Budesonide rectal

Ulcerative Colitis

Ulcerative Colitis Indicated for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis extending up to 40 cm from the anal verge 1 metered dose (2 mg) PR BID for 2 weeks followed by 1 metered dose PR once daily in evening for 4 weeks

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Hepatic Impairment: No dosage adjustment is needed for patients with mild (Child-Pugh Class A) hepatic impairment. Patients with moderate to severe hepatic impairment (Child-Pugh Class B or C) should be monitored for increased signs and/or symptoms of hypercorticism. Discontinuing the use of Budesonide rectal foam should be considered in these patients if signs of hypercorticism are observed

For rectal administration only; not for oral use Before administration, use the bathroom to empty your bowels Each applicator is coated with a lubricant; if additional lubrication is needed, petrolatum or petroleum jelly can also be used Warm the canister in the hands while shaking it vigorously for 10-15 seconds before use Can be used in a standing, lying, or sitting position (eg, while using the toilet) When applied in the evening, use immediately prior to bedtime; try not to empty your bowels again until the next morning

Hypersensitivity

Hypercorticism and adrenal suppression: Follow general warnings concerning glucocorticosteroids. Impaired Adrenal Function in Patients Transferred from Other Glucocorticoids: Taper slowly from glucocorticosteroids with high systemic effects. Increased Risk of Infection, including serious and fatal chicken pox and measles: Monitor patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex. Other Glucocorticosteroid Effects: Monitor patients with other conditions where glucocorticoids may have unwanted effects. Flammable Contents: The contents of Budesonide rectal foam are flammable. Instruct the patient to avoid fire, flame and smoking during and immediately following administration. Monitoring Parameters Monitor patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex. Monitor for withdrawal symptoms and unmasking of allergies (rhinitis, eczema). Monitor patients with other conditions where glucocorticoids may have unwanted effects.

C Pregnancy Category: C Lactation: Rectal foam is likely to result in budesonide in human milk as budesonide delivered by inhalation from a dry-powder inhaler is present in human milk at low concentrations

CYP3A4 Inhibitors (e.g., ketoconazole, grapefruit juice): May cause increased systemic corticosteroid effects; avoid concomitant use.

>10% Decreased blood cortisol (17%) 1-10% Adrenal insufficiency (4%) Nausea (2%) <1% Insomnia (0.4%) Sleep disorder (0.4%) Acne (0.4%) Depression (0.4%) Hyperglycemia (0.4%)

Elicits glucocorticosteroid activity, including anti-inflammatory effects