Kinevac

Mechanism of Action

Cholecystopancreatic-gastrointestinal hormone peptide; produces a substantial reduction in gallbladder size by causing this organ to contract; evacuation of bile that results is similar to that which occurs physiologically in response to endogenous cholecystokinin

Like cholecystokinin, sincalide stimulates pancreatic secretion; concurrent administration with secretin increases both the volume of pancreatic secretion and the out-put of bicarbonate and protein (enzymes) by the pancreas

This combined effect of secretin and sincalide permits the assessment of specific pancreatic function through measurement and analysis of the duodenal aspirate; parameters usually determined are: volume of the secretion; bicarbonate concentration; and amylase content (which parallels the content of trypsin and total protein)

Both cholecystokinin and sincalide stimulate intestinal motility, and may cause pyloric contraction which retards gastric emptying

Absorption

Time to maximal effect: 5-15 minutes

IV Preparation

Reconstitute lyophilized powder by adding 5 mL of sterile water for injection per 5 mcg vial

IV Administration

Varies for specific indication, see Adult Dosing

Storage

Unreconstituted vial: Store at controlled room temperature (25° C [77° F]); excursions permitted to 15-30° C (59-86° F)

Reconstituted vial: May store at room temperature; use within 8 hr of reconstitution

Although no overdosage reports have been received, gastrointestinal symptoms (abdominal cramps, nausea, vomiting and diarrhea) would be expected. Hypotension with dizziness or fainting might also occur. Overdosage symptoms should be treated symptomatically and should be of short duration. Starting with single bolus i.v. injection comparable to the human dose of 0.4 mg/kg, sincalide caused hypotension and bradycardia in dogs. Higher doses injected once or repeatedly in dogs caused syncope and ECG changes in addition. These effects were attributed to sincalide-induced vagal stimulation in that all were prevented by pretreatment with atropine or bilateral vagotomy.

Sincalide is a diagnostic agent that works by stimulating processes in specific organs of the body. Sincalide is injected in preparation for certain medical tests.

Sincalide is used to help diagnose disorders of the gallbladder or pancreas. It is also used to speed up digestion of barium, a contrast agent, given in preparation for x-ray examination of the intestines.

Sincalide may also be used for purposes not listed in this medication guide.

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

Before you receive sincalide, tell your doctor if you have gallstones.

FDA pregnancy category B. Sincalide is not expected to harm an unborn baby during early pregnancy. However, receiving this medication late in pregnancy may result in a miscarriage or premature labor. Before you receive sincalide, tell your doctor if you are pregnant.

It is not known whether sincalide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Sincalide is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting.

Your medical test or x-ray will be performed shortly after sincalide is injected.

Since sincalide is given by a healthcare professional as part of a medical test, you are not likely to miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include nausea, vomiting, diarrhea, and stomach cramps.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Reconstitution and Storage

Sincalide for Injection may be stored at room temperature prior to reconstitution.

To reconstitute, aseptically add 5 mL of Sterile Water for Injection USP to the vial. 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.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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 (see ADVERSE REACTIONS), 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. When Kinevac (Sincalide for Injection) 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.

For the Secretin-Kinevac test of pancreatic function, the patient receives a dose of 0.25 units secretin per kg by intravenous infusion over a 60-minute period. Thirty minutes after the initiation of the secretin infusion, a separate IV infusion of Kinevac 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 Kinevac solution to 30 mL with Sodium Chloride Injection USP and administer at a rate of 1 mL per minute.

To accelerate the transit time of a barium meal through the small bowel, administer Kinevac 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.

Sodium Chloride Injection dilutions may be kept at room temperature and should be used within one hour of dilution.