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CORTIMENT is a brand name for Budesonide, supplied as a tablet (delayed and extended release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Reaction Overview Known corticosteroid-related systemic adverse effects include, but are not limited to, hypercorticism, adrenal suppression, immunosuppression, decreased bone mineral density, cataract, glaucoma, growth retardation, and rarely psychiatric/behavioral effects.
These side effects often depend on the dosage, and duration of treatment. See Warnings and Precautions section. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Pivotal phase 3 clinical trials CORTIMENT 9 mg was mainly assessed in two 8-week pivotal phase 3 randomized controlled studies (CORE I and CORE I studies) in patients with mild to moderate active ulcerative colitis (UC).
A total of 255 patients were treated with CORTIMENT 9 mg, 254 patients with CORTIMENT 6 mg, and 258 patients with placebo (two additional active control arms were also part of the studies, but were not powered. The median duration of drug exposure was approximately 56 days (8 weeks).
The rates of patient with at least one adverse event (AE) were not significantly different across treatment groups (Most AEs were considered mild or moderate, with 8% of patients reporting severe AEs. The most frequently reported AEs were in the Gastrointestinal class (32% of patients), with UC (worsening) as the most frequent AE (13% with CORTIMENT 9 mg, and 14% with placebo), followed by nausea.
The second most frequently reported SOC was “Nervous system”, mainly due to the “headache”. 4% in the CORTIMENT 9 mg, CORTIMENT 6 mg, and placebo groups, respectively. Table 1. 0) AEs are ordered by decreasing frequency in the CORTIMENT 9 mg group The rates of patients with treatment related AEs (ADRs) were not significantly different across treatment groups: 27% of patients treated with CORTIMENT 9 mg, and 25% of those treated with Placebo and CORTIMENT 6 mg.
Similar to the distribution of AEs, the most common were in the “Gastrointestinal” class (14% with CORTIMENT 9 mg, 16% with placebo) mainly due to UC (worsening flare), nausea, and abdominal (upper) pain. 3% with placebo). 7%). The most frequent was “Ulcerative colitis” reported in 11% to 12% of patients in the CORTIMENT 9 mg and placebo groups, and approximately 16% of those in the CORTIMENT 6 mg group.
Hypersensitivity to budesonide, soya, or to any of the ingredients of CORTIMENT. For a complete listing, see Dosage Forms, Composition and Packaging. CORTIMENT should not be used in patients with hypersensitivity to peanut, given the possibility of cross-reactivity between soya and peanut.
- systemic or local bacterial, fungal or viral infections. -active tuberculosis. WARNINGS AND PRECAUTIONS General Caution should be used in patients with infections, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts or with a family history of diabetes or glaucoma or with any other condition where the use of glucocorticoids, including CORTIMENT, may have unwanted effects.
Treatment with CORTIMENT results in lower systemic steroid levels than conventional oral glucocorticoid therapy. , steroid therapy withdrawal symptoms with adrenal suppression). Replacement of high systemic effect glucocorticoids with relatively lower bio-availability formulations such as CORTIMENT may unmask allergies such as rhinitis and eczema that were previously controlled by the systemic drug.
Endocrine and Metabolism Glucocorticoids may cause suppression of the hypothalamus-pituitary-adrenal (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 Adverse Reactions].
, prednisolone). Tapering of the dose of such conventional therapy when treatment with CORTIMENT 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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8%), and 3 patients each of the CORTIMENT 9 mg, and CORTIMENT 6 mg groups. 1% of patients treated with CORTIMENT 9 mg, CORTIMENT 6 mg, and placebo, respectively. The most frequently reported was “Ulcerative Colitis” in four patients: one in the CORTIMENT 9 mg group, and two in the CORTIMENT 6 mg group.
Other treatment-related SAEs were reported in one patient each:
Colon perforation and treatment failure (CORTIMENT 9 mg), Nausea (CORTIMENT 6 mg). There were no treatment-related deaths during the studies. 6%). 2%), and none with placebo. CORTIMENT 9mg Page 9 of 25 Glucocorticoid (GC) Effects (mood/sleep changes, acne, moon face, fluid retention, hirsutism, striae rubrae, flushing) were also assessed in the clinical trials, and were reported with no significant difference in rates according to the treatment groups.
See Table 2. Table 2. Summary of Potential Glucocorticoid Effects in the pooled pivotal Trials (CORE I and II). 0% of those with placebo. The clinical significance of these findings is […]
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.
CORTIMENT 9mg Page 5 of 25 Hepatic/Biliary/Pancreatic/Renal Reduced liver function may affect the elimination of glucocorticoids, resulting in higher systemic exposure to budesonide, and possibly higher risk of systemic adverse events.
(See Pharmacokinetics –Special Populations and Conditions). Therefore caution should be exercised in the administration of the product and monitoring of these patients. Immune system Suppression of immune system & increased risk of infections Suppression of the inflammatory response and immune system increases the susceptibility to infections.
Glucocorticosteroids may mask some signs of infection and new infections may appear during their use. CORTIMENT should not be used if the patient has an uncontrolled infection. Viral infections such as chicken pox and measles may follow a more serious or even fatal course in patients on oral glucocorticoids.
Particular care should be taken to avoid exposure in patients who have not previously had these diseases. 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. If patients are infected or suspected of being infected, consider reduction or discontinuation of glucocorticoid treatment. Hypersensitivity and allergy Anaphylactic reactions have occurred with budesonide formulations [See Adverse Reactions].
CORTIMENT is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of CORTIMENT. CORTIMENT contains soya oil, therefore, CORTIMENT is contraindicated in patients with hypersensitivity to soya. CORTIMENT should not be used in patients with hypersensitivity to peanut, given the possibility of cross-reactivity between soya and peanut.
CORTIMENT contains lactose monohydrate and should not be taken by patients with rare hereditary problems such as galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption. Systemic effects of steroids may occur, particularly when prescribed at high doses and for prolonged periods.
Such effects may include cataract and glaucoma [see Adverse Reactions]. Psychiatric Particular care is required when considering the use of systemic corticosteroids in patients with current or previous history of severe affective disorders, or any of the first degree relatives.
Systemic effects of steroids may occur, particularly when prescribed at high doses and for prolonged periods. Such effects may include very rarely a wide range of psychiatric/behavioral effects [see Adverse Reactions]. CORTIMENT 9mg Page 6 of 25 Sexual Function/Reproduction There is no data on the effect of CORTIMENT on fertility in humans.
There were no effects on fertility in rats after treatment with budesonide.
Special Populations Pregnant Women:
Like other glucocorticosteroids, budesonide is teratogenic. High doses of budesonide administered subcutaneously produced fetal malformations, primarily skeletal defects, in rabbits, rats, and in mice. See more details in TOXICOLOGY - Teratology & Reproductive toxicology.
In the absence of studies in pregnant women, CORTIMENT should be used during pregnancy only if the potential benefits to the mother clearly outweigh the risks to the fetus. In animal studies, budesonide was found to cross the placental […]