Zemimet SR

As an adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM: Initial therapy for treatment of naïve patients w/ inadequate glycemic control by diet & exercise alone. In patients already receiving an identical combination of gemigliptin & metformin as separate tab. 50 mg/1 g FC tab: In 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.

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. Switching from co-administration of gemigliptin & metformin Initiate at the dose already being taken. 50 mg/1 g FC tab 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.

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

Patients w/ history of serious hypersensitivity reactions to gemigliptin, metformin, another dipeptidyl peptidase-4 inhibitor, or biguanides; CHF requiring medication; type 1 diabetes or acute/chronic metabolic acidosis including diabetic ketoacidosis w/ or w/o coma, or history of ketoacidosis; pre-diabetic coma; pulmonary infarction, severe resp insufficiency, & any conditions that induce hypoxemia, excessive alcohol, dehydration, GI symptoms eg, diarrhea & vomiting; renal impairment (serum creatinine levels ≥1.5 mg/dL for men, ≥1.4 mg/L for women or abnormal CrCl); hepatic impairment; debilitated, malnourished or starved patients, & those w/ adrenal or pituitary insufficiency; patients predisposed to developing subnormal vit B₁₂ levels. Discontinue treatment at least 48 hr prior to radiologic study involving the use of intravascular iodinated contrast materials & w/hold for 48 hr subsequent to the procedure & reinstitute only after renal function has been re-evaluated & found to be normal. 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/hold for at least 48 hr subsequent to the procedure & reinstitute only after renal function has been re-evaluated & found to be normal. Patient w/ type 2 DM previously well controlled on gemigliptin/metformin HCl who develops lab abnormalities or clinical illness (especially vague & poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis. Promptly discontinue if hypoxic states occur. Discontinue treatment if a severe hypersensitivity reaction is suspected. Skin of tab may be excreted through feces. Assess renal function & verify as normal before treatment initiation & at least annually thereafter; assess more frequently if renal dysfunction is anticipated. Avoid in patients w/ clinical or lab evidence of hepatic disease. Patient should not consume alcohol during treatment. Do not administer during lactation. Safety & effectiveness have not been established in childn & adolescents. Carefully monitor renal function in the elderly. Gemigliptin: Reports of pancreatitis; severe & disabling arthralgia; bullous pemphigoid. Risk of hypoglycemia w/ sulfonylurea. Not recommended during pregnancy. Metformin: Risk of lactic acidosis; hypoglycemia, especially in deficient caloric intake, strenuous exercise not compensated by caloric supplementation, or concomitant use w/ other glucose lowering agents (eg, sulfonylurea & insulin) or ethanol. Concomitant use w/ medications that may affect renal function or result in significant hemodynamic change or may interfere w/ metformin disposition eg, cationic drugs.

Dyspepsia, nasopharyngitis, dizziness, diarrhea, URTI, increased blood amylase, increased lipase, pyrexia. Gemigliptin: Arthralgia, bacteriuria, headache, constipation. Metformin: Nausea, vomiting, back pain.

Gemigliptin: Decreased exposure w/ strong CYP3A4 inducers eg, rifampicin (rifampin), dexamethasone, phenytoin, carbamazepine, rifabutin & phenobarb. Metformin: Potentiated hypoglycemic effect w/ insulin, sulfonylamides, sulfonylureas, α-glucosidase inhibitors, anabolic steroid, guanethidine, salicylates (aspirin), β-blockers (propranolol), MAOIs, angiotensin receptor antagonists. Potentiated 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/ intravascular administration of iodinated contrast agents. Increased plasma & blood C_max & AUC w/ furosemide. Decreased C_max & AUC of furosemide. Increased plasma C_max & AUC & amount excreted in urine w/ nifedipine. Reduced effect w/ OCT1 inhibitors (eg, verapamil). Increased GI uptake & effect w/ OCT1 inducers (eg, rifampicin). Reduced renal excretion w/ OCT2 inhibitors (cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole). Affected renal excretion & effect w/ OCT2 & OCT1 co-inhibitors (eg, crizotinib, olaparib). Increased risk of lactic acidosis w/ NSAIDs, ACE inhibitors, AIIA, diuretics (especially loop diuretics).

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