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Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been infrequently reported with clarithromycin. This hepatic dysfunction may be severe and is usually reversible. In very rare instances, hepatic failure with fatal outcome has been reported and generally has been associated with serious underlying diseases and/or concomitant medications.
There have been rare reports of hypoglycemia, some of which have occurred in patients taking oral hypoglycemic agents or insulin. There have been postmarketing reports of BIAXIN XL tablets in the stool, many of which have occurred in patients with anatomic (including ileostomy or colostomy) or functional gastrointestinal disorders with shortened GI transit times. As with other macrolides, clarithromycin has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes. Changes in Laboratory Values:Changes in laboratory values with possible clinical significance were as follows: Text Continues Below
Hepatic - elevated SGPT (ALT) < 1%; SGOT (AST) < 1%; GGT < 1%; alkaline phosphatase <1%; LDH < 1%; total bilirubin < 1%
Hematologic - decreased WBC < 1%; elevated prothrombin time 1%
Renal - elevated BUN 4%; elevated serum creatinine < 1%
GGT, alkaline phosphatase, and prothrombin time data are from adult studies only.
Drug Interactions:
Clarithromycin use in patients who are receiving theophylline may be associated with an increase of serum theophylline concentrations. Monitoring of serum theophylline concentrations should be considered for patients receiving high doses of theophylline or with baseline concentrations in the upper therapeutic range. In two studies in which theophylline was administered with clarithromycin (a theophylline sustained-release formulation was dosed at either 6.5 mg/kg or 12 mg/kg
together with 250 or 500 mg q12h clarithromycin), the steady-state levels of C max,C min, and the area under the serum concentration time curve (AUC) of theophylline increased about 20%. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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