Generic Name and Formulations:
Sitagliptin, simvastatin; 50mg/10mg, 50mg/20mg, 50mg/40mg, 100mg/10mg, 100mg/20mg, 100mg/40mg; tabs.
Company:
Merck & Co., Inc.
| 03/07/13 |
| Added 50mg/10mg, 50mg/20mg, 50mg/40mg dosage strengths and updated dosing with regards to renal impairment. |
In patients for whom treatment with both sitagliptin and simvastatin is appropriate. Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Simvastatin is indicated as an adjunctive therapy to diet to: reduce risk of total mortality by reducing CHD deaths and reduce risk of non-fatal MI, stroke, and the need for revascularization procedures in patients at high risk of coronary events; reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia; reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia; reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia.
Swallow whole. Give as single daily dose in the PM. Initially 100mg/40mg per day; already on simvastatin: start with sitagliptin 100mg daily and dose of simvastatin already being taken. Adjust dose if needed after ≥4wks. Moderate renal impairment (CrCl 30–50mL/min): initially 50mg/40mg once daily; already taking simvastatin: start sitagliptin 50mg daily and dose of simvastatin already being taken. Concomitant verapamil, diltiazem, dronedarone: max dose of simvastatin 10mg/day. Concomitant amiodarone, amlodipine, ranolazine: max dose of simvastatin 20mg/day. Homozygous familial hypercholesterolemia: 100mg/40mg per day; moderate renal impairment: 50mg/40mg per day. Chinese patients taking lipid-modifying doses (≥1g/day niacin) of niacin-containing products: caution with simvastatin 40mg dose; increased risk of myopathy.
<18yrs: not established.
Dipeptidyl peptidase-4 (DPP-4) inhibitor + HMG-CoA reductase inhibitor.
Concomitant strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone). Concomitant gemfibrozil, cyclosporine, danazol. Active liver disease. Pregnancy (Cat.X). Nursing mothers.
Not for treating type 1 diabetes or diabetic ketoacidosis. Severe renal impairment or ESRD: not recommended. Assess renal function prior to starting therapy and periodically thereafter. Monitor for pancreatitis, markedly elevated creatine kinase (>10XULN), myopathy; discontinue if occurs. Temporarily withhold dose if experiencing acute or serious condition predisposing to development of renal failure secondary to rhabdomyolysis. Monitor liver function at baseline, then as needed. History of liver disease. Substantial alcohol consumption. History of angioedema with other DPP-4 inhibitors. Elderly.
See Contraindications. Concomitant sulfonylurea or insulin: reduce dose of these to reduce risk of hypoglycemia. Reduce max simvastatin dose if amiodarone, verapamil, diltiazem, amlodipine, ranolazine, voriconazole must be used. Caution with other fibrates, colchicine. Avoid large quantities of grapefruit juice (>1 quart daily). Monitor digoxin, coumarin anticoagulants.
Upper respiratory infection, headache, abdominal pain, constipation, nausea, nasopharyngitis; pancreatitis, myopathy, rhabdomyolysis, hypersensitivity reactions (discontinue if occurs), increased A1C and fasting serum glucose levels.
Hepatic (CYP3A4, 2C8).
Renal, fecal.
NO
Tabs (100mg/10mg, 100mg/20mg, 100mg/40mg)—30, 90, 1000; 50mg/10mg, 50mg/20mg, 50mg/40mg—30, 90
| 03/07/13 |
| Added 50mg/10mg, 50mg/20mg, 50mg/40mg dosage strengths and updated dosing with regards to renal impairment. |
In patients for whom treatment with both sitagliptin and simvastatin is appropriate. Sitagliptin is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Simvastatin is indicated as an adjunctive therapy to diet to: reduce risk of total mortality by reducing CHD deaths and reduce risk of non-fatal MI, stroke, and the need for revascularization procedures in patients at high risk of coronary events; reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia; reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbetalipoproteinemia; reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia.
Swallow whole. Give as single daily dose in the PM. Initially 100mg/40mg per day; already on simvastatin: start with sitagliptin 100mg daily and dose of simvastatin already being taken. Adjust dose if needed after ≥4wks. Moderate renal impairment (CrCl 30–50mL/min): initially 50mg/40mg once daily; already taking simvastatin: start sitagliptin 50mg daily and dose of simvastatin already being taken. Concomitant verapamil, diltiazem, dronedarone: max dose of simvastatin 10mg/day. Concomitant amiodarone, amlodipine, ranolazine: max dose of simvastatin 20mg/day. Homozygous familial hypercholesterolemia: 100mg/40mg per day; moderate renal impairment: 50mg/40mg per day. Chinese patients taking lipid-modifying doses (≥1g/day niacin) of niacin-containing products: caution with simvastatin 40mg dose; increased risk of myopathy.
<18yrs: not established.
Dipeptidyl peptidase-4 (DPP-4) inhibitor + HMG-CoA reductase inhibitor.
Concomitant strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, nefazodone). Concomitant gemfibrozil, cyclosporine, danazol. Active liver disease. Pregnancy (Cat.X). Nursing mothers.
Not for treating type 1 diabetes or diabetic ketoacidosis. Severe renal impairment or ESRD: not recommended. Assess renal function prior to starting therapy and periodically thereafter. Monitor for pancreatitis, markedly elevated creatine kinase (>10XULN), myopathy; discontinue if occurs. Temporarily withhold dose if experiencing acute or serious condition predisposing to development of renal failure secondary to rhabdomyolysis. Monitor liver function at baseline, then as needed. History of liver disease. Substantial alcohol consumption. History of angioedema with other DPP-4 inhibitors. Elderly.
See Contraindications. Concomitant sulfonylurea or insulin: reduce dose of these to reduce risk of hypoglycemia. Reduce max simvastatin dose if amiodarone, dronedarone, verapamil, diltiazem, amlodipine, ranolazine, voriconazole must be used. Caution with other fibrates, colchicine. Avoid large quantities of grapefruit juice (>1 quart daily). Monitor digoxin, coumarin anticoagulants.
Upper respiratory infection, headache, abdominal pain, constipation, nausea, nasopharyngitis; pancreatitis, myopathy, rhabdomyolysis, hypersensitivity reactions (discontinue if occurs), increased A1C and fasting serum glucose levels.
Hepatic (CYP3A4, 2C8).
Renal, fecal.
NO
Tabs (100mg/10mg, 100mg/20mg, 100mg/40mg)—30, 90, 1000; 50mg/10mg, 50mg/20mg, 50mg/40mg—30, 90