Zemimet SR

Gemigliptin 50 mg, metformin HCl 1,000 mg

Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM.

Type 2 DM Adult & patient w/ inadequate glycemic control on metformin monotherapy or dual combination of metformin & sulfonylurea Max recommended daily dose: 1 tab once daily.

Should be taken with food: Take w/ a meal to reduce GI adverse reactions, preferably in the evening. Swallow whole, do not split/crush/chew.

Hypersensitivity. History of serious hypersensitivity. Acute metabolic acidosis; diabetic precoma; dehydration, severe infection, shock, intravascular administration of iodinated contrast agents; acute or chronic disease causing hypoxia eg, cardiac or resp failure, recent MI, shock; acute alcohol intoxication, alcoholism; serious accidental injury. Severe renal failure (estimated GFR <30 mL/min/1.73 m²). Hepatic impairment.

Not to be used in patients w/ any serious hypersensitivity reaction to dipeptidyl peptidase 4 (DPP4) inhibitor or biguanide; type 1 diabetes; for treatment of diabetic ketoacidosis. Discontinue in suspected pancreatitis, lactic & metabolic acidosis; if severe joint pain occurs; 48 hr before elective surgery w/ general, spinal or epidural anaesth; prior to, or at the time of administration of iodinated contrast agent & not reinstituted until 48 hr afterwards. Temporarily discontinue in case of dehydration. Not recommended in patients w/ estimated GFR ≥30 mL/min/1.73 m² & <45 mL/min/1.73 m². Avoid in patients w/ NYHA class III & IV cardiac status. History of pancreatitis. Severe & disabling arthralgia. Peripheral neuropathy. Excessive alcohol intake, inadequately controlled diabetes, ketosis, prolonged fasting & conditions associated w/ hypoxia. Risk of hypoglycemia in combination w/ other antidiabetic medicinal products causing hypoglycemia eg, sulfonylureas. Patients w/ NYHA class I & II cardiac status. Regularly determine serum creatinine conc at least once yrly in patients w/ normal renal function, at least 2-4 times/yr in patients w/ serum creatinine levels ≥ULN & in elderly patients. Assess estimated GFR before treatment initiation & regularly thereafter. Monitor TSH levels regularly in patients w/ hypothyroidism; vit B₁₂ level. Regularly perform usual lab tests for diabetes monitoring. Continue diet w/ regular distribution of carbohydrate intake; energy-restricted diet in overwt patients. Combination w/ sulfonylurea or insulin. Concomitant use w/ medicinal products that can acutely impair renal function (eg, antihypertensives, diuretics, NSAIDs); causing lactic acidosis; CYP3A4 inducers eg, strong moderate (rifampicin, phenytoin, carbamazepine) & moderate (dexamethasone, rifabutin, & phenobarb); OCT2 inhibitors. Not be used w/ alcohol containing products. May affect ability to drive & use machines. Not to be used in hepatic impairment. Renal impairment. Not to be used during pregnancy & lactation. Childn & adolescents <18 yr. Elderly ≥65 yr.

Dyspepsia; increased amylase & lipase.

Increased risk of lactic acidosis w/ alcohol; NSAIDs, including selective COX II inhibitors, ACE inhibitors, AIIA & diuretics especially loop diuretics. Renal failure w/ iodinated contrast agents. Intrinsic hyperglycemic activity w/ systemic & locally given glucocorticoids, β₂ agonists, & diuretics. Decreased blood glucose levels w/ ACE inhibitors. Gemigliptin: Decreased AUC & C_max of pioglitazone. Altered pharmacokinetics & increased AUC w/ ketoconazole. Decreased exposure w/ strong CYP3A4 inducers eg, rifampicin, dexamethasone, phenytoin, carbamazepine, rifabutin & phenobarb. Decreased AUC & C_max w/ strong CYP3A4 inducer eg, rifampicin. Metformin: Decreased anticoagulant effect of phenprocoumon. Reduced hypoglycemic effect w/ levothyroxine. Reduced efficacy w/ organic cation transporters (OCT) 1 inhibitors eg, verapamil. Increased GI absorption & efficacy w/ OCT1 inducers eg, rifampicin. Increased plasma conc w/ OCT2 inhibitors eg, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib & isavuconazole. May alter efficacy & renal elimination w/ OCT1 & OCT2 inhibitors eg, crizotinib & olaparib.

Antidiabetic Agents

A10BD18 - metformin and gemigliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

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