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GLUMETZA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Important Limitations Of Use
GLUMETZA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.
DOSAGE AND ADMINISTRATION
GLUMETZA should be taken once daily with the evening meal. The dosage of GLUMETZA must be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended daily dose of 2000 mg. The starting dose of GLUMETZA in patients who are not currently taking metformin is 500 mg once daily, with the evening meal. The dose can be uptitrated in 500 mg increments no sooner than every 1-2 weeks if a higher dose of GLUMETZA is needed and there are no gastrointestinal adverse reactions.
If GLUMETZA is considered appropriate for a patient already receiving immediate-release metformin, the patient can be switched to GLUMETZA once daily at the same total daily dose, up to 2000 mg once daily.
GLUMETZA tablets must be swallowed whole and never split, crushed or chewed. Occasionally, the inactive ingredients of GLUMETZA 500 mg may be eliminated in the feces as a soft, hydrated mass, while the 1000 mg may leave an insoluble shell that may resemble the original tablet. If a dose of GLUMETZA is missed, patients should be cautioned against taking two doses of 2000 mg the same day. Resume dosing as according to prescribing recommendations. (See PATIENT INFORMATION)
Patients Treated With An Insulin Secretagogue Or Insulin
Co-administration of GLUMETZA 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
Dosage Forms And Strengths
GLUMETZA (metformin hydrochloride extended-release tablets) 500 mg are available as blue, film coated, ovalshaped tablets debossed with “GMZ” on one side and “500” on the other side.
GLUMETZA (metformin hydrochloride extended-release tablets) 1000 mg are available as white, film coated, ovalshaped tablets with “M1000” on one side.
Storage And Handling
GLUMETZA tablets - 500 mg are available as blue, film coated, oval-shaped tablets debossed with “GMZ” on one side and “500” on the other side.
GLUMETZA tablets 1000 mg are available as white, film coated, oval-shaped tablets with “M1000” on one side.
They are supplied as follows:
|Bottles of 100||500 mg||68012-002-13|
|Bottles of 90||1000 mg||68012-003-16|
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F); see [USP Controlled Room Temperature].
Manufactured for Santarus, Inc., a wholly owned subsidiary of Salix Pharmaceuticals, Raleigh, NC 27615. Revised: Sep 2014This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/27/2016
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