Generic name: empagliflozin (EM pa gli FLOE zin)
Brand name: Jardiance
Dosage forms: oral tablet (10 mg; 25 mg)
Drug class: SGLT-2 inhibitors
Empagliflozin is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
Empagliflozin is also used to lower the risk of death from heart attack, stroke, or heart failure in adults with type 2 diabetes who also have heart disease.
Empagliflozin is not for treating type 1 diabetes.
Empagliflozin may also be used for purposes not listed in this medication guide.
Warnings
You should not use empagliflozin if you have severe kidney disease, or if you are on dialysis.
Taking empagliflozin can make you dehydrated, which could cause you to feel weak or dizzy (especially when you stand up).
Empagliflozin 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 empagliflozin if you are allergic to it, or if you have:
- severe kidney disease (or if you are on dialysis).
Tell your doctor if you have ever had:
- liver or kidney disease;
- bladder infections or other urination problems;
- low blood pressure;
- heart problems;
- problems with your pancreas, including surgery;
- if you drink alcohol often; or
- if you are on a low salt diet.
Follow your doctor's instructions about using empagliflozin if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.
You should not use empagliflozin during the second or third trimester of pregnancy.
You should not breastfeed while using this medicine.
Empagliflozin is not approved for use by anyone younger than 18 years old.
How should I take empagliflozin?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
You may take empagliflozin with or without food.
Call your doctor if you are sick with vomiting or diarrhea, if you consume less food or fluid than usual, or if you are sweating more than usual.
Your blood sugar will need to be checked often, and you may also need to test the level of ketones your urine. Empagliflozin 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 ketones in the urine.
You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).
Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.
Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.
Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.
This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using empagliflozin.
Empagliflozin is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.
Store at room temperature away from moisture and heat.
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 empagliflozin?
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.
Empagliflozin side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Seek medical attention right away if you have signs of a 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.
Call your doctor at once if you have:
- little or no urination;
- dehydration symptoms--dizziness, weakness, feeling light-headed (like you might pass out);
- 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, increased urination, blood in your urine, fever, pain in your pelvis or back.
Older adults may be more likely to have side effects from empagliflozin.
Common side effects may include:
- bladder infection; or
- vaginal yeast infection.
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.
Empagliflozin dosing information
Usual Adult Dose for Diabetes Type 2:
Initial dose: 10 mg orally once a day in the morning
-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:
-Limitation of use: Not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
-Volume depletion should be corrected prior to initiating therapy.
Uses:
-An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus.
-To reduce the risk of cardiovascular (CV) death in adult patients with type 2 diabetes mellitus and established CV disease.
Usual Adult Dose for Cardiovascular Risk Reduction:
Initial dose: 10 mg orally once a day in the morning
-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:
-Limitation of use: Not recommended for patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
-Volume depletion should be corrected prior to initiating therapy.
Uses:
-An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus.
-To reduce the risk of cardiovascular (CV) death in adult patients with type 2 diabetes mellitus and established CV disease.
What other drugs will affect empagliflozin?
Tell your doctor about all your other medicines, especially:
- insulin or other oral diabetes medications; or
- a diuretic or "water pill."
This list is not complete. Other drugs may affect empagliflozin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.