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Titolo:
AN OPEN STUDY TO ASSESS THE SAFETY, TOLERANCE AND PHARMACOKINETICS OFAN INTRAVENOUS-INFUSION OF GRANISETRON GIVEN AT 3 MG OVER 30 S IN PATIENTS RECEIVING CHEMOTHERAPY FOR MALIGNANT DISEASE
Autore:
CARMICHAEL J; PHILIP PA; FORFAR C; HARRIS AL;
Indirizzi:
NOTTINGHAM CITY HOSP TRUST,CRC,ACAD UNIT CLIN ONCOL,HUCKNALL RD NOTTINGHAM ENGLAND CHURCHILL HOSP,IMPERIAL CANC RES FUND,DEPT CLIN ONCOL OXFORD OX3 7LJ ENGLAND JOHN RADCLIFFE HOSP,DEPT CARDIOL OXFORD OX3 9DU ENGLAND
Titolo Testata:
Cancer chemotherapy and pharmacology
fascicolo: 1-2, volume: 37, anno: 1995,
pagine: 134 - 138
SICI:
0344-5704(1995)37:1-2<134:AOSTAT>2.0.ZU;2-8
Fonte:
ISI
Lingua:
ENG
Soggetto:
CARDIAC-ARREST; DOMPERIDONE; ANTAGONIST; RECEPTOR; ONDANSETRON; EFFICACY;
Keywords:
GRANISETRON; TOLERANCE; RAPID INFUSION; PHARMACOKINETICS;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Science Citation Index Expanded
Citazioni:
21
Recensione:
Indirizzi per estratti:
Citazione:
J. Carmichael et al., "AN OPEN STUDY TO ASSESS THE SAFETY, TOLERANCE AND PHARMACOKINETICS OFAN INTRAVENOUS-INFUSION OF GRANISETRON GIVEN AT 3 MG OVER 30 S IN PATIENTS RECEIVING CHEMOTHERAPY FOR MALIGNANT DISEASE", Cancer chemotherapy and pharmacology, 37(1-2), 1995, pp. 134-138

Abstract

Granisetron is a highly potent and selective 5-hydroxytryptamine(3) (5-HT3) receptor antagonist indicated for the prevention of cytotoxic-induced nausea and vomiting. Clinical trials have demonstrated granisetron to be effective and well tolerated at a standard dose of 40 mu g/kg or 3 mg given i.v. as a 5-min infusion. In this study, the efficacy and safety of granisetron given as a 30-s infusion was assessed. A total of 21 patients, scheduled to undergo chemotherapy, received a single 3-mg i.v. dose of granisetron over 30 s, completed at 1 h before chemotherapy administration. Patients were allowed two further i.v. dosesof granisetron at 3 mg within the 24-h assessment period. Changes from baseline values in vital signs were analysed prior to granisetron administration and at 30 s as well as 1, 10, 15, 30 and 60 min after granisetron administration. Holter ECG recordings were taken for 6 h prior to and 1 h after administration. No significant change was found in vital signs at 30 s or 1 min after granisetron infusion. There was a small but statistically significant fall in diastolic blood pressure ascompared with baseline and a non-significant trend in favour of a reduction in heart rate at 10 and 15 min. No ECG abnormality was recordedpost-infusion that had not been present pre-infusion. None of these changes was considered to be clinically relevant. The treatment was well tolerated. The most frequently reported adverse events were constipation (n = 6) and headache (n = 5). Maximal plasma levels of granisetron were within the range of 44.57-410 ng/ml except in one patient. The median values recorded for peak concentration (C-max) and area under the curve (AUC) were 195 ng/ml and 71.2 ng h ml(-1), respectively. In conclusion, granisetron at 3 mg was shown to be safe and well toleratedwhen given as a 30-s i.v. infusion to patients receiving chemotherapyfor malignant disease.

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Documento generato il 21/09/20 alle ore 06:33:56