Zemimet SR

Gemigliptin tartrate sesquihydrate 68.9 mg (equiv to gemigliptin pure free base 50 mg), metformin HCl 1 g

As an adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM. Initial therapy for treatment naïve patients w/ inadequate glycemic control by diet & exercise alone. Patients w/ inadequate glycemic control w/ the maximal tolerated dose of metformin alone. In combination w/ sulfonylurea in patients inadequately controlled on their maximal tolerated dose of metformin & a sulfonylurea. In combination w/ insulin in patients w/ inadequate glycemic control w/ insulin monotherapy or insulin/metformin dual therapy. Patients already receiving an identical combination of gemigliptin & metformin as separate tab.

Individualized dosage. 1 tab once daily. Patient who needed 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 or metformin & insulin Gemigliptin 50 mg daily & the dose of metformin already being taken. Switching from co-administration of gemigliptin & metformin Initiate at the dose already being taken. Max daily dose: Gemigliptin 50 mg & metformin 2,000 mg.

Should be taken with food: Swallow whole, do not split/crush/chew.

History of serious hypersensitivity reactions to gemigliptin, metformin, another dipeptidyl peptidase-4 inhibitor, or biguanides. CHF; pre-diabetic coma; pulmonary infarction, severe resp insufficiency, & any conditions that induce hypoxemia, excessive alcohol, dehydration, GI symptoms eg, diarrhea & vomiting. Discontinue use of intravascular iodinated contrast materials at least 48 hr prior to the procedure & w/held for 48 hr subsequent to the procedure & reinstituted only after renal function has been re-evaluated & found to be normal. Patients w/ type 1 diabetes or acute/chronic metabolic acidosis including diabetic ketoacidosis w/ or w/o coma, or history of ketoacidosis. Temporarily suspend therapy in patients w/ severe infection or traumatism & should not be restarted until the patient's oral intake has resumed & renal function has been evaluated as normal. Temporarily discontinue therapy for 48 hr prior to any surgical procedure (except minor procedures not associated w/ restricted intake of food & fluids), & w/held for at least 48 hr subsequent to the procedure & reinstituted only after renal function has been re-evaluated & found to be normal. Debilitated, malnourished or starved patients, & those w/ adrenal or pituitary insufficiency. Predisposed to developing subnormal vit B₁₂ levels in patients w/ inadequate vit B₁₂ or Ca intake or absorption. Renal (serum creatinine levels ≥1.5 mg/dL for men, ≥1.4 mg/L for women or abnormal CrCl) & hepatic impairment. Do not administer during lactation. Childn. Elderly. Gemigliptin: History of pancreatitis. Risk of hypoglycemia w/ sulfonylurea. Not recommended during pregnancy. Metformin: Lactic acidosis. Hypoglycemia due to deficient caloric intake, strenuous exercise not compensated by caloric supplementation, or concomitant use w/ other glucose lowering agents (eg, sulfonylurea & insulin) or ethanol. Promptly discontinue if hypoxic states occur. Severe & disabling arthralgia. Discontinue use of bullous pemphigoid is suspected. Evaluate serum electrolytes & ketones, blood glucose, & if indicated, blood pH, lactate, pyruvate, & levels. Concomitant use w/ cationic drugs.

Gemigliptin: Arthralgia, nasopharyngitis, bacteriuria. URTI, increased blood amylase & lipase, pyrexia. Metformin: Diarrhea & nausea/vomiting.

Gemigliptin: Decreased C_max of metformin (2,000 mg). Decreased AUC & C_max of pioglitazone. Decreased exposure w/ other strong CYP3A4 inducers eg, rifampicin (rifampin), dexamethasone, phenytoin, carbamazepine, rifabutin & phenobarb. Increased AUC w/ ketoconazole. Decreased AUC & C_max w/ rifampicin. Metformin: Potentiated hypoglycemic effect w/ insulin, sulfonylamides, sulfonylureas, α-glucosidase inhibitors, anabolic steroid, guanethidine, salicylates (aspirin), β-blockers (propranolol), MAOIs, angiotensin receptor antagonists; hyperglycemic effect w/ epinephrine, sympathomimetics, corticosteroids, thyroid hormones, follicle hormone, estrogen, OCs, thiazides & other diuretics, pyrazinamide, INH, nicotinic acid, phenothiazines, phenytoin, Ca channel blocking drugs. Increased risk of accumulation & lactic acidosis w/ intake of alcohol or medicinal products that contain alcohol. May lead to renal failure w/ iodinated contrast agents. Increased plasma & blood C_max & AUC w/ furosemide. Increased plasma C_max & AUC & amount excreted in urine w/ nifedipine. May reduce effect w/ OCT1 inhibitors (verapamil, etc). May increase GI uptake & effect w/ OCT1 inducers (rifampicin, etc). May reduce renal excretion w/ OCT2 inhibitors (cimetidine, dolutegravir, lanolazine, trimethoprim, vandetanib, isavuconazole). May affect renal excretion & effect w/ OCT2 & OCT1 co-inhibitors (crizotinib, olaparib, etc). Increased risk of lactic acidosis w/ NSAIDs, ACE inhibitors, AIIA, diuretics (especially loop diuretics, etc).

Antidiabetic Agents

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

Rx