Applies to the following strengths: 100 mg; 300 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Diabetes Type 2
Initial dose: 100 mg orally once a day
-May increase to 300 mg orally once a day for additional glycemic control but only in patients who have tolerated lower dose and who have an eGFR of 60 mL/min/1.73 m2 or greater
Maximum dose: 300 mg/day
-Do not initiate in patients with an eGFR less than 45 mL/min/1.73 m2 as this drug will not be effective.
-If used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue should be considered to reduce the risk of hypoglycemia.
Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.
Renal Dose Adjustments
Mild renal dysfunction (eGFR of 60 mL/min/1.73 m2 or greater): No adjustment recommended.
Moderate renal dysfunction (eGFR of 45 to less than 60 mL/min/1.73 m2): Limit dose to 100 mg orally once a day
Severe renal dysfunction (eGFR less than 45 mL/min/1.73 m2): Initiation of therapy is not recommended
Severe renal dysfunction (eGFR less than 30 mL/min/1.73 m2): Use is contraindicated
If during therapy, eGFR is persistently less than 45 mL/min/1.73 m2: Use is not recommended
Liver Dose Adjustments
Mild to moderate liver dysfunction: No adjustment recommended
Severe liver dysfunction: Not recommended
Patients Concomitantly Receiving Uridine 5-diphospho (UDP)-glucuronosyl transferase (UGT) Enzyme Inducers and Requiring Additional Glycemic Control:
-For eGFR greater than 60 mL/min/1.73 m2: Consider increasing the canagliflozin dose to 300 mg orally once a day
-For eGFR of 45 to less than 60 mL/min/1.73 m2: Consider an alternative antihyperglycemic agent
US BOXED WARNING: LOWER LIMB AMPUTATION:
-An approximately 2-fold increased risk of lower limb amputations associated with this drug was observed in CANVAS (CANagliflozin cardioVascular Assessment Study) and CANVAS-R (study looking at the effects of canagliflozin on renal endpoints) studies, large, randomized, placebo-controlled trials in patients with type 2 diabetes who had established cardiovascular disease (CVD) or were at risk for CVD.
-Amputations of the toes and midfoot were most frequent; however, amputations involving the leg were also observed. Some patients had multiple amputations, some involving both limbs.
-Before initiating, consider factors that may increase the risk of amputation, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers.
-Monitor patients receiving this drug for infection, new pain or tenderness, sores or ulcers involving the lower limbs, and discontinue if these complications occur.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
-Take orally before the first meal of the day; swallow whole
-If a dose is missed, it should be taken as soon as it is remembered; however, double dosing to make up for a missed dose is not recommended
-Correct volume depletion prior to initiating treatment.
-Not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
-Assess fluid status prior to initiation and monitor for signs and symptoms of volume depletion during therapy.
-Verify renal function at baseline, and monitor periodically during therapy.
-Monitor potassium in patients at risk for hyperkalemia.
-Evaluate for the presence of acidosis, including ketoacidosis in symptomatic patients.
-Monitor legs and feet for any new pain, tenderness, sores, ulcers, or infections.
-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.
-This drug will cause the urine to test positive for glucose.
-Ensure adequate fluid intake to avoid adverse reactions related to volume depletion such as orthostatic hypotension.
-Seek medical advice during periods of stress as medical management of glycemic control may change.
-Inform patients that genital mycotic infections, urinary tract infections, and hypersensitivity reactions may occur; patients should be instructed to contact their health care professional.
-Inform patients that use of this drug may increase their risk of bone fractures.
-Patients should be advised that this drug may increase their risk of lower limb amputations and should be instructed to report any new pain, tenderness, sores, ulcers, or infections of legs or feet.
-Patients should be instructed to seek medical attention promptly for signs and symptoms of acute kidney injury such as decreased urine, swelling in the legs or feet.
More about canagliflozin
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- Drug class: SGLT-2 inhibitors
Other brands: Invokana