Description
Dapagliflozin, saxagliptin, and metformin combination is used with proper diet and exercise to lower high blood sugar levels caused by type 2 diabetes. Dapagliflozin works in the kidneys to prevent absorption of glucose (blood sugar). This helps lower the blood sugar level. Saxagliptin helps to control blood sugar levels by making the pancreas gland release more insulin. It also signals the liver to stop producing sugar when there is too much sugar in the blood. Metformin reduces the absorption of sugar from the stomach, reduces the release of stored sugar from the liver, and helps your body use sugar better. This medicine does not help patients who have insulin-dependent or type 1 diabetes. Type 1 diabetic patients must use insulin injections.
This medicine is available only with your doctor's prescription.
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of dapagliflozin, saxagliptin, and metformin combination in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dapagliflozin, saxagliptin, and metformin combination in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acarbose
- Acetazolamide
- Alogliptin
- Aspirin
- Avacopan
- Bexagliflozin
- Bictegravir
- Brinzolamide
- Bupropion
- Capmatinib
- Carbamazepine
- Ceritinib
- Chloroquine
- Chlorothiazide
- Chlorpropamide
- Chlorthalidone
- Cimetidine
- Ciprofloxacin
- Dasabuvir
- Delafloxacin
- Diatrizoate
- Dichlorphenamide
- Dofetilide
- Dolutegravir
- Dorzolamide
- Enoxacin
- Ethiodized Oil
- Fedratinib
- Fexinidazole
- Fosnetupitant
- Furosemide
- Gatifloxacin
- Gemifloxacin
- Glimepiride
- Glipizide
- Glyburide
- Grepafloxacin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acebutolol
- Acetohexamide
- Atenolol
- Betaxolol
- Bisoprolol
- Bitter Melon
- Carteolol
- Carvedilol
- Celiprolol
- Chlorpropamide
- Colesevelam
- Esmolol
- Fenugreek
- Glecaprevir
- Gliclazide
- Glimepiride
- Glipizide
- Gliquidone
- Glucomannan
- Glyburide
- Goldenseal
- Guar Gum
- Hydrastis
- Insulin
- Insulin Aspart, Recombinant
- Insulin Bovine
- Insulin Degludec
- Insulin Detemir
- Insulin Glulisine
- Insulin Lispro, Recombinant
- Isocarboxazid
- Labetalol
- Levobunolol
- Linezolid
- Methylene Blue
- Metipranolol
- Metoprolol
- Nadolol
- Nebivolol
- Oxprenolol
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol abuse, history of or
- Hypovolemia (low blood volume) or
- Pancreatic insulin deficiency, history of—May increase risk for more serious side effects.
- Dehydration or
- Dyslipidemia (high fats or cholesterol in the blood) or
- Genital yeast (fungus) infections (eg, balanitis, balanoposthitis, vulvovaginitis), history of or
- Heart failure, history of or
- Hypotension (low blood pressure) or
- Ketoacidosis (high ketones and acid in the blood) or
- Kidney disease or
- Pancreas problems (eg, pancreatitis) or
- Urinary tract infection (eg, pyelonephritis, urosepsis), history of or
- Vitamin B12 deficiency—Use with caution. May make these conditions worse.
- Diabetic ketoacidosis (high ketones and acid in the blood) or
- Kidney disease, moderate to severe (eg, end-stage kidney disease) or
- Patients receiving dialysis or
- Type I diabetes—Should not be used in patients with these conditions.
- Fever or
- Infection or
- Surgery or
- Trauma—Use with caution. These conditions may cause problems with blood sugar control.
- Liver disease—Use is not recommended in patients with this condition.
Proper Use
Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Do not stop or change your dose unless directed by your doctor.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Tell your doctor if you are on a low-salt or sodium diet.
Swallow the tablet whole. Do not cut, break, or chew it. Take this medicine in the morning with food.
Part of the extended-release tablet may pass into your stool (bowel movement). This is normal and nothing to worry about.
Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and will help the medicine work properly. Exercise regularly and test for sugar in your blood or urine as directed.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (extended-release tablets):
- For type 2 diabetes:
- Adults—At first, 1 tablet once a day, taken in the morning. Each tablet contains 5 milligrams (mg) dapagliflozin, 5 mg saxagliptin, and 1000 mg or 2000 mg metformin. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 10 mg dapagliflozin, 5 mg saxagliptin, and 2000 mg metformin per day.
- Children—Use and dose must be determined by your doctor.
- For type 2 diabetes:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you miss a dose and it is less than 12 hours until your next regular dose, skip the missed dose and take your next dose at the regular time. If you miss a dose and it is 12 hours or more until your next regular dose, take the missed dose as soon as possible, and then go back to your regular schedule.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits especially during the first few weeks that you take this medicine. Blood and urine tests may be needed to check for unwanted effects.
