Jardiance (empagliflozin) is an FDA-approved tablet used to help control blood sugar levels in type 2 diabetes in patients aged 10 years and older, and is also used to reduce the risk of cardiovascular problems in adults with heart failure or cardiovascular disease with type 2 diabetes. Jardiance lowers blood glucose levels (HbA1c) by helping the kidney increase the amount of glucose passing into the urine. Jardiance should be used together with diet and exercise when prescribed for type 2 diabetes.

Jardiance is from the class of medicines called SGLT-2 inhibitors (sodium-glucose cotransporter-2 inhibitors).  Jardiance works for type 2 diabetes by blocking SGLT-2 proteins located in the renal tubules of the kidneys, which are responsible for reabsorbing glucose back into the bloodstream.

Jardiance is available as 10mg tablets and 25 mg tablets.

The way Jardiance works to reduce the risk of cardiovascular or heart failure is thought to be related to changes in heart muscle metabolism from favoring the use of glucose to using a more balanced combination of fatty acids, ketone bodies (ketone), branched-chain amino acids (BCAA) and glucose. Jardiance also improves the heart's diastolic stiffness and diastolic function.

Type 2 diabetes is a long-term condition when your blood sugars (HbA1c) become too high because the body does not produce or use insulin normally.  Over time high blood sugar can cause serious health problems, including heart disease, vision loss, and kidney disease. By having better control of blood sugar levels helps reduce the risk of complications of diabetes.

Who can use Jardiance?

Jardiance is used for:

• patients aged 10 years and older with type 2 diabetes mellitus to lower blood sugar levels when used with diet and exercise. 
• adults with heart failure to reduce the risk of cardiovascular death and hospitalization.
• adults with type 2 diabetes mellitus and established cardiovascular disease to reduce the risk of cardiovascular death.

Jardiance is not recommended:

• for patients with type 1 diabetes mellitus as it may increase the risk of diabetic ketoacidosis  (increased ketones in blood or urine) in these patients.
• to improve blood sugar levels in adults with type 2 diabetes mellitus who have severe kidney problems (if their eGFR is less than 30 mL/min/1.73 m²⁾.

Call your doctor at once if you have signs of a serious side effect, such as stomach pain, vomiting, tiredness, or trouble breathing.

You should not use Jardiance if you have severe kidney disease or if you are on dialysis, or if you have diabetic ketoacidosis.

Taking Jardiance can make you dehydrated, which could cause you to feel weak or dizzy (especially when you stand up).

Tell your doctor if you are sick with vomiting or diarrhea, or if you eat or drink less than usual.

Jardiance can cause serious infections in the penis or vagina. Get medical help right away if you have burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, or if you don't feel well.

Take Jardiance exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. 

Jardiance instructions:

• Jardiance is a tablet that you take by mouth.
• Jardiance is usually take once daily in the morning. You should take it at around the same time each day.
• You may take this medicine with or without food.

• Your doctor may start you on a low dose of this medicine and increase your dose as needed.
• Do not take more or less of it or take it more often than prescribed by your doctor.

Your blood sugar will need to be checked often, and you may also need to test the level of ketones in your urine. This medicine can cause life-threatening ketoacidosis (too much acid in the blood). Even if your blood sugar is normal, contact your doctor if a urine test shows that you have high ketones in the urine.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe glucagon injection in case of severe hypoglycemia.

You may get dehydrated during prolonged illness. Call your doctor if you are sick with vomiting or diarrhea, or if you eat or drink less than usual.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Jardiance.

Your treatment may also include diet, exercise, weight control, and special medical care.

Tell your doctor if you have a planned surgery.

Usual Adult Dose of Jardiance for Diabetes Type 2:

Initial dose 10 mg orally once a day in the morning.

Dose increase: Dose may be increased to 25 mg orally once a day for patients tolerating therapy and requiring additional glycemic control.

Maximum dose: 25 mg per day.

