VARIBAR THIN LIQUID- barium sulfate powder, for suspension

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 .81 g in 1 g

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

VARIBAR THIN LIQUID is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. VARIBAR THIN LIQUID 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 of 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 THIN LIQUID Risk Summary VARIBAR THIN LIQUID is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug. Risk Summary VARIBAR THIN LIQUID is not absorbed systemically by the mother following oral adminis

Product summary:

16.1 How Supplied VARIBAR THIN LIQUID is supplied as a white to lightly colored powder in a multiple-dose polyethylene bottle containing 120 grams of barium sulfate (81% w/w). Provided as: 24 x 148 g bottles (NDC 32909-105-10) 16.2 Storage and Handling Store 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 THIN LIQUID- BARIUM SULFATE POWDER, FOR SUSPENSION
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 THIN LIQUID SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR VARIBAR THIN LIQUID.
VARIBAR THIN LIQUID (BARIUM SULFATE) FOR ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
VARIBAR THIN LIQUID is a radiopaque 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
For oral use only– once reconstituted, administer by infant bottle,
syringe, spoon, or cup. The
recommended dose is:
  ● Adults: 5 mL
  ● Pediatric patients 6 months and older: 1 mL to 3 mL
  ● Pediatric patients younger than 6 months of age: 0.5 mL to 1
mL
During a single modified barium swallow examination, multiple doses
may be administered
Maximum cumulative dose: 80 mL (2.1)
Must reconstitute supplied powder with water prior to use. See Full
Prescribing Information for
reconstitution instructions (2.2)
DOSAGE FORMS AND STRENGTHS
For oral suspension: 120 g barium sulfate (81% w/w) supplied in a
multiple-dose bottle for reconstitution
(3)
CONTRAINDICATIONS
Known or suspected perforation of the gastrointestinal (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
VARIBAR THIN LIQUID (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions: Emergency equipment and trained personnel
should be immediately
available (5.1)
Intra-abdominal leakage: May occur in conditions such as GI fistula,
ulcer, inflammatory bowel disease,
appendicitis or diverticulitis, severe stenosis or obstructing lesions
of the GI tract (5.2)
Delayed GI transit and obstruction: Patients should maintain adequate
hydration in days following
barium sulfate procedure t