Under certain conditions, too much metformin can cause a serious condition called lactic acidosis. The symptoms of lactic acidosis are severe and appear quickly. Lactic acidosis usually occurs when other serious health problems are present, such as a heart attack or kidney failure. The symptoms of lactic acidosis include: abdominal or stomach discomfort, decreased appetite, diarrhea, fast or shallow breathing, a general feeling of discomfort, muscle pain or cramping, and unusual sleepiness, tiredness, or weakness. If you have more than one of these symptoms together, you should get immediate emergency medical help.
Limit how much alcohol you drink while using this medicine. Heavy alcohol use can increase your risk for lactic acidosis.
Pancreatitis (swelling and inflammation of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
If you are rapidly gaining weight, having chest pain, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of a heart problem.
Dizziness, lightheadedness, or fainting may occur with this medicine. This is more common if you have kidney disease, low blood pressure, or if you are taking a diuretic (water pill). Taking plenty of fluids each day may help. Drink plenty of water during exercise or in hot weather. Check with your doctor if you have severe nausea, vomiting, or diarrhea that does not stop. This may cause you to lose too much water.
Ketoacidosis (high ketones and acid in the blood) may occur while you are using this medicine. This can be life-threatening and requires immediate medical attention. Your doctor may give you insulin, fluid, and carbohydrate replacement to treat this condition. Tell your doctor right away if you have nausea, vomiting, trouble breathing, increased thirst or urination, or stomach pain.
Tell your doctor if you have bloody urine, decrease in how much or how often you urinate, painful or difficult urination, lower back or side pain, fever, chills, rapid weight gain, or swelling of the face, finger, or lower legs. These may be symptoms of a serious kidney problem.
This medicine may increase risk of having urinary tract infections, including pyelonephritis or urosepsis. Check with your doctor right away if you have bladder pain, bloody or cloudy urine, difficult, burning, or painful urination, or lower back or side pain.
This medicine may cause vaginal yeast infections in women and yeast infections of the penis in men. This is more common in patients who have a history of genital yeast infections or in men who are not circumcised. Women may have a vaginal discharge, itching, or odor. Men may have redness, itching, swelling, or pain around the penis, or a discharge with a strong odor from the penis. Check with your doctor right away if you have any of these symptoms.
This medicine may cause a rare but serious bacterial infection, called necrotizing fasciitis of the perineum or Fournier's gangrene, which can cause damage to the tissue under the skin in the area between and around the anus and genitals (perineum). Fournier's gangrene may lead to hospitalization, multiple surgeries, or death. Check with your doctor right away if you have fever, unusual tiredness or weakness, or pain, tenderness, redness, or swelling of the area between and around your anus and genitals.
This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.
Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.
This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.
This medicine may cause severe joint pain. Call your doctor right away if you have severe joint pain with this medicine.
This medicine may cause bullous pemphigoid. Tell your doctor if you have large, hard skin blisters while using this medicine.
This medicine may cause some women who do not have regular monthly periods to ovulate. This can increase the chance of pregnancy if you are sexually active. Also, you should not use this medicine during the last 6 months of pregnancy. If you are a woman of childbearing potential, you should discuss birth control options with your doctor.
There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says you have diabetes with a list of all your medicines.
Make sure any doctor or dentist who treats you knows that you are using this medicine. Your doctor may advise you to stop taking this medicine at least 3 days before you have major surgery or diagnostic tests, especially tests that use a contrast dye. This medicine may also affect the results of certain medical tests (eg, urine glucose tests may not be accurate).
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Bladder pain
- bloody or cloudy urine
- difficult, burning, or painful urination
- frequent urge to urinate
- lower back or side pain
Less common
- Agitation
- anxiety
- back pain
- blurred vision
- chills
- cold sweats
- confusion
- cool, pale skin
- decreased awareness or responsiveness
- decreased urine output
- depression
- difficulty in moving
- dizziness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast heartbeat
- fever
- groin pain
- headache
- hostility
- increased hunger
- increased urination
- irritability
- itching of the vagina or outside the genitals
- joint pain
- loss of consciousness
- muscle aches, pains, stiffness, or twitching
- nausea
- nervousness
- nightmares
- pain during sexual intercourse
- rapid weight gain
- seizures
- severe sleepiness
- shakiness
- slurred speech
- stomach pain
- sweating
- swelling of the face, ankles, or hands
- swollen, tender prostate
- thick, white curd-like vaginal discharge without odor or with mild odor
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Rare
- Dry mouth
- rapid breathing
- sunken eyes
- thirst
- wrinkled skin
Incidence not known
- Bloating
- chills
- constipation
- cough
- dark urine
- diarrhea
- difficulty swallowing
- flushed, dry skin
- fruit-like breath odor
- general feeling of discomfort or illness
- hives, itching, skin rash
- indigestion
- large, hard skin blisters
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- loss of appetite
- pain, tenderness, redness, or swelling of the area between the anus and genitals
- pains in the stomach, side, or abdomen, possibly radiating to the back
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- right upper quadrant tenderness
- runny nose
- severe joint pain
- shivering
- sore throat
- tightness in the chest
- trouble sleeping
- troubled breathing
- unexplained weight loss
- vomiting
- weight loss
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Body aches or pain
- ear congestion
- loss of voice
- sneezing
- stuffy nose
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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