Usual Adult Dose for Diabetes Type 2

Initial dose: 200 mg orally once a day administered within one hour of the first meal of the day
Dose titration:

• After at least 2 weeks, increase dose to 400 mg orally once a day, as tolerated
• Decrease dose to 200 mg orally once a day, as necessary

• Correct volume status before starting therapy.
• Assess renal function prior to initiation.
• In decompensated heart failure, treatment may begin as soon as patient is hemodynamically stable.
• If used in combination with insulin or an insulin secretagogue, consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia.
• It is recommended to interrupt therapy prior to major surgery.

• Heart failure
• Type 2 diabetes mellitus and other cardiovascular risk factors
• Chronic kidney disease and other cardiovascular risk factors

Usual Adult Dose for Heart Failure

Initial dose: 200 mg orally once a day administered within one hour of the first meal of the day
Dose titration:

• After at least 2 weeks, increase dose to 400 mg orally once a day, as tolerated
• Decrease dose to 200 mg orally once a day, as necessary

• Correct volume status before starting therapy.
• Assess renal function prior to initiation.
• In decompensated heart failure, treatment may begin as soon as patient is hemodynamically stable.
• If used in combination with insulin or an insulin secretagogue, consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia.
• It is recommended to interrupt therapy prior to major surgery.

• Heart failure
• Type 2 diabetes mellitus and other cardiovascular risk factors
• Chronic kidney disease and other cardiovascular risk factors

Usual Adult Dose for Cardiovascular Risk Reduction

Initial dose: 200 mg orally once a day administered within one hour of the first meal of the day
Dose titration:

• After at least 2 weeks, increase dose to 400 mg orally once a day, as tolerated
• Decrease dose to 200 mg orally once a day, as necessary

• Correct volume status before starting therapy.
• Assess renal function prior to initiation.
• In decompensated heart failure, treatment may begin as soon as patient is hemodynamically stable.
• If used in combination with insulin or an insulin secretagogue, consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia.
• It is recommended to interrupt therapy prior to major surgery.

• Heart failure
• Type 2 diabetes mellitus and other cardiovascular risk factors
• Chronic kidney disease and other cardiovascular risk factors

Usual Adult Dose for Chronic Kidney Disease

Initial dose: 200 mg orally once a day administered within one hour of the first meal of the day
Dose titration:

• After at least 2 weeks, increase dose to 400 mg orally once a day, as tolerated
• Decrease dose to 200 mg orally once a day, as necessary

• Correct volume status before starting therapy.
• Assess renal function prior to initiation.
• In decompensated heart failure, treatment may begin as soon as patient is hemodynamically stable.
• If used in combination with insulin or an insulin secretagogue, consider a lower dose of insulin or the insulin secretagogue to reduce the risk of hypoglycemia.
• It is recommended to interrupt therapy prior to major surgery.

• Heart failure
• Type 2 diabetes mellitus and other cardiovascular risk factors
• Chronic kidney disease and other cardiovascular risk factors

Renal Dose Adjustments

Estimated GFR 25 mL/min/1.73 m2 or greater:

• No adjustment recommended.
• Use caution in patients with estimated GFR less than 30 mL/min/1.73 m2 due to increase in volume-related adverse events.

• Therapy was not initiated in this patient population during safety and efficacy studies.
• In clinical studies, therapy was discontinued when estimated GFR fell below 15 mL/min/1.73 m2 or patient was initiated on chronic dialysis.

Liver Dose Adjustments

• Mild Liver Dysfunction (Child-Pugh Class A): No adjustment recommended
• Moderate to Severe Liver Dysfunction (Child-Pugh Class B and C): Use is not recommended

Dose Adjustments

• Concomitant use of insulin and insulin secretagogues: A lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycemia.

Precautions

CONTRAINDICATIONS:

• In patients with a history of serious hypersensitivity reaction to this drug

Dialysis

• Discontinue therapy in patients initiated on chronic dialysis.

Other Comments

Administration advice:

• Take orally before the first meal of the day.
• Swallow whole; do not cut, crush, or chew.
• If a dose is missed by more than 6 hours, administer at the next scheduled dosing time; do not double doses.
• Withhold therapy for at least 3 days, if possible, for major surgery or procedures associated with prolonged fasting; restart treatment when patient is clinically stable and oral intake has resumed.

• Store at 20C to 25C (68F to 77F)
• Excursions permitted between 15C and 30C (59F and 86F)

• This drug is not indicated for glycemic control.

• Evaluate volume status prior to initiation and ensure patients maintain regular oral intake during treatment.
• Monitor for signs and symptoms of volume depletion (e.g., hypotension) during therapy.
• Verify renal function at baseline and monitor periodically during therapy or as clinically indicated.
• Consider ketone monitoring in patients with type 1 diabetes mellitus or in patients at risk of ketoacidosis.
• Assess for ketoacidosis regardless of presenting blood glucose levels if symptoms occur.

• Read the FDA-approved patient labeling (Medication Guide).
• Check ketones (when possible) if symptoms consistent with ketoacidosis occur, even if blood glucose is not elevated. If symptoms of ketoacidosis (including nausea, vomiting, abdominal pain, tiredness, labored breathing) occur, discontinue this drug and seek medical attention immediately.
• Contact health care provider if symptomatic hypotension occurs.
• Maintain adequate fluid intake; dehydration may increase the risk for hypotension.
• Seek medical advice if symptoms of urinary tract or genital yeast infection occur.
• Promptly seek medical attention if you develop pain/tenderness, redness, or swelling of the genitals/area from genitals back to rectum, as well as a fever above 100.4 F or malaise.
• Immediately report any skin reaction or angioedema and discontinue this drug until you have consulted prescribing health care provider.
• Report pregnancy to health care provider as soon as possible.
• Breastfeeding is not recommended during therapy.
• Take this drug only as prescribed. If a dose is missed by more than 6 hours, take at next scheduled dosing time; do not double your next dose.