What is the most important information I should know about dapagliflozin and saxagliptin?
You should not use this medicine if you have severe kidney disease or if you are on dialysis.
Taking dapagliflozin and saxagliptin can make you dehydrated, which could cause you to feel weak or dizzy (especially when you stand up).
Stop taking this medicine and call your doctor at once if you have signs of a pancreatitis, such as severe pain in your upper stomach spreading to your back, with or without vomiting,
Dapagliflozin 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.
What is dapagliflozin and saxagliptin?
Dapagliflozin and saxagliptin is a combination medicine used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.
Dapagliflozin and saxagliptin 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.
This medicine is not for treating type 1 diabetes or diabetic ketoacidosis.
Dapagliflozin and saxagliptin may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before taking dapagliflozin and saxagliptin?
You should not use dapagliflozin and saxagliptin if you have:
- severe kidney disease (or if you are on dialysis); or
- a history of severe allergic or skin reaction after taking dapagliflozin or saxagliptin.
Tell your doctor if you have ever had:
- kidney disease;
- diabetic ketoacidosis;
- liver disease;
- bladder cancer;
- bladder infections or other urination problems;
- problems with your pancreas, including surgery;
- gallstones;
- high triglycerides (a type of fat in the blood);
- alcoholism;
- if you are on a low salt diet; or
- if you are 65 or older.
Follow your doctor's instructions about using this medicine if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester.
You should not use this medicine during the second or third trimester of pregnancy.
You should not breastfeed while using this medicine.
Dapagliflozin and saxagliptin is not approved for use by anyone younger than 18 years old.
How should I take dapagliflozin and saxagliptin?
Your kidney function may need to be checked before and during treatment with this medicine.
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.
Swallow the tablet whole and do not crush, chew, or break it.
You may take this medicine 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. Dapagliflozin 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 dapagliflozin and saxagliptin.
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. An overdose can cause life threatening hypoglycemia.
Symptoms of severe hypoglycemia include extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions).
What should I avoid while taking dapagliflozin and saxagliptin?
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.
What are the possible side effects of dapagliflozin and saxagliptin?
Get emergency medical help if you have signs of an allergic reaction: hives, itching, flaking or peeling skin; trouble swallowing, 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.
Stop taking this medicine and call your doctor at once if you have:
- severe or ongoing pain in your joints;
-
serious skin reaction --itching, blisters, breakdown of the outer layer of skin;
-
ketoacidosis (too much acid in the blood) --nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;
-
pancreatitis --severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
-
dehydration symptoms --dizziness, weakness, feeling light-headed (like you might pass out); or
-
signs of a bladder infection --pain or burning when you urinate, increased urination, blood in your urine, pain in your pelvis or back.
Some people taking dapagliflozin have had bladder cancer, but it is not clear if this medicine was the actual cause.
Common side effects may include:
- urination problems;
- abnormal blood levels of cholesterol or triglycerides; or
- runny nose, stuffy nose, sinus pain.
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 dapagliflozin and saxagliptin?
Dapagliflozin and saxagliptin may not work as well when you use other medicines at the same time. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all medicines you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about dapagliflozin and saxagliptin.
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 1996-2020 Cerner Multum, Inc. Version: 4.01. Revision date: 6/28/2019.
