Masthead
1990; American Osteopathic Association; Volume: 90; Issue: 2 Linguagem: Inglês
10.1515/jom-1990-frontmatter9002
ISSN1945-1997
Tópico(s)Marriage and Sexual Relationships
Resumo24-hour glycemic control can begin at the breakfast table.When diet and exercise aren't enough, once-a-day MICRONASE provides 24-hour control of both postprandial and fasting blood glucose levels.The usual starting dosage, 2.5 mg to 5 mg once a day, should be taken with breakfast or the first main meal of the day.Some patients, particularly those receiving more than 10 mg daily, may have a more satisfactory response with twice-a-day dosage.All sulfonylureas, including MICRONASE, can cause severe hypoglycemia.Proper patient selection, dosage, and instructions are important.Please see adjacent page for brief summary of prescribing information.CONTRAINDICATIQNS: MICRONASE Tablets are contraindicated in patients with: t.Known hypersensitivity or allergy to the drug.2. Diabetic ketoacidosis, with or without coma.This condition should be treated with insulin.3. Type I diabetes mellitus, as sole therapy.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 noninsulin-dependent diabetes.The study involved 823 patients who were randomly assigned to one of four treatment groups (Diabetes, 19 [Suppl2]: 747-830, 1970).UGDP reported that patients treated for Sto 8 years with diet plus a fixed dose ottolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 21/z 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 ot MICRONASE and of alternative modes ottherapy.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 apply to other oral hypoglycemic drugs in this class.in view ottheir close similarities in mode ot action and chemical structure.PRECAUTIONS: General-Hypoglycemia: All sulfonylureas are capable of producing severe hypoglycemia.Proper patient selection and dosage and instructions are important to avoid hypoglycemic episodes.Renal or hepatic insufficiency may 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 .fihoare taking beta-adrenergic blocking drugs.Hypoglycemia is more likely to occur when calonc 1 ntake IS defic1ent.after severe or prolonged exerc1se.when alcohol IS Ingested, or when more than one glucose-lowering drug is used.Loss of Control of Blood Glucose: In diabetic patients exposed to stress such as fever.trauma.infection or surgery, a loss of control may occur.It may then be necessary to discontinue MICRONASE and administer insulin.Adequate adjustment of dose and adherence to diet should be assessed before classifying a patient as a secondary failure .Information for Patients: Patients should be informed of the potential risks and advantages of MICRONASE and of alternative modes of therapy.They also should be informed about the importance of adherence to dietary instructions, of a regular exercise program.and of regular testing of urine and / or blood glucose.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.Laboratory Tests: Response to MICRONASE Tablets should be monitored by frequent urine glucose tests and periodic blood glucose tests.Measurement of glycosylated hemoglobin levels may be helpful in some patients.Drug Interactions: The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti -inflammatory agents and other drugs that are highly protein bound, salicylates.sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, and beta adrenergic blocking agents.Certain drugs tend to produce hyperglycemia and may lead to loss of control.Th ese drugs include the th iazides and other diuretics, corticosteroids, phenothiazines.thyroid products.estrogens, oral contraceptives, phenytoin, nicotinic acid , sympathomimetics, calcium channel blocking drugs, and isoniazid.A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported.Carcinogenesis, Mutagenesis, and Impairment of Fertility: Studies in rats at doses up to 300 mg( kg( day for 18 months showed no carcinogenic effects.Glyburide is nonmutagenic when studied in the Salmonella microsome test (Ames test) and in the DNA damage/ alkaline elution assay.Pregnancy: Temtogenic effects: Pregnancy Category B. Reproduction studies in rats and rabbits have revealed no evidence of impaired fertility or harm to the fetus due to glyburide.There are no adequate and well controlled studies in pregnant women .This drug should be used during pregnancy only if clearly needed.Insulin should be used during pregnancy to maintain blood glucose as close to normal as possible.Non teratogenic Effects: Prolonged severe hypoglycemia (4to 10 days) has been reported in neonates born to mothers who were receiving a sulfonylurea drug at the time of delivery.MICRONASE should be discontinued at least two weeks before the expected delivery date.Nursing Mothers: Some sulfonylurea drugs are known to be excreted in human milk.Insulin therapy should be considered.Pediatric Use: Safety and effectiveness in children have not been established.ADVERSE REACTIONS: Hypoglycemia: See Precautions and Overdosage sections.Gastrointestinal Reactions: Cholestatic jaundice and hepatitis may occur rarely; MICRONASE Tablets should be discontinued if this occurs.Gastrointestinal disturbances (nausea, epigastric full ness, and heartburn) occurred in 1.8% of patients during clinical trials.They were the most commonly reported adverse reactions.They tend to be dose related and may disappear when dosage IS reduced .Liver function abnormalities have been reported.Dermatologic Reactions: Allergic skin reactions , e.g., pruritus.erythema, urticaria.and morbilliform or maculopapular eruptions occurred in 1.5% of patients during trials.These may be transient and may disappear despite continued use of MICRONASE; if skin reactions persist, the drug should be discontinued .Porphyria cutanea tarda and photosensitivity reactions have been reported with sulfonylureas.Hematologic Reactions: Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas.Metabolic Reactions: Hepatic porphyria and disulfiramlike reactions have been reported with sulfonylureas; however, hepatic porphyria has not been reported with MICRDNASE and disulfiram-like reactions have been reported very rarely.Cases of hyponatremia have been reported with glyburide and all other sulfonylureas.most often in patients who are on other medications or have medical conditions known to cause hyponatremia or increase re lease of antidiuretic hormone.(SIADH) secretion has been reported with certain other sulfonylureas, and it has been suggested that these sulfonylureas may augment the peripheral (antidiuretic) action of ADH and/or increase release of ADH.OVERDOSAGE: Overdosage of sulfonylureas, including MICRONASE Tablets.can produce hypoglycemia.If hypoglycemic coma is diagnosed or suspected, the patient should be given a rapid intravenous injection of concentrated (50%) glutose solution.This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate which will maintain the blood glucose at a level above tOO mg/ dL.Patients should be closely monitored for a minimum of 24 to 48 hours, since hypoglycemia may recur after apparent clinical recovery.Maximum Dose: Daily doses of more than 20 mg are not recommended.Dosage Interval: Once-a-day therapy is usually satisfactory.Some patients, particularly those receiving more than 10 mg daily, may have a more satisfactory response with twice -a-day dosage.Specific Patient Populations: MICRONiiSE is not recommended for use in pregnancy or for use in children.In elderly patients, debilitated or malnourished patients.and patients with impaired renal or hepatic function , the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions.(See Precautions Section).For additional product information see your Upjohn representative.
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