What is Jardiance?
Jardiance (empagliflozin) is an FDA-approved tablet used to help control blood sugar levels in type 2 diabetes 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 10mg tablets are also used for chronic kidney disease (CKD) in adults that have risk of disease prgression. In CKD Jardiance is used to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death and hospitalization.
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.
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:
- adults 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
- to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression
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).
- for the treatment of chronic kidney disease in patients with polycystic kidney disease or patients requiring or with a recent history of intravenous immunosuppressive therapy or greater than 45 mg of prednisone or equivalent for kidney disease as Jardiance is not expected to be effective in these populations.
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.
Before taking this medicine
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;
- have a history of amputation;
- have type 1 diabetes or have had diabetic ketoacidosis;
- have a decrease in your insulin dose;
- are eating less, or there is a change in your diet;
- 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.
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.
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.
How should I take Jardiance?
Take Jardiance exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
- 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 Dose of Jardiance for Diabetes Type 2:
Patients aged 10 years and older.
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.
Usual Adult Dose for Cardiovascular Risk Reduction:
Initial dose: 10 mg orally once a day in the morning, with or without food.
Use: Reduce the risk of cardiovascular death in patients with type 2 diabetes mellitus with established cardiovascular disease.
Usual Adult Dose for Heart Failure with Reduced Ejection Fraction:
Dose: 10 mg orally once a day
Use: Reduce the risk of cardiovascular death and hospitalization in patients with heart failure
Usual Jardiance Dose for adults with chronic kidney disease that is at risk of progression.
Dose: 10 mg orally once daily in the morning, taken with or without food.
Use: To reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease that is at risk of progression.
General Dose 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.
What happens if I miss a dose?
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.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Jardiance?
- Avoid drinking alcohol.
- Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.
Jardiance side effects
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.
Amputations. Jardiance belongs to a groupd of medicines called SGLT2 inhibitors which may increase your risk of lower limb amputations. You may be at a higher risk of lower limb amputation if you have a history of amputation, have had blocked or narrowed blood vessels usually in your leg, or have had diabetic foot infection, ulcers or sores. Call your healthcare provider right away if you have new pain or tenderness, any sores, ulcers, or infections in your leg or foot. Talk to your healthcare provider about proper foot care.
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.
What other drugs will affect Jardiance?
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.
Active Ingredient: empagliflozin.
Inactive Ingredients: lactose monohydrate, microcrystalline cellulose, hydroxypropyl cellulose, croscarmellose sodium, colloidal silicon dioxide and magnesium stearate. In addition, the film coating contains the following inactive ingredients: hypromellose, titanium dioxide, talc, polyethylene glycol, and yellow ferric oxide.
Store at room temperature between 68°F to 77°F (20°C to 25°C).
Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield, CT 06877 USA
Boehringer Ingelheim Pharmaceuticals, Inc.; Ridgefield, CT 06877 USA and Eli Lilly and Company, Indianapolis, IN 46285 USA
Keep your blood sugar levels in check. Lifestyle suggestions to help prevent yeast infections include: choosing loose-fitting cotton garments instead of synthetic fabrics, keeping your genital area dry and maintaining good hygiene. Yeast infections can be easily treated if you take Jardiance, so contact your doctor right away. Continue reading
Yes, Jardiance has been shown to help adult patients with type 2 diabetes lose weight, but this is not an approved use. Jardiance can lead to moderate weight loss (2% to 3%) in patients when taken alone or when combined with other medications, including metformin or a sulfonylurea, but exercise and diet can affect the results. Continue reading
Jardiance has a rare side effect called necrotizing fasciitis of the perineum (Fournier’s gangrene). This is a rare, life-threatening infection caused by bacteria entering the layer of tissue just under the skin in the perineum, the space between the anus and scrotum in men, and the anus and vulva in women. Continue reading
Jardiance is a sodium-glucose cotransporter-2 (SGLT-2) inhibitor used in addition to diet and exercise to help control blood glucose (sugar) and protect the heart in adults and children 10 years of age and older with type 2 diabetes. It's also approved to help protect the kidney, and lower the risk of cardiovascular death and hospitalizations in adults with chronic kidney disease (CKD). Continue reading
The beneficial effect of Jardiance on your blood sugar levels may begin quickly, within the first 1 to 2 weeks. However, Jardiance is an oral drug typically used over the long-term in type 2 diabetes and can offer benefits for heart health, kidney function and weight loss. Continue reading
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Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Jardiance only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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