SYNJARDYXR(empagliflozin and metformin hydrochloride extended-release) tablets(一)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use SYNJARDY XR safely and effectively. See full prescribing information for SYNJARDY XR.
SYNJARDY ® XR (empagliflozin and metformin hydrochloride extended-release) tablets, for oral use
Initial U.S. Approval: 2015
WARNING: LACTIC ACIDOSIS SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL. (5.1)
Risk factors include renal impairment, concomitant use of certain drugs, age ≥65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information. (5.1)
If lactic acidosis is suspected, discontinue SYNJARDY XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. (5.1)
RECENT MAJOR CHANGES
Indications and Usage (1) 12/2016
INDICATIONS AND USAGE
SYNJARDY XR is a combination of empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin hydrochloride, a biguanide, indicated 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 hydrochloride is appropriate.
Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. However, the effectiveness of SYNJARDY XR on reducing the risk of cardiovascular death in adults with type 2 diabetes mellitus and cardiovascular disease has not been established. (1)
Limitations of Use:
Not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis (1)
DOSAGE AND ADMINISTRATION
Individualize the starting dose of SYNJARDY XR based on the patient’s current regimen (2.1)
The maximum recommended total daily dose is 25 mg empagliflozin and 2000 mg metformin hydrochloride (2.1)
Take once daily with a meal in the morning, with gradual dose escalation to reduce the gastrointestinal side effects due to metformin (2.1)
Swallow whole; do not split, crush, dissolve, or chew (2.1)
Assess renal function before initiating. SYNJARDY XR is contraindicated in patients with an eGFR below 45 mL/min/1.73 m2 (2.2, 4)
SYNJARDY XR may need to be discontinued at time of, or prior to, iodinated contrast imaging procedures (2.3)
DOSAGE FORMS AND STRENGTHS
SYNJARDY XR Tablets:
5 mg empagliflozin/1000 mg metformin hydrochloride extended-release
10 mg empagliflozin/1000 mg metformin hydrochloride extended-release
12.5 mg empagliflozin/1000 mg metformin hydrochloride extended-release
25 mg empagliflozin/1000 mg metformin hydrochloride extended-release (3)
CONTRAINDICATIONS
Moderate to severe renal impairment (eGFR below 45 mL/min/1.73 m2), end stage renal disease, or dialysis (4, 5.1, 5.4)
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