Synjardy (Empagliflozin / Metformin HCI)

Synjardy is a combination drug used to treat type 2 diabetes. Empagliflozin helps the kidneys remove extra sugar from the blood through urine, while metformin lowers how much sugar the liver makes and how much sugar the body absorbs from food. Synjardy is prescribed with a balanced diet and regular exercise to help control blood sugar in adults and children ages 10 and older with type 2 diabetes. In adults with type 2 diabetes who also have heart disease, empagliflozin may also reduce the risk of death from heart-related problems.

Directions

Synjardy is taken by mouth twice daily with meals to help reduce stomach upset. The tablets should not be split or crushed.

For adults who are not already taking metformin, treatment often starts with a low dose, such as 5 mg of empagliflozin and 500 mg of metformin twice daily. The dose may be slowly increased depending on blood sugar levels and how well the medicine is tolerated. People who are already taking metformin may switch to a Synjardy dose that offers a similar or slightly higher amount of each medicine.

The exact dose depends on how well blood sugar is controlled and how well the kidneys are working. The highest recommended daily dosage is 25 mg of empagliflozin and 2000 mg of metformin.

Ingredients

The active ingredients in Synjardy are empagliflozin and metformin.

Cautions

Before using this medication, you may want to consult a healthcare provider about the following:

• Any existing health conditions
• Any allergies
• A list of all medications currently being taken

Rare but serious lactic acidosis can occur with symptoms such as unusual tiredness, muscle pain, stomach pain, trouble breathing, dizziness, or feeling cold. This risk is higher in people with kidney problems, liver disease, heart failure, heavy alcohol use, dehydration, or in adults over 65.

Synjardy should not be used in people with severe kidney disease, and kidney function should be checked before starting and regularly during treatment. The medication may need to be paused around certain imaging tests with contrast dye or during surgery.

Diabetic ketoacidosis (DKA) can happen, even with normal blood sugar. Synjardy can increase the risk of ketoacidosis, a serious condition that causes nausea, vomiting, stomach pain, shortness of breath, and extreme fatigue.

Dehydration and low blood pressure are possible. Synjardy can cause fluid loss, which may lead to dizziness, lightheadedness, low blood pressure, or kidney problems, especially in older adults, people with kidney disease or those taking diuretics.

Urinary and genital infections may occur. Synjardy increases sugar in the urine, which raises the risk of yeast infections and urinary tract infections.

Low blood sugar can occur when combined with insulin or certain diabetes drugs. When taken with insulin or medications like sulfonylureas, Synjardy may increase the risk of hypoglycemia.

Foot problems and amputations have been reported. Some patients taking SGLT2 inhibitors like Synjardy have had an increased risk of lower limb amputations, especially those with prior foot ulcers, infections, poor circulation, or nerve damage.

Vitamin B12 levels may drop over time. Long-term use of metformin can lower vitamin B12 levels, which may lead to anemia or nerve symptoms.

Contraindications

Avoid taking or using this medication if any of the following apply:

• Severe kidney impairment
• End-stage renal disease or dialysis
• Hypersensitivity to empagliflozin, metformin, or any inactive ingredients in Synjardy or Synjardy XR
• Acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma

Side Effects

Common side effects of Synjardy include:

• Low blood sugar (especially when used with insulin or sulfonylureas)
• Urinary tract infections
• Yeast infections (vaginal or penile)
• Diarrhea
• Nausea or vomiting
• Gas, indigestion, or stomach discomfort
• Headache
• Weakness
• Stuffy or runny nose and sore throat

More serious side effects can include severe genital or urinary infections, dangerously low blood sugar, allergic reactions, or an increased risk of lower limb amputations.

Rare but life-threatening infections of the genital area (such as necrotizing fasciitis) have been reported.

Seek medical help if you develop severe pain, fever, signs of infection, symptoms of low blood sugar, foot sores, or swelling of the face, lips, or throat.