Nefecon

Nefecon

budesonide

Manufacturer:

Everest

Distributor:

FP Healthcare
Concise Prescribing Info
Contents
Budesonide
Indications/Uses
Primary IgA nephropathy in adults at risk of rapid disease progression w/ a urine protein-to-creatinine ratio ≥1.5 g/g.
Dosage/Direction for Use
16 mg once daily in the morning, at least 1 hr before a meal, for 9 mth.
Administration
Should be taken on an empty stomach: Swallow whole w/ water. Do not open/crush/chew.
Contraindications
Hypersensitivity. Patients w/ severe hepatic impairment (Child-Pugh class C).
Special Precautions
Systemic effects eg, hypercorticism & adrenal suppression may occur. Monitor patients transferred from glucocorticosteroid treatment w/ high systemic availability to those w/ lower systemic availability (eg, budesonide) for symptoms of steroid w/drawal. Glucocorticosteroids should be used w/ caution in patients w/ active or quiescent TB infection, untreated fungal, bacterial, systemic viral or parasitic infections, or ocular herpes simplex. Monitor patients w/ infections, HTN, DM, osteoporosis, peptic ulcer, glaucoma or cataracts, or w/ a family history of diabetes or glaucoma, or w/ any other condition where use of glucocorticosteroids may be associated w/ an increased risk of adverse effects. Risk of visual disturbance. Avoid concomitant treatment w/ potent CYP3A4 inhibitors, including ketoconazole & cobicistat-containing products. Avoid regular ingestion of grapefruit or its juice w/ Nefecon administration. ACTH stimulation test for diagnosing pituitary insufficiency might show false results. Should not be taken by patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency. Safety & efficacy in patients w/ hepatic impairment have not been studied. Monitor patients w/ moderate hepatic impairment (Child-Pugh class B) for increased signs &/or symptoms of hypercorticism. Do not use during pregnancy unless woman's clinical condition requires budesonide treatment. Discontinue breast-feeding or discontinue/abstain from therapy. Safety & efficacy in childn & adolescents <18 yr have not yet been established.
Adverse Reactions
Cushingoid features; DM; HTN; dyspepsia; skin reactions (acne, dermatitis); muscle spasms; peripheral edema, increased wt.
Drug Interactions
Increased plasma levels w/ potent CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine, & grapefruit juice. Reduced systemic exposure w/ CYP3A4 inducers eg, carbamazepine. May reduce serum K when co-administered w/ a medicinal product where the pharmacological effects may be potentiated by low serum K eg, cardiac glucosides, or when co-administered w/ diuretics that lower serum K.
MIMS Class
GIT Regulators, Antiflatulents & Anti-Inflammatories
ATC Classification
A07EA06 - budesonide ; Belongs to the class of corticosteroids acting locally. Used in the treatment of intestinal inflammation.
Presentation/Packing
Form
Nefecon MR hard cap 4 mg
Packing/Price
120's
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