Experiment 1257786

Details

PropertyValue
Pharmacology
Administration routeIM
OrganismEmpty organism
CitationCROUT,JR:. (1978). SPARTEINE SULFATE INTRAMUSCULAR INJECTION AND OXYTOCIN CITRATE BUCCAL TABLETS.. 43()
Amount utilized
Compound isolated
DiseaseTHIS IS A NOTICE THAT THE FDA(USA) PROPOSES TO WITHDRAW APPROVAL OF THE NEW DRUG APPLICATION(NDA) FOR SPARTEINE SULFATE INTRAMUSCULAR INJECTION ON THE GROUNDS THAT THE DRUG HAS NOT BEEN SHOWN TO BE SAFE FOR USE IN THE INDUCTION OF LABOR AND TREATMENT OF HYPOTONIC UTERINE CONTRACTIONS. IT IS CLAIMED THAT THE ACTION OF THE DRUG IS QUITE UNPREDICTABLE AND THAT IT SHOULD NOT BE GIVEN CONCOMITANTLY WITH OXYTOCIN. AT LEAST TWO HOURS SHOULD PASS BEFORE A CHANGE IS MADE FROM ONE DRUG TO THE OTHER. AN OCCASIONAL CASE OF RUPTURE OF THE UTERUS HAS BEEN REPORTED WITH THE USE OF SPARTEINE SULFATE. A REPORT IS PRESENTED ON THE IN VITRO AND IN VIVO PHARMACOLOGY OF SPARTEINE THAT WAS SUPPORTIVE OF THE JUDGEMENT THAT SPARTEINE SULFATE INTRAMUSCULAR INJECTION WAS NOT SAFE WHEN USED IN CONJUNCTION WITH OXYTOCIN BUCCAL TABLETS.
Number1
Qualitative resultACTIVE
AnimalHUMAN(PREGNANT)
Dose expressionDOSE