Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X)
Padagis Israel Pharmaceuticals Ltd
RECTAL
PRESCRIPTION DRUG
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. Budesonide rectal foam is contraindicated in patients with a history of a known hypersensitivity to budesonide or any of the ingredients of budesonide rectal foam. Reactions have included anaphylaxis [see Adverse Reactions (6.2)] . Risk Summary Limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. There are clinical considerations (see Clinical Considerations) . In animal reproduction studies with pregnant rats and rabbits, subcutaneous administration of budesonide during organogenesis at doses 1.2 times and 0.12 times, respectively, the human intrarectal dose of 4 mg/day, resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities. Maternal toxicity was observed in both rats and ra
Budesonide rectal foam is supplied as a kit containing 2 aerosol canisters with 28 PVC applicators coated with paraffin lubricant for administration of the foam (NDC 45802-627-86). Each canister (NDC 45802-627-01) is labeled with a net weight of 33.4 g and contains 14 metered doses. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Handling Budesonide rectal foam contains a flammable propellant. Do not have the canister burned after use and do not spray contents directly towards flames. DO NOT REFRIGERATE.
Abbreviated New Drug Application
BUDESONIDE- BUDESONIDE AEROSOL, FOAM PADAGIS ISRAEL PHARMACEUTICALS LTD ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BUDESONIDE RECTAL FOAM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUDESONIDE RECTAL FOAM. BUDESONIDE RECTAL FOAM INITIAL U.S. APPROVAL: 1997 INDICATIONS AND USAGE Budesonide rectal foam is a glucocorticosteroid 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) DOSAGE AND ADMINISTRATION • • • DOSAGE FORMS AND STRENGTHS Budesonide rectal foam contains 2 mg budesonide per metered dose. (3) CONTRAINDICATIONS Known hypersensitivity to budesonide or any of the ingredients in budesonide rectal foam. (4) WARNINGS AND PRECAUTIONS • • • • • ADVERSE REACTIONS Most common adverse reactions (≥ 2%) are decreased blood cortisol, adrenal insufficiency, and nausea. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PADAGIS AT 1-866-634-9120 OR FDA AT 1- 800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS CYP3A4 Inhibitors (e.g., ketoconazole, grapefruit juice): May cause increased systemic corticosteroid effects; avoid concomitant use. (7.1) USE IN SPECIFIC POPULATIONS • • SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 4/2023 The recommended dosage is 1 metered dose administered twice daily for 2 weeks followed by 1 metered dose administered once daily for 4 weeks. (2.1) For rectal administration only. (2.2) Warm the canister in the hands while shaking it vigorously for 10 to 15 seconds prior to use. (2.2) Hypercorticism and adrenal suppression: Follow general warnings concerning glucocorticosteroids. (5.1) Impaired Adrenal Function in Patients Transferred from Other Glucocorticoids: Taper slowly from glucocorticosteroids with high systemic effects; monitor for withdrawal symptoms and unmasking of allergies (rhinitis, eczema). (5.2) Increased Risk of Infection Pročitajte cijeli dokument