Caution is recommended in patients with infection, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, newly created intestinal anastomoses, psychoses, cardiac insufficiency, glaucoma or cataracts, and in patients with a family history of diabetes or glaucoma.
On transfer from conventional steroid treatment to Entocort, symptoms related to a change of the systemic steroid dose may occur. During tapering the prednisolone and starting treatment with Entocort undesirable effects may appear (see Adverse Reactions).
In cases of infections, extreme caution must be exercised and causal treatment initiated. Chickenpox and measles may worsen in patients treated with oral glucocorticoids. Special caution should therefore be exercised with regard to exposure in patients who have not had these diseases or who lack protection against them. Treatment with VZIG (varicella zoster immunoglobulin) or IVIG (pooled iv immunoglobulin) may be indicated. If chickenpox develops, antiviral therapy may be instituted.
Caution in treatment of growing individuals.
Discontinuation of administration should take place gradually, as endogenous ACTH secretion may be reduced after prolonged treatment with Entocort. Some individuals feel unwell in a non-specific way during the withdrawal phase, with eg pain in muscles and joints. A general insufficient steroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting occur. In these cases a temporary increase of the dose of the systemic glucocorticoid may be necessary.
When Entocort capsules replace a systemic steroid treatment, allergies are sometimes revealed, eg rhinits and eczema, which were previously controlled by the systemic treatment.
Budesonide can reduce the response of the HPA-axis to stress. In situations where patients are to undergo surgery or in other stress situations, a supplementary systemic glucocorticoid is recommended.
The metabolism of budesonide is primarily mediated by CYP3A, a subfamily of cytochrome P450. Inhibition of this enzyme by eg ketoconazole and grapefruit juice can therefore increase the systemic exposure to budesonide and the combination should be avoided, see Interactions.
When Entocort capsules are used chronically in excessive doses, systemic glucocorticosteroid effects such as hypercorticism and adrenal suppression may appear.
Experience is limited of treatment with budesonide or other glucocorticoids in renewed spells of Crohn's disease after a prolonged period of treatment.
There are no direct comparative studies on effects/side effects of long-term treatment with budesonide compared with intermittent treatment with glucocorticoids.
Effects of ability to drive or use machines: No effects have been observed.