Varibar Nectar

• 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 Nectar.
• 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 Nectar. 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 Nectar with care. You could have more side effects.
• Some products are not approved for use in children. Talk with the doctor.
• Some products have sorbitol in them. Very bad health problems like low blood sugar, bleeding, and kidney failure have happened when people who are not able to break down fructose took a product with sorbitol in it. 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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very hard stools (constipation).
• Very bad belly pain.
• Shortness of breath.
• Very bad dizziness or passing out.
• A heartbeat that does not feel normal.
• Flushing.
• Fast or slow heartbeat.
• Feeling agitated.
• Feeling confused.
• Blue or gray skin color.
• Feeling very tired or weak.
• Pale skin.
• Ringing in ears.
• Sweating a lot.
• Chest pain or pressure.
• Coughing up blood.
• Swelling, warmth, numbness, change of color, or pain in a leg or arm.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.

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.

Oral suspension: barium sulfate (40% w/v) supplied in a multiple dose HDPE plastic bottle as a suspension for oral administration. Each bottle contains 240 mL of suspension.

Varibar Nectar is contraindicated in patients with:

• 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 prior 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 for 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 Nectar

The following adverse reactions have been identified from spontaneous reporting or clinical studies of barium sulfate administered orally. Because the reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or to establish a causal relationship to drug exposure:

• Nausea, vomiting, diarrhea and abdominal cramping
• Serious adverse reactions and fatalities include aspiration pneumonitis, barium sulfate impaction, intestinal perforation with consequent peritonitis and granuloma formation, vasovagal and syncopal episodes

Pregnancy

Risk Summary

Varibar Nectar 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 Nectar is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the infant to Varibar Nectar [see Clinical Pharmacology (12.3)].

Pediatric Use

The efficacy of Varibar Nectar in pediatric patients from birth to less than 17 years of age is based on successful opacification of the oropharynx during modified barium swallow examinations [see Clinical Pharmacology (12.1)]. Safety and dosing recommendations in pediatric patients are based on clinical experience [see Dosage and Administration (2.1)].

Varibar Nectar 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)]. Patients with cystic fibrosis or Hirschsprung disease should be monitored for small bowel obstruction after use [see Warnings and Precautions (5.3)]

Geriatric Use

Clinical studies of Varibar Nectar do 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.

Mechanism of Action

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

Pharmacodynamics

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

Pharmacokinetics

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

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