E-Z-Disk 700 mg/1
barium sulfate · TABLET · E-Z-EM, INC.
E-Z-Disk is a tablet containing barium sulfate at 700 mg/1, taken oral. Manufactured by E-Z-EM, INC..
Key Facts
- Brand Name
- E-Z-Disk
- Generic Name
- barium sulfate
- NDC Code (Product)
10361-778- Manufacturer
- E-Z-EM, INC.
- Strength
- 700 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- NDA219840
- Drug Class
- Radiographic Contrast Agent [EPC]
- Marketing Start
- 02/01/2009
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE E-Z-DISK is indicated for the evaluation of esophageal patency in adults and pediatric patients aged 12 years and older. E-Z-DISK is a radiographic contrast agent indicated for the evaluation of esophageal patency in adults and pediatric patients aged 12 years and older. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dose of E-Z-DISK in adults and pediatric patients aged 12 years and older is one 700 mg tablet orally during imaging. Swallow one tablet whole with the aid of one or two swallows of water. Do not cut, crush, or chew the tablet. Advise patients to hydrate following the E-Z-DISK imaging procedure [see Warnings and Precautions ( 5.3 )] . E-Z-DISK is formulated to disintegrate within the gastrointestinal (GI) tract. In the event of prolonged retention, consider implementing appropriate interventions. The recommended dose is one 700 mg tablet orally during imaging. Swallow one tablet whole with the aid of one or two swallows of water. Do not cut, crush, or chew the tablet. ( 2 )
Contraindications
4 CONTRAINDICATIONS E-Z-DISK is contraindicated in patients with: Known severe hypersensitivity to barium sulfate or any of the excipients of E-Z-DISK [see Warnings and Precautions ( 5.1 )] Known, suspected, or high risk of perforation of the GI tract such as patients with a recent GI perforation, acute GI hemorrhage or ischemia, toxic megacolon, severe ileus, recent GI surgery or biopsy, acute GI injury, or recent radiotherapy to the pelvis [see Warnings and Precautions ( 5.2 )] Known obstruction of the GI tract [see Warnings and Precautions ( 5.3 )] High risk of aspiration such as patients with known or suspected tracheoesophageal fistula or obtundation [see Warnings and Precautions ( 5.4 )] Known severe hypersensitivity to barium sulfate or any of the excipients of E-Z-DISK ( 4 ) Known or suspected perforation of the gastrointestinal (GI) tract or conditions associated with high risk of GI perforation ( 4 ) Known obstruction of the GI tract ( 4 ) Conditions associated with high risk of aspiration ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Intra-abdominal Barium Leakage [see Warnings and Precautions ( 5.2 )] Baroliths and Bowel Obstruction [see Warnings and Precautions ( 5.3 )] Aspiration Pneumonitis [see Warnings and Precautions ( 5.4 )] The following adverse reactions associated with the use of E-Z-DISK or other barium sulfate products were identified in postmarketing reports or published clinical studies. Because some of these 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: Cardiovascular disorders : Vasovagal and syncopal episodes Gastrointestinal disorders: Barium sulfate impaction, nausea, vomiting, diarrhea, abdominal cramping Respiratory disorders : Aspiration pneumonitis Adverse Reactions in Pediatric Patients No additional safety signals have been reported in pediatric patients aged 12 years and older. Common adverse reactions include nausea, vomiting, diarrhea, and abdominal cramping. ( …
Frequently Asked Questions
What is E-Z-Disk used for?
E-Z-Disk contains barium sulfate. It is a tablet taken oral. Consult your doctor for specific uses.
Is E-Z-Disk a controlled substance?
E-Z-Disk is not classified as a controlled substance by the DEA.
What is the generic name for E-Z-Disk?
The generic name for E-Z-Disk is barium sulfate. There are 11 other brand versions of barium sulfate.
What is the NDC code for E-Z-Disk 700 mg/1?
The NDC (National Drug Code) for E-Z-Disk 700 mg/1 is 10361-778, listed by E-Z-EM, INC..
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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)