Saxagliptin/metformin | Side Effects, Dosage, Uses & More
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Generic Name:

metformin-saxagliptin, Oral tablet

All Brands

  • Kombiglyze XR
SECTION 1 of 4

Highlights for metformin-saxagliptin

Oral tablet
1

Saxagliptin/metformin is an oral drug that’s used to control blood sugar levels in adults with type 2 diabetes. It’s used along with diet and exercise.

2

The standard starting dosage for people who aren’t being treated with metformin is 5 mg saxagliptin/ 500 mg metformin taken by mouth once per day with dinner. Your doctor may gradually increase your dose if needed.

3

This drug can cause serious side effects, such as lactic acidosis, inflammation of your pancreas, low blood sugar (hypoglycemia), and allergic reactions.

4

You may pass a small, soft mass in your stool that looks like the saxagliptin/metformin tablet. This doesn’t mean that the drug isn’t working.

5

Common side effects include respiratory problems, urinary tract infections, and upset stomach.

IMPORTANT INFORMATION

FDA warning

This drug has a Black Box Warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients to potentially dangerous effects.

Lactic acidosis warning: Lactic acidosis is a rare, but serious side effect of metformin. In this condition, lactic acid builds up in your blood. This is a medical emergency that requires treatment in the hospital. Lactic acidosis is fatal in about half of people who develop it. You should stop taking metformin and call your doctor right away or go to the emergency room if you have signs of lactic acidosis. Symptoms include:

  • tiredness
  • weakness
  • unusual muscle pain
  • trouble breathing
  • unusual sleepiness
  • stomach pains, nausea, or vomiting
  • dizziness or lightheadedness
  • slow or irregular heart rate

Your risk of lactic acidosis may be higher if you drink a lot of alcohol, are dehydrated, or are 80 years of age or older. Your risk may also be higher if you have:

  • liver problems
  • kidney problems
  • heart failure
  • heart attack
  • severe infection
  • stroke
  • certain x-ray tests with injectable dyes or contrast agents
  • surgery

Pancreatitis

Saxagliptin may increase your risk of inflammation of your pancreas (pancreatitis). This can be severe and sometimes fatal. Before you start taking this drug, tell your doctor if you’ve ever had:

  • pancreatitis
  • stones in your gallbladder (gallstones)
  • alcoholism
  • high cholesterol
  • kidney problems

Stop taking this drug and call your doctor right away if you have signs of pancreatitis. You’ll need to be treated. Symptoms include:

  • severe pain in your stomach that won’t go away. You may feel the pain going from your stomach through to your back.
  • swollen, tender stomach
  • nausea or vomiting

Risk of low blood sugar

This drug may cause low blood sugar (hypoglycemia). It may be more severe in people who also take other diabetes drugs, like insulin or sulfonylureas. Symptoms of low blood sugar include:

  • shaking
  • sweating
  • fast heart rate
  • changes in vision
  • increased hunger
  • headache
  • changes in mood

If you have symptoms of low blood sugar, you should test your blood sugar. If it’s low, treat it and call your doctor.

Risk of an allergic reaction

Saxagliptin can cause a serious allergic reaction. If you have an allergic reaction, your doctor will treat it and prescribe another drug for your diabetes. Symptoms include:

  • swelling of your face, lips, or throat
  • trouble swallowing or breathing
  • hives
  • skin rash

Drug features

Saxagliptin/metformin is a prescription drug. It comes in the form of an oral extended-release tablet. The tablet is available as the brand-name drug Kombiglyze XR. There is no generic form of this drug.

This is a combination of two or more drugs in a single form. It is important to know about all the drugs in the combination because they each may have unique traits.

This drug may be used as part of a combination therapy. That means you need to take it with other drugs.

Why it's used

Saxagliptin/metformin is used to control blood sugar levels in adults with type 2 diabetes. It’s used along with diet and exercise.

How it works

Saxagliptin/metformin is a combination of two diabetes medications that work together in different ways to lower your blood sugar levels.

More Details

How it works

Saxagliptin/metformin is a combination of two diabetes medications that work together in different ways to lower your blood sugar levels.

