Valganciclovir hydrochloride overdosage: Difference between revisions
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==Overdosage== | ==Overdosage== | ||
===Experience With Valcyte Tablets=== | ===Experience With Valcyte Tablets=== | ||
One adult developed fatal bone marrow depression (medullary aplasia) after several days of dosing that was at least 10-fold greater than recommended for the patient's estimated degree of renal impairment. | |||
An overdose of Valcyte could also possibly result in increased renal toxicity [see Dosage and Administration (2.5), Use in Specific Populations (8.6)]. | An overdose of Valcyte could also possibly result in increased renal toxicity [see Dosage and Administration (2.5), Use in Specific Populations (8.6)]. | ||
Latest revision as of 23:33, 2 January 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]
Overdosage
Experience With Valcyte Tablets
One adult developed fatal bone marrow depression (medullary aplasia) after several days of dosing that was at least 10-fold greater than recommended for the patient's estimated degree of renal impairment.
An overdose of Valcyte could also possibly result in increased renal toxicity [see Dosage and Administration (2.5), Use in Specific Populations (8.6)].
Because ganciclovir is dialyzable, dialysis may be useful in reducing serum concentrations in patients who have received an overdose of Valcyte [see Clinical Pharmacology (12.3)]. Adequate hydration should be maintained. The use of hematopoietic growth factors should be considered [see Clinical Pharmacology (12.3)].
Experience With Intravenous Ganciclovir
Reports of overdoses with intravenous ganciclovir have been received from clinical trials and during postmarketing experience. The majority of patients experienced one or more of the following adverse events:
Hematological toxicity: pancytopenia, bone marrow depression, medullary aplasia, leukopenia, neutropenia, granulocytopenia
Hepatotoxicity: hepatitis, liver function disorder
Renal toxicity: worsening of hematuria in a patient with pre-existing renal impairment, acute renal failure, elevated creatinine
Gastrointestinal toxicity: abdominal pain, diarrhea, vomiting
Neurotoxicity: generalized tremor, convulsion[1]
References
- ↑ "http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021304s008,022257s003lbl.pdf" (PDF). External link in
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Adapted from the FDA Package Insert.