GLUCOTROL Tablet (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Roerig
Λέξεις κλειδιά
0049-4110 0049-4120
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1. Description
GLUCOTROL (glipizide) is an oral blood-glucose-lowering drug of the sulfonylurea class. The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea. ...
2. Clinical Pharmacology
Mechanism of Action The primary mode of action of GLUCOTROL in experimental animals appears to be the stimulation of insulin secretion from the beta cells of pancreatic islet tissue and is thus dependent ...
3. Indications and Usage
GLUCOTROL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
4. Contraindications
GLUCOTROL is contraindicated in patients with: Known hypersensitivity to the drug. Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin. ...
5. 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 ...
6.1. General
Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with GLUCOTROL or any other anti-diabetic drug. Renal and Hepatic Disease The ...
6.2. Information for Patients
Patients should be informed of the potential risks and advantages of GLUCOTROL and of alternative modes of therapy. They should also be informed about the importance of adhering to dietary instructions, ...
6.3. Laboratory Tests
Blood and urine glucose should be monitored periodically. Measurement of glycosylated hemoglobin may be useful.
6.4. Drug Interactions
The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents, some azoles, and other drugs that are highly protein bound, salicylates, sulfonamides, ...
6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility
A twenty month study in rats and an eighteen month study in mice at doses up to 75 times the maximum human dose revealed no evidence of drug-related carcinogenicity. Bacterial and <em>in vivo</em> mutagenicity ...
6.7. Pregnancy
GLUCOTROL (glipizide) was found to be mildly fetotoxic in rat reproductive studies at all dose levels (5–50 mg/kg). This fetotoxicity has been similarly noted with other sulfonylureas, such as tolbutamide ...
6.8. Labor and Delivery
Nonteratogenic Effects Prolonged severe hypoglycemia (4 to 10 days) has been reported in neonates born to mothers who were receiving a sulfonylurea drug at the time of delivery. This has been reported ...
6.9. Nursing Mothers
Although it is not known whether GLUCOTROL is excreted in human milk, some sulfonylurea drugs are known to be excreted in human milk. Because the potential for hypoglycemia in nursing infants may exist, ...
6.10. Pediatric Use
Safety and effectiveness in children have not been established.
6.11. Geriatric Use
A determination has not been made whether controlled clinical studies of GLUCOTROL included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. Other ...
7. Adverse Reactions
In U.S. and foreign controlled studies, the frequency of serious adverse reactions reported was very low. Of 702 patients, 11.8% reported adverse reactions and in only 1.5% was GLUCOTROL discontinued. ...
9. Overdosage
There is no well documented experience with GLUCOTROL overdosage. The acute oral toxicity was extremely low in all species tested (LD<sub>50</sub> greater than 4 g/kg). Overdosage of sulfonylureas, including ...
10. Dosage and Administration
There is no fixed dosage regimen for the management of diabetes mellitus with GLUCOTROL or any other hypoglycemic agent. In addition to the usual monitoring of urinary glucose, the patients blood glucose ...
11. How Supplied
GLUCOTROL tablets are white, dye-free, scored, diamond-shaped, and imprinted as follows: 5 mg–Pfizer 411; 10 mg–Pfizer 412. 5 mg Bottles: 100s (NDC 0049-4110-66) 10 mg Bottles: 100s (NDC 0049-4120-66) ...
12. Storage and Handling
Store below 86°F (30°C).