Barium Sulfate

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# Overview
Barium Sulfate is a Diagnostic Agent that is FDA approved for the procedure of radiographic visualization of the gastrointestinal tract.   Common adverse reactions include nausea, vomiting, diarrhea and abdominal cramping.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

### Indications
- For radiographic visualization of the gastrointestinal tract.

### Dosage
- The volume and concentration of LIQUID E-ZPAQUE to be administered will depend on the degree and extent of contrast required in the area(s) under examination and on the equipment and technique employed.
- Use undiluted for single contrast filled stomach with small bowel follow-through (typical adult dose: 150 mL to 340 mL); routine small bowel (typical adult dose: 340 mL to 750 mL); followthrough small bowel after double contrast upper GI study (typical adult dose: 340 mL to 750 mL).
If the patient is scheduled for an MR study immediately or shortly after an upper GI procedure with this product, the regions of the GI tract which still contain this product may appear as areas of lowered signal intensity (black) with certain pulse sequences.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Barium Sulfate in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Barium Sulfate in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Barium Sulfate in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Barium Sulfate in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Barium Sulfate in pediatric patients.

# Contraindications
- This product should not be used in patients with known gastric or intestinal perforation or hypersensitivity to barium sulfate products.

# Warnings
- Rarely, severe allergic reactions of an anaphylactoid nature, have been reported following administration of barium sulfate contrast agents. Appropriately trained personnel and facilities should be available for emergency treatment of severe reactions and should remain available for at least 30 to 60 minutes following administration, since delayed reactions can occur.

### Precautions
- Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed. A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, or a previous reaction to a contrast agent, warrant special attention. Caution should be exercised with the use of radiopaque media in severely debilitated patients and in those with marked hypertension or advanced cardiac disease.
- Ingestion of this product is not recommended in patients with a history of food aspiration. If barium studies are required in these patients or in patients in whom integrity of the swallowing mechanism is unknown, proceed with caution. If this product is aspirated into the larynx, further administration should be immediately discontinued.
- After any barium study of the GI tract, it is important to rehydrate the patient as quickly as possible to prevent impaction of the bowel by barium sulfate. To prevent barium sulfate impaction in the bowel, the use of mild laxatives such as milk of magnesia or lactulose, following completion of the examination may also be required. These mild laxatives are recommended on a routine basis and in patients with a history of constipation unless contraindicated.
- Use with caution in patients with complete or nearly complete obstruction of the GI tract.

# Adverse Reactions

## Clinical Trials Experience
- Adverse reactions, such as nausea, vomiting, diarrhea and abdominal cramping, accompanying the use of barium sulfate formulations are infrequent and usually mild. Severe reactions (approximately 1 in 1,000,000) and fatalities approximately 1 in 10,000,000) have occurred. Procedural complications are rare, but may include aspiration pneumonitis, barium sulfate impaction, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities. It is of the utmost importance to be completely prepared to treat any such occurrence.
- Due to the increased likelihood of allergic reactions in atopic patients, it is important that a complete history of known and suspected allergies as well as allergic-like symptoms, e.g., rhinitis, bronchial asthma, eczema and urticaria, must be obtained prior to any medical procedure utilizing these products. A mild allergic reaction would most likely include generalized pruritus, erythema or urticaria (approximately 1 in 250,000). Such reactions will generally respond to an antihistamine such as 50 mg of diphenhydramine or its equivalent. In the rarer, more serious reactions (approximately 1 in 1,000,000) laryngeal edema, bronchospasm or hypotension could develop. Severe reactions which may require emergency measures are often characterized by peripheral vasodilation, hypotension, reflex tachycardia, dyspnea, agitation, confusion and cyanosis progressing to unconsciousness. Treatment should be initiated immediately with 0.3 to 0.5 mL of 1:1000 epinephrine subcutaneously. If bronchospasm predominates, 0.25 to 0.50 grams of intravenous aminophylline should be given slowly. Appropriate vasopressors might be required. Adrenocorticosteroids, even if given intravenously, exert no significant effect on the acute allergic reactions for a few hours. The administration of these agents should not be regarded as emergency measures for treatment of allergic reactions.
- Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardia following the administration of any diagnostic agent. Such reactions are usually non-allergic in nature and are best treated by having the patient lie flat for an additional 10 to 30 minutes under observation.

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Barium Sulfate in the drug label.

# Drug Interactions
- The presence of barium sulfate formulations in the GI tract may alter the absorption of therapeutic agents taken concomitantly. In order to minimize any potential change in absorption, the separate administration of barium sulfate from that of other agents should be considered.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- Radiation is known to cause harm to the unborn fetus exposed in utero. Therefore, radiographic procedures should only be used when, in the judgement of the physician, its use is deemed essential to the welfare of the pregnant patient.
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Barium Sulfate in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Barium Sulfate during labor and delivery.

### Nursing Mothers
- Barium sulfate products may be used during lactation.

### Pediatric Use
There is no FDA guidance on the use of Barium Sulfate with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Barium Sulfate with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Barium Sulfate with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Barium Sulfate with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Barium Sulfate in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Barium Sulfate in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Barium Sulfate in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Barium Sulfate in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral
- Rectal

### Monitoring
There is limited information regarding Monitoring of Barium Sulfate in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Barium Sulfate in the drug label.

# Overdosage
- On rare occasions following repeated administration, severe stomach cramps, nausea, vomiting, diarrhea or constipation may occur. These are transitory in nature and are not considered serious. Symptoms may be treated according to currently accepted standards of medical care.

# Pharmacology

## Mechanism of Action

## Structure
- LIQUID E-Z-PAQUE is a barium sulfate suspension (60% w/v, 41% w/w) for oral administration. Each 100 mL contains 60 g barium sulfate. Barium sulfate, due to its high molecular density is opaque to x-rays and, therefore, acts as a positive contrast agent for radiographic studies. The active ingredient is barium sulfate and its structural formula is BaSO4. Barium sulfate occurs as a fine, white, odorless, tasteless, bulky powder which is free from grittiness. Its aqueous suspensions are neutral to litmus. It is practically insoluble in water, solutions of acids and alkalies, and organic solvents.
- Carboxymethyllcellulose sodium, citric acid, natural and artificial strawberry lemon cream flavor, polysorbate 80, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, sodium citrate, sorbitol solution, xanthan gum.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Barium Sulfate in the drug label.

## Pharmacokinetics
- Barium sulfate, due to its high molecular density is opaque to x-rays and, therefore, acts as a positive contrast agent for radiographic studies. Barium sulfate is biologically inert and, therefore, is not absorbed or metabolized by the body and is eliminated unchanged from the body.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Barium Sulfate in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Barium Sulfate in the drug label.

# How Supplied
- LIQUID E-Z-PAQUE is supplied in the following quantities:

## Storage
- Store product to protect from freezing and excessive heat (above 40C).
- SHAKE WELL PRIOR TO USE, THE PRODUCT MUST BE FULLY SUSPENDED.

# Images

## Drug Images

## Package and Label Display Panel

### PRINCIPAL DISPLAY PANEL

### Ingredients and Appearance

# Patient Counseling Information
- Before administration of this product patients should be instructed to:
- Inform their physician if they are pregnant.
- Inform their physician if they are allergic to any drugs or food, or if they have had any prior reactions to barium sulfate products or other contrast agents used for x-ray procedures (see PRECAUTIONS: GENERAL).
- Inform their physician about any other medications they are currently taking.

# Precautions with Alcohol
- Alcohol-Barium Sulfate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- E-Z-HD

# Look-Alike Drug Names
There is limited information regarding Barium Sulfate Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price