Saxagliptin belongs to a drug class called dipeptidyl peptidase-4 (DDP-4) inhibitors. A class of drugs refers to medications that work similarly. They have a similar chemical structure and are often used to treat similar conditions.

As you eat, insulin is released into your bloodstream. Insulin is needed to move carbohydrates from the meal from your bloodstream into your cells. In type 2 diabetes, your body doesn’t make enough insulin or it can’t use the insulin that it makes properly.

DPP-4 causes the hormones that release insulin to become inactive. Saxagliptin stops the DPP-4 enzyme from working, so that the hormones can help release insulin and lower you blood sugar levels.

Metformin belongs to a class of drugs called biguanides.

Metformin reduces the amount of glucose (sugar) made by your liver, lowers the amount of glucose your body absorbs, and increases the effect of insulin on your body. This lowers your blood sugar levels.

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SECTION 2 of 4

metformin-saxagliptin Side Effects

Oral tablet

More Common Side Effects

The most common side effects that occur with saxagliptin/metformin include:

  • upper respiratory tract infection

  • stuffy or runny nose and sore throat

  • urinary tract infection

  • nausea and vomiting

  • diarrhea

  • headache

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious Side Effects

If you experience any of these serious side effects, call your doctor right away. If your symptoms are potentially life threatening or if you think you’re experiencing a medical emergency, call 9-1-1.

  • lactic acidosis. Symptoms include:

    • weakness, tiredness, or sleeping more than usual
    • unusual muscle pain
    • trouble breathing
    • unexplained stomach problems with nausea, vomiting, or diarrhea
    • feeling cold, especially in your arms and legs
    • dizziness or lightheadedness
    • slow or irregular heart rate
  • inflammation of your pancreas (pancreatitis). Symptoms include:

    • severe pain from your abdomen to your back that doesn’t go away
  •  low blood sugar (hypoglycemia). Symptoms include:

    • shaking
    • sweating
    • rapid heart rate
    • changes in vision
    • intense hunger
    • headache
    • changes in mood
  • allergic reaction. Symptoms include:

    • swelling of your lips, throat, face, and skin
    • trouble breathing or swallowing
    • raised, red areas on your skin (hives)
    • itching, flaking, or peeling skin
    • skin rash
  • severe joint pain

Pharmacist's Advice
Healthline Pharmacist Editorial Team

This drug does not cause drowsiness. However, it may cause a low blood sugar reaction.

If you have a low blood sugar reaction, you need to treat it.

  • For mild hypoglycemia (55–70 mg/dL), treatment is 15–20 grams of glucose (a type of sugar). You need to eat or drink one of the following:
    • 3–4 glucose tablets
    • a tube of glucose gel
    • ½ cup of juice or regular, non-diet soda
    • 1 cup of nonfat or 1% cow’s milk
    • 1 tablespoon of sugar, honey, or corn syrup
    • 8–10 pieces of hard candy, such as lifesavers
  • Test your blood sugar 15 minutes after you treat the low sugar reaction. If your blood sugar is still low, then repeat the above treatment again.
  • Once your blood sugar is back in the normal range, eat a small snack if your next planned meal or snack is more than 1 hour later. 

If you don’t treat low blood sugar, you can have a seizure, pass out, and possibly develop brain damage. Low blood sugar can even be fatal. If you pass out because of a low sugar reaction or cannot swallow, someone will have to give an injection of glucagon to treat the low sugar reaction. You may need to go to the emergency room.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
SECTION 3 of 4

metformin-saxagliptin May Interact with Other Medications

Oral tablet

Saxagliptin/metformin can interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Note: You can reduce your chances of drug interactions by having all of your prescriptions filled at the same pharmacy. That way, a pharmacist can check for possible drug interactions.

Alcohol interaction

You should limit how much alcohol you drink while taking this drug. Alcohol can lower or raise your blood sugar levels, and it may also increase your risk of lactic acidosis.

Medications that might interact with this drug

Human immunodeficiency virus (HIV) drugs

These drugs may increase the amount of saxagliptin/metformin in your body. This can raise your risk of side effects. Your doctor may reduce your dose of saxagliptin to 2.5 mg if you take one of these drugs.

