Macnil Tablets

Glyburide tablets, USP is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

• Patients should be retitrated when transferred from glyburide tablets or other oral hypoglycemic agents
• There is no fixed dosage regimen for the management of diabetes mellitus with glyburide tablets
• In addition to the usual monitoring of urinary glucose, the patient's blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, ie , inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, ie , loss of adequate blood glucose lowering response after an initial period of effectiveness
• Glycosylated hemoglobin levels may also be of value in monitoring the patient's response to therapy
• Short-term administration of glyburide tablets may be sufficient during periods of transient loss of control in patients usually controlled well on diet
• Usual Starting Dose The usual starting dose of glyburide tablets is 2.5 to 5 mg daily, administered with breakfast or the first main meal
• Those patients who may be more sensitive to hypoglycemic drugs should be started at 1.25 mg daily. (See PRECAUTIONS section for patients at increased risk.) Failure to follow an appropriate dosage regimen may precipitate hypoglycemia
• Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy. …

• Glyburide tablets are contraindicated in patients with: Known hypersensitivity or allergy to the drug
• Diabetic ketoacidosis, with or without coma
• This condition should be treated with insulin
• Type I diabetes mellitus
• Concomitant administration of bosentan. …

PRECAUTIONS General Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with glyburide tablets or any other anti-diabetic drug. Hypoglycemia: All sulfonylureas including glyburide are capable of producing severe hypoglycemia. Proper patient selection and dosage and instructions are important to avoid hypoglycemic episodes. Renal or hepatic insufficiency may cause elevated drug levels of glyburide and the latter may also diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycemic reactions. …

Hypoglycemia: See Precautions and Overdosage Sections. Gastrointestinal Reactions: Cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure; glyburide tablets should be discontinued if this occurs. Liver function abnormalities, including isolated transaminase elevations, have been reported. Gastrointestinal disturbances, eg , nausea, epigastric fullness, and heartburn are the most common reactions, having occurred in 1.8% of treated patients during clinical trials. They tend to be dose related and may disappear when dosage is reduced. …

Overdosage of sulfonylureas, including glyburide tablets, can produce hypoglycemia. Mild hypoglycemic symptoms, without loss of consciousness or neurological findings, should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. …

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