Saxagliptin and metformin (Oral)

Saxagliptin and metformin combination is used along with diet and exercise to manage high blood sugar (glucose) levels in people with type 2 diabetes. Saxagliptin helps to control blood sugar levels by prompting the pancreas to release more insulin. It also tells the liver to stop producing sugar when there is too much sugar in the blood. Metformin decreases the absorption of sugar from the stomach, lowers the release of stored sugar from the liver, and assists your body in using sugar more effectively. This medicine does not help patients who have insulin-dependent or type 1 diabetes.

This medicine is available only with your doctor's prescription.

Your doctor will want to check how you are doing at regular visits, especially during the first few weeks you take this medicine. Blood and urine tests may be needed to look for side effects.

Let your doctor or dentist know you are taking this medicine. Your doctor may tell you to stop taking this medicine for a short time before you have major surgery or tests that use contrast dye.

In some cases, too much metformin can lead to a condition called lactic acidosis. The symptoms of lactic acidosis are severe, happen quickly, and usually occur when other health issues are present, like a 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 you have symptoms of lactic acidosis, you should get emergency medical help right away.

Pancreatitis (swelling and inflammation of the pancreas) may happen while you are using this medicine. Contact your doctor immediately if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

If you are gaining weight quickly, having shortness of breath, chest pain, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrists, ankles, or feet, see your doctor right away. These may be signs of a heart problem.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema. These reactions can be life-threatening and need immediate medical attention. Contact your doctor immediately if you have a rash, itching, large swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals, trouble breathing, or chest tightness.

This medicine may cause hypoglycemia (low blood sugar). This is more likely to happen when this medicine is taken with certain other medicines. Low blood sugar needs to be treated before it makes you pass out (become unconscious). People experience different symptoms of low blood sugar. It is important for you to know which symptoms you usually have, so you can treat it quickly. Talk to your doctor about the best way to handle low blood sugar.

Hyperglycemia (high blood sugar) may happen if you do not take enough of your medicine, skip a dose, overeat, do not follow your meal plan, have a fever or infection, or do not exercise as much as you usually do. High blood sugar can be very serious and must be treated quickly. It is important for you to recognize your symptoms to treat it promptly. Speak to your doctor about the best way to manage high blood sugar.

This medicine may cause severe joint pain. Call your doctor right away if you experience severe joint pain with this medicine.

This medicine may cause bullous pemphigoid. Inform your doctor if you have large, hard skin blisters while taking this medicine.

Do not take other medicines unless you have talked about them with your doctor. This includes prescription or over-the-counter (OTC) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor will weigh the risks against the benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how saxagliptin and metformin combination affects children. Safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in the elderly that would limit the usefulness of saxagliptin and metformin combination. However, older patients are more likely to have kidney issues related to age, which may require caution for those taking this medicine. This medicine is not recommended for patients 80 years of age and older who have kidney problems.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if an interaction might occur. In these cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are highlighted based on their significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or may change some of the other medicines you take.

• Acetrizoic Acid
• Diatrizoate
• Ethiodized Oil
• Iobenzamic Acid
• Iobitridol
• Iocarmic Acid
• Iocetamic Acid
• Iodamide
• Iodipamide
• Iodixanol
• Iodohippuric Acid
• Iodopyracet
• Iodoxamic Acid
• Ioglicic Acid
• Ioglycamic Acid
• Iohexol
• Iomeprol
• Iopamidol
• Iopanoic Acid
• Iopentol
• Iophendylate
• Iopronic Acid
• Ioseric Acid
• Iosimide
• Iotasul
• Iothalamate
• Iotrolan
• Iotroxic Acid
• Ioxaglate
• Ioxitalamic Acid
• Ipodate
• Metrizamide
• Metrizoic Acid
• Tyropanoate Sodium

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of use for one or both medicines.

