Glynase Pres-Tab Side Effects
Please note - some side effects for Glynase Pres-Tab may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects by Body System - for Healthcare Professionals
Applies to: compounding powder; oral tablet
Hypoglycemia, an extension of glyburide's pharmacologic effects, may be severe, protracted, refractory to glucose infusion, and, in some cases, may require diazoxide. It most commonly presents as coma or disturbed consciousness. Other signs of hypoglycemia include tachycardia, tremor, chest pain, weakness, and increased sweating. In one review of 57 spontaneously reported cases, the mean dose of glyburide associated with hypoglycemia was 10 mg per day although there were cases with doses as low as 2.5 mg per day. The median age in these cases was 75 years. Ten patients died. In another review of 13 cases, in which renal failure, advanced age, and congestive heart failure were deemed to be predisposing factors, hypoglycemia persisted for more than 60 hours in two patients.
Patients with renal dysfunction, liver disease, adrenal or pituitary insufficiency, or congestive heart failure may be at increased risk for hypoglycemia as are those who are elderly, debilitated, or malnourished. In addition, acute illness, lack of adherence to diet, ethanol ingestion, or strenuous exercise may precipitate hypoglycemia.
Metabolic side effects have included hypoglycemia, an extension of glyburide's pharmacologic effects, in 1.6% to 3.1% of patients. Hypoglycemia has been severe and protracted in some cases. Fatalities have been reported. In addition, hyponatremia and disulfiram-like reactions have been reported. Glyburide metabolism and elimination, as well as hepatic gluconeogenesis and glycogenolysis, may be impaired in patients with renal dysfunction and/or liver disease.
Hematologic side effects have included rare reports of leukopenia, thrombocytopenia, eosinophilia, and hemolytic anemia.
Hepatic side effects have included cholestatic jaundice and hepatitis which may rarely progress to liver failure. Elevations in serum transaminase, alkaline phosphatase, and bilirubin have been reported. Elevations in liver function tests were usually mild and often returned to normal despite continued therapy. Rare cases of acute hepatic hypersensitivity characterized by pruritus, icterus, and cholestatic jaundice have also been reported. In addition, at least two cases of granulomatous hepatitis have been associated with glyburide use.
Renal side effects have included polyuria and nocturia.
Dermatologic side effects have occurred in 1.5% of patients in clinical trials and include pruritus, erythema, urticaria, morbilliform and maculopapular eruptions, and vesiculobullous rash. In addition, pemphigus vulgaris, porphyria cutanea tarda, Stevens-Johnson syndrome, and photosensitivity were reported.
Gastrointestinal side effects have occurred in up to 1.8% of patients in clinical trials and included nausea, vomiting, dyspepsia, abdominal fullness, diarrhea, and anorexia. Gastrointestinal side effects tended to be mild and transient.
Hypersensitivity side effects have predominantly included dermatological effects but have also included acute hepatic hypersensitivity, cholestatic jaundice, necrotizing angiitis, hemolytic anemia, angioedema, arthralgia, myalgia, and vasculitis.
Ocular side effects have included changes in accommodation and blurred vision.Top
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