Description
Janumet XR cp
Janumet XR cp is an extended-release oral medicine for type 2 diabetes. It combines sitagliptin and metformin hydrochloride in one tablet. The verified 100 mg/1000 mg strength corresponds to 100 mg sitagliptin and 1000 mg metformin hydrochloride extended-release. It is intended to improve glycaemic control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise.
Active Ingredient and Medicine Class
Janumet XR contains two antihyperglycaemic agents: sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin, a biguanide. The product is an extended-release combination tablet.
Established Medical Uses
Regulatory labelling supports use in adults with type 2 diabetes mellitus to improve blood glucose control. It is not indicated for type 1 diabetes, and it has not been studied in people with a history of pancreatitis.
How It Works
Sitagliptin inhibits DPP-4, which helps increase the activity of incretin hormones involved in glucose regulation. Metformin is a biguanide that helps lower glucose production by the liver and improve insulin sensitivity. Used together, they target blood sugar control through complementary mechanisms.
Important Safety Information
Key safety concerns include metformin-associated lactic acidosis risk, especially in significant kidney impairment. The FDA label states Janumet XR should not be used when eGFR is below 30 mL/min/1.73 m², should not be initiated at eGFR 30 to 45 mL/min/1.73 m², and requires reassessment if kidney function later falls below 45 mL/min/1.73 m². Important contraindications include severe renal impairment, metabolic acidosis, and hypersensitivity reactions to either component. Serious pancreatitis has been reported with DPP-4 inhibitors, and renal function should be assessed before use. Clinically significant interactions may occur with drugs that affect kidney function or increase the risk of lactic acidosis.
Possible Side Effects
Common adverse effects include gastrointestinal symptoms such as nausea, diarrhoea, abdominal discomfort and vomiting, largely related to metformin. Other recognised reactions include headache, upper respiratory symptoms and hypoglycaemia when used with other glucose-lowering medicines. Serious reactions can include pancreatitis, severe allergic reactions, and lactic acidosis.
Scientific Evidence
Peer-reviewed reviews support the clinical rationale for combining sitagliptin with metformin in type 2 diabetes, with complementary glucose-lowering effects and generally acceptable tolerability in appropriate patients. Reviews of metformin extended-release formulations also support their use as a well-established option for glycaemic control, while noting the main limitation of gastrointestinal adverse effects.
Medical Information Notice
This educational summary is based on sources available at the time of review and does not replace the official patient leaflet or individual assessment by a qualified healthcare professional.
Medical Sources
- U.S. Food and Drug Administration / DailyMed: JANUMET XR (sitagliptin and metformin hydrochloride extended-release) prescribing information. View source
- U.S. Food and Drug Administration: JANUMET XR prescribing information PDF. View source
- Deacon CF, Lebovitz HE, et al.: Sitagliptin/metformin fixed-dose combination in type 2 diabetes mellitus: an evidence-based review of its place in therapy. Diabetes, Metabolic Syndrome and Obesity. 2016. PubMed