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metformin and saxagliptin

Pronunciation: met FOR min and SAX a GLIP tin

Brand: Kombiglyze XR

Kombiglyze 2.5 mg-1000 mg

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Kombiglyze 5 mg-1000 mg

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Kombiglyze 5 mg-500 mg

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What is the most important information I should know about metformin and saxagliptin?

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You should not use this medication if you are allergic to metformin (Actoplus Met, Avandamet, Fortamet, Glucophage, Riomet) or saxagliptin (Onglyza), if you have kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking metformin and saxagliptin.

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Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or irregular heart rate, dizziness, or feeling very weak or tired.

What is metformin and saxagliptin?

Metformin and saxagliptin are oral diabetes medicines that help control blood sugar levels. Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Saxagliptin works by regulating the levels of insulin your body produces after eating.

The combination of metformin and saxagliptin is used to treat type 2 diabetes. This medication is not for treating type 1 diabetes.

Metformin and saxagliptin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking metformin and saxagliptin?

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Some people develop a life-threatening condition called lactic acidosis while taking metformin. You may be more likely to develop lactic acidosis if you have liver or kidney disease, heart attack or congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol.

Multum donot

Do not use this medication if you are allergic to metformin (Actoplus Met, Avandamet, Fortamet, Glucophage, Riomet) or saxagliptin (Onglyza), if you have kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking metformin and saxagliptin. Be sure your caregivers know ahead of time that you are using this medication.

To make sure you can safely take metformin and saxagliptin, tell your doctor if you have any of these other conditions:

  • liver disease;
  • heart disease; or
  • if you are over 80 years old;
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Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with metformin and saxagliptin.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

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It is not known whether metformin and saxagliptin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take metformin and saxagliptin?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

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Take metformin and saxagliptin with a meal.

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Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

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Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating.

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

Multum donot

Ask your doctor how to adjust your metformin and saxagliptin dose if needed. Do not change your medication dose or schedule without your doctor's advice.

Metformin and saxagliptin is only part of a complete program of treatment that may also include diet, exercise, weight control, foot care, and eye care. Follow your diet, medication, and exercise routines very closely.

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Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

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An overdose of metformin may cause lactic acidosis. Get emergency medical help if you have: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.

What should I avoid while taking metformin and saxagliptin?

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Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

What are the possible side effects of metformin and saxagliptin?

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This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or irregular heart rate, dizziness, or feeling very weak or tired.

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

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Stop using this medicine and call your doctor at once if you have a serious side effect such as:

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
  • pain or burning when you urinate; or
  • swelling or rapid weight gain.

Less serious side effects may include:

  • diarrhea, mild nausea;
  • headache; or
  • cold symptoms such as runny or stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect metformin and saxagliptin?

Tell your doctor about all other medicines you use, especially:

  • an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), telithromycin (Ketek), trimethoprim (Proloprim, Primsol, Bactrim, Cotrim, Septra), or vancomycin (Vancocin, Lyphocin);
  • antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
  • heart or blood pressure medication such as amiloride (Midamor), digoxin (Lanoxin), diltiazem (Cartia, Cardizem), furosemide (Lasix), nifedipine (Nifedical), procainamide (Procan, Pronestyl, Procanbid), quinidine (Quin-G), triamterene (Dyrenium), and others; or
  • HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra).

You may be more likely to have hyperglycemia (high blood sugar) if you take metformin and saxagliptin with other drugs that can raise blood sugar, such as:

  • diuretics (water pills);
  • steroids (prednisone and others);
  • niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);
  • phenothiazines (Compazine and others);
  • thyroid medicine (Synthroid and others);
  • birth control pills and other hormones;
  • seizure medicines (Dilantin and others); or
  • diet pills or medicines to treat asthma, colds or allergies.

You may be more likely to have hypoglycemia (low blood sugar) if you take metformin and saxagliptin with other drugs that can lower blood sugar, such as:

  • some nonsteroidal anti-inflammatory drugs (NSAIDs);
  • aspirin or other salicylates (including Pepto-Bismol);
  • a blood thinner (warfarin, Coumadin, Jantoven, and others);
  • heart or blood pressure medication (Accupril, Altace, Lotensin, Prinivil, Vasotec, Zestril, and others);
  • sulfa drugs (Bactrim, Septra, Sulfatrim, SMX-TMP, and others);
  • a monoamine oxidase inhibitor (MAOI); or
  • insulin or another oral diabetes medication, such as acarbose (Precose), chlorpropamide (Diabinese), glipizide (Glucotrol, Metaglip), glimepiride (Amaryl, Avandaryl, Duetact), glyburide (DiaBeta, Micronase, Glucovance), metformin (Glucophage), miglitol (Glyset), pioglitazone (Actos), rosiglitazone (Avandia), tolazamide (Tolinase), or tolbutamide (Orinase).

These lists are not complete and there are many other medicines that can increase or decrease the effects of metformin and saxagliptin on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about metformin and saxagliptin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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