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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 Diabetes Type 2

Individualize dosage based on patient's current regimen

Empagliflozin/metformin IMMEDIATE-RELEASE:
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 1000 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

Empagliflozin/metformin EXTENDED-RELEASE:
Patients on metformin:
-Initial dose: empagliflozin 10 mg plus similar total daily dose of metformin orally once a day
Patients on empagliflozin:
-Initial dose: empagliflozin at the same total daily dose plus metformin 1000 mg/day orally once a day
Patients on empagliflozin and metformin:
-Initial dose: same total daily dose of each component (or nearest appropriate dose of metformin) orally once 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.
-Empagliflozin has been shown to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV disease, however, the effectiveness of this combination drug in reducing the risk of CV death has not been established.
-Correct volume depletion prior to beginning this drug.

Use: As 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:
-Immediate-release: Take orally twice a day with meals
-Extended-release: Take orally once a day with morning meal; swallow whole, do not split, crush, dissolve or chew before swallowing

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 patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
-Correct volume depletion prior to initiating treatment.
-This drug may need to be temporarily stopped prior to radiologic studies utilizing iodinated contrast materials or for surgical procedures when restricted food or fluid intake is expected; adequate renal function should be confirmed prior to restarting therapy.

Monitoring:
-Verify renal function at baseline, repeat at least annually and more often in elderly patients or as clinically indicated
-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
-Monitor low-density lipoprotein levels during drug treatment.
-Evaluate for the presence of acidosis, including ketoacidosis in symptomatic patients even if blood sugar is less than 250 mg/dL.

Patient advice:
-Patients should be advised about the importance of regular glycemic monitoring and the need to seek medical advice during periods of stress as medical management of diabetes may change.
-Patients should be instructed to maintain adequate fluid intake.
-Patients should be instructed to report genital mycotic infections, urinary tract infections, or any unusual symptoms.
-Patients should be informed about the symptoms of lactic acidosis and ketoacidosis and conditions that might predispose them to developing it; they should understand when to contact their healthcare professional and when they should seek immediate medical attention.
-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.
-Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding; premenopausal women should understand there is a risk of unintended pregnancy.

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