Glucotrol Contre Indication
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Hypoglycemia was not reported for any placebo patients. Dermatologic Reactions In clinical trials, allergic skin reactions, i. These bekirkupeli.000webhostapp.com be transient and may disappear despite continued use of glipizide XL; if skin reactions persist, the drug should be discontinued.
The relationship of Doctor Consultations gratuites – Levitra Oral Jelly à vendre pas cher – Meds À Bas Prix to reliably estimate their frequency or establish a causal Glucotrol Contre indication to drug exposure.
Abdominal pain Cholestatic and hepatocellular forms of liver injury accompanied by jaundice Leukopenia, Glucotrol Contre Indication, agranulocytosis, thrombocytopenia, hemolytic lukaspa.000webhostapp.com [see Warnings and Precautions 5.
Drug Interactions Drugs Affecting Glucose Metabolism A number of medications affect glucose metabolism and may require Glucotrol XL dose adjustment and close monitoring for hypoglycemia or worsening glycemic control.
What is glipizide?
When these medications are administered to a patient receiving Glucotrol XL, monitor the patient closely for hypoglycemia. When these medications are discontinued from a patient receiving Glucotrol XL, monitor the patient closely for worsening glycemic control. The following are examples of medication that may reduce the glucose-lowering effect of Glucotrol XL, leading to worsening glycemic control: When such Glucotrol Contre indications are administered to patients receiving Glucotrol XL, monitor the patients closely for worsening glycemic control.
When these medications are discontinued from patients receiving Glucotrol XL, monitor the patient closely for hypoglycemia. Alcohol, Glucotrol Contre Indication, beta-blockers, clonidine, and reserpine may lead to either potentiation or weakening of the glucose-lowering effect. Increased frequency of monitoring may be required when Glucotrol XL is co-administered with these drugs, Glucotrol Contre Indication.
The signs of hypoglycemia may be reduced or absent in Glucotrol Contre indications taking sympatholytic drugs such as beta-blockers, clonidine, guanethidine, and reserpine. Miconazole Monitor patients closely for hypoglycemia when Glucotrol XL is co-administered with miconazole.
A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported [see Clinical Phamacology Fluconazole Monitor patients closely for hypoglycemia when Glucotrol XL is co-administered with fluconazole, Glucotrol Contre Indication.
Concomitant treatment with fluconazole increases plasma concentrations of glipizide, which may lead to hypoglycemia [see Clinical Pharmacology Colesevelam Glucotrol XL should be administered at least 4 hours prior to the administration of colesevelam.
Colesevelam can reduce the maximum plasma concentration and total exposure of glipizide when the two are coadministered [see Clinical Pharmacology However, sulfonylureas including glipizide cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. Therefore, Glucotrol XL should be discontinued at least two weeks before expected delivery see Clinical Considerations.
Poorly controlled diabetes in pregnancy is also associated Glucotrol Contre indication risks to the Glucotrol Contre indication and fetus see Clinical Considerations. In animal studies, there were no effects on embryofetal development following administration of glipizide to pregnant rats and Glucotrol Contre indications during organogenesis at doses times and 8 times the human dose based on body surface area, respectively.
However, increased pup mortality was observed in rats administered glipizide from gestation day 15 throughout lactation at doses 2 times the maximum human dose based on body surface area see Data. The estimated Glucotrol Contre indication risk of miscarriage for the indicated population is unknown. Poorly controlled diabetes increases the fetal risk for Glucotrol Contre indication birth defects, stillbirth, and macrosomia related morbidity.
Prolonged severe hypoglycemia, lasting 4—10 days, has been reported in neonates born to mothers receiving a sulfonylurea at the time of delivery and has been reported with the use of agents with a prolonged half-life, Glucotrol Contre Indication. Observe newborns for symptoms of hypoglycemia and respiratory distress and manage accordingly.
There were no adverse effects on embryo-fetal development at any of the doses tested. Lactation Risk Summary Breastfed infants of lactating women using Glucotrol XL should be monitored for symptoms of hypoglycemia see Clinical Considerations. Although glipizide was undetectable in human milk in one small clinical lactation study; this result is not conclusive because of the limitations of the assay used in the study. There are no data on the effects of glipizide on milk production, Glucotrol Contre Indication.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Glucotrol XL and any potential adverse effects on the breastfed child from Glucotrol XL or from the underlying maternal condition.
Clinical Considerations Monitoring for adverse reactions Monitor breastfed infants for signs of hypoglycemia e. Pediatric Use Safety and effectiveness in children have not been established. Geriatric Use There were no overall differences in effectiveness or safety between younger and older patients, but greater sensitivity of some individuals cannot be ruled out.
Elderly patients are particularly susceptible to the hypoglycemic action of anti-diabetic agents. Hypoglycemia may be difficult to recognize in these patients. Therefore, dosing should be conservative to avoid hypoglycemia [see Dosage and Administration 2. Hepatic Impairment There is no information regarding the effects of hepatic impairment on the disposition of glipizide.
If Glucotrol Contre indication occurs in such patients, it may be prolonged and appropriate management should be instituted [see Dosage and Administration 2. Overdosage Overdosage of sulfonylureas including Glucotrol XL can produce severe hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated with oral glucose.
Severe hypoglycemic reactions with coma, seizure, or other neurological impairment are medical emergencies requiring immediate treatment.
The patient should be treated with glucagon or intravenous glucose. Patients should be closely monitored for a minimum of 24 to 48 hours since hypoglycemia may recur after apparent clinical recovery. Clearance of glipizide from plasma may be prolonged in persons with liver disease. Because of the extensive protein binding of glipizide, dialysis is unlikely to be of benefit.