These drugs include:

  • atazanavir (Reyataz)
  • indinavir (Crixivan)
  • nelfinavir (Viracept)
  • ritonavir (Norvir)
  • saquinavir (Invirase)

Antibiotics

These drugs may increase the amount of saxagliptin/metformin in your body. This can raise your risk of side effects. Your doctor may reduce your dose of saxagliptin to 2.5 mg if you take one of these drugs.

These drugs include:

  • clarithromycin (Biaxin)
  • telithromycin (Ketek)

Antifungal drugs

These drugs may increase the amount of saxagliptin/metformin in your body. This can raise your risk of side effects. Your doctor may reduce your dose of saxagliptin to 2.5 mg if you take one of these drugs.

These drugs include:

  • itraconazole (Sporanox, Onmel)

Heart drugs

Taking these drugs with saxagliptin/metformin may increase levels of metformin in your body. This raises your risk for side effects, including lactic acidosis.

These drugs include:

  • amiloride (Midamor)
  • digoxin (Lanoxin)
  • procainamide
  • triamterene (Dyrenium)

Pain drugs

Taking these drugs with saxagliptin/metformin may increase levels of metformin in your body. This raises your risk for side effects, including lactic acidosis.

These drugs include:

  • morphine (Avinza, MS contin, Kadian)

Malaria drugs

Taking these drugs with saxagliptin/metformin may increase levels of metformin in your body. This raises your risk for side effects, including lactic acidosis.

These drugs include:

  • quinidine
  • quinine

Antibiotics

Taking these drugs with saxagliptin/metformin may increase levels of metformin in your body. This raises your risk for side effects, including lactic acidosis.

These drugs include:

  • trimethoprim
  • vancomycin (Vancocin)

Acid-reducing drugs

Taking these drugs with saxagliptin/metformin may increase levels of metformin in your body. This raises your risk for side effects, including lactic acidosis.

These drugs include:

  • cimetidine
  • ranitidine

Cationic drugs

These drugs can cause saxagliptin/metformin to build up in your body. Your doctor will need to watch you closely and possibly adjust the dose of your medications.

These drugs include:

  • ranitidine (Zantac)
  • cimetidine (Tagamet)

Water pills (diuretics)

Taking these drugs with saxagliptin/metformin may raise your blood sugar levels.

These drugs include:

  • thiazides, such as:
    • hydrochlorothiazide
    • chlorthalidone
    • chlorothiazide
    • indapamide
    • metolazone
  • loop diuretics, such as:
    • furosemide
    • bumetanide
    • torsemide

Oral birth control pills

Taking these drugs with saxagliptin/metformin may raise your blood sugar levels.

Estrogens

Taking these drugs with saxagliptin/metformin may raise your blood sugar levels.

Phenytoin (Dilantin)

Taking this drug with saxagliptin/metformin may raise your blood sugar levels.

Corticosteroids

Taking these drugs with saxagliptin/metformin may raise your blood sugar levels.

These drugs include:

  • prednisone
  • dexamethasone
  • methylprednisolone

Isoniazid

Taking this drug with saxagliptin/metformin may raise your blood sugar levels.

Drugs to treat heart problems

Taking these drugs with saxagliptin/metformin may raise your blood sugar levels.

These drugs include:

  • calcium channel blockers, such as:
    • amlodipine
    • diltiazem
    • nifedipine
    • niacin

Thyroid drugs

Taking these drugs with saxagliptin/metformin may raise your blood sugar levels.

Psychosis and nausea medicines

Taking these drugs with saxagliptin/metformin may raise your blood sugar levels.

These drugs include:

  • chlorpromazine
  • fluphenazine
  • perphenazine
  • thioridazine
  • trifluoperazine

Heart attack drugs/medicines that increase blood pressure

Taking these drugs with saxagliptin/metformin may raise your blood sugar levels.

These drugs include:

  • epinephrine
  • dopamine

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.

People with type 1 diabetes

People with type 1 diabetes. This drug shouldn’t be used to treat type 1 diabetes. You’ll need insulin instead.

People with kidney problems

People with kidney problems may have a higher risk for lactic acidosis.

People with liver problems

People with liver problems may have a higher risk for lactic acidosis.

