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Glipgludin

Glipgludin

metformin + sitagliptin

Manufacturer:

Magbro Healthcare

Distributor:

MedChoice Endocrine Group
Concise Prescribing Info
Contents
Per 50 mg/500 mg FC tab Sitagliptin phosphate monohydrate 50 mg, metformin HCl 500 mg. Per 100 mg/1 g XR-FC tab Sitagliptin phosphate monohydrate 100 mg, metformin HCl 1 g
Indications/Uses
Adjunct to diet & exercise to improve glycemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated w/ combination of sitagliptin & metformin.
Dosage/Direction for Use
Individualized dosage. Do not exceed max recommended daily dose of 100 mg sitagliptin.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, w/ or w/o coma. Severe renal impairment (eGFR <30 mL/min/1.73 m2). Temporarily discontinue use in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials.
Special Precautions
Discontinue if hypersensitivity reaction, pancreatitis or bullous pemphigoid is suspected; evidence of renal impairment is present; in case of hypoxic states or lactic acidosis. Temporarily discontinue use at the time of or prior to radiologic studies, & w/hold for 48 hr subsequent to the procedure in patients w/ eGFR ≥30-<60 mL/min/1.73 m2, in patients w/ history of hepatic impairment, alcoholism, or heart failure, or in patients who will be administered intra-arterial iodinated contrast. Should not be used in patients w/ type 1 diabetes or for the treatment of diabetic ketoacidosis. Monitor renal function before initiation of therapy & at least annually thereafter. Consider lowering dose of sulfonylurea or insulin when used in combination to reduce risk of sulfonylurea- or insulin-induced hypoglycemia. Reports of serious hypersensitivity reactions & bullous pemphigoid. Promptly w/hold treatment in the presence of any condition associated w/ hypoxemia, dehydration, or sepsis. Temporarily suspend for any surgical procedure (except minor procedures not associated w/ restricted intake of food & fluids). Consider w/holding treatment in case of temporary loss of glycemic control (in times of stress eg, fever, trauma, infection, surgery). Reports of subnormal levels of previously normal serum vit B12 levels w/o clinical manifestations; perform routine serum vit B12 in predisposed individuals. Evaluate promptly for evidence of ketoacidosis or lactic acidosis in patients w/ previously well-controlled type 2 diabetes who develop lab abnormalities or clinical illness. Caution w/ concomitant use of medications that may affect renal function or result in significant hemodynamic change or may interfere w/ metformin disposition. Avoid excessive alcohol intake, acute or chronic, during treatment. Risk of lactic acidosis in patients w/ renal impairment. Avoid in patients w/ clinical or lab evidence of hepatic disease. Not recommended during pregnancy. Should not be used by nursing mothers. Caution in the elderly.
Adverse Reactions
Diarrhea, nausea, dyspepsia, flatulence, vomiting, headache, hypoglycemia, abdominal pain.
Drug Interactions
Metformin: Decreased AUC & Cmax of glyburide & furosemide. Increased plasma & blood Cmax & AUC w/ furosemide. Increased plasma Cmax & AUC & amount excreted in urine w/ nifedipine. Systemic exposure & risk for lactic acidosis may be increased w/ drugs that interfere w/ common renal tubular transport systems involved in the renal elimination of metformin eg, organic cationic transporter-2 (OCT2)/multidrug & toxin extrusion (MATE) inhibitors eg, ranolazine, vandetanib, dolutegravir, & cimetidine. Risk of loss of glycemic control w/ certain drugs that tend to produce hyperglycemia eg, thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OC, phenytoin, nicotinic acid, sympathomimetics, Ca channel blockers, & INH.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BD07 - metformin and sitagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Presentation/Packing
Form
Glipgludin FC tab 50 mg/500 mg
Packing/Price
30's (P585/box, P19.5/film-coated tab)
Form
Glipgludin XR-FC tab 100 mg/1 g
Packing/Price
30's (P37.5/XR-FC tab, P1,125/box)
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