General: MAGLITIN should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Pancreatitis: There have been reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, MAGLITIN and other potentially suspect medicinal products should be discontinued.
Use in Patients with Renal Impairment: MAGLITIN is renally excreted. To achieve plasma concentrations of MAGLITIN similar to those in patients with normal renal function, lower dosages are recommended in patients with eGFR <45 mL/min/1.73 m2, as well as in ESRD patients requiring hemodialysis or peritoneal dialysis.
Hypoglycemia in Combination with a Sulfonylurea or with Insulin: To reduce the risk of sulfonylurea-or insulin-induced hypoglycemia, a lower dose of sulfonylurea or insulin may be considered.
Hypersensitivity Reactions: These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Onset of these reactions occurred within the first 3 months after initiation of treatment with MAGLITIN, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue MAGLITIN, assess for other potential causes for the event, and institute alternative treatment for diabetes.
Bullous Pemphigoid: If bullous pemphigoid is suspected, MAGLITIN should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment.
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