E-Z Paste oral and rectal

Barium sulfate is in a group of drugs called contrast agents. Barium sulfate works by coating the inside of your esophagus, stomach, or intestines which allows them to be seen more clearly on a CT scan or other radiologic (x-ray) examination.

Barium sulfate is used to help diagnose certain disorders of the esophagus, stomach, or intestines.

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

Tell your doctor if you are pregnant or breast-feeding before your medical test.

Also tell your doctor if you have ever had an allergic reaction to a contrast agent.

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Barium sulfate comes in tablets, paste, cream, or liquid forms.

In some cases, barium sulfate is taken by mouth. The liquid form may also be used as a rectal enema.

You may need to begin using this medication at home a day before your medical test. Follow your doctor's instructions about how much of the medication to use and how often.

If you are receiving barium sulfate as a rectal enema, a healthcare professional will give you the medication at the clinic or hospital where your testing will take place.

Do not crush, chew, or break a barium sulfate tablet. Swallow the pill whole.

Dissolve the barium sulfate powder in a small amount of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

If you receive the medication as a liquid to take by mouth, shake the liquid well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Carefully follow your doctor's instructions about what to eat or drink within the 24-hour period before your test.

Drink plenty of liquids to prevent constipation.

Store at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

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

Call your doctor at once if you have:

• severe stomach pain;

• severe cramping, diarrhea, or constipation;

• ringing in your ears;

• sweating, confusion, fast heart rate; or

• pale skin, blue-colored skin, weakness.

Common side effects may include:

• mild stomach cramps;

• nausea, vomiting;

• loose stools or mild constipation.

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.

Applies to barium sulfate: compounding powder, oral capsule, oral cream, oral paste, oral powder for reconstitution, oral suspension, oral tablet, oral and rectal powder for reconstitution, oral and rectal suspension, rectal powder for reconstitution, rectal suspension

General

General side effects including severe reactions (approximately 1 in 1,000,000) and fatalities (approximately 1 in 10,000,000) have been reported.[Ref]

Other

Other side effects caused by procedural complications have been rare. Procedural complications have included aspiration pneumonitis, barium impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities.[Ref]

Cardiovascular

It is of the utmost importance to be completely prepared to treat any EKG changes.[Ref]

Cardiovascular side effects including EKG changes have been reported following or during barium enema procedures.[Ref]

Gastrointestinal

Gastrointestinal side effects including nausea, vomiting, diarrhea, and abdominal cramping accompanying the use of barium sulfate (the active ingredient contained in E-Z Paste) formulations have been infrequent and usually mild.[Ref]

Some side effects of E-Z Paste may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.