• Abametapir
• Abiraterone Acetate
• Acetazolamide
• Alogliptin
• Aspirin
• Bexagliflozin
• Bictegravir
• Brinzolamide
• Bupropion
• Capmatinib
• Ceritinib
• Chloroquine
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Cimetidine
• Ciprofloxacin
• Dasabuvir
• Delafloxacin
• Dichlorphenamide
• Dofetilide
• Dolutegravir
• Dorzolamide
• Enoxacin
• Fedratinib
• Fexinidazole
• Fosnetupitant
• Furosemide
• Gatifloxacin
• Gemifloxacin
• Glimepiride
• Glipizide
• Glyburide
• Grepafloxacin
• Hydrochlorothiazide
• Hydroflumethiazide
• Hydroxychloroquine
• Indapamide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Iopromide
• Ioversol
• Isavuconazole
• Lanreotide
• Levofloxacin
• Levoketoconazole
• Liraglutide
• Lomefloxacin
• Mavacamten
• Methazolamide
• Metolazone
• Moxifloxacin
• Nateglinide
• Netupitant
• Norfloxacin
• Octreotide
• Ofloxacin
• Omaveloxolone
• Ombitasvir
• Paritaprevir
• Pasireotide
• Phenobarbital
• Pioglitazone
• Polythiazide
• Pramlintide
• Primidone
• Ranolazine
• Repaglinide
• Semaglutide
• Simeprevir
• Sitagliptin
• Somatrogon-ghla
• Sotagliflozin
• Sparfloxacin
• Tafenoquine
• Thioctic Acid
• Tolazamide
• Tolbutamide
• Topiramate
• Triamterene
• Trovafloxacin
• Vandetanib
• Zonisamide

Using this medicine with any of the following medicines may increase the 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 frequency of use for one or both medicines.

• Acebutolol
• Acetohexamide
• Atenolol
• Betaxolol
• Bisoprolol
• Bitter Melon
• Carteolol
• Carvedilol
• Celiprolol
• Chlorpropamide
• Colesevelam
• Esmolol
• Fenugreek
• Gliclazide
• Glimepiride
• Glipizide
• Gliquidone
• Glucomannan
• Glyburide
• Guar Gum
• 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
• Ozanimod
• Patiromer
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Psyllium
• Rasagiline
• Rifampin
• Safinamide
• Selegiline
• Sotalol
• Timolol
• Tirzepatide
• Tolazamide
• Tolbutamide
• Tranylcypromine
• Verapamil

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around meal times, or with certain foods, due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions are highlighted based on their significance and are not necessarily all-inclusive.

Other Medical Problems

Having other medical conditions may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Excessive alcohol use or
• Congestive heart failure or
• Dehydration or
• History of gallstones or
• Hypertriglyceridemia (high triglycerides or fats in the blood) or
• Kidney disease or
• Liver disease or
• History of pancreas problems or
• Sepsis (severe infection) or
• Weakened physical condition—Use with caution. May worsen side effects.

• Anemia or
• Vitamin B12 deficiency—Use with caution. May worsen these conditions.

• History of angioedema (swelling of the face, lips, tongue, throat, arms, or legs) with other dipeptidyl peptidase-4 (DPP-4) inhibitors—Use with caution. May increase the risk of this condition occurring again.

• History of heart failure or
• Kidney disease—May increase the risk for heart failure.

• Severe kidney disease or
• Metabolic acidosis (including diabetic ketoacidosis)—Should not be used in patients with these conditions.

Along with its intended effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may require 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
• nasal congestion
• nausea
• nightmares
• runny nose
• seizures
• shakiness
• slurred speech
• sneezing
• sore throat
• unusual tiredness or weakness

Rare

• Cough or hoarseness

Incidence not known

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• 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
• tightness in the chest
• 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. Your health care professional may also have 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

• Abdominal or stomach pain
• itching
• pain or tenderness around the eyes and cheekbones
• redness of the skin
• weakness
• welts

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.

In the U.S.

• Kombiglyze XR

Available Dosage Forms:

• Tablet, Extended Release

Therapeutic Class: Hypoglycemic

Pharmacologic Class: Saxagliptin

Chemical Class: Metformin

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, break, 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.

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.