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Kombiglyze XR 5mg/1000mg Tablet
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Indications & Clinical Uses
- Kombiglyze XR 5 mg/1000 mg is no longer marketed in the United States: all three strengths are listed as discontinued in the FDA's Drugs@FDA database under NDA 200678, with a Federal Register determination that the product was not withdrawn for safety or effectiveness reasons.
- It is a fixed-dose tablet combining saxagliptin, a DPP-4 inhibitor, with extended-release metformin hydrochloride, approved as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.
- It is not for type 1 diabetes or diabetic ketoacidosis.
- The extended-release tablet is taken once daily with the evening meal and is not interchangeable with the European brand Komboglyze, which contains immediate-release metformin and is taken twice daily with meals.
- Saxagliptin on its own is marketed as Onglyza.
Side Effects
- Kombiglyze XR carries a boxed warning for lactic acidosis: metformin can accumulate and cause a rare but potentially fatal build-up of acid, with reported deaths, low body temperature, low blood pressure and slow heartbeat.
- Get urgent help for unusual tiredness, muscle cramps, difficulty breathing, stomach pain, feeling cold or a slow or irregular pulse.
- Common side effects are upper respiratory tract infection, urinary tract infection, headache, nasopharyngitis, diarrhoea, nausea and vomiting; stomach upset from metformin often settles with time.
- Serious reactions include acute pancreatitis, with severe persistent abdominal pain spreading to the back, heart failure with breathlessness or swelling, severe disabling joint pain, blistering skin disease known as bullous pemphigoid, and allergic reactions with rash or facial swelling.
- Low blood sugar (hypoglycaemia) is mainly a risk when it is combined with insulin or a sulfonylurea.
Precautions & Warnings
- Kombiglyze XR must not be used if your eGFR is below 30 mL/min/1.73 m2, or if you have metabolic acidosis or diabetic ketoacidosis.
- Kidney function is checked before treatment and at least yearly, and more often if you are over 65 or take medicines that affect the kidneys.
- Treatment is stopped before imaging with iodinated contrast dye or before surgery, and restarted only once kidney function is confirmed stable.
- Tell your provider about heart failure, liver disease, alcohol use or any history of pancreatitis.
- Swallow the tablet whole with the evening meal; never split, crush or chew it, and an empty tablet shell may appear in the stool.
- Vitamin B12 should be measured periodically because metformin can lower it.
- Insulin or sulfonylurea doses may need reducing.
- It is not recommended in pregnancy or breastfeeding.
Avoid Interactions
- Alcohol increases the risk of lactic acidosis with the metformin in Kombiglyze XR and should be limited; binge drinking is dangerous.
- Carbonic anhydrase inhibitors such as topiramate and acetazolamide, iodinated contrast dye and medicines that reduce blood flow to the kidneys also raise that risk.
- Cationic drugs cleared by the kidneys, including ranolazine, vandetanib, dolutegravir and cimetidine, can raise metformin levels.
- Strong CYP3A4/5 inhibitors such as ketoconazole, itraconazole, clarithromycin, ritonavir and nefazodone increase saxagliptin exposure, so the saxagliptin dose is limited to 2.5 mg daily.
- Insulin and sulfonylureas increase the chance of low blood sugar and often need a lower dose.
- Efficacy is reduced by strong CYP3A4/5 inducers such as rifampicin, and by corticosteroids, diuretics and other medicines that raise blood sugar.
- Tell your provider about all medicines and supplements.
References
Frequently Asked Questions
Kombiglyze XR (saxagliptin with extended-release metformin) lowers blood sugar in adults with type 2 diabetes, alongside diet and exercise. It is not used for type 1 diabetes. The brand is discontinued in the United States, though Drugs@FDA records that it was not withdrawn for safety or effectiveness reasons.
Kombiglyze XR is taken as one tablet once daily with the evening meal. Swallow it whole: never split, crush or chew the extended-release tablet. A soft tablet shell may appear in your stool, which is normal. The maximum daily dose is 5 mg saxagliptin with 2000 mg metformin.
Common side effects of Kombiglyze XR are upper respiratory and urinary tract infections, headache, diarrhoea and nausea. Its boxed warning is lactic acidosis from metformin, which can be fatal. Get urgent help for unusual tiredness, muscle cramps, breathlessness, feeling cold, or severe stomach pain spreading to the back.
Limit alcohol, which raises the risk of lactic acidosis with metformin. Kombiglyze XR is stopped before scans using iodinated contrast dye and before surgery, and must not be used if your eGFR is below 30. Strong CYP3A4 inhibitors such as ketoconazole mean the saxagliptin dose is capped at 2.5 mg.
Kidney function is checked before starting Kombiglyze XR and at least once a year, more often if you are over 65 or take medicines affecting the kidneys. HbA1c tracks blood sugar control, and vitamin B12 is measured periodically because metformin can lower it over time.
Komboglyze is the European brand of saxagliptin with immediate-release metformin, taken twice daily with meals. Kombiglyze XR contains extended-release metformin and is taken once daily with the evening meal. The two are not interchangeable, and the similar names can lead to the wrong dosing frequency.
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