E-Z-HD

DESCRIPTION

E-Z-HD (barium sulfate) is a radiographic contrast agent that is supplied as a fine white powder for oral suspension (98%w/w barium sulfate) for oral administration. It is designated chemically as BaSO4 with a molecular weight of 233.43 g/mol, and a density of 4.5 g/cm³ . The chemical structure of barium sulfate is:

E-Z-HD contains excipients including: acacia, carrageenan, citric acid, ethyl maltol, natural and artificial cherry flavor, natural and artificial strawberry flavor, polysorbate 80, saccharin sodium, simethicone, sodium citrate, and sorbitol.

INDICATIONS

E-Z-HD is indicated for use in double-contrast radiographic examinations of the esophagus, stomach and duodenum to help visualize the gastrointestinal (GI) tract in patients 12 years and older.

DOSAGE AND ADMINISTRATION

The recommended dose of reconstituted E-Z-HD for adults and pediatric patients 12 years and older is between 65 and 135 mL given orally (155 to 321 grams of barium sulfate, respectively). Volumes closer to 65 mL are recommended for the examination of the esophagus and volumes up to 135 mL are recommended for examination of the entire upper GI tract.

The E-Z-HD powder must be reconstituted prior to administration by a healthcare provider according to the following instructions:

• Accurately measure 65 mL of water and add this water to the bottle containing the supplied E-Z-HD powder
• Replace cap securely on bottle and shake vigorously for 30 seconds
• Wait 5 minutes and re-shake bottle thoroughly. Reconstitution yields approximately 140 mL of E-Z-HD for oral suspension containing 2.38 grams of barium sulfate per mL
• Administer the reconstituted E-Z-HD for oral suspension immediately upon reconstitution
• To use with a straw, remove the adhesive label from top of the cap. Remove cap and use straw to push out cap liner. Replace cap
• Discard any unused suspension

HOW SUPPLIED

Dosage Forms And Strengths

For oral suspension: 340 grams of barium sulfate supplied as a fine, white powder in a single-dose HDPE plastic bottle for reconstitution.

E-Z-HD for oral suspension is supplied as a fine white powder in a single-dose HDPE plastic bottle containing 340 grams of barium sulfate. For reconstitution instructions, see DOSAGE AND ADMINISTRATION.

Provided as: 24 bottles per pack (NDC 32909-764-01)

Storage And Handling

Store at USP controlled room temperature, 20 to 25°C (68 to 77° F).

Manufactured for Bracco Diagnostics Inc. Monroe Township, NJ 08831 by EZEM Canada Inc Anjou (Quebec) Canada H1J 2Z4. Revised: Jan 2016

SIDE EFFECTS

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

DRUG INTERACTIONS

No information provided.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Hypersensitivity Reactions

Barium sulfate preparations contain a number of excipients, including natural and artificial flavors and may induce serious hypersensitivity reactions. The manifestations include hypotension, bronchospasm and other respiratory impairments, dermal reactions including rashes, urticaria, and itching. A history of bronchial asthma, atopy, or a previous reaction to a contrast agent may increase the risk for hypersensitivity reactions. Emergency equipment and trained personnel should be immediately available for treatment of a hypersensitivity reaction.

Intra-abdominal Barium Leakage

Administration of E-Z-HD may result in leakage of barium at any level of the GI tract in the presence of conditions such as carcinomas, GI fistula, inflammatory bowel disease, gastric or duodenal ulcer, appendicitis, or diverticulitis, and in patients with a severe stenosis at any level of the GI tract, especially if it is distal to the stomach. The barium leakage has been associated with peritonitis and granuloma formation. The use of E-Z-HD is contraindicated in patients at high risk of perforation of the GI tract [see CONTRAINDICATIONS].

Delayed Gastrointestinal Transit And Obstruction

Orally administered barium sulfate may accumulate proximal to a constricting lesion of the colon, causing obstruction or impaction with development of baroliths (inspissated barium associated with feces) and may lead to abdominal pain, appendicitis, bowel obstruction, or rarely perforation. Patients with the following conditions are at higher risk for developing obstruction or baroliths: severe stenosis at any level of the GI tract, impaired GI motility, electrolyte imbalance, dehydration, on a low residue diet, taking medications that delay GI motility, and constipation. To reduce the risk of delayed GI transit and obstruction, patients should maintain adequate hydration during and in the days following a barium sulfate procedure. Consider the administration of laxatives.

Aspiration Pneumonitis

Oral administration of barium is associated with aspiration pneumonitis, especially in patients with a history of food aspiration or with compromised swallowing mechanism. Vomiting following oral administration of barium sulfate may lead to aspiration pneumonitis. In patients at risk for aspiration, begin the procedure with a small ingested volume of E-Z-HD. The use of E-Z-HD is contraindicated in patients at high risk of aspiration [see CONTRAINDICATIONS]. Discontinue administration of E-Z-HD immediately if aspiration is suspected.

Systemic Embolization

Barium sulfate products may occasionally intravasate into the venous drainage of the large bowel and enter the circulation as a “barium embolus” leading to potentially fatal complications which include systemic and pulmonary embolism, disseminated intravascular coagulation, septicemia and prolonged severe hypotension. Although this complication is exceedingly uncommon after oral administration of a barium sulfate suspension, monitor patients for potential intravasation when administering barium sulfate.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

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

Use In Specific Populations

Pregnancy

Risk Summary

E-Z-HD is not absorbed systemically following oral administration, and maternal use is not expected to result in fetal exposure to the drug.

Lactation

Risk Summary E-Z-HD is not absorbed systemically by the mother following oral administration, and breastfeeding is not expected to result in exposure of the infant to E-Z-HD.

Pediatric Use

Double-contrast radiographic examinations of the esophagus, stomach and duodenum may be used in pediatric patients 12 years and older.

Geriatric Use

Clinical studies of E-Z-HD 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.

OVERDOSE

No information provided.

CONTRAINDICATIONS

E-Z-HD is contraindicated in patients:

• Known or suspected perforation of the GI tract
• Known obstruction of the GI tract
• At 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 rectum or prostate
• At high risk of aspiration such as those with prior aspiration, tracheo-esophageal fistula, or obtundation
• With known severe hypersensitivity to barium sulfate or any of the E-Z-HD excipients

CLINICAL PHARMACOLOGY

Mechanism Of Action

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

Pharmacokinetics

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