Barium Sulfate
FDA Drug Information • Also known as: E-Z-Disk, E-Z-Hd, E-Z-Paque, E-Z-Paste, Entero Vu 24%, Liquid Polibar Plus, Readi-Cat 2, Readi-Cat...
- Brand Names
- E-Z-Disk, E-Z-Hd, E-Z-Paque, E-Z-Paste, Entero Vu 24%, Liquid Polibar Plus, Readi-Cat 2, Readi-Cat 2 Banana Smoothie, Readi-Cat 2 Berry Smoothie, Readi-Cat 2 Creamy Vanilla Smoothie, Readi-Cat 2 Mochaccino Smoothie, Tagitol V, Varibar Honey, Varibar Nectar, Varibar Pudding, Varibar Thin Honey, Varibar Thin Liquid
- Drug Class
- Radiographic Contrast Agent [EPC]
- Route
- ORAL
- Dosage Form
- CREAM
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
11 DESCRIPTION VARIBAR NECTAR (barium sulfate) is a radiographic contrast agent for oral administration that is supplied as a 40% w/v, smooth, off- white to lightly colored free-flowing suspension with an apple aroma. The active ingredient is designated chemically as BaSO 4 which has a density of 4.5 g/cm 3 , a molecular weight of 233.4 g/mol, and the following chemical structure: VARIBAR NECTAR has a viscosity of 300 cPs and contains the following excipients: carboxymethylcellulose sodium, citric acid, glycerin, maltodextrin, natural and artificial apple flavor, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, xanthan gum, and xylitol. barium-sulfate-structure
What Is Barium Sulfate Used For?
1 INDICATIONS AND USAGE VARIBAR NECTAR is indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. VARIBAR NECTAR is a radiographic contrast agent indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION For oral use only – administered by syringe, spoon, or cup. The recommended dose is: Adults: 5 mL Pediatric patients 6 months and older: 1-3 mL Pediatric patients younger than 6 months of age: 0.5-1 mL Maximum cumulative dose: 30 mL During a single modified barium swallow examination, multiple doses of VARIBAR NECTAR may be administered. ( 2 ) 2.1 Recommended Dosing The recommended dose of VARIBAR NECTAR administered orally by syringe, spoon, or cup: Adults 5 mL Pediatric patients 6 months and older 1-3 mL Pediatric patients younger than 6 months of age 0.5-1 mL (This amount may be administered by an oral syringe or, alternatively, an infant bottle) During a single modified barium swallow examination, multiple doses of VARIBAR NECTAR may be administered as appropriate to assess the patient during multiple swallows and different radiographic views. The maximum cumulative dose is 30 mL. Once opened, write the discard after date on the immediate container label. Discard any unused product after 21 days. 2.2 Important Administration Instructions For oral use only. Encourage patients to hydrate following the barium sulfate procedure.
Side Effects (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
Contraindications
4 CONTRAINDICATIONS VARIBAR NECTAR is contraindicated in patients with: known or suspected perforation of the GI tract known obstruction of the GI tract 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 the pelvis high risk for aspiration such as those with known or suspected tracheo-esophageal fistula or obtundation known severe hypersensitivity to barium sulfate or any of the excipients of VARIBAR NECTAR Known or suspected perforation of the GI tract ( 4 ) Known obstruction of the GI tract ( 4 ) Conditions associated with high risk of GI perforation ( 4 ) Patients with tracheo-esophageal fistula ( 4 ) Known severe hypersensitivity to barium sulfate or any of the excipients of VARIBAR NECTAR ( 4 )
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied VARIBAR NECTAR is supplied in both a multiple-dose HDPE bottle containing 240 mL of barium sulfate (40% w/v) and a multiple-dose glass vial containing 70 mL of barium sulfate (40% w/v). Provided as: 12 x 240 mL bottles (NDC 32909-116-00); 12 x 70 mL vials (32909-116-55). Storage and Handling Store at USP controlled room temperature 20°C to 25°C (68° F to 77° F). Protect from freezing. Once opened, VARIBAR NECTAR may be used for up to 21 days when stored at USP controlled room temperature, 20°C to 25°C (68° F to 77° F).
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.