title: [Recent findings based on the results of the post-marketing surveillance of vancomycin hydrochloride for intravenous infusion].
abstract: Vancomycin Hydrochloride for Intravenous Infusion (VCM) was launched as a therapeutic agent for infections caused by Methicillin-Cephem Resistant Staphylococcus aureus (MRSA) in October 1991. The results of the post-marketing surveillance conducted in accordance with GPMSP for 6 years after the launch are as follows. The population studied included 3,037 patients administered this drug intravenously at 1,099 institutions across Japan from October 1991 through September 1997, and among which, 28 patients were excluded because the follow-up was impossible. Consequently, 3,009 patients were included in the safety evaluation and 2,827 patients in the efficacy evaluation, excluding 182 patients due to the off-label use, etc. The daily dosage of this drug was 40 mg/kg for pediatric patients and 1 or 2 g for adult/elderly patients, and the duration of treatment was commonly 1-3 weeks. The daily dosage and the duration of treatment tended to be decreased over years. The improvement rate by disease was in the 70 to 79% range for respiratory tract infections such as pneumonia, and 80% or more for other diseases such as sepsis and osteomyelitis. With respect to the bacteriological efficacy against MRSA, the eradication rate was 66.9%. The number of cases with adverse drug reactions including clinical laboratory abnormalities was 404 patients (13.43%) and a total of 561 adverse drug reactions were reported. Although there was no trend of particularly high frequency of adverse drug reactions even among elderly patients. Based on the above, VCM is a highly useful drug, which is reliably expected to be effective against MRSA infections, and it seems that VCM should be administered promptly to patients in which MRSA has been identified as a causative pathogen. For the use of VCM, if the optimum dose and mode of administration are selected while taking account of the age and renal function, adverse drug reactions can also be reduced.
authors.affiliation: Tokyo Senbai Hospital.
authors.forename: Kaoru
authors.initials: K
authors.lastname: Shimada
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007223:Infant; D007262:Infusions, Intravenous; D008297:Male; D016106:Methicillin Resistance; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing / Q000379:methods; D013203:Staphylococcal Infections / Q000188:drug therapy*; D013211:Staphylococcus aureus; D014640:Vancomycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D014640:Vancomycin