Canagliflozin / Metformin Dosage
Applies to the following strength(s): 50 mg-500 mg ; 50 mg-1000 mg ; 150 mg-500 mg ; 150 mg-1000 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Diabetes Type 2
Initial dose: Individualize dose based on patient's current regimen:
Canagliflozin-Metformin Immediate-Release tablets: Take orally twice a day with meals
-In patients not currently on canagliflozin or metformin: canagliflozin 50 mg-metformin 500 mg orally twice a day
-In patients on metformin: canagliflozin 50 mg plus one-half of the total daily metformin dose orally twice a day
-In patients on canagliflozin: one-half daily dose of canagliflozin plus metformin 500 mg orally twice a day
-In patients already on canagliflozin and metformin: Switch to canagliflozin-metformin at the same total daily dose divided into 2 doses taken orally twice a day
Canagliflozin-Metformin Extended-release (XR tablets): Take orally once a day with morning meal
-In patients not currently on canagliflozin or metformin: Initial dose: canagliflozin 100 mg-metformin 1000 mg orally once a day
-In patients on metformin: canagliflozin 100 mg plus total daily metformin dose (or nearest appropriate) orally once a day
-In patients on canagliflozin: current daily dose of canagliflozin plus metformin 1000 mg orally once a day
-In patients already treated with canagliflozin and metformin: Switch to canagliflozin-metformin at the same total daily dose (or nearest appropriate) orally once a day
Maintenance dose: Adjust based on efficacy and tolerability; canagliflozin may be increased from 100 mg/day to 300 mg/day; a gradual dose escalation of metformin will help to reduce gastrointestinal side effects.
Maximum dose: Canagliflozin 300 mg/day; Metformin 2000 mg/day
-When used in combination with insulin or an insulin secretagogue, a lower dose of insulin or insulin secretagogue may be considered to reduce the risk of hypoglycemia.
-For patients taking an evening dose of metformin extended-release (XR) switching to canagliflozin-metformin XR once a day, skip the last evening dose of metformin XR before starting canagliflozin-metformin XR the following morning.
Use: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both canagliflozin and metformin is appropriate.
Renal Dose Adjustments
Moderate to severe renal impairment (eGFR below 45 mL/min/1.73m2) and ESRD: Use is contraindicated
-Moderate Renal Dysfunction (eGFR of 45 to less than 60 mL/min/1.73m2): Limit dose of canagliflozin-metformin to canagliflozin 50 mg twice a day
-Moderate Renal Dysfunction (eGFR of 45 to less than 60 mL/min/1.73m2): Limit dose of canagliflozin-metformin to canagliflozin 100 mg once a day
IODINATED CONTRAST PROCEDURE:
-Stop this drug at time of, or prior to, an iodinated contrast imaging procedure for patients with an eGFR between 45 and 60 mL/min/1.73m2 ; reevaluate eGFR 48 hours after the imaging procedure and restart drug if renal function is stable.
Liver Dose Adjustments
Metformin is not recommended in patients with clinical or laboratory evidence of hepatic disease.
Elderly: Monitor renal function more frequently and adjust dose based on renal function.
Concomitant use with UDP-Glucuronosyl Transferase (UGT) Enzyme Inducers:
-Consider increasing the dose of canagliflozin to 150 mg twice a day (or 300 mg once a day) in patients currently tolerating 50 mg twice a day (or 100 mg once a day) who have an eGFR greater than 60 mL/min/1.73m2
-Consider another antihyperglycemic agent in patients with an eGFR of 45 mL/min/1.73m2 to less than 60 mL/min/1.73m2
Concomitant use with drugs that increase the risk of metformin-associated lactic acidosis; impair renal function; result in significant hemodynamic changes, interfere with acid-base balance; or increase metformin accumulation should be undertaken with increased monitoring.
Iodinated Contrast Imaging Procedures:
-Stop this drug at time of, or prior to, an iodinated contrast imaging procedure for patients with an eGFR between 45 and 60 mL/min/1.73m2
-Stop this drug at time of, or prior to, an iodinated contrast imaging procedure; for patients with a history of liver disease, alcoholism, or heart failure.
-Stop this drug at time of, or prior to, an iodinated contrast imaging procedure for patients who will be administered intra-arterial iodinated contrast.
Reevaluate eGFR 48 hours after the imaging procedure and only restart this drug if renal function is stable.
US BOXED WARNING: Lactic Acidosis
-Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Onset 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), an 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 older, radiological study with contrast, surgery and other procedures, hypoxic states (e.g. congestive heart failure), excessive alcohol intake, and hepatic impairment.
-Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information.
-If metformin-associated lactic acidosis is suspected, immediately discontinue this drug and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.
US BOXED WARNING: Based on an increased risk of leg and foot amputations observed in the CANVAS and CANVAS-R (Canagliflozin Cardiovascular Assessment Study and Renal Endpoints) clinical trials, a Boxed Warning will be added to the canagliflozin drug labels to describe this risk.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Canagliflozin-Metformin Immediate-Release Tablets:
-Take orally twice a day with meals
Canagliflozin-Metformin Extended-Release Tablets:
-Take orally once a day after breakfast
-Store in the original container to protect from moisture
-May store in pill box or pill organizer for up to 30 days.
-This drug should not be used in patients with type 1 diabetes mellitus or for diabetic ketoacidosis
-Correct volume depletion prior to initiating treatment
-Assess renal function using eGFR.
-Stop this drug at time of, or prior to, an iodinated contrast imaging procedure for patients with an eGFR between 45 and 60 mL/min/1.73m2 ; for patients with a history of liver disease, alcoholism, or heart failure; for patients who will be administered intra-arterial iodinated contrast. Reevaluate eGFR 48 hours after the imaging procedure and only restart this drug if renal function is stable.
-Assess fluid status prior to initiation and monitor for signs and symptoms of volume depletion during therapy
-Verify renal function at baseline, repeat at least annually and more often as clinically indicated
-Monitor serum potassium levels periodically, especially in patients with impaired renal function and those predisposed to hyperkalemia due to medications or other medical conditions.
-Measure hematologic parameters annually; consider obtaining a serum Vitamin B12 every 2 to 3 years
-Monitor low-density lipoprotein levels.
-Monitor glycemic control
-Evaluate for the presence of acidosis, including ketoacidosis in symptomatic patients.
-Monitor for genital mycotic infections.
-Monitor for any new pain, tenderness, sore, ulcer, or infection in feet and legs.
-Patients should be instructed to keep tablets in the original bottle and not to place into pill boxes or pill organizers.
-Patients should be told this drug will cause the urine to test positive for glucose.
-Patients should be instructed to maintain adequate fluid intake to avoid adverse reactions related to volume depletion such as orthostatic hypotension.
-Patients should be reminded that during periods of stress medical management of diabetes may change and they should know when to contact their health care provider.
-Inform patients that genital mycotic infections, urinary tract infections, and hypersensitivity reactions may occur; they should contact their health care professional if these occur.
-Patients experiencing symptoms of ketoacidosis such as difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue, or sleepiness should be instructed to seek immediate medical attention.
-Inform patients about the risk of lactic acidosis, conditions that might predispose them to its occurrence, and symptoms to watch for and report.
-Advise patients 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.
-Tell patients that while gastrointestinal symptoms might be common when initiating treatment, gastrointestinal problems after initiation should be reported.
-Inform patients that use of canagliflozin may increase their risk of bone fractures.
-Patients should be instructed to report any new pain, tenderness, sore, ulcer, or infection of legs and feet.
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