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Dapagliflozin / Metformin Dosage

Applies to the following strength(s): 5 mg-500 mg ; 5 mg-1000 mg ; 10 mg-500 mg ; 10 mg-1000 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 dose based on current treatment regimen:
Maintenance dose: Take orally once a day; titrate gradually based on effectiveness and tolerability
Maximum dose: Dapagliflozin 10 mg-metformin 2000 mg per day

Comments:
-Patients taking an evening dose of metformin XR should skip their last dose before starting this drug; take this drug once daily in the morning with food.
-When used in combination with insulin or insulin secretagogue, a lower dose of with insulin or insulin secretagogue may be considered to reduce the risk of hypoglycemia.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate.

Renal Dose Adjustments

Moderate to severe renal impairment (eGFR less than 60 mL/min/1.73 m2 or CrCl less than 60 mL/min) or ESRD: Use is contraindicated
Mild renal impairment (eGFR 60 mL/min/1.73 m2 or greater): No adjustment recommended

Liver Dose Adjustments

Not recommended in patients with hepatic impairment.

Dose Adjustments

Therapeutic drug monitoring/range: Steady-state plasma concentrations of metformin are achieved within 24 to 48 hours and are generally less than 1 mcg/mL. Metformin levels greater than 5 mcg/mL have been implicated as the cause of lactic acidosis.

Iodinated Contrast Imaging Procedures:
-In patients with a history of liver disease, alcoholism, or heart failure: this drug should be stopped at time of, or prior to an iodinated contrast imaging procedure.
-In all patients who will be administered intra-arterial iodinated contrast: this drug should be stopped at the time of, or prior to the procedure.
RESTART: Renal function should be reevaluated 48 hours after the imaging procedure and if renal function is stable this drug may be restarted.

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 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 once daily in the morning with food
-Tablets must be swallowed whole; do not crush, cut, or chew
-Tablet shells may appear in feces as a soft mass that may resemble the original tablet.

General:
-Not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis
-Correct volume depletion prior to initiating treatment.
-Temporarily stop treatment prior to radiologic studies utilizing iodinated contrast materials in patients with a history of liver disease, alcoholism, or heart failure, and in all patients who will be administered intra-arterial iodinated contrast; may resume after 48-hours once adequate renal function is confirmed.

Monitoring:
-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
-Measure hematologic parameters annually; consider obtaining a serum Vitamin B12 every 2 to 3 years
-Evaluate for the presence of acidosis, including ketoacidosis in symptomatic patients

Patient advice:
-This drug will cause the urine to test positive for glucose.
-Tablet shells may appear in feces, and this should not cause alarm.
-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.

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