What is the most important information I should know about ertugliflozin and metformin?
You should not use this medicine if you have severe kidney disease, if you are on dialysis, or if you have diabetic ketoacidosis. Ertugliflozin and metformin is not for treating type 1 diabetes.
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 ertugliflozin and metformin.
This medicine can make you dehydrated, which could cause you to feel weak or dizzy (especially when you stand up).
Metformin may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, irregular heart rate, dizziness, or feeling very weak or tired.
Ertugliflozin and metformin can also cause infections in the bladder or genitals (penis or vagina). Call your doctor if you have genital pain or itching, genital odor or discharge, increased urination, pain or burning when you urinate, or blood in your urine.
What is ertugliflozin and metformin?
Ertugliflozin and metformin helps control blood sugar levels. Ertugliflozin works by helping the kidneys get rid of glucose from your bloodstream. Metformin works by helping your liver release lower amounts of sugar into your blood.
Ertugliflozin and metformin is a combination medicine used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. This medicine is not for treating type 1 diabetes.
Ertugliflozin and metformin may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking ertugliflozin and metformin?
You should not use this medicine if you are allergic to ertugliflozin or metformin, or if you have:
- severe kidney disease (or if you are on dialysis); or
- diabetic ketoacidosis (call your doctor for treatment).
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.
To make sure ertugliflozin and metformin is safe for you, tell your doctor if you have ever had:
- kidney disease (your kidney function may need to be checked before you take this medicine);
- high ketone levels in your blood or urine;
- liver disease;
- a bladder infection or urination problems;
- low blood pressure;
- blood circulation problems, especially in your legs;
- nerve damage in your legs;
- a diabetic foot ulcer or amputation;
- heart problems;
- problems with your pancreas, including surgery;
- if you drink alcohol often; or
- if you are on a low salt diet.
Some people taking metformin develop a serious condition called lactic acidosis. This may be more likely if you have liver or kidney disease, congestive heart failure, surgery, a heart attack or stroke, a severe infection, if you are 65 or older, if you are dehydrated, or if you drink a lot of alcohol. Talk with your doctor about your risk.
Follow your doctor's instructions about using ertugliflozin and metformin if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester of pregnancy.
Ertugliflozin and metformin may harm an unborn baby if you take the medicine during your second or third trimester. Tell your doctor if you become pregnant while using ertugliflozin and metformin.
This medicine could make it easier for you to get pregnant. Ask your doctor about using birth control to prevent pregnancy, even if you are premenopausal and do not have regular periods.
It is not known whether ertugliflozin and metformin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
Ertugliflozin and metformin is not approved for use by anyone younger than 18 years old.
How should I take ertugliflozin and metformin?
This medicine is usually taken twice per day with meals. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Ertugliflozin and metformin works best if you take it with 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. Ertugliflozin and metformin 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.
Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or 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.
This medicine can cause unusual results with certain lab tests. Tell any doctor who treats you that you are using ertugliflozin and metformin.
Ertugliflozin and metformin is only part of a treatment program that may also include diet, exercise, weight control, regular blood sugar testing, and special medical care. Follow your doctor's instructions very closely.
Your doctor may have you take extra vitamin B12 while you are taking ertugliflozin and metformin. Take only the amount of vitamin B12 that your doctor has prescribed.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
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 ertugliflozin and metformin?
Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis while taking this medicine.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
What are the possible side effects of ertugliflozin and metformin?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, irregular heart rate, dizziness, or feeling very weak or tired.
Call your doctor at once if you have:
- new pain, tenderness, sores, ulcers, or infections in your legs or feet;
- little or no urination;
-
ketoacidosis (too much acid in the blood) --nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;
-
dehydration symptoms --dizziness, weakness, feeling light-headed (like you might pass out);
-
signs of a bladder infection --pain or burning when you urinate, increased urination, blood in your urine, fever, pain in your pelvis or back; or
-
signs of a genital infection (penis or vagina) --pain, burning, itching, rash, redness, odor, or discharge.
Some side effects may be more likely to occur in older adults.
Common side effects may include:
- genital infections;
- indigestion, upset stomach;
- nausea, vomiting, diarrhea, gas;
- headache, weakness; or
- urinating more than usual.
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 ertugliflozin and metformin?
When you start or stop taking ertugliflozin and metformin, your doctor may need to adjust the doses of any other diabetes medicines you use on a regular basis.
Other drugs may interact with ertugliflozin and metformin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about ertugliflozin and metformin.
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.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2018 Cerner Multum, Inc. Version: 1.01. Revision date: 1/12/2018.
