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ENTOCORT is a brand name for Budesonide, supplied as a capsule (sustained-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ENTOCORT (budesonide controlled ileal release capsules) are indicated for: • the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon and • the maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Particular care is needed in patients who are transferred from systemic glucocorticosteroid treatment with higher systemic effect to ENTOCORT. • When ENTOCORT is used to replace prednisolone in steroid dependent patients, the daily dose should not exceed 6 mg.
• When treatment with ENTOCORT is initiated, the prednisolone dose should be tapered, as these patients may experience adrenal cortical suppression. Therefore, monitoring of adrenocortical function may be considered in these patients.
2 Recommended Dose and Dosage Adjustment Active Disease The recommended daily dose for induction of remission is 9 mg, administered once daily in the morning, for up to 8 weeks. The dose should be taken before meals. Full effect is usually achieved within 2 - 4 ENTOCORT® (Budesonide Controlled Ileal Release Capsules) Page 5 of 31 weeks.
Maintenance of Remission Following an 8 week course of treatment for the active disease and once the patient’s symptoms are controlled (Crohn’s Disease Activity Index [CDAI]<150), ENTOCORT 6 mg is recommended, administered daily in the morning before breakfast, for maintenance of clinical remission up to 3 months.
If symptom control is still maintained at 3 months, an attempt to taper to complete cessation is recommended. The rate of tapering should be patient-specific and the patient should be monitored by the treating physician during this period.
Continued treatment with ENTOCORT 6 mg for more than 3 months has not been shown to provide substantial clinical benefit. 3 Pediatrics). 4 Administration The capsules should be swallowed whole with water, and not chewed, broken or crushed before being swallowed.
ENTOCORT should be taken before meals. 5 Missed Dose If a dose of ENTOCORT is missed, patients should be instructed not to take a double dose of ENTOCORT to make up for missed doses but to take the next dose on time.
). , prednisolone). Tapering of the dose of such conventional therapy when treatment with ENTOCORT is initiated and monitoring of adrenocortical function may be needed in these patients. , pain in muscles and joints), or experience flare up of allergies previously controlled by the conventional systemic corticosteroid drug.
A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting occur. In these cases, a temporary adjustment in the dose of systemic glucocorticosteroids may sometimes be necessary.
Gastrointestinal Glucocorticosteroids should be used with caution in patients if there is a probability of bowel perforation as well as the probability of obstruction, abscess or other pyogenic infection and fresh intestinal anastomoses.
Glucocorticosteroid therapy may cause hyperacidity of peptic ulcer. 4 Drug-Drug Interactions). Hepatic/Biliary/Pancreatic There may be an enhanced systemic effect of budesonide in patients with liver cirrhosis since the metabolism of budesonide may be impaired and, as with other glucocorticosteroids, there may be enhanced effects in those with hypothyroidism.
Reduced liver function may affect the elimination of corticosteroids. The intravenous pharmacokinetics of budesonide are, however, similar in cirrhotic patients and in healthy subjects. The pharmacokinetics after oral ingestion of budesonide were affected by compromised liver function as evidenced by increased systemic availability.
5 Post-Market Adverse Reactions). ENTOCORT should be discontinued if allergic reactions are experienced (see 2 CONTRAINDICATIONS). Immune Glucocorticosteroids may mask some signs of infections and new infections may appear. A decreased resistance to localized infection has been observed during glucocorticosteroid therapy.
General Although treatment with ENTOCORT causes significantly less lowering of plasma cortisol compared to conventional glucocorticosteroids, the knowledge with regard to treatment during the following conditions is limited and therefore cautioned: active peptic ulcer, osteoporosis, acute glomerulonephritis, myasthenia gravis, exanthematous diseases, diverticulitis, thrombophlebitis, psychic disturbances, diabetes, hypertension, hyperthyroidism, acute coronary disease, limited cardiac reserve and pregnancy.
In such cases the benefits of an oral glucocorticosteroid must be weighed against the risks. With the recommended therapeutic doses of budesonide, the risk/benefit ratio seems to be low for the long-term systemic effects. However, as with any other glucocorticosteroid, patients should be carefully followed up for systemic adverse effects.
During long-term therapy, adrenal function and hematological status should be periodically assessed. Patients should be advised to inform subsequent physicians of the prior use of glucocorticosteroids. 4 Drug-Drug Interactions) caused a four to seven fold increase of the systemic exposure to oral budesonide.
If treatment with CYP3A inhibitors, including ketoconazole and cobicistat-containing products (and possibly other azoles such as fluconazole, itraconazole or miconazole) together with budesonide is indicated, reduction of the budesonide dose should be considered if side effects typical of systemic glucocorticosteroids occur.
