Empagliflozin and metformin
Generic Name: empagliflozin and metformin (EM pa gli FLOE zin and met FOR min)
Brand Name: Synjardy, Synjardy XR
What is empagliflozin and metformin?
empagliflozin and metformin is not for treating type 1 diabetes.
Empagliflozin and metformin may also be used for purposes not listed in this medication guide.
You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.
In rare cases, this medicine 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
severe kidney disease (or if you are on dialysis); or
If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking this medicine.
Tell your doctor if you have ever had:
liver or kidney disease;
heart problems, low blood pressure;
a bladder infection or urination problems;
problems with your pancreas, including surgery; or
if you are on a low-salt diet.
You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.
Tell your doctor right away if you become pregnant. Empagliflozin may harm the unborn baby if you take this medicine during your second or third trimester.
Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.
You should not breast-feed while using this medicine.
Empagliflozin and metformin is not approved for use by anyone younger than 18 years old.
How should I take empagliflozin and metformin?
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.
Take this medicine with food to prevent upset stomach.
Do not crush, chew, or break an extended-release tablet. Swallow it whole.
Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, and feeling shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.
Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and 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, blurred vision, headache, and tiredness.
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.
Your doctor may have you take extra vitamin B12 while you are taking empagliflozin and metformin. Take only the amount of vitamin B12 that your doctor has prescribed.
Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medicine, which can lead to severely low blood pressure or a serious electrolyte imbalance.
If you need surgery or medical tests, tell any doctor who treats you that you are using empagliflozin and metformin.
Empagliflozin and metformin 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 (with food) 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. You may have severely low blood sugar (extreme weakness, nausea, tremors, sweating, confusion, trouble speaking, fast heartbeats, or seizure).
What should I avoid while taking empagliflozin and metformin?
Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.
Empagliflozin and metformin 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 rare but 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.
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;
lactic acidosis--unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired; 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.
Side effects may be more likely to occur in older adults.
Common side effects may include:
stomach pain, gas, indigestion, nausea, vomiting, diarrhea;
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 and metformin dosing information
Usual Adult Dose for Diabetes Type 2:
Individualize dosage based on patient's current regimen
Patients on metformin:
-Initial dose: empagliflozin 10 mg plus similar total daily dose of metformin divided orally twice a day
Patients on empagliflozin:
-Initial dose: empagliflozin at the same total daily dose plus metformin 1000 mg/day divided orally twice a day
Patients on empagliflozin and metformin:
-Initial dose: same total daily dose of each component (or nearest appropriate dose of metformin) divided orally twice a day
Patients on metformin:
-Initial dose: empagliflozin 10 mg plus similar total daily dose of metformin orally once a day
Patients on empagliflozin:
-Initial dose: empagliflozin at the same total daily dose plus metformin 1000 mg/day orally once a day
Patients on empagliflozin and metformin:
-Initial dose: same total daily dose of each component (or nearest appropriate dose of metformin) orally once a day
Maintenance: Adjust dose based on efficacy and tolerability; a gradual dose escalation of metformin will help to reduce gastrointestinal side effects.
Maximum dose: empagliflozin: 25 mg/day; metformin: 2000 mg/day
-When used in combination with insulin or an insulin secretagogue, a lower dose of insulin or insulin secretagogue should be considered to reduce the risk of hypoglycemia.
-Empagliflozin has been shown to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV disease, however, the effectiveness of this combination drug in reducing the risk of CV death has not been established.
-Correct volume depletion prior to beginning this drug.
Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin is appropriate.
What other drugs will affect empagliflozin and metformin?
Many drugs can affect empagliflozin and metformin, making empagliflozin and metformin less effective or increasing your risk of lactic acidosis. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Copyright 1996-2018 Cerner Multum, Inc. Version: 2.01.
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