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Buy Metaglip (Glipizide, Metformin Hydrochloride) antidiabetic medication
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METAGLIP (GLIPIZIDE, METFORMIN HCL) TABLETS: PRESCRIBING INFORMATION

DESCRIPTION

Metaglip (Glipizide and Metformin HCl) 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 molecular formula of C21H27N5O4S, a molecular weight of 445.55 and 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.

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 alpha-glucosidase inhibitors. It is a white to off-white crystalline compound with a molecular formula of C4H12ClN5 (monohydrochloride) and a molecular weight of 165.63. 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.

Metaglip 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: povidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate. The tablets are film coated, which provides color differentiation.


CLINICAL PHARMACOLOGY

Mechanism of Action

Metaglip combines glipizide and metformin hydrochloride, 2 antihyperglycemic agents with complementary mechanisms of action, to improve glycemic control in patients with type 2 diabetes.

Glipizide appears to lower blood glucose acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. Extrapancreatic effects may play a part in the mechanism of action of oral sulfonylurea hypoglycemic drugs. The mechanism by which glipizide lowers blood glucose during longterm administration has not been clearly established. In man, stimulation of insulin secretion by glipizide in response to a meal is undoubtedly of major importance. Fasting insulin levels are not elevated even on long-term glipizide administration, but the postprandial insulin response continues to be enhanced after at least 6 months of treatment.

Metformin hydrochloride is an antihyperglycemic agent that improves glucose tolerance in patients with type 2 diabetes, lowering both basal and postprandial plasma glucose. Metformin hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.


PHARMACOKINETICS

  • Metaglip pharmacokinetics


    PHARMACOKINETICS IN SPECIAL POPULATIONS

  • Metaglip pharmacokinetics in special populations


    CLINICAL STUDIES

  • Metaglip clinical studies


    INDICATIONS AND USAGE

    Metaglip (Glipizide and Metformin HCl) tablets is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.


    CONTRAINDICATIONS

  • Metaglip contraindications


    WARNINGS

  • Metaglip warnings


    SPECIAL WARNING

  • Metaglip special warning


    PRECAUTIONS

  • Metaglip precautions


    PRECAUTIONS FOR METFORMIN HYDROCHLORIDE

  • Metaglip precautions for metformin hydrochloride


    DRUG INTERACTIONS

  • Metaglip drug interactions


    NONCLINICAL TOXICOLOGY

  • Metaglip nonclinical toxicology


    USE IN PREGNANCY

  • Metaglip use in pregnancy


    USE IN SPECIFIC POPULATIONS

  • Metaglip use in specific populations


    ADVERSE REACTIONS

  • Metaglip adverse reactions


    OVERDOSAGE

  • Metaglip overdosage


    DOSAGE AND ADMINISTRATION

  • Metaglip dosage and administration


    HOW SUPPLIED

    Metaglip 2.5 mg / 250 mg tablet is a pink oval-shaped, biconvex film-coated tablet with "BMS" debossed on one side and "6081" debossed on the opposite side, in bottles of 100 tablets.

    Metaglip 2.5 mg / 500 mg tablet is a white oval-shaped, biconvex film-coated tablet with "BMS" debossed on one side and "6077" debossed on the opposite side, in bottles of 100 tablets.

    Metaglip 5 mg / 500 mg tablet is a pink oval-shaped, biconvex film-coated tablet with "BMS" debossed on one side and "6078" debossed on the opposite side, in bottles of 100 tablets.


    STORAGE

    Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]

    Manufactured and distributed by Merck, Bristol-Myers Squibb pharmaceutical companies and their divisions.

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