TM Owner Merck & Co.
Janumet 50mg + 500mg Tablet
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Indications & Clinical Uses
- Janumet 50 mg/500 mg film-coated tablets contain two oral antidiabetic medicines: sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride, a biguanide.
- Janumet is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with Type 2 diabetes mellitus when treatment with both sitagliptin and metformin is appropriate.
- It is not for Type 1 diabetes and must not be used to treat diabetic ketoacidosis, and it has not been studied in people with a history of pancreatitis.
- Tablets are taken twice daily with meals; the usual starting dose for someone not already on metformin is 50 mg/500 mg twice daily, up to a maximum of 100 mg sitagliptin with 2000 mg metformin hydrochloride per day.
- Janumet is the immediate-release product taken twice daily and is NOT interchangeable with Janumet XR, the once-daily extended-release tablet.
- Janumet is also authorised in the European Union, held by Merck Sharp & Dohme B.V., Netherlands.
Side Effects
- The side effects reported most often with Janumet, in 5% or more of patients and more often than with placebo, are diarrhoea (about 7.5%), upper respiratory tract infection (about 6.2%) and headache (about 5.9%); nausea, vomiting, wind and abdominal discomfort from the metformin component are also frequent and usually ease if the tablets are taken with food.
- Janumet carries a BOXED WARNING for metformin-associated lactic acidosis: post-marketing cases have resulted in death, hypothermia, hypotension and resistant bradyarrhythmias.
- Stop Janumet and get emergency help for unusual muscle pain, difficulty breathing, unusual sleepiness, severe nausea or vomiting, feeling very cold, dizziness or a slow or irregular heartbeat.
- Also seek urgent care for severe persistent abdominal pain spreading to the back (possible acute pancreatitis), blistering or eroded skin (bullous pemphigoid), severe disabling joint pain, swelling of the face or tongue, or new breathlessness with ankle swelling.
Precautions & Warnings
- Kidney function must be assessed before starting Janumet and at least yearly afterwards; it is contraindicated when eGFR is below 30 mL/min/1.73 m2, in metabolic acidosis including diabetic ketoacidosis, and in anyone who has had a serious hypersensitivity reaction to Janumet, sitagliptin or metformin.
- The risk of lactic acidosis rises with renal impairment, age 65 or over, hepatic disease, hypoxic states, dehydration, surgery and excessive alcohol intake.
- Janumet is normally stopped at the time of, or before, an iodinated contrast imaging procedure when eGFR is 30 to 60 and restarted 48 hours later once kidney function has been rechecked, and it is also stopped before surgery with restricted food and fluid intake.
- Long-term metformin can lower vitamin B12, so B12 should be measured periodically, particularly with anaemia or nerve symptoms.
- Janumet alone rarely causes low blood sugar, but the risk rises with insulin or a sulfonylurea, which can affect driving.
Avoid Interactions
- Drugs and substances that INCREASE the risk of lactic acidosis or metformin toxicity: alcohol, which potentiates the effect of metformin on lactate metabolism, so binge drinking must be avoided; carbonic anhydrase inhibitors such as topiramate, acetazolamide and zonisamide; iodinated contrast media given for CT or angiography; and drugs that compete for renal cationic transport, including ranolazine, vandetanib, dolutegravir and cimetidine, which raise metformin blood levels.
- Combining Janumet with insulin or an insulin secretagogue such as a sulfonylurea increases the risk of hypoglycaemia, and the dose of those medicines often has to be reduced.
- Medicines that RAISE blood glucose, such as corticosteroids and thiazide diuretics, can reduce the benefit of Janumet and call for closer monitoring.
- Sitagliptin itself has no clinically meaningful interaction with digoxin, warfarin, simvastatin or oral contraceptives.
- Tell your prescriber about every medicine, herbal product and supplement, and about any planned scan or operation.
References
Frequently Asked Questions
Janumet (sitagliptin and metformin) is a twice-daily tablet used with diet and exercise to improve blood sugar control in adults with Type 2 diabetes. It is not for Type 1 diabetes or diabetic ketoacidosis. Sitagliptin boosts your own insulin after meals; metformin lowers the glucose made by your liver.
Take Janumet (sitagliptin/metformin) twice daily with meals to reduce stomach upset. The usual starting dose is one 50 mg/500 mg tablet twice a day, rising to a maximum of 100 mg sitagliptin and 2000 mg metformin daily. Swallow the tablets whole; do not split or crush them.
The commonest side effects of Janumet (sitagliptin/metformin) are diarrhoea (7.5%), upper respiratory infection (6.2%) and headache (5.9%). Its boxed warning is metformin-associated lactic acidosis, which can be fatal. Get emergency help for muscle pain, breathlessness, unusual sleepiness, feeling very cold, or a slow, irregular heartbeat.
Avoid heavy or binge drinking with Janumet (sitagliptin/metformin), because alcohol raises the risk of lactic acidosis. Tell your provider before any CT scan using contrast dye or any operation, as Janumet is usually paused. Take care with topiramate, acetazolamide, cimetidine, dolutegravir, insulin and sulfonylureas.
Kidney function (eGFR) is checked before Janumet (sitagliptin/metformin) starts and at least once a year, because the tablet is contraindicated below 30 mL/min/1.73 m2. HbA1c tracks blood sugar control, and vitamin B12 is measured periodically because long-term metformin can lower it.
No. Janumet (sitagliptin/metformin) is the immediate-release tablet taken twice daily with meals, while Janumet XR is an extended-release tablet taken once daily, usually with the evening meal. The two are not interchangeable tablet for tablet, so check the carton carefully before each dose.
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