Synjardy XR (Empagliflozin / Metformin HCI)

Each Synjardy XR tablet contains empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin hydrochloride, a biguanide. Inactive ingredients include polyethylene oxide, hypromellose, and magnesium stearate. The tablet film coating and ink include hypromellose, titanium dioxide, polydextrose, polyethylene glycol, talc, carnauba wax, purified water, ferrosoferric oxide, propylene glycol, isopropyl alcohol, ferric oxide yellow (5 mg/1,000 mg; 10 mg/1,000 mg; 25 mg/1,000 mg), ferric oxide red (10 mg/1,000 mg), and FD and C blue#2/indigo carmine aluminum lake (12.5 mg/1,000 mg; 25 mg/1,000 mg).

Synjardy XR has FDA Boxed Warnings regarding cases of lactic acidosis associated with metformin that led to death, hypothermia, low blood pressure, and resistant, slow heart arrhythmias. Patients who have kidney problems, are using certain medications, are 65 years old or older, have radiological studies with contrast, have surgery or other procedures, have low oxygen levels, consume excessive amounts of alcohol, or have liver problems may be at increased risk. Before you start treatment with Synjardy XR, tell your doctor about the following:, All the medications you take, including prescription and over-the-counter medications, Your allergies, Your medical history and health problems, If you are pregnant or breastfeeding, Ketoacidosis, a life threatening problem, can occur during treatment with Synjardy XR., Volume loss, especially in patients with kidney problems, older patients, and in patients taking fluid pills, can occur with the use of Synjardy XR., Serious urinary tract infections can occur with the use of Synjardy XR. Contact your doctor right away if you develop signs and symptoms of a urinary tract infection., Low blood sugar can occur with the use of Synjardy XR, especially if patients are also taking insulin or other blood sugar-lowering medications. Patients are recommended to treat their low blood sugar as their doctor has instructed., A rare but serious, potentially fatal condition called gangrene can occur with the use of Synjardy XR. Seek medical care right away if you have fever, fatigue, or pain, tenderness, redness, or swelling in the genital or perineal area., Fungal infections in the genital areas can occur with the use of Synjardy XR., Serious allergic reactions, including angioedema (swelling underneath the skin), can occur with the use of Synjardy XR., Vitamin B12 levels may become lower with the use of Synjardy XR. All the medications you take, including prescription and over-the-counter medications, Your allergies, Your medical history and health problems, If you are pregnant or breastfeeding

Common Synjardy XR side effects include urinary tract infection, fungal infection in the genital areas, diarrhea, nausea, vomiting, gas, stomach discomfort, indigestion, headache, and weakness. However, these are not all the side effects that can occur. Contact your doctor right away if you develop side effects that bother you or won't go away.