Generic drug of the therapeutic class: Gastro-Entero-Hepatology
Active ingredients: Budesonide
Capsule of gastro-resistant microgranules
Bottle of 90 capsules with gastro-resistant microgranules
· Attack treatment for mild to moderate Crohn's disease affecting the ileum and / or ascending colon.
· Maintenance treatment of Crohn's disease (maximum duration of 9 months): pending the efficacy of immunosuppressive therapy, prednisolone substitution in corticosteroid-dependent patients at doses up to 30 mg prednisolone or equivalent.
· Prolongation of remission of Crohn's disease after attack treatment.
Dosage ENTOCORT 3 mg Capsule of gastro-resistant microgranules Bottle of 90 capsules with gastro-resistant microgranules
Reserved for adults
Capsules should be swallowed with a glass of water. They must not be crunched or chewed.
In all cases, stopping treatment should be done gradually by reducing the doses.
The recommended dose is 3 capsules (9 mg budesonide), in one dose in the morning for 8 weeks.
The optimal therapeutic response is usually achieved in 2 to 4 weeks.
Maintenance treatment in corticosteroid patients:
The recommended dose is 2 capsules (6 mg budesonide), in a single dose in the morning. If necessary, treatment may be continued for a maximum of 9 months, with gradual reduction of the dosage.
Prolongation of Remission of Crohn's Disease after Attack Treatment:
The recommended dose is 2 capsules (6 mg budesonide), in a single dose in the morning.
If necessary, treatment may be continued for a maximum of 9 months, with gradual reduction of the dosage.
This drug is generally contraindicated in the following situations (there is, however, no absolute contraindication for life-threatening corticosteroid therapy):
· Any infectious condition,
· Certain viruses in evolution (herpes, chickenpox, shingles),
· Psychotic states not yet controlled by a treatment,
· Live vaccines,
· Hypersensitivity to different constituents
Entocort side effects
Frequent (1 to 10%)
Metabolism and nutrition disorders
Behavioral disorders such as nervousness, insomnia and mood changes
Skin and subcutaneous tissue disorders
Cutaneous reactions (urticaria, exanthema)
Reproductive and breast function disorders
Uncommon (0.1 to 1%)
Nervous system disorders
Very rare (<0 to 0.1%)
Immune system disorders
In clinical trials, the incidence of clinical corticosteroid adverse events was twice as low with ENTOCORT compared to equipotent prednisolone therapy.
The typical adverse effects of glucocorticoids administered systemically can not be ruled out with ENTOCORT. However, they are especially to be feared in important doses or during a prolonged treatment over several months:
Hypokalemia, metabolic alkalosis, fluid retention, high blood pressure, congestive heart failure.
Endocrine and metabolic disorders:
Iatrogenic Cushing's syndrome, inertia of ACTH secretion, sometimes permanent adrenocortical atrophy, decreased glucose tolerance, revelation of latent diabetes, stunting or retarded growth in children, menstrual irregularities.
Musculoskeletal problems :
Muscular atrophy preceded by muscle weakness (increased protein catabolism), osteoporosis, pathological fractures especially vertebral compression, aseptic osteonecrosis of the femoral heads.
Some cases of tendon ruptures have been described in an exceptional way, in particular in co-prescription with fluoroquinolones.
Gastroduodenal ulcers, ulceration of the small bowel, perforations and gastrointestinal bleeding, acute pancreatitis have been reported.
Acne; purpura; bruising, hypertrichosis, delayed healing.
Euphoria, insomnia, excitement, manic-like access, confusional states or confuso-oniric convulsions (rarely, generally or intrathecally); depressive state upon discontinuation of treatment.
Some forms of glaucoma and cataracts.