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UCERIS is a brand name for Budesonide, supplied as a foam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: UCERIS (budesonide) rectal foam is a glucocorticosteroid indicated for the induction of remission in adult patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. 1.1 Pediatrics Pediatrics (<18 years of age) No data are available to Health Canada; therefore, Health…
Verbatim from this product's HC label. Tap a section to expand.
, Recommended Dose and Dosage Adjustment. 2 CONTRAINDICATIONS UCERIS is contraindicated 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 Section
1 Adverse Reaction Overview The most frequently reported adverse drug reaction (>10%) during 2 placebo-controlled, 6-week trials (Study BUCF3001 and BUCF3002) was blood cortisol decreased (11% in the UCERIS rectal foam-treated group and 1% in the placebo group).
The most common reason for study discontinuation was blood cortisol decreased and adrenal insufficiency. One serious adverse reaction of severe acute generalized exanthematous pustulosis occurred in conjunction with a staphylococcal infection in the UCERIS rectal foam group.
2 Clinical Trial Adverse 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 reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. In the clinical trials, the overall exposure to UCERIS rectal foam was in 332 patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge.
The median duration of exposure was 42 days. However, UCERIS rectal foam was studied primarily in 2 placebo-controlled, 6-week trials in patients with active disease (Study BUCF3001 and Study BUCF3002). In these trials, 268 patients received UCERIS rectal foam 2 mg twice a day for 2 weeks followed by 2 mg once a day for 4 weeks.
Adverse reactions were experienced by 21% of subjects (56 of 268) in the UCERIS rectal foam- treated group and 6% subjects (16 of 278) in the placebo group. The most common adverse reactions (≥ 1% of the UCERIS rectal foam or placebo group and at higher frequency in the UCERIS rectal foam group) were decreased blood cortisol, adrenal insufficiency, rash and headache (Table 2).
, Special Populations. 2 Geriatrics Geriatrics (>65 years of age) There is no sufficient and adequate data in clinical studies with UCERIS for patients aged 65 and over to determine whether they respond differently than younger patients.
2 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment. 2 CONTRAINDICATIONS UCERIS is contraindicated 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 Section 5 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Active or quiescent tuberculosis infection. Untreated fungal, bacterial, systemic viral or parasitic infections. Ocular herpes simplex. 1 Dosing Considerations UCERIS rectal foam is only to be applied rectally.
It is not for oral use. The patient should empty their bowels before using UCERIS rectal foam. Each applicator is coated with a lubricant. If additional lubrication is needed, petrolatum or petroleum jelly can also be used. 2 Recommended Dose and Dosage Adjustment The recommended dosage regimen is 1 metered dose administered rectally twice daily for 2 weeks followed by 1 metered dose administered rectally once daily for 4 weeks.
3 WARNINGS AND PRECAUTIONS, Special Populations, Pediatrics). No dosage adjustment required in patients 65 years of age and older. 4 WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics). No dosage adjustment required in patients with hepatic or renal impairment.
3 Administration Prior to applying the Rectal Foam, you should use the bathroom in order to empty your bowels. Warm the canister in the hands while shaking it vigorously for 10 to 15 seconds prior to use. , while using the toilet). Apply UCERIS rectal foam in the morning and the evening for the first 2 weeks of treatment; then once daily in the evening for the next 4 weeks.
UCERIS is contraindicated 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 Section 5 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Active or quiescent tuberculosis infection. Untreated fungal, bacterial, systemic viral or parasitic infections. Ocular herpes simplex.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Budesonide in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Decreased blood cortisol was defined as a morning cortisol level of < 5 mcg/dL. Adrenal insufficiency was defined as a cortisol level of < 18 mcg/dL at 30 minutes post challenge with adrenocorticotropic hormone (ACTH). 1) #Decreased blood cortisol was defined as a morning cortisol level of < 5 mcg/dL †Adrenal insufficiency was defined as a cortisol level of < 18 mcg/dL at 30 minutes post challenge with ACTH.
Of the 46 UCERIS rectal foam treated patients with decreased blood cortisol (defined as a morning cortisol level of < 5 mcg/dL) reported as an adverse event, none had adrenal insufficiency (defined as a cortisol level of < 18 mcg/dL at 30 minutes post challenge with ACTH) (see Table 3).
