Trispan Adverse Reactions





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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.
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