This medicine is used along with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.
Qternmet XR is NOT for:
people with type 1 diabetes.
people with diabetic ketoacidosis (increased ketones in your blood or urine).
Qternmet XR is only for people currently taking metformin.
It is not known if this medicine is safe and effective in children younger than 18 years of age.
Qternmet XR side effects
Qternmet XR may cause serious side effects, including:
See Important information.
Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis has happened in people who have type 1 diabetes or type 2 diabetes, during treatment with dapagliflozin, one of the medicines in Qternmet XR. Ketoacidosis is a serious condition, which may need to be treated in a hospital. Ketoacidosis may lead to death. Ketoacidosis can happen with dapagliflozin even if your blood sugar is less than 250 mg/dL. Stop taking Qternmet XR and call your healthcare provider right away if you get any of the following symptoms:
nausea
tiredness
vomiting
trouble breathing
stomach area (abdominal) pain
If you get any of these symptoms during your treatment, if possible check for ketones in your urine, even if your blood sugar is less than 250 mg/dL.
Kidney problems. Sudden kidney injury has happened to people taking dapagliflozin. Talk to your healthcare provider right away if you:
reduce the amount of food or liquid you drink, for example if you are sick and cannot eat, or
you start to lose liquids from your body with vomiting, diarrhea, or being in the sun too long.
Serious urinary tract infections. Serious urinary tract infections that may lead to hospitalization have happened in people who are taking dapagliflozin. Tell your healthcare provider if you have any signs or symptoms of a urinary tract infection such as a burning feeling when passing urine, a need to urinate often, the need to urinate right away, pain in the lower part of your stomach (pelvis), or blood in the urine. Sometimes people also may have a fever, back pain, nausea or vomiting.
Low blood sugar (hypoglycemia). If you take Qternmet XR with another medicine that can cause low blood sugar, such as a sulfonylUrea or insulin, this can increase your risk of getting low blood sugar. Tell your healthcare provider if you take other diabetes medicines. Signs and symptoms of low blood sugar may include:
shaking or feeling jittery
hunger
change in mood
sweating
headache
confusion
rapid heartbeat
drowsiness
irritability
change in vision
weakness
A rare but serious bacterial infection that causes damage to the tissue under the skin (necrotizing fasciitis) in the area between and around the anus and genitals (perineum). Necrotizing fasciitis of the perineum has happened in women and men who take dapagliflozin, one of the medicines in Qternmet XR. Necrotizing fasciitis of the perineum may lead to hospitalization, may require multiple surgeries and may lead to death. Seek medical attention immediately if you have fever or you are feeling very weak, tired or uncomfortable (malaise) and you develop any of the following symptoms in the area between and around the anus and genitals:
pain or tenderness
swelling
redness of skin (erythema)
Serious allergic Reaction. Qternmet XR may cause serious allergic reactions. Stop taking Qternmet XR and get medical help right away if you develop any of the following symptoms of a serious allergic reaction including:
swelling of the face, lips, tongue, throat and other areas of your skin
difficulty with swallowing or breathing
skin rash, itching, flaking, or peeling
raised red patches on your skin (hives)
Low vitamin B12 (vitamin B12 deficiency). Using metformin for long periods of time may cause a decrease in the amount of vitamin B12 in your blood, especially if you have HAD low vitamin B12 levels before. Your healthcare provider may do blood tests to check your vitamin B12 levels.
Vaginal yeast infection. Women who take Qternmet XR may get vaginal yeast infections. Symptoms of a vaginal yeast infection include:
vaginal odor
white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese)
vaginal itching
Yeast infection of the penis (balanitis). Men who take Qternmet XR may get a yeast infection of the skin around the penis. Certain men who are not circumcised may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis. Other symptoms of a yeast infection of the penis include:
redness, itching, or swelling of the penis
rash of the penis
foul smelling discharge from the penis
pain in the skin around the penis
Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medicine and your symptoms do not go away.
Increased fats in your blood (bad cholesterol or LDL).
Bladder cancer. In studies of dapagliflozin in people with diabetes, bladder cancer occurred in a few more people who were taking dapagliflozin than in people who were taking other diabetes medicines. There were too few cases to know if bladder cancer was related to dapagliflozin. You should not take Qternmet XR if you have bladder cancer. Tell your healthcare provider right away if you have any of the following symptoms:
blood or a red color in your urine
pain while you urinate
Joint pain. Some people who take DPP-4 inhibitors like saxagliptin, may develop joint pain that can be severe. Call your healthcare provider right away if you have severe joint pain.
