Linagliptin / Metformin Dosage
Applies to the following strength(s): 2.5 mg-500 mg ; 2.5 mg-850 mg ; 2.5 mg-1000 mg ; 5 mg-1000 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Diabetes Type 2
Linagliptin-metformin immediate release tablets:
-Initial dose for patients currently not receiving metformin: linagliptin 2.5 mg/metformin 500 mg orally twice a day
-Initial dose for patients currently receiving metformin: linagliptin 2.5 mg in combination with one-half of current metformin dose orally twice a day
-Initial dose for patients currently receiving linagliptin and metformin as individual components: switch to combination product containing the same doses of each component orally twice a day
Maintenance dose: Individualize dose based on safety and efficacy
Maximum dose: linagliptin 5 mg/day; Metformin 2000 mg/day
Linagliptin-metformin extended-release tablets:
-Initial dose for patients currently not receiving metformin: linagliptin 5 mg/metformin extended-release 1000 mg orally once a day
-Initial dose for patients currently receiving metformin: linagliptin 5 mg in combination with a similar total daily dose of metformin orally once a day
-Initial dose for patients currently receiving linagliptin and metformin as individual components: switch to combination product containing similar doses of each component orally once a day
Maintenance dose: Individualize dose based on safety and efficacy
Maximum dose: linagliptin 5 mg/day; Metformin 2000 mg/day; maximum dose should be taken as two linagliptin 2.5 mg/metformin extended-release 1000 mg tablets orally once a day
Comment: When used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue may be necessary to reduce the risk of hypoglycemia.
Use: To improve glycemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise when treatment with both linagliptin and metformin are appropriate.
Renal Dose Adjustments
-Renal impairment (serum creatinine 1.5 mg/dL or greater in men, 1.4 mg/dL or greater in women, or abnormal CrCl): Use is contraindicated
-Severe renal impairment (eGFR below 30 mL/min/1.73 m2): Use is contraindicated
-Moderate renal impairment (eGFR 30 to 45 mL/min/1.73 m2): Do not initiate therapy
-If eGFR falls below 45 mL/min/1.73 m2: Assess benefit risk of continuing therapy.
-If eGFR falls below 30 mL/min/1.73 m2: Discontinue therapy.
Liver Dose Adjustments
Not recommended in patients with liver impairment.
Iodinated Contrast Imaging Procedures:
Immediate-release: Temporarily discontinue for any surgical procedure (except minor procedures not associated with restricted food/fluid intake); restart once oral intake has resumed and renal function has been evaluated as normal.
Extended-release: Temporarily discontinue at time of or prior to an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after imaging procedure and restart therapy if renal function is stable.
US BOXED WARNING: Risk of lactic acidosis
-Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis is characterized by elevated blood lactate levels (greater than 5 mmol/L), anion gap, acidosis (without evidence of ketonuria or ketonemia) and increased lactate/pyruvate ratio; and metformin plasma levels generally greater than 5 mcg/mL.
-Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., cationic drugs such as topiramate), age 65 years or greater, radiological study with contrast, surgery, and other procedures, hypoxic state (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.
-Steps to reduce the risk of and manage metformin-associated lactic acidosis in high risk groups are provided in the full prescribing information.
-If metformin-associated lactic acidosis is suspected, immediately discontinue therapy and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-Take orally twice a day with meals
-Take orally once a day with a meal
-Swallow whole; do not split, crush, dissolve, or chew before swallowing
-Incompletely dissolved tablets may be eliminated in the feces; if this occurs assess adequacy of glycemic control.
-Not for use in patients with type 1 diabetes or diabetic ketoacidosis.
-When used in combination with insulin or an insulin secretagogue, a lower dose of insulin or insulin secretagogue may be necessary to reduce the risk of hypoglycemia.
-Therapy should be temporarily stopped prior to radiologic studies utilizing iodinated contrast materials and for surgical procedures when restricted food or fluid intake is expected; adequate renal function should be confirmed before reinitiating therapy. See dose adjustment section for guidance.
Renal: Assess eGFR at baseline, repeat at least annually or more often as clinically indicated
Hematologic: Measure hematologic parameters annually; monitor B12 levels every 2 to 3 years if warranted
-Monitor for signs and symptoms of pancreatitis; severe and disabling arthralgia; signs and symptoms of lactic acidosis
-Monitor glycemic control
-Inform patients about the risk of lactic acidosis, conditions that might predispose them to its occurrence, and symptoms to watch for and report.
-Advise patient that this drug may need to be temporarily stopped if undergoing radiologic studies with intravascular iodinated contrast materials or surgical procedures that will limit food or fluid intake.
-Advise patients on the risks of excessive alcohol intake.
-Patients should be instructed to seek medical attention promptly for severe and persistent abdominal pain and/or any signs or symptoms of serious allergic reactions.
-Inform patients that hypoglycemia may occur, especially if used in combination with insulin or a sulfonylurea; patients should be knowledgeable on treating hypoglycemia and urged to use caution when operating hazardous equipment, including driving a car.
-Patients should be instructed to report unusual muscle pain.