Varibar Pudding

In the U.S.

• Bar-Test
• Entero VU
• E-Z-Cat Dry
• E-Z-Disk
• E-Z-HD
• Readi-Cat 2
• Readi-Cat 2 Smoothie
• Tagitol V
• Varibar
• Varibar Pudding
• Volumen

In Canada

• Acb
• Baro-Cat
• Colobar-100
• Epi-C
• Epi-Stat
• Esobar
• Esopho-Cat Esophageal Cream
• E-Z-Cat
• E-Z-Hd
• E-Z-Jug
• E-Z-Paque
• Gel-Unix 10

Available Dosage Forms:

• Cream
• Tablet
• Paste
• Suspension
• Powder for Suspension
• Liquid

Therapeutic Class: Diagnostic Agent, Radiological Contrast Media

• It is used before an x-ray or an alike test.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
• This medicine prevents many other drugs from getting into the body. If you take other drugs, check with your doctor or pharmacist to see if you need to take them at some other time than Varibar Pudding.
• To prevent hard stools (constipation) or bowel block from this medicine, your doctor may have you use a laxative like milk of magnesia or lactulose after using Varibar Pudding. Follow what your doctor has told you. Talk with your doctor.
• Drink lots of noncaffeine liquids after using this medicine unless told to drink less liquid by your doctor.
• If you are 65 or older, use Varibar Pudding with care. You could have more side effects.
• Some products are not approved for use in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Varibar Pudding, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Varibar Pudding (barium oral cream and paste). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Varibar Pudding.

Review Date: October 4, 2017

Recommended Dosing

• The recommended oral dose of Varibar Pudding delivered by oral syringe or spoon:
  • Adults 5 mL
  • Pediatric patients 1-3 mL
• During a single modified barium swallow examination, multiple doses of Varibar Pudding may be administered as appropriate, to assess the patient during multiple swallows and different radiographic views.
• The maximum cumulative dose is 30 mL oral.
• Once opened, write the discard after date on the immediate container label. Discard any unused product after 21 days.

Important Administration Instructions

• Advise patients to hydrate following the barium sulfate procedure.
• Advise patient at risk for constipation or delayed gastrointestinal transit to monitor for worsening of their condition after administration of barium sulfate and seek medical attention if worsening and advise using laxatives to enhance gastrointestinal transit.

Pregnancy

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)]

Lactation

Risk Summary

Varibar Pudding 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. [see Clinical Pharmacology (12.3)]

Pediatric Use

The efficacy of Varibar Pudding in pediatric patients above 6 months of age 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 above 6 months of age are based on clinical experience [see Indications (1), Dosage and Administration (2.1)].

Varibar Pudding is contraindicated in pediatric patients with tracheo-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)]. Pediatric patients with cystic fibrosis or Hirschsprung disease should be monitored for bowel obstruction after use [see Warnings and Precautions (5.3)].

Geriatric Use

Clinical studies of Varibar Pudding 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

Carcinogenesis, Mutagenesis, Impairment of Fertility

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

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 to 25°C (68 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 to 25°C (68 to 77° F).