Skin reaction. Some people who take DPP-4 inhibitors, one of the medicines in Qternmet XR, may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your healthcare provider right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your healthcare provider may tell you to stop taking Qternmet XR.
The most common side effects include:
upper respiratory tract infection
abnormal amounts of fats in the blood (dyslipidemia)
urinary tract infection
These are not all of the possible side effects. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Before taking Qternmet XR
Do not take Qternmet XR if you:
are allergic to dapagliflozin, saxagliptin, metformin, or any of the ingredients. See the end of this Medication Guide for a list of ingredients.
Symptoms of a serious allergic reaction may include:
swelling of the face, lips, throat and other areas of your skin
difficulty with swallowing or breathing
skin rash, itching, flaking or peeling
raised red areas on your skin (hives)
If you have any of these symptoms, stop taking Qternmet XR and contact your healthcare provider or go to the nearest hospital emergency room right away.
have moderate to severe kidney problems or are on dialysis.
have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in your blood or urine).
How to use Qternmet XR
Take Qternmet XR tablets exactly as your healthcare provider tells you to take it.
Do not change your dose without talking to your healthcare provider.
Take the tablets by mouth one time each day in the morning with food.
Swallow the tablets whole. Do not cut, crush or chew the tablets.
You may sometimes pass a soft mass in your stools (bowel movement) that looks like Qternmet XR tablets.
During periods of stress on the body, such as fever, trauma, infection or surgery, contact your healthcare provider right away as your medicine needs may change.
Stay on your prescribed diet and exercise program during treatment.
Your healthcare provider may do certain blood tests before you start, and during your treatment.
Your healthcare provider should test your blood to measure how well your kidneys are working before and during your treatment.
Your healthcare provider will check your diabetes with regular blood tests, including your blood sugar levels and your HbA1c.
Follow your healthcare provider’s instructions for treating low blood sugar (hypoglycemia). Talk to your healthcare provider if low blood sugar is a problem for you.
Qternmet XR will cause your urine to test positive for glucose.
If you miss your daily dose, and it is more than 12 hours until your next dose, take the missed dose as soon as possible with food.
If you miss a daily dose and it is less than 12 hours until your next dose, skip the missed dose. Take the next dose at your regular time.
If you take too much or overdose, call your healthcare provider, or go to the nearest hospital emergency room right away.
Warnings
Serious side effects can happen to people taking Qternmet XR, including:
Lactic Acidosis. Metformin, one of the medicines in Qternmet XR, can cause a rare but serious condition called lactic acidosis (a build-up of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.
Call your healthcare provider right away if you have any of the following symptoms, which could be signs of lactic acidosis:
you feel cold in your hands or feet
you feel dizzy or lightheaded
you have a slow or irregular heartbeat
you feel very weak or tired
you have unusual (not normal) muscle pain
you have trouble breathing
you feel unusual sleepiness or sleep longer than usual
you have stomach pains, nausea, or vomiting
Most people who have had lactic acidosis with metformin have other things that, combined with the metformin use, led to the lactic acidosis. Tell your healthcare provider if you have any of the following, because you have a higher chance for getting lactic acidosis with Qternmet XR if you:
have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye
have liver problems
drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking
get dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids.
have surgery
have a heart attack, severe infection, or stroke.
The best way to keep from having a problem with lactic acidosis from metformin is to tell your healthcare provider if you have any of the problems in the list above. Your healthcare provider may decide to stop your Qternmet XR for a while if you have any of these problems.
Inflammation of the pancreas (pancreatitis). Saxagliptin, one of the medicines in Qternmet XR, can cause inflammation of the pancreas, which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis.
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Before you start treatment, tell your healthcare provider if you have ever had:
inflammation of your pancreas (pancreatitis)
stones in your gallbladder (gallstones)
a history of alcoholism
high blood triglyceride levels
It is not known if having these medical problems will make you more likely to get pancreatitis with Qternmet XR.
Stop taking Qternmet XR and contact your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.
Heart failure. Heart failure means your heart does not pump blood well enough. Before you start treatment, tell your healthcare provider if you have ever had heart failure or have problems with your kidneys.
Contact your healthcare provider right away if you have any of the following symptoms:
increasing shortness of breath or trouble breathing, especially when you lie down
swelling or fluid retention, especially in the feet, ankles, or legs
an unusually fast increase in weight
unusual tiredness
These may be symptoms of heart failure.
Dehydration. Qternmet XR can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at a higher risk of dehydration if you:
have low blood pressure
take medicines to lower your blood pressure, including water pills (diuretics)
are 65 years of age or older
are on a low salt diet
have kidney problems
Qternmet XR can have other serious side effects. See Qternmet XR side effects./p>
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