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Manufactured by Bristol-Myers Squibb

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KOMBIGLYZE XR Uses, Side Effects, Interactions, Warnings & Dosing



KOMBIGLYZE XR is the brand name for saxagliptin and metformin HCl and is available as an extended-release tablet.

What dosages is KOMBIGLYZE XR available in?

What dosages is KOMBIGLYZE XR available in?

KOMBIGLYZE XR is available as an extended-release tablet that contains one of the following combinations:

  • 5 mg saxagliptin/500 mg metformin HCl
  • 5 mg saxagliptin/1000 mg metformin HCl
  • 2.5 mg saxagliptin/1000 mg metformin HCl
What is KOMBIGLYZE XR used for?

What is KOMBIGLYZE XR used for?

KOMBIGLYZE XR is a DPP4 inhibitor / Biguanide combination used to treat type 2 diabetes.

How does KOMBIGLYZE XR work?

How does KOMBIGLYZE XR work?

KOMBIGLYZE XR is a combination of metformin (a biguanide) and saxagliptin (a DPP4 inhibitor). KOMBIGLYZE XR works by lowering the amount of sugar made by your liver, decreasing the amount of sugar absorbed by your intestine, increasing the amount of insulin your body makes, and helps your body respond better to insulin.

How do I take KOMBIGLYZE XR?

How do I take KOMBIGLYZE XR?

The starting dose of KOMBIGLYZE XR depends on what medications you are currently taking for diabetes. Depending on how you respond, your healthcare provider will adjust your dose. The maximum dose for KOMBIGLYZE XR is 5 mg/2000 mg (saxagliptin/metformin) by mouth once daily with dinner.

Is it safe for me to take KOMBIGLYZE XR?

Is it safe for me to take KOMBIGLYZE XR?

KOMBIGLYZE XR is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication in the following:

  • Renal impairment
  • Hypersensitivity to metformin hydrochloride
    Metabolic acidosis, including diabetic ketoacidosis
  • History of a serious hypersensitivity reaction (e.g., anaphylaxis, angioedema, exfoliative skin conditions) to KOMBIGLYZE XR or saxagliptin
KOMBIGLYZE XR Common Side Effects

KOMBIGLYZE XR Common Side Effects

Common side effects of KOMBIGLYZE XR:

  • Diarrhea
  • Nausea and vomiting
  • Headache
  • Upper respiratory tract infection (a viral infection that affects the nose, throat, and airways)
  • Bladder infection
  • Runny or stuffy nose and sore throat
KOMBIGLYZE XR Serious Side Effects

KOMBIGLYZE XR Serious Side Effects

Serious side effects are rare with KOMBIGLYZE XR. Contact your healthcare provider immediately if you experience any of the following.

  • Build up of lactic acid in the blood (feeling of increased tiredness and weakness, stomach pain, muscle pain, increased sleepiness, breathing problems)
  • Signs of an allergic reaction like trouble breathing or swallowing, swelling (of your face, lips, tongue, or throat), peeling skin, rash, or hives
  • Inflammation of the pancreas (severe and persistent stomach pain, back pain, vomiting)
  • Heart failure (feeling out of breath, swelling of your feet, ankles or legs, fast increase in weight)
  • Large fluid-filled blisters on the skin
Effects of other drugs, drug classes and over-the-counter products on KOMBIGLYZE XR

Effects of other drugs, drug classes and over-the-counter products on KOMBIGLYZE XR

The following medications may interact with KOMBIGLYZE XR:

  • Coadministration with strong CYP3A4/5 inhibitors (e.g., ketoconazole) significantly increases saxagliptin concentrations. Limit
  • KOMBIGLYZE XR dose to 2.5 mg/1000 mg once daily
  • Cationic drugs eliminated by renal tubular secretion may reduce metformin elimination: use with caution


Bristol-Myers Squibb

Is KOMBIGLYZE XR safe in pregnancy?

Is KOMBIGLYZE XR safe in pregnancy?

There are no adequate and well-controlled studies in pregnant women with KOMBIGLYZE XR or its individual components. Because animal reproduction studies are not always predictive of
human response, KOMBIGLYZE XR, like other antidiabetic medications, should be used during pregnancy only if clearly needed


What to do if you missed your KOMBIGLYZE XR dose

The FDA's medical product safety reporting program for health professionals, patients and consumers.

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NowPatient has taken all reasonable steps to ensure that all material is factually accurate, complete, and current. However, the knowledge and experience of a qualified healthcare professional should always be sought after instead of using the information on this page. Before taking any drug, you should always speak to your doctor or another qualified healthcare provider.

The information provided here about medications is subject to change and is not meant to include all uses, precautions, warnings, directions, drug interactions, allergic reactions, or negative effects. The absence of warnings or other information for a particular medication does not imply that the medication or medication combination is appropriate for all patients or for all possible purposes.

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