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

GLIPIZIDE

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DESCRIPTION



DESCRIPTION




CLINICAL PHARMACOLOGY

Mechanism of Action

Pharmacokineticsbelow).


Other Effects



Pharmacokinetics


INDICATIONS & USAGE


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 21/2 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




















Information for Patients



Physician Counseling Information for Patients


Drug Interactions




Carcinogenesis, Mutagenesis, Impairment of Fertility


Pregnancy










Nursing Mothers


Pediatric Use


Geriatric Use

ADVERSE REACTIONS



Hypoglycemia
PRECAUTIONSandOVERDOSAGEsections.

Gastrointestinal
Gastrointestinal disturbances are the most common reactions. Gastrointestinal complaints were reported with the following apprroximate incidence: nuasea and diarrhea, one in seventy; constipation and gastralgia, one in one hundred. They appear to be dose-related and may disappear on division or reduction of dosage. Cholestatic jaundice may occur rarely with sulfonyluras: Glipizide should be discontinued if this occurs.


Dermatologic
Allergic skin reactions including erythema, morbilliform of maculopapular eruptions, urticaria, pruritus, and eczema have been reported in about one in seventy patients. These may be transent and may disappear despite continued use of glipizide; if skin reactions persist, the drug should be discontinued. Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonyluras.


Hematologic


Metabolic


Endocrine Reactions


Miscellaneous


Laboratory Tests


Postmarketing Experience
The following adverse events have been reported in postmarketing surveillance:



OVERDOSAGE



DOSAGE & ADMINISTRATION





Initial Dose


Titration


Maintenance



Patients Receiving Insulin





Patients Receiving Other Oral Hypoglycemic Agents

HOW SUPPLIED



STORAGE AND HANDLING




PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

GLIPIZIDE

GLIPIZIDE TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:52125-199(NDC:0172-3649)
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
lactose monohydrate
cellulose, microcrystalline
STARCH, CORN
SILICON DIOXIDE
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
white (White to off-white) 8 mm 9201;TEVA ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:52125-199-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074497 2013-01-03


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Be sure to consult your doctor before taking any medication!
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