Sincalide (Monograph)

Drug class: Gallbladder Function
VA class: DX101
CAS number: 25126-32-3

Medically reviewed by Drugs.com on Nov 21, 2024. Written by ASHP.

Introduction

Sincalide, the synthetic C-terminal octapeptide of the hormone cholecystokinin (cholecystokinin-pancreozymin, pancreozymin), causes gallbladder contraction resulting in reduction of gallbladder size and in evacuation of bile.

Uses for Sincalide

Postevacuation Cholecystography

Sincalide is used to evacuate the gallbladder after it has filled with an oral cholecystographic contrast media for postevacuation cholecystography. However, the diagnostic value of gallbladder contraction during cholecystography is controversial and some patients may not respond to the drug. The manufacturer states that sincalide may be used when the physician deems the procedure necessary but wishes to avoid use of a fatty meal to stimulate the gallbladder. Although no comparative studies have been published, some clinicians state that sincalide may be preferable to a fatty meal to stimulate the gallbladder because it produces a more prompt and less variable response.

For postevacuation cholecystography, a 40% reduction in gallbladder size is considered to be a satisfactory response. In patients who respond, sincalide in doses of 20 ng/kg produces maximal contraction of the gallbladder within 5–15 minutes after IV administration as compared to 30–60 minutes after a fatty meal. Although a few patients who do not respond to sincalide in doses of 20 ng/kg may respond to 40 ng/kg, doses greater than 20 ng/kg usually do not cause a further decrease and may in fact cause a lesser reduction in gallbladder size, possibly because constriction of the neck of the gallbladder results and prevents emptying. Studies to date indicate that visualization of the cystic and common bile ducts can be achieved in 47–88% of patients who receive usual doses of sincalide for postevacuation cholecystography.

Gallbladder Bile Sampling

Sincalide is used to stimulate the gallbladder to provide a sample of gallbladder bile that may be aspirated from the duodenum for determination of its composition including cholesterol saturation, calcium bilirubinate crystals, bile-stained epithelial cells, and bacteria.

Pancreatic Dysfunction

Sincalide may be used in conjunction with secretin as an aid in the diagnosis of chronic pancreatic dysfunction or carcinoma by stimulating pancreatic secretions that may be aspirated from the duodenum for analysis of volume and composition and/or cytology. There are no published studies comparing the use of sincalide in conjunction with secretin to the use of secretin alone for this purpose.

Other Uses

Sincalide has been used to diagnose gallbladder dysfunction in patients with biliary dyskinesia^{† [off-label]} by stimulating the gallbladder, thus reproducing biliary pain; however, the accuracy of this test is controversial.

Sincalide Dosage and Administration

Reconstitution and Administration

Sincalide is administered IV.

The commercially available sincalide powder for injection is reconstituted by adding 5 mL of sterile water for injection to the vial containing 5 mcg of sincalide to provide a solution containing 1 mcg of the drug per mL.

Dosage

The usual adult dose of sincalide to induce contraction of the gallbladder is 0.02 mcg/kg (1.4 mcg for a 70 kg adult). To prevent contraction of the neck of the gallbladder, the drug should be injected slowly over a 30- to 60-second period. If satisfactory contraction of the gallbladder does not occur in 15 minutes, a second dose of 0.04 mcg/kg may be administered.

Postevacuation Cholecystography

For postevacuation cholecystography, sincalide is given to stimulate contraction of the gallbladder after initial cholecystographic examinations are performed using an oral roentgenographic contrast medium. Additional radiographs are then taken at 5-minute intervals for 15 minutes. For visualization of the cystic and common bile duct, it may be necessary to take radiographs at 1-minute intervals during the first 5 minutes after administration of sincalide.

Gallbladder Bile Sampling

To obtain duodenal fluid for analysis of bile composition or volume and content of pancreatic secretions, a double-lumen tube is passed through the patient’s mouth after he has fasted overnight. Under fluoroscopic guidance, one portion of the tube is positioned in the stomach; and the other is positioned beyond the papilla of Vater for collection of duodenal contents. Gastric contents are aspirated by continuous suction to prevent them from passing into the duodenum.

Pancreatic Dysfunction

To stimulate the pancreas to aid in the diagnosis of pancreatic dysfunction, secretin in a dose of 0.25 Clinical Units/kg is infused IV over a 60-minute period. Thirty minutes after the secretin infusion has been started, a sincalide dose of 0.02 mcg/kg is infused separately over 30 minutes. For example, the total dose of sincalide for a 70 kg patient is 1.4 mcg; this may be administered by diluting 1.4 mL of the reconstituted sincalide injection to 30 mL with 0.9% sodium chloride injection and infusing the solution at a rate of 1 mL/minute.

Cautions for Sincalide

Adverse Effects

Sincalide frequently causes nausea, abdominal pain or discomfort, and an urge to defecate. Dizziness and flushing may also occur. Adverse effects of sincalide are usually the result of the pharmacologic actions of the drug. Adverse effects usually occur immediately following injection of the drug and may last for a few minutes.

Precautions and Contraindications

Stimulation of gallbladder contraction in patients with small gallbladder stones could lead to their evacuation, resulting in blockage of the cystic or common bile duct; therefore, sincalide should be used with caution in these patients. However, the manufacturer states that the risk of this is minimal because sincalide, when given as directed, does not ordinarily cause complete contraction of the gallbladder.

When sincalide is used with secretin, the cautions applicable to that drug should be considered.

Sincalide is contraindicated in patients who are sensitive to the drug.

Pediatric Precautions

Safe use of sincalide in children has not been established.

Pregnancy

Pregnancy

Safe use of sincalide during pregnancy has not been established.

Pharmacology

Sincalide is similar to cholecystokinin in pharmacologic actions. Both agents cause gallbladder contractions resulting in reduction of gallbladder size and in evacuation of bile. They also cause decreased intestinal transit time, decreased esophageal sphincter tone, inhibition of gastric secretions, and delayed gastric emptying time.

Sincalide reportedly stimulates the acinar cells of the pancreas; however, there are no published studies on the effects of sincalide on pancreatic function. When given in conjunction with secretin to patients with normal pancreatic function, sincalide reportedly stimulates pancreatic secretion of protein, trypsin, and amylase, and potentiates secretin-induced increases in pancreatic secretion of water and bicarbonate.

Sincalide Pharmacokinetics

The pharmacokinetics of sincalide have not been determined. Following IV administration of usual doses of sincalide, peak decreases in gallbladder size occur in 5–15 minutes and the gallbladder returns to basal size within 1 hour.

Chemistry and Stability

Chemistry

Sincalide is the synthetic C-terminal octapeptide of the hormone cholecystokinin (cholecystokinin-pancreozymin, pancreozymin). Sincalide occurs as a white, lyophilized powder. The drug is very slightly soluble in water and practically insoluble in alcohol.

Stability

Sincalide powder for injection may be stored at room temperature. Following reconstitution with sterile water for injection to a concentration of 1 mcg/mL, sincalide injection has a pH of 5.5–6.5 and is stable for 24 hours at room temperature.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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