Sincalide 5 ug/5mL
Sincalide · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · MAIA Pharmaceuticals, Inc.
Sincalide is an injectable medication that mimics cholecystokinin, a natural hormone in your body, and is used to stimulate gallbladder contractions during diagnostic imaging tests. It helps doctors visualize how well your gallbladder is functioning.
Key Facts
- Brand Name
- Sincalide
- Generic Name
- Sincalide
- NDC Code (Product)
70511-131- Manufacturer
- MAIA Pharmaceuticals, Inc.
- Strength
- 5 ug/5mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA210850
- Drug Class
- Cholecystokinin Analog [EPC]
- Marketing Start
- 11/25/2022
Recall History
Olympia Compounding Pharmacy dba Olympia Pharmacy
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
KRS Global Biotechnology, Inc
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Olympia Compounding Pharmacy dba Olympia Pharmacy
Super Potent and Failed Reconstitution Time
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Sincalide for Injection is 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; stimulate pancreatic secretion in combination 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. 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 sma…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended Adult Dosage and Administration by Indication: To Stimulate Contraction of the Gallbladder 0.02 mcg/kg as a single dose over 30 to 60 seconds via intravenous injection. If satisfactory contraction does not occur in 15 minutes, administer a dose of 0.04 mcg/kg over 30 to 60 seconds. (2.1) Alternatively consider an intravenous infusion to reduce gastrointestinal adverse reactions: 0.12 mcg/kg diluted in 100 mL of 0.9% Sodium Chloride Injection USP and infused over 50 minutes at a rate of 2 mL per minute. (2.1, 2.2, 5.3) To Stimulate Pancreatic Secretion in Combination with Secretin 30 minutes after initiation of secretin for injection, administer 0.02 mcg/kg diluted in 30 mL of 0.9% Sodium Chloride Injection USP and infused over 30 minutes at a rate of 1 mL per minute. (2.1, 2.2) To Accelerate Transit of a Barium Meal Through the Small Intestine: After the barium meal is beyond the proximal jejunum, administer 0.04 mcg/kg over 30 to 60 seconds via intravenous injection. (2.1) If satisfactory transit of the barium meal has not occurred in 30 minutes, administer a second dose of 0.04 mcg/kg over 30 to 60 seconds. (2.1) Alternatively consider an i…
Contraindications
4 CONTRAINDICATIONS Sincalide for Injection is contraindicated in patients with: a history of a hypersensitivity reaction to sulfites or sincalide. Serious hypersensitivity reactions have included anaphylaxis and anaphylactic shock [see Warnings and Precautions (5.1), Adverse Reactions (6)]. intestinal obstruction. History of hypersensitivity to sulfites or sincalide. (4, 5.1) Intestinal obstruction. (4)
Drug Interactions
7 DRUG INTERACTIONS Drugs that Affect Gallbladder Motility or Contractile Response : May interfere with response to sincalide. Consider discontinuing these drugs prior to administration of Sincalide for Injection, when used to stimulate contraction of the gallbladder. (7.1) 7.1 Drugs that Affect Gallbladder Motility or Contractile Response Drugs that may stimulate or inhibit gallbladder motility or contractile response, may interfere with the response to sincalide. Consider discontinuing these drugs prior to administration of Sincalide for Injection, when used to simulate contraction of the gallbladder.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: • Anaphylaxis, anaphylactic shock, and other serious hypersensitivity reactions [see Warnings and Precautions (5.1)] • Evacuation of gallstones [see Warnings and Precautions (5.2)] • Adverse reactions with intravenous injection [see Warnings and Precautions (5.3)] • Preterm labor or spontaneous abortion [see Warnings and Precautions (5.4)] The following adverse reactions associated with the use of sincalide were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. The most frequent adverse reactions (20% or greater) are gastrointestinal: abdominal discomfort or pain, and nausea; these may not necessarily indicate an abnormality of the biliary tract unless there is other clinical or radiologic evidence of disease. Less common adverse reactions include: Hypersensitivity reactions : anaphylaxis and anaphylactic shock, hypotension, throat tightness, bradycardia, shortn…
Frequently Asked Questions
What is Sincalide used for?
Sincalide is an injectable medication that mimics cholecystokinin, a natural hormone in your body, and is used to stimulate gallbladder contractions during diagnostic imaging tests. It helps doctors visualize how well your gallbladder is functioning.
Is Sincalide a controlled substance?
Sincalide is not classified as a controlled substance by the DEA.
What is the generic name for Sincalide?
The generic name for Sincalide is Sincalide. There are 2 other brand versions of Sincalide.
What is the NDC code for Sincalide 5 ug/5mL?
The NDC (National Drug Code) for Sincalide 5 ug/5mL is 70511-131, listed by MAIA Pharmaceuticals, Inc..