sincalide

FDA Drug Profile — KINEVAC, SINCALIDE

Drug Details

Generic Name
sincalide
Brand Names
KINEVAC, SINCALIDE
Application Number
NDA017697
Sponsor
Bracco Diagnostics Inc.
NDC Codes
3
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, POWDER
Routes
INTRAVENOUS
Active Ingredients
SINCALIDE

Indications and Usage

1 INDICATIONS AND USAGE Sincalide for Injection is indicated in adults to: to stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals; to stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology; to accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. Sincalide for Injection is a cholecystokinin (CCK) analog indicated in adults to: stimulate gallbladder contraction, as may be assessed by various methods of diagnostic imaging, or to obtain by duodenal aspiration a sample of concentrated bile for analysis of cholesterol, bile salts, phospholipids, and crystals. ( 1 ) stimulate pancreatic secretion in combination with secretin prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology. ( 1 ) accelerate the transit of a barium meal through the small bowel, thereby decreasing the time and extent of radiation associated with fluoroscopy and x-ray examination of the intestinal tract. ( 1 )