4 Drug-Drug Interactions). Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral use Capsule (sustained-release), 3 mg Acetyltributyl citrate, Ethyl cellulose, Gelatin, Iron oxide, Methacrylic acid and Ethyl acrylate copolymer, Polysorbate 80, Silicon dioxide, Simethicone (Antifoam M), Sodium lauryl sulphate, Sucrose and Starch, Corn (Sugar Spheres), Talc, Titanium dioxide, Triethyl citrate ENTOCORT® (Budesonide Controlled Ileal Release Capsules) Page 7 of 31 As with other drugs primarily being metabolized through CYP3A, regular ingestion of grapefruit or its juice, should be avoided in connection with budesonide administration (other juices such as orange juice or apple juice do not inhibit CYP3A).
ENTOCORT is contraindicated for the following: • Systemic or local bacterial, fungal or viral infections. • In patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Active tuberculosis.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Viral infections such as chicken pox and measles can have a more serious or fatal course in patients on immunosuppressant glucocorticosteroids. In adults who have not had these diseases, particular care should be taken to avoid exposure.
If exposed to chicken pox or measles, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If chicken pox develops, treatment with antiviral agents may be considered.
g. 1 Dosing Considerations). Monitoring and Laboratory Tests Because adrenal function may be suppressed, an ACTH stimulation test for diagnosing pituitary insufficiency might show false results (low values). Ophthalmologic Visual disturbance may be reported with systemic and topical corticosteroid use.
If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which, may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
Glucocorticosteroids may cause elevation of intraocular pressure in glaucoma patients. ENTOCORT® (Budesonide Controlled Ileal Release Capsules) Page 9 of 31 Peri-Operative Considerations In situations where patients are subject to surgery or other stress situations, supplementation with a conventional glucocorticosteroid is recommended.
Reproductive Health:
Female and Male Potential • Sexual Function/Reproduction There are no data on the effect of ENTOCORT on fertility in humans. There were no effects on fertility in rats after treatment with budesonide. 1 Pregnant Women Administration of ENTOCORT during pregnancy should be avoided unless there are compelling reasons.
In experimental animal studies, budesonide was found to cross the placental barrier. Like other glucocorticosteroids, budesonide is teratogenic to rodent species. High doses of budesonide administered subcutaneously produced fetal malformations, primarily skeletal defects, in rabbits, rats, and in mice.
The relevance of these findings to humans has not yet been established. In the absence of further studies in humans, budesonide should be used during pregnancy only if the potential benefits clearly outweigh the risk to the fetus. Infants born of mothers who have received substantial doses of glucocorticosteroids during pregnancy should be carefully observed for hypoadrenalism.
2 Breast-feeding Budesonide is excreted in breast milk. However, based on data from inhaled budesonide, at therapeutic doses of ENTOCORT, exposure to the infant is anticipated to be low. The use of ENTOCORT in nursing mothers requires that the possible benefits of the drug be weighed against the potential hazards to the mother, or infant.
3 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics Although clinical studies included a number of patients over the age of 65, no clinical trials specifically designed for elderly patients have been performed.
No overall differences in effectiveness were observed between geriatric patients and younger patients. 1 Adverse Reaction Overview Known corticosteroid-related systemic adverse […]
5 Drug-Food Interactions. Carcinogenesis and Mutagenesis Budesonide, evaluated in six different test systems, did not show any mutagenic or clastogenic effects. An increased incidence of brain gliomas observed in male rats could not be verified in a repeat carcinogenicity study.
Liver changes (primary hepatocellular neoplasms) found in male rats were observed with budesonide as well as other glucocorticosteroids. Available clinical experience shows no indication that budesonide or other glucocorticosteroids induce brain gliomas or primary hepatocellular neoplasms in man.
See 16 NON-CLINICAL TOXICOLOGY. g. pain in muscles and joints. A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting may occur. In these cases, a temporary increase in the dose of systemic glucocorticosteroids is sometimes necessary.
Endocrine and Metabolism Glucocorticoids may cause suppression of the HPA axis and reduce the stress response. Where patients are subject to surgery or other stresses, supplementary systemic glucocorticoid treatment is recommended. Systemic effects of steroids may occur, particularly when prescribed at high doses and for prolonged periods.
Such effects may include Cushing's syndrome, adrenal suppression, growth retardation, decreased bone mineral density, cataract, glaucoma and very rarely a wide range of psychiatric/behavioral effects (see