Synjardy XR (Empagliflozin / Metformin HCI)

Description

Synjardy XR (empagliflozin and metformin hydrochloride extended-release) contains two drugs and is used with diet and exercise to treat type 2 diabetes in adult patients.

Synjardy XR comes in oral tablets of the following strengths:

• 5 mg empagliflozin/1,000 mg metformin HCl extended-release
• 10 mg empagliflozin/1,000 mg metformin HCl extended-release
• 12.5 mg empagliflozin/1,000 mg metformin HCl extended-release
• 25 mg empagliflozin/1,000 mg metformin HCl extended-release

Directions

Take Synjardy XR as prescribed by your doctor. Notify your doctor or pharmacist about any questions or concerns you may have.

Each patient's Synjardy XR dose depends on their kidney function and current treatment regimen.

Generally, the dose is to take one tablet by mouth one time a day. It's recommended to take it with breakfast. The maximum recommended dose is 25 mg empagliflozin/2,000 mg metformin HCl daily. Swallow the tablet whole; avoid crushing, chewing, or splitting it.

If you're having iodinated contrast imaging, you may need to stop taking Synjardy XR at the time of, or before, receiving the procedure.

Ingredients

Empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor and metformin hydrochloride, a biguanide, is contained in each Synjardy XR tablet.

Polyethylene oxide, hypromellose, and magnesium stearate are the inactive ingredients. 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) make up the tablet film coating and ink.

Contraindications

Patients should avoid treatment with Synjardy XR if they have severe kidney problems, metabolic acidosis, or an allergy to empagliflozin, metformin, or any of the other ingredients.

Cautions

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 taking Synjardy XR, discuss the following with your doctor:
• All the medications you take, including prescription and over-the-counter medications
• Your allergies
• Your medical history and health problems
• Your pregnancy or breastfeeding status
• Ketoacidosis is a life threatening problem that may occur while being treated with Synjardy XR.
• Some patients, especially those who have kidney problems, are elderly, or are taking fluid pills, may experience volume loss during treatment with Synjardy XR.
• Some patients may develop serious urinary tract infections during treatment with Synjardy XR. Immediately notify your doctor of any signs and symptoms of a urinary tract infection that may develop.
• Synjardy XR may cause low blood sugar, especially in patients who are also taking insulin or other blood sugar-lowering medications. It is recommended to treat your low blood sugar as instructed by your doctor.
• Gangrene, a rare but serious, potentially fatal condition, can occur during treatment with Synjardy XR. Seek medical care immediately if you develop a fever, fatigue, or pain, tenderness, redness, or swelling in the genital or perineal area.
• Synjardy XR may increase the risk of fungal infections in the genital areas. 
• Synjardy XR may cause serious allergic reactions, including angioedema (swelling underneath the skin).
• Synjardy XR may cause vitamin B12 deficiency.

Side Effects

Urinary tract infection, fungal infection in the genital areas, diarrhea, nausea, vomiting, gas, stomach discomfort, indigestion, headache, and weakness are common Synjardy XR side effects. However, these are not all the side effects that can be caused by Synjardy XR.

Tell your doctor immediately if you have side effects that are bothersome or persistent.

Reference:

1. Synjardy XR (empagliflozin and metformin hydrochloride extended-release tablets), for oral use. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 2022.

About Dr. Savannah Muncy (Page Author)

Dr. Muncy (PharmD) studied science and education as an undergraduate before attending the Appalachian College of Pharmacy where she completed her PharmD in three years. She is currently using her pharmacy and healthcare expertise to write medical content for clients all around the world. She is focused on delivering the most current, accurate, and engaging information to healthcare professionals and patients. Read More....