FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Sincalide may be used: 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 (especially in conjunction 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
History
There is currently no drug history available for this drug.
Other Information
- Upon reconstitution with 3 ml normal saline, the vial contains
- 1 mcg/ml Sincalide
- 5 mg Mannitol
- Lyophilized product should be stored at room temperature. After reconstitution with normal saline, the vial can be stored in the refrigerator for use within 12 hours.
Normal dosing is 0.02 micrograms per kilogram patient weight. A 70 kg patient would receive 1.4 mcg or 1.4 ml
Sources
Sincalide Manufacturers
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Anazaohealth Corporation
Sincalide | Anazaohealth Corporation
To reconstitute, aseptically add 3 mL of preservative free 0.9% sodium chloride to the vial and swirl. This solution may be kept at room temperature and should be used within 8 hours of reconstitution, after which time any unused portion should be discarded.
The vial should be inspected visually for particulate matter and discoloration prior to administration.
For prompt contraction of the gallbladder, a dose of 0.02 mcg sincalide per kg (1.4 mcg/70 kg) is injected intravenously over a 30- to 60-second interval; if satisfactory contraction of the gallbladder does not occur in 15 minutes, a second dose, 0.04 mcg sincalide per kg, may be administered. To reduce the intestinal side effects, an intravenous infusion may be prepared at a dose of 0.12 mcg/kg in 100 mL of Sodium Chloride Injection USP and given at a rate of 2 mL per minute; alternatively, an intramuscular dose of 0.1 mcg/kg may be given.
To accelerate the transit time of a barium meal through the small bowel, administer Sincalide after the barium meal is beyond the proximal jejunum. (Sincalide, like cholecystokinin, may cause pyloric contraction.) The recommended dose is 0.04 mcg sincalide per kg (2.8 mcg/70 kg) injected intravenously over a 30- to 60- second interval; if satisfactory transit of the barium meal has not occurred in 30 minutes, a second dose of 0.04 mcg sincalide per kg may be administered. For reduction of side effects, a 30-minute IV infusion of sincalide [0.12 mcg per kg (8.4 mcg/70 kg) diluted to approximately 100 mL with Sodium Chloride Injection USP] may be administered
Storage and HandlingThe preparation should be stored at room temperature
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