Baro-Cat

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:

Rare

• Bloating
• constipation (severe, continuing)
• cramping (severe)
• nausea or vomiting
• stomach pain
• tightness in the chest
• troubled breathing

Incidence not known

• Anxiety
• blood in the stools
• blood in the urine
• blurred vision
• bruising
• chest pain
• confusion
• cough
• coughing or vomiting blood
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast heartbeat
• hives or welts, itching, or skin rash
• noisy breathing
• persistent bleeding or oozing from puncture sites, mouth, or nose
• redness of the skin
• sudden shortness of breath or troubled breathing
• sweating
• 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

• Constipation or diarrhea
• cramping

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.

Serious adverse reactions, including death, have been reported with the administration of barium sulfate formulations and are usually associated with the technique of administration, the underlying pathological condition and/or patient hypersensitivities.

Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. Oral administration of barium sulfate suspension by an infant sucking a bottle and administration of large quantities by catheter are reported to likely result in aspiration into the tracheobronchial tree. Cardiopulmonary arrest leading to fatality has been reported in infants following aspiration. Aspiration of smaller amounts may cause inflammation.

Barium sulfate preparations used as radiopaque media contain a number of additives to provide diagnostic properties and patient palatability. Allergic responses following the use of barium sulfate suspensions have been reported. Skin irritation, redness, inflammation and hives have been reported for infants and small children following spillage of barium sulfate suspension on their skin. These responses are thought to be caused by the flavors and/or preservatives used in the product.

Barium sulfate suspension has been reported to cause obstruction of the small bowel (impaction) in pediatric patients with cystic fibrosis. It has also been reported to cause fluid overload from the absorption of water during studies in infants when Hirschsprung’s Disease is suspected.

Barium sulfate suspension intravasation can be a serious complication. Mortality has been reported as a result of vaginal or rectal intravasation and is believed to be due to massive pulmonary embolism occurring within minutes of the inciting event.

In patients with increased cranial pressure, barium sulfate suspension enemas present an additional risk of further increasing intracranial pressure.

Care must be taken during the insertion of an enema tip into the patient to prevent application of pressure to the vagus nerve which can lead to vasovagal reactions and syncopal episodes. Cardiac arrhythmia or other cardiovascular side effects can occur as a result of colon distention.

Applies to barium sulfate: oral cream, oral liquid, oral paste, oral powder for suspension, oral suspension, oral tablet

Along with its needed effects, barium sulfate (the active ingredient contained in Baro-Cat) 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 while taking barium sulfate:

Rare

• Bloating
• constipation (severe, continuing)
• cramping (severe)
• nausea or vomiting
• stomach pain
• tightness in the chest
• troubled breathing

Incidence not known

• Anxiety
• blood in the stools
• blood in the urine
• blurred vision
• bruising
• chest pain
• confusion
• cough
• coughing or vomiting blood
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast heartbeat
• hives or welts, itching, or skin rash
• noisy breathing
• persistent bleeding or oozing from puncture sites, mouth, or nose
• redness of the skin
• sudden shortness of breath or troubled breathing
• sweating
• unusual tiredness or weakness

Some side effects of barium sulfate 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

• Constipation or diarrhea
• cramping

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 Baro-Cat) formulations have been infrequent and usually mild.[Ref]

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