Trispan 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).