Comments:

• Not recommended for patients with type 1 diabetes mellitus as it may increase the risk of diabetic ketoacidosis.
• Not recommended to improve glycemic control in patients with an eGFR less than 30 mL/min/1.73 m2 as it is unlikely to be effective.
• Volume depletion should be corrected prior to initiating therapy.
   

Usual Adult Dose for Cardiovascular Risk Reduction:

Initial dose: 10 mg orally once a day in the morning.

Dose increase: May increase to 25 mg orally once a day for patients tolerating therapy and requiring additional glycemic control.

Maximum dose: 25 mg per day

Comments:

• Not recommended for patients with type 1 diabetes mellitus as it may increase the risk of diabetic ketoacidosis.
• Not recommended to improve glycemic control in patients with an eGFR less than 30 mL/min/1.73 m2 as it is unlikely to be effective.
• Volume depletion should be corrected prior to initiating therapy.
   

Usual Adult Dose for Heart Failure with Reduced Ejection Fraction:

Dose: 10 mg orally once a day

Comments:

• Not recommended for patients with type 1 diabetes mellitus as it may increase the risk of diabetic ketoacidosis.
• Volume depletion should be corrected prior to initiating therapy.
• For patients with heart failure (HF) and reduced ejection fraction, there is insufficient date to recommend use in patients with an eGFR less than 20 mL/min/1.73 m2.
   

You should not use Jardiance if you are allergic to empagliflozin, any of the inactive tablet ingredients, or if you have:

• severe kidney disease (or if you are on dialysis).

To make sure Jardiance is safe for you, tell your doctor if you have or have ever had:

• a bladder infection or urination problems;

• a genital infection (penis or vagina);

• problems with your pancreas, including surgery;

• alcoholism, or if you currently drink large amounts of alcohol;

• if you are on a low salt diet, you are eating less, or there is a change in your diet;

• if you are 65 or older; or

• liver or kidney disease.

Jardiance is not for treating type 1 diabetes.

Pregnancy

Talk to your doctor if you are pregnant or plan to become pregnant. This medicine may harm your unborn baby. You should not use Jardiance during the second or third trimester of pregnancy. Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant, controlling diabetes is very important during pregnancy.

Breastfeeding.

Talk to your doctor if you are breastfeeding or plan to breast feed. Do not breastfeed while you are taking Jardiance. This medicine may pass into your breast milk and may harm your baby. Talk with your healthcare provider about the best way to feed your baby if you are taking this medicine.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Avoid drinking alcohol.
• Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have signs of an allergic reaction to Jardiance: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical attention right away if you have signs of a serious genital infection (penis or vagina): burning, itching, odor, discharge, pain, tenderness, redness or swelling of the genital or rectal area, fever, not feeling well. These symptoms may get worse quickly.

Serious Jardiance side effects

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• low blood sugar - headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery;
• dehydration - dizziness, confusion, feeling very thirsty, less urination;
• ketoacidosis (too much acid in the blood) - nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing; or
• signs of a bladder infection - pain or burning when you urinate, blood in your urine, pain in pelvis or back.

Common Jardiance side effects may include:

• a bladder infection; or
• yeast infection in women (vaginal itching or discharge).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may increase or decrease the effects of Jardiance on lowering your blood sugar. Tell your doctor about all your current medicines and any you start or stop using, especially:

• angiotensin-converting enzyme (ACE) inhibitors eg benazepril (Lotensin, in Lotrel), captopril, enalapril (Epaned, Vasotec, in Vaseretic), fosinopril, lisinopril (Prinivil, Qbrelis, Zestril, in Zestoretic), moexipril, perindopril (in Prestalia), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril. 
• angiotensin receptor blockers such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (Diovan, in Diovan HCT, in Exforge). 
• aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); digoxin (Lanoxin);
• diuretics ('water pills'). 
• insulin or oral medications for diabetes such as glimepiride (Amaryl, in Duetact), glipizide (Glucotrol), glyburide (DiaBeta, Glynase), and tolbutamide. 

This list is not complete. Other drugs may interact with this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. To check for interactions click on the link below.