"The U.S. Food and Drug Administration today approved Trulicity (dulaglutide), a once-weekly subcutaneous injection to improve glycemic control (blood sugar levels), along with diet and exercise, in adults with type 2 diabetes.
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JANUMET 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 is appropriate. [See Clinical Studies]
Important Limitations of Use
JANUMET 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. [See WARNINGS AND PRECAUTIONS]
DOSAGE AND ADMINISTRATION
The dosage of JANUMET 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 health care provider.
JANUMET should generally be given twice daily with meals, with gradual dose escalation, to reduce the gastrointestinal (GI) side effects due to metformin.
The starting dose of JANUMET should be based on the patient's current regimen. JANUMET should be given twice daily with meals. The following doses are available:
50 mg sitagliptin/500 mg metformin hydrochloride
50 mg sitagliptin/1000 mg metformin hydrochloride.
The recommended starting dose in patients not currently treated with metformin is 50 mg sitagliptin/500 mg metformin hydrochloride twice daily, with gradual dose escalation recommended to reduce gastrointestinal side effects associated with metformin.
The starting dose in patients already treated with metformin should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and the dose of metformin already being taken. For patients taking metformin 850 mg twice daily, the recommended starting dose of JANUMET is 50 mg sitagliptin/1000 mg metformin hydrochloride twice daily.
Patients treated with an insulin secretagogue or insulin
Co-administration of JANUMET with an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia [see WARNINGS AND PRECAUTIONS].
No studies have been performed specifically examining the safety and efficacy of JANUMET in patients previously treated with other oral antihyperglycemic agents and switched to JANUMET. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring as changes in glycemic control can occur.
Dosage Forms And Strengths
- 50 mg/500 mg tablets are light pink, capsule-shaped, film-coated tablets with “575” debossed on one side.
- 50 mg/1000 mg tablets are red, capsule-shaped, film-coated tablets with “577” debossed on one side.
Storage And Handling
No. 6747 — Tablets JANUMET, 50 mg/500 mg, are light pink, capsule-shaped, film-coated tablets with “575” debossed on one side. They are supplied as follows:
NDC 0006-0575-61 unit-of-use bottles of 60
NDC 0006-0575-62 unit-of-use bottles of 180
NDC 0006-0575-52 unit dose blister packages of 50
NDC 0006-0575-82 bulk bottles of 1000.
No. 6749 — Tablets JANUMET, 50 mg/1000 mg, are red, capsule-shaped, film-coated tablets with “577” debossed on one side. They are supplied as follows:
NDC 0006-0577-61 unit-of-use bottles of 60
NDC 0006-0577-62 unit-of-use bottles of 180
NDC 0006-0577-52 unit dose blister packages of 50
NDC 0006-0577-82 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].
Dist. by : Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA
Last reviewed on RxList: 11/8/2012
This monograph has been modified to include the generic and brand name in many instances.
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