Drugplain

Readi-Cat 2 20 mg/mL

Barium Sulfate · SUSPENSION · E-Z-EM Canada Inc

No Recall History
Plain English

Readi-Cat 2 is a prescription suspension containing barium sulfate at 20 mg/mL, taken oral. Manufactured by E-Z-EM Canada Inc.

Key Facts

Brand Name
Readi-Cat 2
Generic Name
Barium Sulfate
NDC Code (Product)
32909-744
Manufacturer
E-Z-EM Canada Inc
Strength
20 mg/mL
Dosage Form
SUSPENSION
Route
ORAL
Marketing Status
HUMAN PRESCRIPTION DRUG
Application #
NDA208143
Drug Class
Radiographic Contrast Agent [EPC]; X-Ray Contrast Activity [MoA]
Marketing Start
11/01/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

urticaria27 reports
diarrhoea26 reports
acute kidney injury18 reports
pruritus18 reports
renal failure18 reports
dyspnoea16 reports
chronic kidney disease15 reports
rash15 reports
abdominal pain14 reports
no adverse event14 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE READI-CAT 2 and READI-CAT 2 SMOOTHIES are indicated for use in computed tomography (CT) of the abdomen to delineate the gastrointestinal (GI) tract in adult and pediatric patients. READI-CAT 2 and READI-CAT 2 SMOOTHIE are radiographic contrast agents, indicated for use in computed tomography (CT) of the abdomen to delineate the gastrointestinal (GI) tract in adult and pediatric patients ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION For oral use only: Adults and pediatric patients 12 years and older: 450 mL to 900 mL (9 g to 18 g of barium sulfate, respectively) ( 2.1 ) Patients younger than 12 years of age: scale down dose based on relative GI volume ( 2.1 ) 2.1 Recommended Dosage Base dosing on individual needs and procedure to be performed. Adult and pediatric patients 12 years and older: 450 mL to 900 mL (9 g to 18 g of barium sulfate) Patients younger than 12 years of age: adjust dose based on relative GI volume 2.2 Administration Instructions For oral use only Shake bottle vigorously for 30 seconds prior to oral administration Administer undiluted prior to scan Discard any unused suspension Advise patients to hydrate following the barium sulfate procedure

Contraindications

4 CONTRAINDICATIONS READI-CAT 2 products are contraindicated in patients: with known or suspected perforation of the GI tract with known obstruction of the GI tract at high risk of GI perforation such as those with a recent prior GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, post GI surgery or biopsy, acute GI injury or burn, or recent radiotherapy to pelvis at high risk of aspiration such as those with prior aspiration, tracheo-esophageal fistula, or obtundation known severe hypersensitivity to barium sulfate or any of the excipients of READI-CAT 2 or READI-CAT 2 SMOOTHIES Known or suspected perforation of the GI tract ( 4 ) Known obstruction of the GI tract ( 4 ) Conditions associated with high risk of GI perforation or aspiration ( 4 ) Known hypersensitivity to barium sulfate or any of the excipients of READI-CAT 2 products ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions have been identified from spontaneous reporting or clinical studies of barium sulfate administered orally. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure: Nausea, vomiting, diarrhea and abdominal cramping Serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes Common adverse reactions include nausea, vomiting, diarrhea and abdominal cramping ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Frequently Asked Questions

What is Readi-Cat 2 used for?

Readi-Cat 2 contains Barium Sulfate. It is a suspension taken oral. Consult your doctor for specific uses.

Is Readi-Cat 2 a controlled substance?

Readi-Cat 2 is not classified as a controlled substance by the DEA.

What is the generic name for Readi-Cat 2?

The generic name for Readi-Cat 2 is Barium Sulfate. There are 11 other brand versions of Barium Sulfate.

What is the NDC code for Readi-Cat 2 20 mg/mL?

The NDC (National Drug Code) for Readi-Cat 2 20 mg/mL is 32909-744, listed by E-Z-EM Canada Inc.

Product NDC

32909-744

Package NDC

32909-744-03

Other Barium Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)