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Empagliflozin / Metformin Dosage

Applies to the following strength(s): 5 mg-500 mg ; 12.5 mg-1000 mg ; 5 mg-1000 mg ; 12.5 mg-500 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Diabetes Type 2

Individualize dosage based on patient's current regimen; Total daily dose should be given orally in 2 equally divided doses with meals

Patients on metformin:
-Initial dose: empagliflozin 10 mg plus similar total daily dose of metformin divided orally twice a day
Patients on empagliflozin:
-Initial dose: empagliflozin at the same total daily dose plus metformin 500 mg/day divided orally twice a day
Patients on empagliflozin and metformin:
-Initial dose: same total daily dose of each component (or nearest appropriate dose of metformin) divided orally twice a day

Maintenance: Adjust dose based on efficacy and tolerability; a gradual dose escalation of metformin will help to reduce gastrointestinal side effects.
Maximum dose: empagliflozin: 25 mg/day; metformin: 2000 mg/day

Comments:
-When used in combination with insulin or an insulin secretagogue, a lower dose of insulin or insulin secretagogue should be considered to reduce the risk of hypoglycemia.
-Correct volume depletion prior to beginning this drug.

Use: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate.

Renal Dose Adjustments

Moderate to severe renal impairment (eGFR less than 45 mL/min/1.73 m2 ) or ESRD: Use is contraindicated

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/1.73 m2 .
-Stop this drug in patients who will be administered intra-arterial iodinated contrast.
-Stop this drug in patients with a history of hepatic impairment, alcoholism, or heart failure.
-Reevaluate eGFR 48 hours after the imaging procedure; this drug may be restarted once adequate renal function is confirmed.

Liver Dose Adjustments

Avoid use in patients with clinical or laboratory evidence of hepatic disease.

Dose Adjustments

Elderly:
-Monitor renal function more frequently and adjust dose based on renal function; metformin should not be initiated unless measurement of CrCl demonstrates that renal function is not reduced.
-The risk of volume depletion associated with empagliflozin use should be taken into account

Concomitant use with Cationic Drugs:
-Cationic drugs may reduce metformin elimination; careful patient monitoring and dose adjustment may be necessary.

Concomitant Insulin or Insulin Secretagogue:
-Consider dose adjustment of insulin or insulin secretagogue to prevent hypoglycemia

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/1.73 m2 .
-Stop this drug in patients who will be administered intra-arterial iodinated contrast.
-Stop this drug in patients with a history of hepatic impairment, alcoholism, or heart failure.
-Reevaluate eGFR 48 hours after the imaging procedure; this drug may be restarted once adequate renal function is confirmed.

Precautions

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. Laboratory abnormalities include elevated blood lactate (greater than 5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), increased lactate/pyruvate ratio, and metformin plasma levels generally greater than 5 mcg/mL.
-Risk factors include renal impairment, concomitant use of certain drugs (e.g., cationic drugs such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), excessive alcohol intake, and hepatic impairment.
-Steps to reduce the risk of lactic acidosis and manage in 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 measure 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.

Dialysis

Contraindicated

Other Comments

Administration advice:
-Take orally twice a day with meals

Missed dose: If a dose is missed, take as soon as remembered, but do not double next dose

General:
-This drug should not be used in Type 1 diabetes mellitus or diabetic ketoacidosis
-Correct volume depletion prior to initiating treatment
-Temporarily stop treatment prior to radiologic studies utilizing iodinated contrast materials and for surgical procedures when restricted food or fluid intake is expected; may resume after 48 hours and once adequate renal function is confirmed.

Monitoring:
-Assess fluid status prior to initiation and monitor for signs and symptoms of volume depletion during therapy
-Measure hematologic parameters annually; consider obtaining a serum Vitamin B12 every 2 to 3 years
-Monitor glycemic control
-Verify renal function at baseline, repeat at least annually and more often as clinically indicated
-Monitor low-density lipoprotein levels during drug treatment.
-Evaluate for the presence of acidosis, including ketoacidosis in symptomatic patients.

Patient advice:
-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 diabetes 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.
-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 patient that this drug will 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.
-Instruct patients to inform healthcare providers of pregnancies as soon as possible

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