Sincalide

Sincalide is used to help diagnose problems with the gallbladder or pancreas.

Sincalide is also used to speed up the digestion of barium, which is a contrast agent given before x-ray exams of the intestines.

Sincalide may also be used for reasons not mentioned in this medication guide.

Sincalide is given through an infusion into a vein.

A healthcare provider will give you this injection as part of your medical test or x-ray.

You should not receive sincalide if you have a blockage in your intestines.

Tell your doctor if you are pregnant. Receiving sincalide during pregnancy may result in a miscarriage or premature labor.

You should not be treated with sincalide if you are allergic to it, or if you have a blockage in your intestines.

Tell your doctor if you have ever had:

• gallstones.

Tell your doctor if you are pregnant. Receiving this medicine during pregnancy may result in a miscarriage or premature labor.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Sincalide may cause serious side effects. Call your doctor right away if you have:

• severe nausea, vomiting, diarrhea, or stomach cramps; or
• a light-headed feeling, like you might pass out.

Common side effects of sincalide may include:

• stomach pain or discomfort; or
• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Barium Meal Transit:

To accelerate the transit time of a barium meal through the small bowel, sincalide should be administered after the barium meal is beyond the proximal jejunum (sincalide, like cholecystokinin, may cause pyloric contraction). The recommended dose is 0.04 mcg per kg IV over a 30- to 60-second interval. If satisfactory transit of the barium meal has not occurred in 30 minutes, a second dose may be administered. To reduce intestinal side effects, a 30-minute IV infusion 0.12 mcg per kg diluted to approximately 100 mL with sodium chloride may be administered.

Usual Adult Dose for Pancreatic Secretion:

To test pancreatic function: 0.25 units per kg IV over a 60-mlnute period. Thirty minutes after the initiation of the infusion, a separate IV infusion at a total dose of 0.02 mcg per kg is administered over a 30-minute interval (for example, the total dose for a 70 kg patient is 1.4 mcg of sincalide; therefore, dilute 1.4 mL of reconstituted solution to 30 mL with sodium chloride Injection and administer at a rate of 1 mL per minute).

Usual Adult Dose for Gallbladder Contraction:

Initial dose: IV: 0.02 mcg/kg over 30 to 60 minutesIf satisfactory contraction of the gallbladder does not occur in 15 minutes, a second dose, 0.04 mcg/kg IV may be administered.To reduce intestinal side effects, an intravenous infusion may be prepared at a dose of 0.12 mcg/kg in 100 mL of sodium chloride Injection and given at a rate of 2 mL per minute. Alternatively, an intramuscular dose of 0.1 mcg/kg may be given. When sincalide is used in cholecystography, roentgenograms are usually taken at five-minute Intervals after the injection. For visualization of the cystic duct, it may be necessary to take roentgenograms at one-minute intervals during the first five minutes after the injection.

Sincalide is given as a single dose and is not taken daily.

Since sincalide is administered by a healthcare professional in a medical setting, an overdose is unlikely to happen.

Follow your doctor's instructions regarding any restrictions on food, drinks, or activities.

Other drugs may affect sincalide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.