People with heart problems

People with heart problems, including congestive heart failure, may be at an increased risk for lactic acidosis.

People with a history or risk for diabetic ketoacidosis

This drug shouldn’t be used to treat diabetic ketoacidosis. You’ll need insulin instead.

Pregnant women

This drug is a pregnancy category B drug. That means two things:

  1. Studies of the drug in pregnant animals have not shown risk to the fetus.
  2. There aren’t enough studies done in pregnant women to show the drug poses a risk to the fetus.

Tell your doctor if you’re pregnant or plan to become pregnant. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Women who are breast-feeding

It isn’t known if this drug passes into breast milk. If it does, it may cause serious effects in a child who is breast-fed.  

You and your doctor may need to decide if you’ll take if this drug or breast-feed.

For seniors

As you age, your kidneys may not work as well as they once did. This could cause the drug to build up in your body and lead to more side effects, such as lactic acidosis. Metformin shouldn’t be used in people with kidney problems.

Your doctor should monitor your kidney function while you’re taking this drug.

For children

The safety and effectiveness of this drug hasn’t been established in people younger than 18 years.

Special kid safety:

  • Always store this drug in containers with childproof lids. Keep them closed tightly.
  • Keep your medication in a safe place, like a locked medicine cabinet, even if you don't think your child can reach it.

Lancets (a needle used to draw blood from your finger) are used to test your blood sugar. Don’t throw out lancets into trash cans or recycling bins, and never flush them down the toilet. Ask your pharmacist for a safe container for disposing used lancets. Your community may have a program for disposing lancets. If throwing out the container in the trash, label it “do not recycle.”

When to call the doctor

  • When your body is under stress, such as fever, trauma (like a car accident), infection, or surgery, the amount of diabetes medicine that you need may change. Tell your doctor right away if you have any of these problems.
  • If your dose of this drug isn’t working well, your diabetes won’t be under control. You’ll have signs of high blood sugar (hyperglycemia). Call your doctor if you have any of the following symptoms:
    • urinating more often than usual
    • intense thirst
    • intense hunger, even though you’re eating
    • extreme fatigue
    • blurry vision
    • cuts or bruises that are slow to heal
    • tingling, pain, or numbness in your hands or feet

Allergies

This drug can cause a severe allergic reaction. Symptoms include:

  • swelling of your lips, throat, face, and skin
  • trouble breathing or swallowing
  • raised, red areas on your skin (hives)
  • itching, flaking, or peeling skin
  • skin rash 

Don’t take this drug again if you’ve ever had an allergic reaction to it before. Taking it a second time after an allergic reaction could be fatal.

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How to Take metformin-saxagliptin (Dosage)

Oral tablet

All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

What are you taking this medication for?

Type 2 diabetes

Brand: Kombiglyze XR

Form: Oral tablet
Strengths: 
  • 5 mg saxagliptin/500 mg metformin HCl extended-release
  • 5 mg saxagliptin/1,000 mg metformin HCl extended-release
  • 2.5 mg saxagliptin/1,000 mg metformin HCl extended-release
Adult dosage (ages 18–64 years)
  • The recommended starting dosage for people who aren’t being treated with metformin is 5 mg saxagliptin/ 500 mg metformin taken once per day with dinner.
  • If you’re already taking metformin, your dosage of saxagliptin/metformin should be the same metformin dose that you’re already taking.
  • If needed, your doctor may gradually increase your dose to reduce your chance for nausea, vomiting, and diarrhea from metformin.
  • The maximum daily dosage is 5 mg saxagliptin/ 2,000 mg metformin.
Child dosage (ages 0–17 years)

This medicine hasn’t been studied in children and shouldn’t be used in people younger than 18 years.

Senior dosage (ages 65 years and older)

Your body may process this drug more slowly. Your doctor may start you on a lowered dose so that too much of this drug doesn’t build up in your body. Too much of the drug in your body can be toxic.

Warnings

You may sometimes pass a soft mass in your stool that looks like saxagliptin/metformin. This doesn’t mean that the drug isn’t working.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.
Pharmacist's Advice
Healthline Pharmacist Editorial Team

This drug comes with serious risks if you don’t take it as prescribed.

