Description
Saxagliptin and metformin combination is used together with proper diet and exercise to treat high blood sugar levels in patients with type 2 diabetes. Saxagliptin helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing sugar (glucose) 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 is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Tablet, Extended Release
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 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 saxagliptin and metformin combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart 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
- Abemaciclib
- Abiraterone Acetate
- Abiraterone Acetate, Micronized
- Acarbose
- Acetazolamide
- Alogliptin
- Apalutamide
- Arimoclomol
- Aspirin
- Atazanavir
- Avacopan
- Bexagliflozin
- Bictegravir
- Boceprevir
- Brinzolamide
- Bupropion
- Capmatinib
- Carbamazepine
- Ceritinib
- Chloroquine
- Chlorothiazide
- Chlorpropamide
- Chlorthalidone
- Cimetidine
- Ciprofloxacin
- Clarithromycin
- Cobicistat
- Conivaptan
- Dasabuvir
- Delafloxacin
- Diatrizoate
- Dichlorphenamide
- Dofetilide
- Dolutegravir
- Dorzolamide
- Enoxacin
- Ethiodized Oil
- Fedratinib
- Fexinidazole
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
- Atenolol
- Betaxolol
- Bisoprolol
- Bitter Melon
- Carteolol
- Carvedilol
- Celiprolol
- Colesevelam
- Esmolol
- Fenugreek
- Glecaprevir
- Glucomannan
- Goldenseal
- Guar Gum
- Hydrastis
- Isocarboxazid
- Labetalol
- Levobunolol
- Linezolid
- Methylene Blue
- Metipranolol
- Metoprolol
- Nadolol
- Nebivolol
- Oxprenolol
- Ozanimod
- Patiromer
- Penbutolol
- Phenelzine
- Pibrentasvir
- Pindolol
- Practolol
- Procarbazine
- Propranolol
- Psyllium
- Rasagiline
- Rifampin
- Safinamide
- Selegiline
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 use disorder, history of or
- Congestive heart failure or
- Dehydration or
- Gallstones or
- Hypertriglyceridemia (high triglycerides or fats in the blood) or
- Hypoxemia (decreased oxygen in the blood) or
- Kidney disease or
- Liver disease or
- Pancreatitis (swelling of the pancreas) or
- Sepsis (severe infection) or
- Weakened physical condition—Use with caution. May cause side effects to become worse.
- Anemia or
- Vitamin B12 deficiency—Use with caution. May make these conditions worse.
- Angioedema (swelling of the face, lips, tongue, throat, arms, or legs), history with other dipeptidyl peptidase-4 (DPP-4) inhibitors—Use with caution. May increase the risk of this condition occurring again.
- Diabetic ketoacidosis or metabolic acidosis (high ketones or acid in the blood or urine) or
- Kidney disease, severe or
- Type 1 diabetes—Should not be used in patients with these conditions.
- Heart failure, history of or
- Kidney disease—May increase risk for heart failure.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of unwanted effects.
This medicine usually comes with a Medication Guide. Read the information carefully and make sure you understand it before taking this medicine. If you have any questions, ask your doctor.
Carefully follow the special meal plan your doctor gave you. This is a very important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.
Take the medicine with the evening meal to help reduce unwanted stomach effects that may occur during the first few weeks of treatment.
Swallow the extended-release tablet whole. Do not crush, cut, or chew it.
While taking the extended-release tablet, part of the tablet may pass into your stools. This is normal and is nothing to worry about.
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:
- For patients taking metformin alone:
- Adults—The metformin dose is the same as the dose you are already taking. Your doctor may adjust your dose until your blood sugar is controlled. However, the dose is usually not more than 5 milligrams (mg) of saxagliptin and 2000 mg of metformin once a day.
- Children—Use and dose must be determined by your doctor.
- For patients taking saxagliptin alone:
- Adults—At first, one tablet containing 5 milligrams (mg) of saxagliptin and 500 mg of metformin once a day. Your doctor may adjust your dose until your blood sugar is controlled. However, the dose is usually not more than 5 mg of saxagliptin and 2000 mg of metformin once a day.
- Children—Use and dose must be determined by your doctor.
- For patients using 2.5 milligrams (mg) of saxagliptin and extended-release metformin together:
- Adults—One tablet containing 2.5 mg of saxagliptin and 1000 mg of metformin once a day.
- Children—Use and dose must be determined by your doctor.
- For patients taking metformin alone:
- 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.
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
Your doctor will want to 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.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine before having major surgery or diagnostic tests, especially tests that use a contrast dye.
Do not let yourself get dehydrated. Be sure to drink extra fluids when you exercise or increase your activity, or if you have vomiting or diarrhea.
Under certain conditions, too much metformin can cause a condition called lactic acidosis. It usually occurs when other serious health problems are present, including heart attack or kidney failure. Symptoms of lactic acidosis include: 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 symptoms of lactic acidosis occur, you should get immediate emergency medical help.
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.
Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme fatigue, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain. These may be signs of heart failure.
It is very important to carefully follow any instructions from your health care team about:
- Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
- Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines, such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
- Counseling—Other family members need to learn how to help with side effects if they occur. Also, patients with diabetes may need special counseling about the changes in the dosing of their diabetes medicine that might occur with lifestyle changes, such as changes in exercise or diet. Furthermore, counseling on contraception and pregnancy may be needed, because of the problems that can occur in patients with diabetes during pregnancy.
- Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
- In case of emergency—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 and that lists all of your medicines.
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. Some symptoms of low blood sugar include: behavior changes that are similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headache, nausea, shakiness, slurred speech, or unusual tiredness or weakness. Talk to your doctor about how 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, and serious skin reactions. These conditions may be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, itching, a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, skin flaking or peeling, trouble breathing, or chest tightness while you are using this medicine.
This medicine may cause severe and disabling joint pain. Call your doctor right away if you have severe joint pain while using this medicine.
This medicine may cause bullous pemphigoid. Tell your doctor if you have large, hard skin blisters while using this medicine.
Limit the amount of alcohol you drink while you are using this medicine. Heavy alcohol use can increase your chances of serious side effects.
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
- Anxiety
- bladder pain
- bloody or cloudy urine
- blurred vision
- body aches or pain
- chills
- cold sweats
- confusion
- cool, pale skin
- cough
- depression
- difficult, burning, or painful urination
- difficulty with breathing
- dizziness
- ear congestion
- fast heartbeat
- fever
- frequent urge to urinate
- headache
- increased hunger
- loss of voice
- lower back or side pain
- nausea
- nightmares
- seizures
- shakiness
- slurred speech
- sneezing
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Rare
- Cough or hoarseness
Incidence not known
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- chest tightness
- constipation
- darkened urine
- difficulty with swallowing
- hives or skin rash
- indigestion
- large, hard skin blisters
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- unusual bleeding or bruising
- vomiting
- 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
- Diarrhea
- muscle aches
Less common
- Itching
- pain or tenderness around the eyes and cheekbones
- redness of the skin
- stomach pain
- weakness
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.
DRG-20074625
