Warnings and Precautions

Post-marketing anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions have been reported during and within one hour following administration of sincalide. If anaphylaxis or other hypersensitivity reactions occur, immediately discontinue the infusion and initiate appropriate medical treatment.

Stimulation of gallbladder contraction can lead to small gallbladder stone evacuation, resulting in lodging in the cystic duct or in the common bile duct.

Sincalide may cause adverse reactions such as nausea, vomiting, abdominal pain or cramping, dizziness, and flushing., To reduce the risk of adverse reactions, administer sincalide over 50 minutes for simulation of gallbladder contraction or over 30 minutes to accelerate transit of a barium meal through the small intestine.

Pregnant patients, should be advised that sincalide can effect smooth muscle, which may cause spontaneous abortion or premature induction of labor.

The most common adverse reactions (≥ 20%) include abdominal discomfort or pain, and nausea.

• 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
• Stimulate pancreatic secretion (especially in conjunction with secretin) prior to obtaining a duodenal aspirate for analysis of enzyme activity, composition, and cytology
• 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

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full Prescribing Information for Sincalide for Injection.

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