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NOW AVAILABLE
DESIGNED TO STAY IN PLACE1-3
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UCERIS (budesonide) 2mg rectal foam is available nationwide
Stock up now: NDC 65649-651-03
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DEAR PHARMACIST,
Doctors are now prescribing a topical rectal therapy from Salix for the induction of remission in patients with active mild to moderate distal ulcerative colitis up to 40 cm from the anal verge: UCERIS rectal foam. If you haven't already, it's time to order your supply.
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Please scroll down for Important Safety Information
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WHOLESALE ORDERING INFORMATION
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WHOLESALER
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PRODUCT NUMBER
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Amerisource Bergen
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10159497
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Cardinal
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5053442
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McKesson
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3415569
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Please contact your wholesaler with the above product number.
DOSING AND PACKAGING INFORMATION1
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The recommended 6-week course of therapy for UCERIS rectal foam requires 2 boxes/kits. Each box contains 2 canisters with 14 metered doses per canister, 28 lubricated applicators, and disposable bags. Please keep the following dosing and storage instructions in mind:
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The recommended dosing regimen is 1 metered dose twice daily for the first 2 weeks, followed by 1 metered dose once daily for 4 weeks
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UCERIS rectal foam should be stored at room temperature, between 68°F and 77°F (20°C to 25°C)
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2 daily doses
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2 daily doses
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1 daily dose
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1 daily dose
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For additional instructions or information about UCERIS rectal foam, download the full Prescribing Information at
www.ucerisfoam.com
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Thank you for keeping UCERIS rectal foam available for your patients.
Regards,
Salix Pharmaceuticals
INDICATION
UCERIS (budesonide) rectal foam is 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.
IMPORTANT SAFETY INFORMATION
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UCERIS (budesonide) rectal foam is contraindicated in patients with a history of a known hypersensitivity to budesonide or any of the ingredients of UCERIS foam. Reactions have included anaphylaxis.
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When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Since UCERIS foam contains a glucocorticosteroid, general warnings concerning glucocorticoids should be followed.
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Patients with moderate to severe hepatic impairment should be monitored for increased signs and/or symptoms of hypercorticism. Discontinuing the use of UCERIS foam should be considered in these patients if signs of hypercorticism are observed.
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Care is needed in patients who are transferred from glucocorticosteroid treatment with higher systemic effects to glucocorticosteroids with lower systemic effects, such as UCERIS foam, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal suppression or benign intracranial hypertension, may develop. Taper patients slowly from systemic corticosteroids if transferring to UCERIS foam. Monitor for withdrawal symptoms and unmasking of allergies.
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Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Monitor patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex. More serious or even fatal courses of chickenpox or measles can occur in susceptible patients.
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Monitor patients with 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.
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The contents of UCERIS foam are flammable. Instruct the patient to avoid fire, flame and smoking during and immediately following administration.
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Patients should temporarily discontinue use of UCERIS foam before initiation of bowel preparation for colonoscopy.
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Concomitant use of inhibitors of Cytochrome P450 3A4 (such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine and grapefruit juice) should be avoided and patients should be closely monitored for increased signs and/or symptoms of hypercorticism. Advise patients to avoid grapefruit and grapefruit juice, which is known to inhibit CYP3A4, when taking UCERIS foam.
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UCERIS foam may cause fetal harm. Discontinue in nursing mothers after taking into account the importance of the drug to the mother.
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In clinical studies, the most common adverse reactions (incidence ≥2%) were decreased blood cortisol, adrenal insufficiency, and nausea.
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Click here for full Prescribing Information for UCERIS rectal foam or visit www.ucerisfoam.com
References: 1. UCERIS Rectal Foam Prescribing Information. Salix Pharmaceuticals; November 2015. 2. Sandborn WJ, Bosworth B, Zakko S, et al. Budesonide foam induces remission in patients with mild to moderate ulcerative proctitis and ulcerative proctosigmoiditis [published online January 30, 2015]. Gastroenterology. 2015;148(4):740-750. 3. Gross V, Bar-Meir A, Lavy A, et al. Budesonide foam versus budesonide enema in active ulcerative proctitis and procosigmoiditis. Aliment Pharmacol Ther. 2006;23(2):303-312.
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Salix Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC.
UCERIS® is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.
© 2016 Valeant Pharmaceuticals North America LLC.
UCEF.0023.USA.16
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