Metformin and Saxagliptin

Metformin and Saxagliptin is a prescription medication used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. This medicine is not for treating type 1 diabetes. 

• Metformin and Saxagliptin are available under various brand names: Kombiglyze XR 

Common side effects of Metformin and Saxagliptin include:

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

Serious side effects of Metformin and Saxagliptin include:

• hives, itching, peeling skin; difficult breathing; swelling of the face, lips, tongue, or throat.
• severe pain in the upper stomach spreading to the back, nausea and vomiting, loss of appetite, or fast heartbeats.
• unusual muscle pain.
• feeling cold.
• trouble breathing.
• feeling dizzy, light-headed, tired, or very weak;
• stomach pain, vomiting;
• irregular heart rate,
• severe autoimmune reaction--itching, blisters, breakdown of the outer layer of skin;
• severe or ongoing pain in the joints;
• pain or burning while urinating; or
• symptoms of heart failure--shortness of breath (even while lying down), swelling in the legs or feet, rapid weight gain.

Rare side effects of Metformin and Saxagliptin include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet, Extended Release

• 5 mg/500 mg
• 2.5 mg/1000 mg
• 5 mg/1000 mg

Diabetes mellitus, type 2

Adult dosage

• Oral: Maximum: Saxagliptin 5 mg/metformin 2 g ER per day.
• Patients inadequately controlled on metformin alone:
• Oral: Initial: Saxagliptin 2.5 to 5 mg once daily plus the current daily dose of metformin. Patients who require saxagliptin 2.5 mg and metformin above 1 g/day should not be switched to the combination product.
• Oral: Initial: Saxagliptin 5 mg/metformin 500 mg ER once daily. Patients who require saxagliptin 2.5 mg and are metformin naive or require metformin above 1 g/day should not be switched to the combination product.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Metformin and Saxagliptin have severe interactions with no other drugs.
• Metformin and Saxagliptin have serious interactions with at least 26 other drugs.
• Metformin and Saxagliptin have moderate interactions with at least 249 other drugs.
• Metformin and Saxagliptin have minor interactions with at least 138 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to metformin or saxagliptin (Onglyza), or if you have severe kidney disease or diabetic ketoacidosis 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Metformin and Saxagliptin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Metformin and Saxagliptin?”

Cautions

• You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.
• 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 may need to temporarily stop taking metformin and saxagliptin. Be sure your caregivers know ahead of time that you are using this medication.
• Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Pregnancy and Lactation

• Follow your doctor's instructions about using Metformin and Saxagliptin if you are pregnant, or you become pregnant. Controlling diabetes is very important during pregnancy and having high blood sugar may cause complications in both the mother and the baby.
• Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.
• Lactation
  • It may not be safe to breastfeed while using Metformin and Saxagliptin. Ask your doctor about any risks.