ENTOCIR

Generic Name/API: Budesonide

Manufacturer: Tillotts Pharma AG

Dosage Forms & Strength & Pack Size:
Capsule: 3 mg, 50’s

Storage:
KEEP CONTAINER TIGHTLY CLOSED AT ALL TIMES WHEN NOT IN USE.

Store at 20° to 25°C.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

Indications: Capsules: Crohn’s disease involving the ileum and/or the ascending
colon. Induction of remission in patients with active microscopic colitis.
Enema: Ulcerative colitis involving the rectum, the sigmoid and the descending
colon.

Contraindications: Hypersensitivity to budesonide or any of the other
ingredients.
Precautions: Pregnancy. Lactation. Children.
Capsules: Close medical supervision is required in the following diseases:
Infections, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataract, family history of diabetes or glaucoma. Chickenpox, measles or any other condition where glucocorticosteroids may have unwanted effects.
Enema: contains lactose and methyl- , propyl –parahydroxybenzoate.
Special care: Capsules: Before surgery or other stress situations.
Capsules/Enema: Patients with symptoms such as blurred vision or other visual disturbances. When switching from other steroids.
Interactions: CYP3A4 inhibitors (i.a. ketokonazol, cobicistat), estrogens, oral contraceptives, ACTH stimulation test for diagnosing pituitary insufficiency.
Capsules: Grapefruit juice
Side effects: Capsules and Enema: Skin reactions (urticaria, exanthema); depression; psychomotor hyperactivity; insomnia; anxiety; aggression; cataract including subcapsular cataract; vision, blurred; ecchymosis; anaphylactic reaction.
Capsules: Cushingoid features; hypokalemia; behavioural changes such as nervousness and mood swings; palpitations; dyspepsia; muscle cramps; menstrual disorders; tremor; growth retardation.
Enema: Gastrointestinal disturbances, e.g. flatulence; nausea; diarrhea; agitation; signs or symptoms of systemic glucocorticosteroid effects, including
hypofunction of the adrenal gland.

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