Pronunciation:

SIN-ka-lide

Brand Names:

• Kinevac

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Diagnostic Agent

Uses of This Medicine:

Sincalide injection is a diagnostic aid used to help diagnose certain problems of the gallbladder and pancreas. It is also used to speed up barium digestion to decrease radiation exposure during bowel examination (eg, fluoroscopy, x-ray examination).

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of sincalide injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Although appropriate studies on the relationship of age to the effects of sincalide injection have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

• Bowel blockage—Should not be used in patients with this condition.

• Gallstones (gallbladder stones)—Use with caution. May increase risk for more side effects.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine before you have your medical test done. It is given through a needle placed into one of your veins.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while receiving the medicine to make sure that this medicine is working properly and to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Tell your doctor if you are pregnant before receiving this medicine. Sincalide may cause pre-term labor and early pregnancy loss in pregnant women. Talk to your doctor if you have concerns about this.

This medicine stimulates the gallbladder to contract. If you have small gallstones, they may get stuck in the cystic duct or in the common bile duct and cause blockage. Talk to your doctor if you have concerns about this.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

Blurred vision

confusion

cough

difficulty swallowing

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fainting

headache

hives, itching, skin rash

loss of consciousness

nervousness

numbness of the face, lips, and eyes

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

seizures

slow or fast heartbeat

stomach cramping

sweating

tightness of the chest

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Nausea

stomach discomfort or pain

Less common

Diarrhea

feeling of warmth

increased sweating

redness of the face, neck, arms, and occasionally, upper chest

sneezing

urge to defecate

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.