Glipizide description, usages, side effects, indications, overdosage, supplying and lots more!

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Glipizide

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

GLIPIZIDE DESCRIPTION



Glipizide



CLINICAL PHARMACOLOGY

Mechanism of Action

Pharmacokineticsbelow).


Other Effects



Pharmacokinetics


INDICATIONS & USAGE


GLIPIZIDE CONTRAINDICATIONS




WARNINGS

SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY
The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. The study involved 823 patients who were randomly assigned to one of four treatment groups (Diabetes, 19, supp. 2: 747-830, 1970).
UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2-1/2 times that of patients treated with diet alone. A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality. Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning. The patient should be informed of the potential risks and advantages of glipizide and of alternative modes of therapy.
Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.

PRECAUTIONS

General

















Laboratory Tests


Information for Patients



Physician Counseling Information for Patients


Drug Interactions




Carcinogenesis, Mutagenesis, Impairment of Fertility


Pregnancy








Nursing Mothers


Pediatric Use


Geriatric Use

GLIPIZIDE ADVERSE REACTIONS



Hypoglycemia
PRECAUTIONSandOVERDOSAGEsections.

Gastrointestinal


Dermatologic


Hematologic
PRECAUTIONS), aplastic anemia, and pancytopenia have been reported with sulfonylureas.

Metabolic


Endocrine Reactions


Miscellaneous


Laboratory Tests


Post-Marketing Experience
The following adverse events have been reported in post-marketing surveillance:



OVERDOSAGE



DOSAGE & ADMINISTRATION





Initial Dose


Titration


Maintenance

PRECAUTIONSsection).

Patients Receiving Insulin





Patients Receiving Other Oral Hypoglycemic Agents

HOW SUPPLIED


5 mg:round, white, scored tablets, debossed GG 771 on one side and plain on the reverse side, and supplied as:



10 mg:round, white, scored tablets, debossed GG 772 on one side and plain on the reverse side, and supplied as:



STORAGE AND HANDLING



PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Glipizide


Glipizide

Glipizide

GLIPIZIDE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52125-105(NDC:0781-1452)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
GLIPIZIDE GLIPIZIDE 5 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
CROSCARMELLOSE SODIUM
lactose monohydrate
MAGNESIUM STEARATE
SILICON DIOXIDE
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
white 8 mm GG771 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52125-105-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074305 2012-09-24


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Be sure to consult your doctor before taking any medication!
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