displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
Glipizide and metformin hydrochloride tablets contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes, glipizide and metformin hydrochloride.
Glipizide is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea. Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. The structural formula is represented below.
C21H27N5O4S M.W. 445.55
Metformin hydrochloride is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide monohydrochloride) is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or α-glucosidase inhibitors. It is a white to off-white crystalline compound. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is as shown:
C4H12ClN5 M.W. 165.63
Glipizide and metformin hydrochloride is available for oral administration in tablets containing 2.5 mg glipizide with 250 mg metformin hydrochloride, 2.5 mg glipizide with 500 mg metformin hydrochloride, and 5 mg glipizide with 500 mg metformin hydrochloride. In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol-part. hydrolyzed, povidone, starch, talc, and titanium dioxide. Additionally, 2.5 mg/250 mg and 5 mg/500 mg tablets contain iron oxide black, iron oxide red, and iron oxide yellow. The tablets are film-coated, which provides color differentiation.
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Glipizide and metformin hydrochloride tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
Glipizide and metformin hydrochloride tablets are contraindicated in patients with:
Glipizide and metformin hydrochloride tablets should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function (see also PRECAUTIONS).
- Renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels ≥ 1.5 mg/dL [males], ≥ 1.4 mg/dL [females], or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS).
- Known hypersensitivity to glipizide or metformin hydrochloride.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
Glipizide and metformin hydrochloride tablets are available as follows:
2.5 mg/250 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7455” on the other in:
bottles of 100 (NDC 54868-0795-0).
2.5 mg/500 mg are white, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7456” on the other in:
bottles of 10 (NDC 54868-5188-1)
bottles of 30 (NDC 54868-5188-0)
bottles of 60 (NDC 54868-5188-2).
5 mg/500 mg are pink, film-coated, modified capsule-shaped tablets, debossed with the “93” on one side and “7457” on the other in:
bottles of 10 (NDC 54868-5467-1)
bottles of 30 (NDC 54868-5467-0)
bottles of 60 (NDC 54868-5467-2).
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Manufactured In Israel By:
TEVA PHARMACEUTICAL IND. LTD.
Jerusalem, 91010, Israel
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. D 10/2009
Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146
displayName: SPL PATIENT PACKAGE INSERT SECTION
FDA Article Code: 42230-3
Glipizide and Metformin Hydrochloride Tablets
PRINCIPAL DISPLAY PANELS
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4