
Cautions: do not inject into the tendon. Injections at short intervals should be avoided; strict aseptic conditions must be observed.
Paediatric population: No data are available.
Method of administration: Precautions to be taken before handling or administering the medicinal product: TRISPAN can be injected via the intra-articular, sublesional and intralesional routes or used for infiltration therapy. TRISPAN must not be injected intravenously. Injections into adipose tissue should also be avoided, as circumscribed cellulite formation may possibly occur as a result of subcutaneous adipose tissue atrophy.
If pain should occur during the injection, it should be discontinued immediately.
For instructions on reconstitution/dilution of the medicinal product before administration, see Special precautions for disposal and other handling under Cautions for Usage.
Overdosage
There are no known acute cases of intoxication with triamcinolone hexacetonide. Enhanced side effects (see Adverse Reactions), especially on the endocrine system, metabolism and electrolyte balance, can be expected in the event of an overdose.
There is no known antidote for Trispan.
Contraindications
Hypersensitivity to triamcinolone hexacetonide or to any of the excipients listed in Description.
TRISPAN must not be used in preterm or newborn infants, due to the benzyl alcohol content.
Intraarticular injections are contraindicated in cases of: Infections within or in the immediate vicinity of the joint to be treated; bacterial arthritis; instability of the joint to be treated; bleeding diathesis (spontaneous or caused by anticoagulants); periarticular calcification; non-vascularised osteonecrosis; tendon rupture; Charcot's joint.
Otherwise, there are no contraindications for short-term use in life-threatening indications. The anticipated success of therapy must be weighed against the possible undesirable effects.
In prolonged therapy: Gastrointestinal ulcers, severe osteoporosis, psychiatric history, acute viral infections (herpes zoster, herpes simplex, varicella), HBsAG-positive chronic active hepatitis, about 8 weeks before and up to 2 weeks after prophylactic vaccinations, systemic mycoses and parasitoses, poliomyelitis, lymphadenitis after BCG vaccination, narrow and open-angle glaucoma.
Special Precautions
Serious Neurologic Adverse Reactions with Epidural Administration: Serious neurologic events, some resulting in death, have been reported with epidural injections of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use.
Intra-articular administration of glucocorticoids causes a substance-specific increase in the risk of joint infection.
In some patients, local inflammation may temporarily worsen a few hours after the intra-articular glucocorticoid injection ("post-injection flare"), which is assumed to be a reaction to the injected microcrystals. This reaction normally resolves after 1 to 3 days. If it should persist for more than 24 hours, joint infection must be excluded.
Prolonged and repeated use of glucocorticoids in weight-bearing joints may lead to a worsening of degenerative changes within the joint. Possibly, one cause is overload of the affected joint following resolution of pain or other symptoms. In such cases, when repeating intra-articular injections, the dosing recommendations stated must therefore be observed at all times (see Dosage & Administration).
In cases of existing infection, Trispan may only be used with specific, concomitant anti-infective therapy. In patients with a history of tuberculosis (caution: reactivation), it may only be used with tuberculostatic protection.
The course of specific viral diseases (chickenpox, 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 Trispan, prophylactic treatment should be initiated as appropriate.
Due to the risk of intestinal perforation, Trispan may be used only when strictly indicated and with appropriate monitoring in the presence of severe ulcerative colitis with imminent perforation, diverticulitis or intestinal anastomosis (immediately postoperative).
During long-term therapy with Trispan, regular medical check-ups are indicated (including ophthalmological check-ups at three-monthly intervals). At comparatively high doses, adequate potassium intake and sodium restriction should be ensured and serum potassium levels monitored.
When terminating or, if necessary, discontinuing long-term administration, the following risks should be considered: exacerbation or relapse of the underlying disease, acute adrenocortical insufficiency (especially in stressful situations, e.g. during infections, after accidents, at times of increased physical stress), cortisone withdrawal syndrome.
Diabetics: Whilst using Trispan, a potentially increased need for insulin or oral antidiabetics should be considered in patients with diabetes.
Patients with hypertension: During treatment with Trispan, regular blood pressure monitoring is required in patients with difficult-to-control hypertension.
Patients with heart failure: Patients with severe heart failure must be carefully monitored, as there is a risk of deterioration.
Other patient groups: Patients with rare hereditary problems of fructose intolerance should not use Trispan.
Effect on testing methods: Skin reactions to allergy tests may be suppressed.
The use of Trispan can lead to positive results in doping tests. The use of Trispan as a doping agent may endanger health.
Effects on ability to drive and use machines: There are no indications of any impairment in the ability to drive and use machines.
Use in Children: Trispan may not be used during the growth years unless very strictly indicated.
Benzyl alcohol may cause toxic and anaphylactoid reactions in infants and children up to 3 years of age.
Use in Elderly: In elderly patients, Trispan should be used only after special consideration of the benefits and risks (increased risk of osteoporosis).
Use In Pregnancy & Lactation
Pregnancy: Triamcinolone should not be used in the first 5 months of pregnancy, as animal trials have indicated teratogenic effects and no findings are available with regard to the safety of human use during this period. In long-term use, intrauterine growth impairment cannot be excluded. When treating at the end of pregnancy, there is a risk of adrenocortical atrophy for the foetus.
Breast-feeding: Glucocorticoids are excreted in human milk. Breast-feeding should be discontinued if treatment with higher doses or long-term treatment is required.
Fertility: No experience is available regarding the effects of Trispan on fertility.
