E-Z-PAQUE- barium sulfate 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 0.6 g in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Liquid E-Z-PAQUE is indicated for use in single contrast radiographic examinations of the esophagus, stomach, and small bowel to visualize the gastrointestinal (GI) tract in adult and pediatric patients. Liquid E-Z-PAQUE is contraindicated in patients with the following conditions: - 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 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 prior aspiration, tracheo-esophageal fistula, or obtundation - known severe hypersensitivity to barium sulfate or any of the excipients of Liquid E-Z-PAQUE Risk Summary Liquid E-Z-PAQUE 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 Liquid E-Z-PA

Product summary:

How Supplied Liquid E-Z-PAQUE (barium sulfate) is a suspension (60% w/v) supplied as a unit dose in a single use HDPE plastic bottle containing 213 grams of barium sulfate in 355 mL. Provided as: 12 x 355 mL bottles (NDC 32909-187-02). Storage and Handling Store at USP controlled room temperature 20 to 25°C (68 to 77° F). Protect from freezing.

Authorization status:

New Drug Application

Summary of Product characteristics

E-Z-PAQUE- BARIUM SULFATE 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
LIQUID E-Z-PAQUE SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR LIQUID E-Z-PAQUE.
LIQUID E-Z-PAQUE (BARIUM SULFATE) ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
Liquid E-Z-PAQUE is a radiographic contrast agent indicated for use in
single contrast radiographic examinations of the
esophagus, stomach, and small bowel to visualize the gastrointestinal
(GI) tract in adult and pediatric patients (1)
DOSAGE AND ADMINISTRATION
Adults: Recommended oral dose is 150 mL to 750 mL (87g to 435g of
barium sulfate, respectively) (2.1)
Pediatric patients: adjust dose based on relative GI volume (2.1)
DOSAGE FORMS AND STRENGTHS
Oral suspension 213 g barium sulfate (60% w/v) (3)
CONTRAINDICATIONS
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 severe hypersensitivity to barium sulfate or any of the
excipients of Liquid E-Z-PAQUE (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions: Emergency equipment and trained personnel
should be immediately available (5.1)
Intra-abdominal barium 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 a barium sulfate
procedure to avoid obstruction or impaction (5.3)
Aspiration pneumonitis: Patients with history of food aspiration or
with swallowing disorders are at increased risk (5.4)
ADVERSE REACTIONS
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
SEE 17 FOR PATIENT COUNSELING