Varibar Thin Liquid (Page 2 of 2)

8.5 Geriatric Use

Clinical studies of VARIBAR THIN LIQUID 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.

11 DESCRIPTION

VARIBAR THIN LIQUID (barium sulfate) is a radiographic contrast agent that is supplied as a white to lightly colored powder for suspension (81% w/w) with an apple aroma for oral administration. The active ingredient barium sulfate is designated chemically as BaSO4 with a molecular weight of 233.4 g/mol, a density of 4.5 g/cm3 , and the following chemical structure:

Barium Sulfate Chemical Structure

VARIBAR THIN LIQUID has a viscosity of <15 cPs when reconstituted and contains the following excipients: carboxymethylcellulose sodium, citric acid, maltodextrin, natural and artificial apple flavor, polysorbate 80, saccharin sodium, simethicone, sodium citrate, sorbitol and xylitol.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Due to its high atomic number, barium (the active ingredient in VARIBAR THIN LIQUID) is opaque to x-rays and therefore acts as a positive contrast agent for radiographic studies.

12.2 Pharmacodynamics

Barium sulfate is biologically inert and has no known pharmacological effects.

12.3 Pharmacokinetics

Under physiological conditions, barium sulfate passes through the gastrointestinal tract in an unchanged form and is absorbed only in small, pharmacologically insignificant amounts.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No animal studies have been performed to evaluate the carcinogenic potential of barium sulfate or potential effects on fertility.

16 HOW SUPPLIED/STORAGE AND HANDLING

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).

17 PATIENT COUNSELING INFORMATION

After administration, advise patients to:

  • Maintain adequate hydration [see Dosage and Administration (2.2) and Warnings and Precautions (5.3)].
  • Seek medical attention for worsening of constipation or slow gastrointestinal passage [see Warnings and Precautions (5.3)].
  • Seek medical attention for any delayed onset of hypersensitivity: rash, urticaria, or respiratory difficulty [see Warnings and Precautions (5.1)].


Rx Only

Manufactured by
EZEM Canada Inc
Anjou (Quebec) Canada H1J 2Z4

For
Bracco Diagnostics Inc.
Monroe Township, NJ 08831

VARIBAR is a registered trademark of E-Z-EM, Inc.

Varibar® Thin Liquid — Barium Sulfate for Suspension
NDC: 32909-105-10

Varibar Thin Liquid -- Internal
(click image for full-size original)
Varibar Thin Liquid -- External
(click image for full-size original)
VARIBAR THIN LIQUID
barium sulfate powder, for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:32909-105
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Barium Sulfate (Barium Sulfate) Barium Sulfate .81 g in 1 g
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid
carboxymethylcellulose sodium
dimethicone 1000
maltodextrin
polysorbate 80
silicon dioxide
sorbitol
trisodium citrate dihydrate
xylitol
saccharin sodium
Product Characteristics
Color WHITE Score
Shape Size
Flavor APPLE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:32909-105-10 24 BOTTLE, PLASTIC in 1 CASE contains a BOTTLE, PLASTIC
1 148 g in 1 BOTTLE, PLASTIC This package is contained within the CASE (32909-105-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208036 04/30/2019
Labeler — E-Z-EM Canada Inc (204211163)
Registrant — E-Z-EM, INC. (002041226)
Establishment
Name Address ID/FEI Operations
E-Z-EM Canada Inc 204211163 PACK (32909-105), LABEL (32909-105), MANUFACTURE (32909-105), ANALYSIS (32909-105)

Revised: 04/2019 E-Z-EM Canada Inc

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