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Saxagliptin/Metformin HCL Extended-Release 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

Saxagliptin/Metformin HCL Extended-Release is a DPP4 inhibitor / Biguanide combination used to treat type 2 diabetes.

Saxagliptin/Metformin HCL Extended-Release is a combination of metformin (a biguanide) and saxagliptin (a DPP4 inhibitor). Saxagliptin/Metformin HCL Extended-Release 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.

The starting dose of Saxagliptin/Metformin HCL Extended-Release 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 Saxagliptin/Metformin HCL Extended-Release is 5 mg/2000 mg (saxagliptin/metformin) by mouth once daily with dinner.

Saxagliptin/Metformin HCL Extended-Release 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 Saxagliptin/Metformin HCL Extended-Release or saxagliptin

Common side effects of Saxagliptin/Metformin HCL Extended-Release:

• 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

Serious side effects are rare with Saxagliptin/Metformin HCL Extended-Release. 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

The following medications may interact with Saxagliptin/Metformin HCL Extended-Release:

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

Various FDA-approved generic manufacturers

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

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