Barium sulfate for fluoroscopy

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT BARIUM SULFATE FOR X-RAY (BARIUM SULFATE X-RAY GRADE)

Composition:

Active substance: barium sulfate;

1 sachet contains 80 g of barium sulfate.

Pharmaceutical form. Powder for suspension.

Main physicochemical properties: contents of the sachet – white or almost white powder, free from foreign particles, practically insoluble in water.

Pharmacotherapeutic group.

X-ray contrast agents not containing iodine. ATC Code V08BA02.

Pharmacological properties.

Pharmacodynamics. Barium sulfate coats the mucous membrane of the gastrointestinal tract and provides a clear image of the mucosal microrelief during radiological examinations of the gastrointestinal tract. Enhances image contrast during radiological examinations of the gastrointestinal tract. Maximum contrast of the esophagus, stomach, and duodenum is achieved immediately after oral administration; of the small intestine — within 15–90 minutes (depending on gastric emptying rate and viscosity of the preparation). The quality of visualization of the distal parts of the small and large intestine depends on body position and hydrostatic pressure.

Pharmacokinetics. Has low toxicity. Is not absorbed in the gastrointestinal tract and does not enter the systemic circulation. Excreted completely in feces within 24–28 hours.

Clinical characteristics.

Indications.

Radiological examination of the pharynx, esophagus, stomach, and intestine (including the double-contrast method).

Contraindications.

The medicinal product should not be used:

• in case of hypersensitivity to barium sulfate;
• in case of impaired integrity of the gastrointestinal tract walls (or suspicion thereof);
• in esophagotracheal fistula;
• in patients with dysphagia or impaired swallowing (risk of aspiration);
• immediately prior to emergency surgery on the esophagus or gastrointestinal tract;
• in patients with intestinal malformations (connections with the mediastinum), malformations of the pleural or abdominal cavity;
• in patients with recent trauma or chemical burns of the esophagus and intestinal tract, intestinal wall ischemia, necrotizing enterocolitis;
• in patients with complete or partial intestinal obstruction;
• in constipation;
• in esophageal stenosis;
• in gastrointestinal bleeding;
• in atresia of the gastrointestinal tract;
• after surgical interventions on gastrointestinal organs;
• in malabsorption syndrome;
• in food allergy.

Should be prescribed with caution in patients with severe general condition or bronchial asthma.

Interaction with other medicinal products and other forms of interaction.

Decreased intestinal peristalsis caused by medication or other factors may lead to swelling of residual barium sulfate suspension and impaired intestinal patency.

Concomitant use with other medicinal products is not recommended, as residual barium sulfate in the gastrointestinal tract may alter their absorption.

Special precautions for use.

Use only under inpatient conditions.

The suspension should be administered only under medical supervision.

Should be prescribed to infants and elderly patients with organ impairment (multimorbidity), especially involving the cardiovascular system, only for compelling indications, as examinations including preparatory procedures may be stressful for these patients.

Thorough assessment of risk versus benefit is required when prescribing to patients:

• with pronounced stenosis, especially distal to the stomach;
• with conditions or diseases associated with an increased risk of perforation, e.g. gastrointestinal fistulas and carcinoma, inflammatory bowel diseases, diverticulitis and diverticulosis, as well as amoebiasis.

Barium sulfate should not be administered within 7 days following a biopsy performed during endoscopic examination, and should be avoided for up to 4 weeks after radiotherapy of the cervix, thorax, or abdominal cavity, depending on the site and extent of the procedure. To avoid potentially serious adverse effects, care must be taken to ensure that barium sulfate does not enter parenteral compartments such as tissues, vascular space, body cavities, or respiratory tract.

Aspiration, intravasation, or perforation require immediate expert intervention (intensive care, surgery).

To prevent severe constipation, adequate hydration of the patient after the examination is essential. When oral medication is planned, particular caution is advised in patients with poor general condition.

Use during pregnancy or breastfeeding.

Barium sulfate is not recommended during pregnancy. If examination is necessary during lactation, breastfeeding should be withheld for 24 hours after the procedure.

Ability to affect reaction speed when driving or operating machinery.

No effect.

Method of Administration and Dosage.

The suspension is prepared with boiled or distilled water immediately before use. For radiographic examination of the pharynx, esophagus, stomach, and small intestine, it is administered orally; for irigoscopy — it is administered rectally.

For radiographic examination of the pharynx, esophagus, stomach, and intestines, Barium Sulfate for radiography is prescribed orally as an aqueous suspension. To prepare the suspension, the powder is mixed with warm boiled or distilled water in a ratio from 1:1 to 4:1 (mass:volume) for adults and from 1:1.5 to 1:2 (mass:volume) for children, and thoroughly stirred for 4–5 minutes (a mixer may be used). The dose for adults per examination depends on the method used and ranges from 50 ml to 300 ml of suspension; for children — from 50 ml to 100 ml.

For radiographic examination of the large intestine in adults, the suspension is administered rectally: a suspension prepared from 300 g of powder and 1500 ml of water is introduced via enema into the rectum; the dose per examination is 1000–1500 ml of suspension.

Children.

The medicinal product is used in pediatric practice.

Overdose.

In case of oral overdose, there is a risk of constipation, and in extreme cases, formation of baroliths.

Treatment consists of cleansing enemas and/or administration of saline laxatives.

When a very large amount of barium sulfate is administered rectally, electrolyte loss may occur due to a large volume of water, which can be prevented by adding sodium chloride to the solution. Electrolyte homeostasis can also be restored by targeted infusion therapy.

Adverse reactions.

Single cases of so-called "barium" appendicitis have been reported.

When using effervescent agents during double-contrast procedures — discomfort in the epigastric region.

Frequency of adverse effects is defined as:

very common (≥ 1/10);

common (≥ 1/100 to < 1/10);

uncommon (≥ 1/1000 to < 1/100);

rare (≥ 1/10000 to < 1/1000);

very rare (< 1/10000);

unknown (frequency cannot be estimated from available data).

Adverse reaction reporting.

Reporting of adverse reactions following the registration of the medicinal product is of great importance. It enables continuous monitoring of the benefit-risk balance of this medicinal product. Healthcare professionals and patients, or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

80 g per sachet; 10 sachets per cardboard box.

Prescription status.

Prescription only.

Manufacturer.

LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and place of business.

22 Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.