"The U.S. Food and Drug Administration today approved Farxiga (dapaglifozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes.
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JANUMET® XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both sitagliptin and metformin extended-release is appropriate. [See Clinical Studies.]
Important Limitations Of Use
JANUMET XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using JANUMET XR. [See WARNINGS AND PRECAUTIONS.]
DOSAGE AND ADMINISTRATION
The dose of JANUMET XR should be individualized on the basis of the patient's current regimen, effectiveness, and tolerability while not exceeding the maximum recommended daily dose of 100 mg sitagliptin and 2000 mg metformin. Initial combination therapy or maintenance of combination therapy should be individualized and left to the discretion of the healthcare provider.
- In patients not currently treated with metformin, the recommended total daily starting dose of JANUMET XR is 100 mg sitagliptin and 1000 mg metformin hydrochloride (HCl) extended-release. Patients with inadequate glycemic control on this dose of metformin can be titrated gradually, to reduce gastrointestinal side effects associated with metformin, up to the maximum recommended daily dose.
- In patients already treated with metformin, the recommended total daily starting dose of JANUMET XR is 100 mg sitagliptin and the previously prescribed dose of metformin.
- For patients taking metformin immediate-release 850 mg twice daily or 1000 mg twice daily, the recommended starting dose of JANUMET XR is two 50 mg sitagliptin/1000 mg metformin hydrochloride extended-release tablets taken together once daily.
- Maintain the same total daily dose of sitagliptin and metformin when changing between JANUMET (sitagliptin and metformin HCl immediate-release) and JANUMET XR. Patients with inadequate glycemic control on this dose of metformin can be titrated gradually, to reduce gastrointestinal side effects associated with metformin, up to the maximum recommended daily dose.
JANUMET XR should be administered with food to reduce the gastrointestinal side effects associated with the metformin component. JANUMET XR should be given once daily with a meal preferably in the evening. JANUMET XR should be swallowed whole. The tablets must not be split, crushed, or chewed before swallowing. There have been reports of incompletely dissolved JANUMET XR tablets being eliminated in the feces. It is not known whether this material seen in feces contains active drug. If a patient reports repeatedly seeing tablets in feces, the healthcare provider should assess adequacy of glycemic control [see PATIENT INFORMATION].
The 100 mg sitagliptin/1000 mg metformin hydrochloride extended-release tablet should be taken as a single tablet once daily. Patients using two JANUMET XR tablets (such as two 50 mg sitagliptin/500 mg metformin hydrochloride extended-release tablets or two 50 mg sitagliptin/1000 mg metformin hydrochloride extended-release tablets) should take the two tablets together once daily.
No studies have been performed specifically examining the safety and efficacy of JANUMET XR in patients previously treated with other oral antihyperglycemic agents and switched to JANUMET XR. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
Recommendations For Use In Renal Impairment
Assess renal function prior to initiation of JANUMET XR and periodically thereafter.
JANUMET XR is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2. Discontinue JANUMET XR if the patient's eGFR later falls below 30 mL/min/1.73 m2 [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].
Initiation of JANUMET XR in patients with an eGFR between 30 and 45 mL/min/1.73 m2 is not recommended.
In patients taking JANUMET XR whose eGFR later falls below 45 mL/min/1.73 m2, assess the benefit risk of continuing therapy and limit dose of the sitagliptin component to 50 mg once daily.
Discontinuation For Iodinated Contrast Imaging Procedures
Discontinue JANUMET XR at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism, or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Reevaluate eGFR 48 hours after the imaging procedure; restart JANUMET XR if renal function is stable [see Use In Specific Populations].
Dosage Forms And Strengths
- 100 mg/1000 mg tablets are blue, bi-convex oval, film-coated tablets with “81” debossed on one side.
- 50 mg/500 mg tablets are light blue, bi-convex oval, film-coated tablets with “78” debossed on one side.
- 50 mg/1000 mg tablets are light green, bi-convex oval, film-coated tablets with “80” debossed on one side.
Storage And Handling
No. 3961 - Tablets JANUMET XR, 50 mg/500 mg, are light blue, bi-convex oval, film-coated tablets with “78” debossed on one side. They are supplied as follows:
NDC 0006-0078-61 unit-of-use bottles of 60
NDC 0006-0078-62 unit-of-use bottles of 180
NDC 0006-0078-82 bulk bottles of 1000.
No. 3962 - Tablets JANUMET XR, 50 mg/1000 mg, are light green, bi-convex oval, film-coated tablets with “80” debossed on one side. They are supplied as follows:
NDC 0006-0080-61 unit-of-use bottles of 60
NDC 0006-0080-62 unit-of-use bottles of 180
NDC 0006-0080-82 bulk bottles of 1000.
No. 3963 - Tablets JANUMET XR, 100 mg/1000 mg, are blue, bi-convex oval, film-coated tablets with “81” debossed on one side. They are supplied as follows:
NDC 0006-0081-31 unit-of-use bottles of 30
NDC 0006-0081-54 unit-of-use bottles of 90
NDC 0006-0081-82 bulk bottles of 1000.
Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature.] Store in a dry place with cap tightly closed. When container is subdivided, dispense into a USP tightly closed, moisture-resistant container.
Distributed by: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 0888 USA. Revised: Jan 2017This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/31/2017
Additional Janumet XR Information
- Janumet XR Drug Interactions Center: sitagliptin-metformin oral
- Janumet XR Side Effects Center
- Janumet XR FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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