VARIBAR PUDDING- barium sulfate paste

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Barium Sulfate (UNII: 25BB7EKE2E) (Barium Sulfate - UNII:25BB7EKE2E)

Available from:

E-Z-EM Canada Inc

INN (International Name):

Barium Sulfate

Composition:

Barium Sulfate 400 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

VARIBAR PUDDING is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older. VARIBAR PUDDING is contraindicated in patients with: - known or suspected perforation of the gastrointestinal (GI) tract; - known obstruction of the GI tract; - high risk of GI perforation such as those with a recent 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 hypersensitivity to barium sulfate or any of the excipients of VARIBAR PUDDING. Risk Summary VARIBAR PUDDING is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. [see Clinical Pharmacology (12.3)] Risk Summary VARIBAR PUDDING is not absorbed syste

Product summary:

VARIBAR PUDDING is supplied as a paste in a multiple-dose polyethylene tube containing 230 mL of barium sulfate (40 % w/v). Provided as: 12 X 230 mL tubes (NDC 32909-125-22) Store at USP controlled room temperature 20°C to 25°C (68°F to 77°F). Protect from freezing. Once opened, VARIBAR PUDDING 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).

Authorization status:

New Drug Application

Summary of Product characteristics

VARIBAR PUDDING- BARIUM SULFATE PASTE
E-Z-EM CANADA INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VARIBAR PUDDING SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VARIBAR PUDDING.
VARIBAR PUDDING (BARIUM SULFATE) ORAL PASTE
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
VARIBAR PUDDING 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
6 months of age and older (1)
DOSAGE AND ADMINISTRATION
For oral use only – administered by syringe or spoon (2.1)
Adults: 5 mL
Pediatric patients: 1-3 mL
Multiple doses may be administered
Maximum cumulative dose : 30 mL
DOSAGE FORMS AND STRENGTHS
Oral paste: barium sulfate (40% w/v) in a 230 mL multiple dose tube
for oral administration (3)
CONTRAINDICATIONS
VARIBAR PUDDING is contraindicated in patients with:
Known or suspected perforation of the gastrointestinal (GI) tract (4)
Conditions associated with high risk for GI perforation (4)
Known obstruction of the GI tract (4)
Patients with trachea-esophageal fistula (4)
Known hypersensitivity to barium sulfate or any of the excipients of
VARIBAR PUDDING (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions: Emergency equipment and trained personnel
should be immediately
available (5.1)
Intra-abdominal leakage: May occur with conditions which increase the
risk for perforation such as –
carcinomas, GI fistula, Inflammatory bowel disease, gastric or
duodenal ulcer, appendicitis, diverticulitis,
or severe stenosis or obstructing lesions of the GI tract (5.2)
Obstruction: Patients should maintain adequate hydration in days
following barium sulfate procedure to
avoid obstruction or impaction by baroliths (5.3)
Aspiration Pneumonitis: Aspiration may occur during the modified
barium swallow examination, monitor
the patient for aspiration (5.4)
ADVERSE REACTIONS
Common adverse reactions include nausea, vomiting, diarr