SYNJARDYXR(empagliflozin and metformin hydrochloride extended-release) tablets(二)
Metabolic acidosis, including diabetic ketoacidosis (1, 4, 5.1)
History of serious hypersensitivity reaction to empagliflozin or metformin (4)
WARNINGS AND PRECAUTIONS
Lactic acidosis: See boxed warning (5.1)
Hypotension: Before initiating SYNJARDY XR assess and correct volume status in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms during therapy. (5.2)
Ketoacidosis: Assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue SYNJARDY XR, eva luate and treat promptly. Before initiating SYNJARDY XR, consider risk factors for ketoacidosis. Patients on SYNJARDY XR may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis. (5.3)
Acute kidney injury and impairment in renal function: Consider temporarily discontinuing in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue and promptly treat. Monitor renal function during therapy (5.4)
Urosepsis and Pyelonephritis: eva luate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated (5.5)
Hypoglycemia: Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating SYNJARDY XR (5.6)
Genital mycotic infections: Monitor and treat as appropriate (5.7)
Vitamin B12 deficiency: Metformin may lower vitamin B12 levels. Monitor hematologic parameters annually. (5.8)
Increased LDL-C: Monitor and treat as appropriate (5.9)
Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with SYNJARDY XR. (5.10)
ADVERSE REACTIONS
Most common adverse reactions associated with empagliflozin (5% or greater incidence) were urinary tract infection and female genital mycotic infections. (6.1)
Most common adverse reactions associated with metformin (>5%) are diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257 or 1-800-459-9906 TTY, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Carbonic anhydrase inhibitors may increase risk of lactic acidosis. Consider more frequent monitoring. (7.2)
Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of metformin. Consider the benefits and risks of concomitant use. (7.2)
Alcohol can potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake. (7.2)
USE IN SPECIFIC POPULATIONS
Pregnancy: Advise females of the potential risk to a fetus especially during the second and third trimesters. (8.1)
Lactation: SYNJARDY XR is not recommended when breastfeeding. (8.2)
Females and Males of Reproductive Potential: Advise premenopausal females of the potential for an unintended pregnancy (8.3).
Geriatric patients: Higher incidence of adverse reactions related to volume depletion and reduced renal function. Assess renal function more frequently (5.2, 5.4, 8.5)
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