If you don't take it at all or miss doses

If you stop taking this medication, miss doses, or don’t take it on schedule, your blood sugar levels will rise. Over time, high blood sugar levels can harm your eyes, kidneys, nerves, or heart. This can lead to heart attack, stroke, blindness, kidney failure and dialysis, and limb amputations.

If you take too much

If you take too much of this drug, call your doctor or local Poison Control Center, or go to the emergency room right away. If you take too much of this medication, your blood sugar may become too low (hypoglycemia). Symptoms of low blood sugar include:

  • shaking
  • sweating
  • rapid heart rate
  • changes in vision
  • intense hunger
  • headache
  • changes in mood

What to do if you miss a dose

If you forget to take your dose, skip the dose. Take your next dose of this drug as prescribed unless your doctor tells you differently.

Don’t take an extra dose the next day. This could cause toxic side effects.

How to tell if the drug is working

If this drug is working, your symptoms of high blood sugar should decrease. You may not urinate as often or be as thirsty or hungry. Your blood sugar readings will also be lower.

This drug is used for long-term treatment.

Important considerations for taking this drug

Don’t crush, cut, or chew this drug

This drug should be swallowed whole.

Store this drug carefully

  • Store this drug at room temperature between 59°F (15°C) and 86°F (30°C).
  • Don’t freeze this drug.
  • Keep this drug away from light.
  • Keep it away from high temperature.
  • Keep your drugs away from areas where they could get wet, such as bathrooms. Store this drug away from moisture and damp locations.

Travel

When traveling with your medication:

  • Always carry your medication with you or in your carry-on bag.
  • Don’t worry about airport x-ray machines. They can’t hurt this medication.
  • You may need to show airport staff your pharmacy’s label to clearly identify the medication. Keep the original prescription label with you when traveling.
  • This medication needs to be refrigerated. You may need to use an insulated bag with a cold pack to keep the temperature when traveling.
  • Don’t leave this medicine in the car, especially when the temperature is hot or freezing.

Self-management

You’ll need to test your blood sugar levels at home using a blood glucose monitor, and keep track of your readings. Your doctor may adjust your dose of this drug based on your blood sugar levels.

You’ll need to learn how to do the following:

  • use a blood glucose monitor to test your blood sugar regularly at home
  • recognize the signs and symptoms of high and low blood sugar
  • be able to treat low and high blood sugar reactions

While taking this drug, you’ll need to regularly test your blood sugar. You may need to purchase the following:

  • sterile alcohol wipes
  • lancing device and lancets (a pricking needle used to prick your finger to draw a drop of blood for testing blood sugar)
  • blood sugar test strips
  • blood glucose monitoring machine
  • needle container for safe disposal of lancets

Clinical monitoring

Before starting and while taking this drug, your doctor may check your:

  • blood sugar levels
  • glycosylated hemoglobin (A1C) levels. This test measures your blood sugar control over the last 2–3 months.
  • liver function. People with reduced liver function may have a higher risk of lactic acidosis.
    • kidney function. If you have kidney problems, you may be at an increased risk for lactic acidosis.
    • vitamin B12 levels. Metformin may lower your vitamin B12 levels.

Your doctor will also monitor you for signs of lactic acidosis and inflammation of your pancreas (pancreatitis).

Your diet

Managing type 2 diabetes well includes eating a healthy diet.

You should talk to your doctor about how to change your eating habits. In general, a healthy diet is made up of fruits, vegetables, whole grains, fiber-rich foods, fish, and good fats, such as avocados, almonds, and olives.

Hidden costs

In addition to the medicine, you may need to purchase the following:

  • sterile alcohol wipes
  • lancing device and lancets (pricking needles used to prick your finger to draw a drop of blood for testing blood sugar)
  • blood sugar test strips
  • blood glucose monitoring machine
  • needle container for safe disposal of lancets

Insurance

Many insurance companies will require a prior authorization before they approve the prescription and pay for this drug.

Are there any alternatives?

There are other drugs available to treat your condition. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.

What does the pill look like?

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Content developed in collaboration with University of Illinois-Chicago, Drug Information Group

Medically reviewed by Creighton University, Center for Drug Information and Evidence-Based Practice on September 8, 2015

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
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