Generic Name: metformin and saxagliptin (met FOR min and SAX a GLIP tin)
Brand Names: Kombiglyze XR
What is Kombiglyze XR?
Kombiglyze XR contains a combination of 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.
Kombiglyze XR is used to treat type 2 diabetes. Kombiglyze XR is not for treating type 1 diabetes.
Kombiglyze XR may also be used for purposes not listed in this medication guide.
Important information about Kombiglyze XR
You should not use Kombiglyze XR 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 Kombiglyze XR.
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.
Before taking Kombiglyze XR
Do not use Kombiglyze XR 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).
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.
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 Kombiglyze XR. Be sure your caregivers know ahead of time that you are using this medication.
To make sure you can safely take Kombiglyze XR, tell your doctor if you have any of these other conditions.
heart disease; or
if you are over 80 years old;
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 Kombiglyze XR.
FDA pregnancy category B. Kombiglyze XR is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether metformin and saxagliptin passes into breast milk or if it could harm a nursing baby. Do not use Kombiglyze XR without telling your doctor if you are breast-feeding a baby.
See also: Kombiglyze XR pregnancy and breastfeeding warnings (in more detail)
How should I take Kombiglyze XR?
Take Kombiglyze XR 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.
Take Kombiglyze XR with a meal. Do not crush, chew, or break an extended-release Kombiglyze XR tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time. 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.
Ask your doctor how to adjust your Kombiglyze XR dose if needed. Do not change your medication dose or schedule without your doctor's advice.
Kombiglyze XR 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.
Store Kombiglyze XR at room temperature away from moisture and heat.
See also: Kombiglyze XR dosage (in more detail)
What happens if I miss a dose?
Take the missed dose as soon as you remember (be sure to take Kombiglyze XR 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?
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). 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 Kombiglyze XR?
Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.
Kombiglyze XR side effects
Kombiglyze XR 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. Get emergency medical help if you have any of these signs of an allergic reaction to Kombiglyze XR: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using Kombiglyze XR 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 Kombiglyze XR side effects may include:
diarrhea, mild nausea;
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.
See also: Kombiglyze XR side effects (in more detail)
What other drugs will affect Kombiglyze XR?
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 Kombiglyze XR 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 Kombiglyze XR 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 Kombiglyze XR 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.
More Kombiglyze XR resources
- Kombiglyze XR Prescribing Information (FDA)
- Kombiglyze XR Advanced Consumer (Micromedex) - Includes Dosage Information
- Kombiglyze XR extended-release tablets MedFacts Consumer Leaflet (Wolters Kluwer)
Compare Kombiglyze XR with other medications
Where can I get more information?
- Your pharmacist can provide more information about Kombiglyze XR.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Kombiglyze XR only for the indication prescribed.
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.
Copyright 1996-2012 Cerner Multum, Inc. Version: 3.02. Revision Date: 2012-05-11, 1:36:59 PM.