Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use

Depending on the dose and duration of therapy, adrenocortical insufficiency caused by glucocorticoid therapy may still persist for several months and, in isolated cases, for more than one year after discontinuation of therapy. If specific, physically stressful situations (accident, surgery, childbirth, etc.) arise during treatment with Sterocort 4 mg, a temporary dose increase may become necessary. Due to the potential risk in stressful situations, the patient should therefore be issued with a corticosteroid card during prolonged therapy.
Administration of glucocorticoids may also be required in physically stressful situations if adrenocortical insufficiency persists after the end of therapy.
Therapy-induced, acute adrenocortical insufficiency can be minimised by slow dose reduction if discontinuation is envisaged.
Treatment with Sterocort 4 mg may lead to an increased risk of bacterial, viral, parasitic, opportunistic and fungal infections due to immunosuppression. The symptoms of an existing or developing infection can be masked, thus making diagnosis more difficult. Latent infections such as tuberculosis or hepatitis B can be reactivated.

In the following disorders, therapy with Sterocort 4 mg should be administered only when very strictly indicated; with adjuvant targeted anti-infective therapy if necessary: - acute viral infections (hepatitis B, herpes zoster, herpes simplex, varicella, herpetic keratitis),
- HBsAg-positive chronic active hepatitis,
- approximately 8 weeks before and up to 2 weeks after prophylactic vaccination with live vaccines,
- systemic fungal disease and parasitoses (e.g. nematodes),
- in patients with suspected or confirmed strongyloidiasis (threadworm infection), glucocorticoids can lead to the activation and mass proliferation of these parasites, - poliomyelitis,
- lymphadenitis after BCG vaccination,
- acute and chronic bacterial infections,
- in patients with a history of tuberculosis use only with tuberculostatic protection.

In addition, therapy with Sterocort 4 mg should be administered only when strictly indicated, with specific adjuvant therapy if necessary, in cases of:
- gastrointestinal ulcers,
- osteoporosis,
- severe heart failure,
- difficult-to-control hypertension,
- difficult-to-control diabetes mellitus,
- psychiatric disorders (including history thereof), including suicidal ideation: neurological or psychiatric monitoring is recommended.
- narrow and open-angle glaucoma: ophthalmic monitoring and adjuvant therapy are recommended.
- corneal ulcerations and corneal lesions: ophthalmic monitoring and adjuvant therapy are recommended.

Due to the risk of intestinal perforation, Sterocort 4 mg may only be used when urgently indicated, alongside appropriate monitoring, in cases of:
- severe ulcerative colitis with the threat of perforation, possibly even without peritoneal irritation,
- diverticulitis,
- intestinal anastomosis (immediately postoperatively).

The signs of peritoneal irritation after gastrointestinal perforation may be absent in patients receiving high glucocorticoid doses.

During the use of Sterocort 4 mg in patients with diabetes, a possibly increased need for insulin or oral antidiabetics should be considered.

During treatment with Sterocort 4 mg, regular blood pressure monitoring is required particularly when using high doses and in patients with difficult-to-control hypertension.

Patients with severe heart failure must be carefully monitored due to the risk of exacerbation.

At high doses, bradycardia may occur.
Severe anaphylactic reactions may occur.

The risk of tendinopathies, tendinitis and tendon rupture is increased when fluoroquinolones and glucocorticosteroids are co-administered.

Concomitant myasthenia gravis may initially deteriorate during treatment with Sterocort 4 mg.

Inoculations with inactivated vaccines are possible in principle. However, it should be noted that the immune response and hence successful vaccination may be compromised at higher corticosteroid dosages.

During long-term therapy with Sterocort 4 mg, regular medical check-ups (including ophthalmological checks at three-monthly intervals) are indicated.

Phaeochromocytoma crisis
After the use of corticosteroids, the occurrence of a phaeochromocytoma crisis has been reported, which may be fatal. In patients with suspected or diagnosed phaeochromocytoma, corticosteroids should only be used after an appropriate benefit-risk assessment.

Visual disturbance
Visual disturbances can occur when corticosteroids are used systemically or topically. If a patient presents with symptoms such as blurred vision or other visual disturbances, referral of the patient to an ophthalmologist for assessment of possible causes should be considered; the latter include, among others, cataract, glaucoma or rare diseases such as central serous retinopathy (CSR), which have been reported after the use of systemic or topical corticosteroids.

At high doses, adequate potassium intake and sodium restriction should be ensured and the serum potassium level monitored.


Depending on the dosage and duration of treatment, a negative effect on calcium metabolism must be anticipated; hence, osteoporosis prophylaxis is recommended. This applies particularly if concomitant risk factors are present, such as familial predisposition, advanced age, post menopause, insufficient protein and calcium intake, heavy smoking, excessive alcohol consumption and lack of physical exercise. Prevention consists of adequate calcium and vitamin D intake, as well as physical exercise. In cases of pre-existing osteoporosis, drug treatment should also be considered.

When ending or, if necessary, interrupting long-term administration, consideration should be given to the following risks:
Exacerbation or relapse of the underlying disease, acute adrenocortical insufficiency, cortisone withdrawal syndrome.

The course of specific viral diseases (chickenpox, measles) may be particularly severe in patients treated with glucocorticoids. At particular risk are immunocompromised (immunosuppressed) patients with no previous chickenpox or measles infection. If these patients come into contact with individuals with measles or chickenpox during treatment with Sterocort 4 mg, prophylactic treatment should be initiated as appropriate.

Paediatric population
In the growth phase of children, the benefit/risk ratio of treatment with Sterocort 4 mg should be carefully assessed. Due to the growth-inhibiting effect of triamcinolone, height gain should be regularly monitored during long-term therapy.

Elderly patients
As elderly patients are at increased risk of osteoporosis, the benefit/risk ratio of treatment with Sterocort 4 mg should be carefully assessed.

Patients with rare hereditary problems of galactose intolerance, complete lactase deficiency or glucose-galactose malabsorption should not take Sterocort 4 mg.

Use of Sterocort 4 mg can lead to positive results in doping tests.

Effects on Driving

4.7 Effects on ability to drive and use machines

To date, there is no evidence that Sterocort 4 mg impairs the ability to drive or use machines or to work without a safe foothold.