Zemimet SR

Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM. Initial therapy for treatment-naive patients w/ inadequate glycemic control by diet & exercise alone. In patients already receiving identical combination of gemigliptin & metformin as separate tab. In patients w/ inadequate glycemic control w/ max tolerated metformin dose. In combination w/ sulfonylurea in patients w/ inadequate glycemic control w/ sulfonylurea & metformin dual therapy; w/ insulin in patients w/ inadequate glycemic control w/ insulin monotherapy or insulin & metformin dual therapy; w/ dapagliflozin in patients w/ inadequate glycemic control w/ dapagliflozin & metformin dual therapy.

Individualized dosage not exceeding max recommended daily dose: Gemigliptin 50 mg/metformin 2,000 mg. Patient who needs gemigliptin 50 mg & not currently treated w/ metformin Initially gemigliptin 50 mg/metformin 500 mg once daily w/ gradual dose escalation. Patient w/ inadequate glycemic control w/ metformin monotherapy or w/ dual combination of metformin & sulfonylurea, metformin & insulin or metformin & dapagliflozin Gemigliptin 50 mg daily + current metformin dose. Switching from co-administration of gemigliptin & metformin Initiate based on current metformin dose.

May be taken with or without food: Swallow whole, do not split/crush/chew.

Hypersensitivity to gemigliptin, metformin HCl or biguanides. History of serious hypersensitivity reactions to another dipeptidyl peptidase 4 inhibitor. Patients w/ CHF requiring medication. Acute or chronic metabolic acidosis; diabetic pre-coma; acute conditions w/ potential to alter renal function; acute or chronic disease causing tissue hypoxia; debilitated, malnourished or starved patients & w/ adrenal or pituitary insufficiency; acute alcohol intoxication, alcoholism; pulmonary infarction, severe resp insufficiency & conditions inducing hypoxemia, GI symptoms. Hepatic impairment. Pregnancy & lactation.

Hypersensitivity reaction. Not to be used in patients w/ type 1 diabetes. Not an insulin substitute. Discontinue use if pancreatitis, bullous pemphigoid are suspected. Temporarily discontinue use if dehydration occurs. Not recommended in patients w/ NYHA class III-IV cardiac status. Lactic acidosis; hypoglycemia; severe & disabling arthralgia. Patients w/ NYHA class I, II cardiac status. Regularly monitor TSH levels in patients w/ hypothyroidism; vit B₁₂ level. Assess GFR & serum creatinine levels prior to & regularly thereafter. Perform usual lab tests for diabetes monitoring. Long-term use. Overwt patients should continue energy-restricted diet. Discontinue use prior to, during & 48 hr after iodinated contrast agent administration; 48 hr prior to elective surgery w/ general, spinal or epidural anaesth. Hypoglycaemia w/ insulin or sulfonylureas. Concomitant use w/ antihypertensives, diuretics, NSAIDs. 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.

Hypoglycemia.

Gemigliptin: Decreased C_max of metformin. Decreased AUC & C_max of pioglitazone. Increased AUC w/ ketoconazole. Decreased AUC w/ rifampicin. Not recommended w/ other strong CYP3A4 inducers eg, dexamethasone, phenytoin, carbamazepine, rifabutin, phenobarb. Metformin: Increased risk of lactic acidosis w/ alcohol, iodinated contrast agents, NSAIDs including selective COX-II & ACE inhibitors, AIIA, diuretics. Intrinsic hyperglycemic activity w/ glucocorticoids, β₂-agonist, diuretics. Decreased blood glucose levels w/ ACE inhibitors. Decreased anticoagulant effect of phenprocoumon. Reduced hypoglycemic effect w/ l-thyroxine. 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. Altered 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.

B