Glipizide 10mg tablet

Side Effects Side Effects Nausea , vomiting , loss of appetite, diarrhea , constipation , upset stomach , gas, headache , and weight gain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects.

Many people using this medication do not have serious side effects. This condition should be treated with 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 patients who were randomly assigned to one of four treatment groups Diabetes, 19, supp. UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide 1. 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 Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with glipizide or any other anti-diabetic drug. If hypoglycemia should occur in such patients, it may be prolonged and appropriate management should be instituted. Hypoglycemia All sulfonylurea drugs are capable of producing severe hypoglycemia. Proper patient selection, dosage, and instructions are important to avoid hypoglycemic episodes.

Renal or hepatic insufficiency may cause elevated blood levels of glipizide and the latter may also diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycemic reactions. Elderly, debilitated or malnourished patients, and those with adrenal or pituitary insufficiency, are particularly susceptible to the hypoglycemic action of glucose-lowering drugs.

Hypoglycemia may be difficult to recognize in the elderly, and in people who are taking beta-adrenergic blocking drugs. Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used.

Loss of Control of Blood Glucose When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of control may occur.

At such times, it may be necessary to discontinue glipizide and administer insulin. The effectiveness of any oral hypoglycemic drug, including glipizide, in lowering blood glucose to a desired level decreases in many patients over a period of time, which may be due to progression of the severity of the diabetes or to diminished responsiveness to the drug. This phenomenon is known as secondary failure, to distinguish it from primary failure in which the drug is ineffective in an individual patient when first given.

Hemolytic Anemia Treatment of patients with glucose 6-phosphate dehydrogenase G6PD deficiency with sulfonylurea agents can lead to hemolytic anemia. Because glipizide belongs to the class of sulfonylurea agents, caution should be used in patients with G6PD deficiency and a non-sulfonylurea alternative should be considered. In post-marketing reports, hemolytic anemia has also been reported in patients who did not have known G6PD deficiency. Laboratory Tests Blood and urine glucose should be monitored periodically.

Measurement of glycosylated hemoglobin may be useful. Information for Patients Patients should be informed of the potential risks and advantages of glipizide and of alternative modes of therapy. The risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members. Primary and secondary failure should also be explained. Physician Counseling Information for Patients In initiating treatment for type 2 diabetes, diet should be emphasized as the primary form of treatment.

Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed, and cardiovascular risk factors should be identified and corrective measures taken where possible. Use of glipizide or other antidiabetic medications must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitution or as a convenient mechanism for avoiding dietary restraint.

Furthermore, loss of blood glucose control on diet alone may be transient, thus requiring only short-term administration of glipizide or other antidiabetic medications. Maintenance or discontinuation of glipizide or other antidiabetic medications should be based on clinical judgment using regular clinical and laboratory evaluations. 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, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, quinolones and beta adrenergic blocking agents.

When such drugs are administered to a patient receiving glipizide, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving glipizide, the patient should be observed closely for loss of control. In vitro binding studies with human serum proteins indicate that glipizide binds differently than tolbutamide and does not interact with salicylate or dicumarol. If hypoglycemia occurs in such patients, it may be prolonged and appropriate management should be instituted [see Dosage and Administration 2.

Overdosage Overdosage of sulfonylureas including glipizide extended-release tablets 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. Glipizide ER Description Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class. 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.

Glipizide extended-release tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use and is designed to deliver 2. Each tablet contains the following inactive ingredients: Glipizide ER - Clinical Pharmacology Sulfonylureas bind to the sulfonylurea receptor in the pancreatic beta-cell plasma membrane, leading to closure of the ATP-sensitive potassium channel, thereby stimulating the release of insulin.

The postprandial insulin and C-peptide responses 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 glipizide extended-release tablets-treated patients combined compared to placebo, although minor elevations were observed at some doses. In studies of glipizide extended-release tablets in subjects with type 2 diabetes 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 subjects treated with 20 mg had a greater reduction in fasting plasma glucose compared to subjects treated with 5 mg. Beginning 2 to 3 hours after administration of glipizide extended-release tablets, plasma drug concentrations gradually rise reaching maximum concentrations within 6 to 12 hours after dosing.

With subsequent once daily dosing of glipizide extended-release tablets, 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.

Your doctor may occasionally change your dose to make sure you get the best results. Take glipizide 30 minutes before a meal. If you take glipizide once daily, take it 30 minutes before breakfast. Glipizide extended-release Glucotrol XL should be taken with breakfast. Do not crush, chew, or break an extended-release tablet. Breaking the pill may cause too much of the drug to be released at one time. Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Visit your doctor regularly. Know the signs of low blood sugar hypoglycemia and how to recognize them: Always keep a source of sugar available in case you have symptoms of low blood sugar.

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