VARIBAR THIN HONEY- 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 400 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

VARIBAR THIN HONEY is indicated for modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients. VARIBAR THIN HONEY 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 HONEY Risk Summary VARIBAR THIN HONEY 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 HONEY is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the infant to the drug. The efficacy of VARIBAR THIN HONEY in pediatric patients is based on successful opacification of the pharynx during modified barium swallow examinations [see Clinical Pharmacology (12.1)] . Safety and dosing recommendations in pediatric patients are based on clinical experience. VARIBAR THIN HONEY is contraindicated in pediatric patients with trachea-esophageal fistula. [see Contraindications (4)]. Pediatric patients with a history of asthma or food allergies may be at increased risk for development of hypersensitivity reactions [see Warnings and Precautions (5.1)]. Monitor patients with cystic fibrosis or Hirschsprung disease for bowel obstruction after use [see Warnings and Precautions (5.3)] . Clinical studies of VARIBAR THIN HONEY did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Product summary:

16.1 How Supplied VARIBAR THIN HONEY is supplied as a suspension in a multiple-dose polyethylene bottle containing 250 mL of barium sulfate (40 % w/v). Provided as: 12 x 250 mL bottles (NDC 32909-121-07) 16.2 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 THIN HONEY 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 THIN HONEY- 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
VARIBAR THIN HONEY
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VARIBAR
THIN HONEY.
VARIBAR THIN HONEY (BARIUM SULFATE) ORAL SUSPENSION
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
VARIBAR THIN HONEY 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 – administer by syringe, spoon, or cup. The
recommended dose is:
Adults: 5 mL
Pediatric patients: 1 to 3 mL
During a single modified barium swallow examination, multiple doses
may be administered
Maximum cumulative dose: 30 mL (2)
DOSAGE FORMS AND STRENGTHS
Oral suspension: barium sulfate (40% w/v) supplied in a multiple-dose
bottle for oral administration (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 HONEY (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 to avoid obstruction or impaction (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, diarrhea and
abdominal cramp (6)
TO REPORT SUSPECTED ADVERSE REACTI