Sitagliptin/Metformin Hydrochloride Extended-Release Tablets (Janumet XR) is a fixed-dose combination antihyperglycemic medication. It contains sitagliptin (a dipeptidyl peptidase-4 inhibitor) and metformin hydrochloride (a biguanide agent), and is specifically used to improve blood glucose control in adults with type 2 diabetes, as an adjunct to diet and exercise.

How to Use Sitagliptin/Metformin Hydrochloride Extended-Release Tablets (Janumet XR)

Indications and Recommended Dosage

Sitagliptin/Metformin Hydrochloride Extended-Release Tablets are indicated for the control of blood glucose in adult patients with type 2 diabetes.

The recommended dosage is once daily, taken orally with meals.

If a patient needs to take two tablets of Sitagliptin/Metformin Hydrochloride Extended-Release Tablets, both tablets should be taken together at one time.

Principles of Individualized Administration

The dosage should be adjusted individually based on the patient’s current medication regimen, therapeutic efficacy, and tolerability.

The maximum recommended daily dosage is 100 mg of sitagliptin and 2000 mg of metformin hydrochloride (as extended-release tablets).

For patients not currently receiving metformin treatment, the recommended starting dosage is 100 mg of sitagliptin and 1000 mg of metformin hydrochloride, taken once daily. A gradual increase in dosage is recommended to reduce metformin-related gastrointestinal side effects.

Dosage Adjustment of Sitagliptin/Metformin Hydrochloride Extended-Release Tablets (Janumet XR)

Dosage Adjustment Based on Renal Function

Before initiating treatment with Sitagliptin/Metformin Hydrochloride Extended-Release Tablets, renal function must be assessed by estimating the glomerular filtration rate (eGFR).

For patients with an eGFR of less than 45 mL/min/1.73 m², the dosage of the sitagliptin component should be limited to 50 mg once daily.

For patients taking immediate-release metformin hydrochloride at a dosage of 850 mg twice daily or 1000 mg twice daily, the recommended starting dosage of Sitagliptin/Metformin Hydrochloride Extended-Release Tablets is two tablets (each containing 50 mg of sitagliptin and 1000 mg of metformin hydrochloride), taken together once daily.

Administration in Special Populations for Sitagliptin/Metformin Hydrochloride Extended-Release Tablets (Janumet XR)

Patients with Renal Impairment

Sitagliptin/Metformin Hydrochloride Extended-Release Tablets are contraindicated in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m²).

If a patient’s eGFR subsequently decreases to less than 30 mL/min/1.73 m², Sitagliptin/Metformin Hydrochloride Extended-Release Tablets should be discontinued.

Initiation of Sitagliptin/Metformin Hydrochloride Extended-Release Tablets is not recommended for patients with an eGFR between 30 and 45 mL/min/1.73 m².

For patients with an eGFR between 30 and 60 mL/min/1.73 m², Sitagliptin/Metformin Hydrochloride Extended-Release Tablets should be discontinued at the time of, or prior to, undergoing imaging procedures involving the use of iodinated contrast agents.

Reassess eGFR 48 hours after the imaging procedure; if renal function remains stable, restart Sitagliptin/Metformin Hydrochloride Extended-Release Tablets.

Patients with Hepatic Impairment

Cases of metformin-associated lactic acidosis have been reported in patients with hepatic impairment.

This may be related to impaired lactate clearance, leading to elevated lactate levels in the blood.

The use of Sitagliptin/Metformin Hydrochloride Extended-Release Tablets should be avoided in patients with clinical or laboratory evidence of liver disease.