All cases of adrenal insufficiency resolved. Table 3 summarizes the percentages of patients reporting glucocorticoid related effects in the 2 placebo-controlled trials (Studies BUCF3001 and BUCF3002). 4) 0 * Decreases in serum cortisol levels associated with budesonide treatment were seen at Weeks 1 and 2 (twice-daily treatment) in the UCERIS rectal foam group, but gradually returned to baseline levels during the 4 weeks of once daily treatment.
4% of those in the placebo group. 9% with placebo. No clinically significant differences were observed with respect to the overall percentages of patients with any glucocorticoid related effects between UCERIS rectal foam and placebo after 6 weeks of therapy.
For additional details on morning cortisol levels and the response to the ACTH stimulation test, see Section 12 PHARMACEUTICAL INFORMATION. 3 Post-Market Adverse Reactions The following adverse reactions have been reported for other oral and rectal formulations of budesonide.
Cardiac disorders: hypertension Gastrointestinal disorders: pancreatitis General disorders and administration site conditions: pyrexia, peripheral edema Immune System Disorders: anaphylactic reactions Nervous System Disorders: dizziness, benign intracranial hypertension Psychiatric Disorders: mood swings Skin and subcutaneous tissue disorders: pruritus, maculo-papular rash, allergic dermatitis
When applied in the evening, use immediately prior to bedtime. Try not to empty your bowels again until the next morning. Applicators should be used only once. Please discard the applicator after use. 4 Missed Dose If a dose of UCERIS rectal foam is missed, it should be administered as soon as possible, unless it is almost time for the next dose.
A patient should not use two UCERIS doses at the same time to make up for a missed dose. 4 OVERDOSAGE Acute overdosage with UCERIS rectal foam is unlikely. However, UCERIS rectal foam is absorbed systemically and chronic overdosage may result in signs/symptoms of hypercorticism.
For management of a suspected drug overdose, contact your regional poison control centre. PrUCERIS™ Product Monograph Page 6 of 30 5 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging UCERIS rectal foam is formulated as an emulsion which is filled into an aluminum canister with an aerosol propellant.
It is available in 1 strength: 2 mg budesonide per metered dose. 6 WARNINGS AND PRECAUTIONS General Caution should be taken 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 glucocorticosteroids may have unwanted effects.
These patients should be monitored for the occurrence of such effects, and the benefits of a corticosteroid enema must be weighed against the risks when needed. Concomitant treatment with CYP3A4 inhibitors (such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine and grapefruit and grapefruit juice) should be avoided as it may increase the budesonide systemic exposure (see 8 DRUG INTERACTIONS).
Monitor patients who are transferred from glucocorticosteroid treatment with higher systemic effects to glucocorticosteroids with lower systemic effects, such as UCERIS rectal foam, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal suppression or benign intracranial hypertension, may develop.
Adrenocortical function monitoring may be required in these patients and the dose of glucocorticosteroid treatment with high systemic effects should be reduced cautiously. , rhinitis and eczema), which were previously controlled by the systemic drug.
CAUTION:
The contents of UCERIS rectal foam includes n-butane, isobutane and propane as propellants which are flammable. Avoid fire, flame, and smoking during and immediately following administration. Patients should temporarily discontinue the use of UCERIS before initiation of bowel preparation for colonoscopy and consult their health care provider before resuming therapy.
Route of Administration Dosage Form / Strength/Composition All Non-medicinal Ingredients Rectal Foam, 2 mg budesonide per metered dose Cetyl Alcohol, Citric Acid Monohydrate, Edetate Disodium, Emulsifying Wax, Polyoxyl (10) Stearyl Ether, Propylene Glycol, Purified Water Propellant: Isobutane, N-Butane, Propane PrUCERIS™ Product Monograph Page 7 of 30 Carcinogenesis and Mutagenesis See NON-CLINICAL TOXICOLOGY.
Endocrine and Metabolism Hypercorticism and Adrenal Axis Suppression When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Glucocorticosteroids can suppress or reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress.
In situations where […]