Amaziptin-M 1000

Sitagliptin HCl 50 mg, metformin HCl 1 g

Type 2 DM for adults as an 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/ the combination of sitagliptin & metformin. In combination w/ sulphonylurea (ie, triple combination therapy) as an adjunct to diet & exercise in patients inadequately controlled on their maximal tolerated dose of metformin & sulphonylurea. As triple combination therapy w/ peroxisome proliferator-activated receptor γ (PPARγ) agonist (ie, thiazolidinedione) as an adjunct to diet & exercise in patients inadequately controlled on their maximal tolerated dose of metformin & PPARγ agonist. As add-on to insulin (ie, triple combination therapy) as an adjunct to diet & exercise to improve glycemic control in patients when stable dose of insulin & metformin alone do not provide adequate glycemic control.

Individualised dosage. Max daily dose of sitagliptin: 100 mg. Patient inadequately controlled on maximal tolerated dose of metformin monotherapy Initially sitagliptin 50 mg bid + dose of metformin already being taken. Switching from co-administration of sitagliptin & metformin Initiate at the dose of sitagliptin + metformin already being taken. Patient inadequately controlled on dual combination therapy w/ maximal tolerated dose of metformin & sulphonylurea Sitagliptin 50 mg bid + dose of metformin similar to the dose already being taken. Patient inadequately controlled on dual combination therapy w/ maximal tolerated dose of metformin & PPARγ agonist Sitagliptin 50 mg bid + dose of metformin similar to the dose already being taken. Patient inadequately controlled on dual combination therapy w/ insulin & maximal tolerated dose of metformin Sitagliptin 50 mg bid + dose of metformin similar to the dose already being taken. Renal impairment GFR 60-89 mL/min Max daily dose: Metformin 3,000 mg divided into 2-3 doses + sitagliptin 100 mg, 45-59 mL/min Max daily dose: Metformin 2,000 mg divided into 2-3 doses + sitagliptin 100 mg, 30-44 mL/min Max daily dose: Metformin 1,000 mg divided into 2-3 doses + sitagliptin 50 mg.

Should be taken with food.

Hypersensitivity. Any type of acute metabolic acidosis (eg, lactic acidosis & diabetic ketoacidosis); diabetic pre-coma; acute conditions w/ potential to alter renal function eg, dehydration, severe infection, shock, intravascular administration of iodinated contrast agents; acute or chronic disease which may cause tissue hypoxia eg, cardiac or resp failure, recent MI, shock; acute alcohol intoxication, alcoholism. Severe renal failure (GFR <30 mL/min) & hepatic impairment. Lactation.

Hypersensitivity reactions. Not to be used in patients w/ type 1 diabetes & must not be used for the treatment of diabetic ketoacidosis. Risk of developing acute pancreatitis. Patients w/ history of pancreatitis. Assess GFR before treatment initiation & regularly thereafter. Discontinue use if bullous pemphigoid is suspected; at the time of surgery under general, spinal or epidural anaesth & restart no earlier than 48 hr following surgery or resumption of oral nutrition & that renal function has been re-evaluated & is stable; prior to or at the time of imaging procedure & not restarted until at least 48 hr after, provided that renal function has been re-evaluated & found to be stable. Change in clinical status of patients w/ previously controlled type 2 diabetes. Not to be used during pregnancy. Childn & adolescents from birth to <18 yr. Elderly. Metformin: Acute worsening of renal function & increased risk of lactic acidosis.

Hypoglycemia; nausea, flatulence, vomiting. Pancreatitis & hypersensitivity reactions.

Increased risk of lactic acidosis w/ alcohol intoxication. May lead to contrast-induced nephropathy w/ iodinated contrast agents. Perform frequent blood glucose monitoring especially at the beginning of treatment w/ glucocorticoids (systemic & local route), β-2-agonist, & diuretics due to their intrinsic hyperglycemic activity. May decrease blood glucose levels w/ ACE inhibitors. Increased risk of hypoglycemia w/ sulphonylurea or insulin. Metformin: Increased risk of lactic acidosis w/ medicinal products that can adversely affect renal function eg, NSAIDs, including selective COX II inhibitors, ACE inhibitors, AIIAs & diuretics, especially loop diuretics. May increase systemic exposure & increased risk of lactic acidosis w/ organic cationic transporter-2 (OCT2)/multidrug & toxin extrusion (MATE) inhibitors (eg, ranolazine, vandetanib, dolutegravir, & cimetidine). Sitagliptin: May alter pharmacokinetics in patients w/ severe renal impairment or ESRD w/ potent CYP3A4 inhibitors (ie, ketoconazole, itraconazole, ritonavir, clarithromycin). Small effect on plasma digoxin conc (increased plasma AUC & C_max). May be a mild inhibitor of P-gp.

Antidiabetic Agents

A10BD07 - metformin and sitagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

Rx