The Chemical Abstracts name of glipizide is 1-cyclohexyl[[p-[2- 5-methylpyrazinecarboxamido ethyl] phenyl]sulfonyl]urea. Glipizide is a whitish, odorless powder with a pKa of 5. It is insoluble in water and alcohols, but soluble in 0. Inert ingredients in the 2. It Glucotrol Contre indications, however, of an osmotically active drug core surrounded by a semipermeable membrane.
The core itself is divided into two layers: The membrane surrounding the tablet is permeable to water but not to Glucotrol Contre indication or osmotic excipients, Glucotrol Contre Indication. As water from the gastrointestinal tract enters the tablet, pressure increases in the osmotic layer and “pushes” against the drug layer, Glucotrol Contre Indication, resulting in the release of drug through a small, laser-drilled orifice in the membrane on the drug side of the tablet.
The function of the Glucotrol XL Extended Release Tablet depends upon the existence of an osmotic gradient between the contents of the bi-layer core and fluid in the GI tract.
The biologically inert components of the tablet remain intact during GI transit and are eliminated in the feces as an insoluble shell. Glucotrol XL – Clinical Pharmacology Mechanism of Action Glipizide primarily Glucotrol Contre indications blood Glucotrol Contre indication by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. Sulfonylureas bind to the sulfonylurea receptor in the pancreatic beta-cell plasma membrane, leading to Glucotrol Contre indication of the ATP-sensitive potassium channel, thereby stimulating the release of insulin.
Pharmacodynamics The insulinotropic response to a meal is enhanced with Glucotrol XL administration in diabetic patients. The postprandial insulin and C-peptide Glucotrol Contre indications continue to be enhanced after at least 6 months of treatment.
In two randomized, double-blind, dose-response studies comprising a total of patients, there was no significant increase in fasting insulin in all Glucotrol XL-treated patients combined compared to placebo, although minor elevations were observed at some doses. In studies of Glucotrol XL in subjects with type 2 diabete mellitus, once daily administration produced reductions in hemoglobin A1c, fasting plasma glucose and postprandial glucose.
The relationship between dose and reduction in hemoglobin A1c was not established, however Glucotrol Contre indications treated with 20 mg had a greater reduction in Glucotrol Contre indication plasma glucose compared to subjects treated with 5 mg. Beginning 2 to 3 hours after administration of Glucotrol XL, plasma drug concentrations gradually rise reaching maximum concentrations within 6 to 12 hours after dosing.
With subsequent once daily dosing of Glucotrol XL, plasma glipizide concentrations are maintained throughout the 24 hour dosing interval with less peak to trough fluctuation than that observed with twice daily dosing of immediate release glipizide, Glucotrol Contre Indication.
Steady-state plasma concentrations were achieved by at least the fifth day of dosing with Glucotrol XL in 21 males with type 2 diabetes mellitus and patients younger than 65 years. No accumulation of drug was observed in patients with type 2 diabetes mellitus during chronic dosing with Glucotrol XL.
Glucotrol XL Drug Imprint
Administration of Glucotrol XL with food has no effect on the 2 to 3 Glucotrol Contre indication lag time in drug absorption. There was no change in Glucotrol Contre indication response between the fed and fasting state. In a multiple dose study in 26 males with type 2 diabetes mellitus, the pharmacokinetics of glipizide were linear with Glucotrol XL in that the plasma drug concentrations increased proportionately with dose.
In a single dose study in 24 healthy subjects, four 5-mg, two mg, and one mg Glucotrol XL tablets were bioequivalent.
In a separate single dose study in 36 healthy subjects, Glucotrol Contre Indication, four 2. Distribution The mean volume of distribution was approximately 10 liters after single intravenous doses in patients with type 2 diabetes mellitus. Metabolism The major metabolites of glipizide are products of aromatic hydroxylation and have no hypoglycemic activity.
Elimination Glipizide is eliminated primarily by hepatic biotransformation: The mean total body clearance of glipizide was approximately 3 liters per hour after single intravenous doses in patients with type 2 diabetes mellitus. The mean terminal elimination half-life of glipizide ranged from 2 to 5 hours after single or multiple doses in patients with type 2 diabetes mellitus. Specific Populations Studies characterizing the pharmacokinetics of glipizide in pediatric patients have not been performed, Glucotrol Contre Indication.
There were no differences in the pharmacokinetics of glipizide after single dose administration to older diabetic subjects compared to younger healthy subjects [see Use in Specific Populations 8. The pharmacokinetics of glipizide has not been evaluated in patients with varying degree of renal impairment. Limited data indicates that glipizide biotransformation products may remain in circulation for a longer time in subjects with renal impairment than that seen in subjects with normal renal function.
The pharmacokinetics of glipizide has not been evaluated in Glucotrol Contre indications with hepatic impairment. Drug-drug Interactions Miconazole A potential interaction between oral miconazole and oral glipizide leading to severe hypoglycemia has been reported. Whether this interaction also occurs with the intravenous, Glucotrol Contre Indication, topical, or vaginal preparations of miconazole is not known [see Drug Interactions 7.
Fluconazole Concomitant treatment with fluconazole increases plasma concentrations of glipizide. The mean percentage increase in the glipizide AUC after fluconazole administration was Colesevelam Colesevelam can reduce the maximum plasma Glucotrol Contre indication and total exposure of glipizide when the two are coadministered.
Nonclinical Toxicology 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 in vivo mutagenicity tests were uniformly negative. Studies in rats of both sexes at doses up to 20 times the human dose based on body surface area, showed no effects on fertility.