SYNJARDYXR(empagliflozin and metformin hydrochloride extended-release) tablets(十四)
UTIONS (5.3)]
Urosepsis and pyelonephritis [see WARNINGS AND PRECAUTIONS (5.5)]
7 DRUG INTERACTIONS
7.1 Drug Interactions with Empagliflozin
Diuretics
Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion [see WARNINGS AND PRECAUTIONS (5.2)].
Insulin or Insulin Secretagogues
Coadministration of empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia [see WARNINGS AND PRECAUTIONS (5.6)].
Positive Urine Glucose Test
Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.
Interference with 1,5-anhydroglucitol (1,5-AG) Assay
Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.
7.2 Drug Interactions with Metformin Hydrochloride
Drugs that Reduce Metformin Clearance
Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see CLINICAL PHARMACOLOGY (12.3)]. Consider the benefits and risks of concomitant use.
Carbonic Anhydrase Inhibitors
Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with SYNJARDY XR may increase the risk of lactic acidosis. Consider more frequent monitoring of these patients [see WARNINGS AND PRECAUTIONS (5.1) and CLINICAL PHARMACOLOGY (12.3)].
Drugs Affecting Glycemic Control
Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving SYNJARDY XR, the patient should be closely observed to maintain adequate glycemic control [see CLINICAL PHARMACOLOGY (12.3)]. When such drugs are withdrawn from a patient receiving SYNJARDY XR, the patient should be observed closely for hypoglycemia.
Alcohol
Alcohol is known to potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake while receiving SYNJARDY XR.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on animal data showing adverse renal effects, SYNJARDY XR is not recommended during the second and third trimesters of pregnancy.
Limited available data with SYN |