Adverse Reactions
The following frequencies are used for the evaluation of undesirable effects: Very common (≥1/10); Common (≥1/100 - <1/10); Uncommon (≥1/1,000 - <1/100); Rare (≥1/10,000 - <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).
The risk of undesirable effects in short-term glucocorticoid use is low, with the exception of parenteral high­-dose therapy, during which infections can be expected to clinically manifest, even during short-term administration.
In prolonged use, undesirable effects of varying degrees of severity can be regularly anticipated.
Following intra-articular use of glucocorticoids, adverse reactions occur mainly within the area of the injection site and the endocrine system.
General disorders and administration site conditions: Local irritation is common (transient relapse of inflammation after the injection, pain lasting for 1-3 days, so-called "post-injection flare"). Signs of intolerability (sensations of heat, redness, swelling) are also possible.
Associated with the administration technique, there may be injury to blood vessels or nerves, as well as periarticular and articular structures. As with any puncture of the joints, germs may be introduced (infection). Via a differential diagnosis, joint infection should be distinguished from crystal synovitis which, unlike joint infections, may occur as early as after a few hours but causes no general symptoms and resolves within a few days. The onset of crystal synovitis depends on factors such as the size of crystals in the preparation.
Endocrine disorders: The greatest risks of long-term therapy are adrenal suppression and induction of cushingoid symptoms (moon face, truncal obesity).
The following may also occur: disturbances in sex hormone secretion (amenorrhoea, hirsutism, impotence); reduced glucose tolerance, diabetes mellitus.
Metabolism and nutrition disorders: Sodium retention with oedema formation, increased potassium excretion (caution: arrhythmias).
Skin and subcutaneous tissue disorders: Atrophy of the skin and subcutaneous tissue at the injection site is possible if corticosteroids are not injected carefully into the joint cavity. In addition, there have been reports of striae rubrae, petechiae, ecchymoses, steroid acne, delayed wound healing, perioral dermatitis and local pigmentation disorders (hypo- or depigmentation).
Rarely, hypersensitivity reactions occur, e.g. exanthema.
Musculoskeletal and connective tissue disorders: Muscle atrophy, osteoporosis (even short-term use of low doses can cause bone loss), aseptic osteonecrosis (head of the humerus, femur and tibia), peri- and intraarticular calcification, tendon damage (ruptures also possible).
Psychiatric disorders: Depression, irritability, euphoria, increased drive and appetite.
Nervous system disorders: Pseudotumor cerebri, manifestation of latent epilepsy.
Gastrointestinal disorders: Gastrointestinal ulcers, gastrointestinal bleeding, pancreatitis.
Vascular disorders: Hypertension, increased risk of arteriosclerosis and thrombosis, vasculitis (also as withdrawal syndrome after long-term therapy).
Blood and lymphatic system disorders: Moderate leukocytosis, lymphopenia, eosinopenia, polycythaemia.
Immune system disorders: Weakened immune defense, masking of infections.
Very rarely, hypersensitivity reactions and even anaphylactic reactions are possible.
Eye disorders: Cataract, glaucoma.
Rarely, hypersensitivity reactions may occur as a result of benzyl alcohol.
Paediatric population: The safety profile for children is comparable with that of adults. There are no differences with regard to the frequency, nature and severity of adverse reactions.
Glucocorticoids may cause growth retardation in children.
Drug Interactions
Enzyme inducers e.g. barbiturates, phenytoin, primidone, rifampicin, reduce the glucocorticoid effect.
Oestrogens (e.g. ovulation inhibitors) can enhance the clinical effect of Trispan.
Non-steroidal anti-inflammatory agents (e.g. salicylates, indometacin): The risk of gastrointestinal ulcerations and bleeding may be increased.
Oral antidiabetics and insulin: The hypoglycaemic effect is reduced.
Oral anticoagulants (coumarin derivatives) are attenuated in their effect; adjustment of the anticoagulant dose is required during concomitant use.
ACE inhibitors: If co-administered, there may be an increased risk that blood count changes may occur.
Atropine and other anticholinergics: A further increase in intraocular pressure cannot be excluded with concomitant use of Trispan.
Cardiac glycosides: Potassium deficiency may potentiate their effect.
Saluretics: In concomitant use, there is further potassium excretion.
Laxatives: The potassium loss may be accentuated.
Praziquantel: As a result of corticosteroids, a decrease in the blood concentration of praziquantel is possible.
Chloroquine, hydroxychloroquine, mefloquine: During concomitant use, there is an increased risk that myopathies and cardiomyopathies may occur.
Somatropin: The effect of somatropin can be reduced during long-term administration of Trispan.
Thyroid diagnostics: When protirelin is given, the rise in TSH may be reduced.
Ciclosporin: The blood levels of ciclosporin are increased; increased risk of cerebral seizures.
Paediatric population: Interaction studies have only been performed in adults.
Caution For Usage
Special precautions for disposal and other handling: Shake well before use.
Trispan can be diluted with Lidocaine HCl 1% or 2%. There is no special storage condition for the dilution.
Incompatibilities: This medicinal product must not be mixed with other medicinal products except those mentioned previously in Special precautions for disposal and other handling.
Storage
Shelf life: 3 years.
ATC Classification
H02AB08 - triamcinolone ; Belongs to the class of glucocorticoids. Used in systemic corticosteroid preparations.
Presentation/Packing
Susp for inj (amp) 20 mg/mL (crystal, milky white suspension, readily resuspendable) x 10's.
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