Product Elements:
Neulumex barium sulfate barium sulfate barium sulfate anhydrous citric acid benzoic acid dimethicone 350 dimethicone 1000 potassium sorbate saccharin sodium silicon dioxide sodium benzoate sorbitol trisodium citrate dihydrate water xanthan gum neulumex barium sulfate barium sulfate barium sulfate anhydrous citric acid benzoic acid dimethicone 350 dimethicone 1000 potassium sorbate saccharin sodium silicon dioxide sodium benzoate sorbitol trisodium citrate dihydrate water xanthan gum
Drug Interactions:
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.
Indications and Usage:
Indications and usage: for use in computed tomography to opacify the gi tract.
Warnings:
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.
General Precautions:
General: 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 barium 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 barium is aspirated into the larynx, further administration should be immediately discontinued. information for patients: before administration of this product, patients receiving barium sulfate diagnostic agents shoul
Read more...d 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 in x-ray procedures (see precautions-general ). inform their physician about any other medications they are currently taking. seek immediate medical attention if they experience an allergic reaction after using this product. 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.
Dosage and Administration:
Dosage and administration: the volume of the ct barium sulfate suspension to be administered will depend on the degree and extent of contrast required in the area(s) under examination and on the technique employed. for oral administration: gi tract marking: the patient should begin drinking neulumex approximately 20 â 30 minutes prior to the scheduled procedure. it is recommended that the patient consume multiple bottles, about 900 ml to 1,350 ml total volume prior to the exam or use as directed by physician. for improved gastric marking have patient consume the final 200 ml immediately prior to scan. bowel marking is consistent due to the uniformity of the 0.1% concentration of baso 4 . bowel lumen marking can be improved by increasing the volume of neulumex consumed (see below). other dosing regimens may be followed as applicable. in patients where marking is problematic, such as obesity and delayed transit, improved marking may be possible by increasing the total volume of neul
Read more...umex administered up to 1,800 ml or four (4) bottles.
Contraindications:
Contraindications: this product should not be used in patients with known or suspected gastrointestinal perforation or hypersensitivity to barium sulfate or any component of this barium sulfate formulation.
Adverse Reactions:
Adverse reactions: 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, granuloma formation, intravasation, embolization and peritonitis following intestinal perforation, vasovagal and syncopal episodes, and fatalities.
Drug Interactions:
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 Pregnancy:
Usage in pregnancy: 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.
Overdosage:
Overdosage: on rare occasions following repeated administration, severe stomach cramps, nausea, vomiting, diarrhea or constipation may occur. these indicated responses can be present in both fluoroscopic and ct procedures. these are transitory in nature and are not considered serious. symptoms may be treated according to currently accepted standards of medical care.
Description:
Description: neulumex is a barium sulfate suspension 0.1% w/v, 0.1% w/w for oral administration. each 100 ml contains 0.1 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 baso 4 . 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. inactive ingredients: citric acid, natural gum, benzoic acid, sodium citrate, natural and artificial blueberry flavor, potassium sorbate, purified water, saccharin sodium, simethicone emulsion, sodium benzoate, and sorbitol.
Clinical Pharmacology:
Clinical pharmacology: 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 from the gi tract unchanged.
How Supplied:
How supplied: neulumex is supplied in the following quantity: 450 ml bottles, ndc 32909-927-03 rx only shake well prior to use manufactured by e-z-em canada inc for bracco diagnostics inc. monroe township, nj 08831 tel: 1-516-333-8230 1-800-544-4624 rev. 02/20 cl110501
Information for Patients:
Information for patients: before administration of this product, patients receiving barium sulfate diagnostic agents 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 in x-ray procedures (see precautions-general ). inform their physician about any other medications they are currently taking. seek immediate medical attention if they experience an allergic reaction after using this product.
Package Label Principal Display Panel:
Neulumex carton ndc 32909-927-03 neulumex 32909-927-03 carton
Neulumex bottle ndc 32909-927-03 neulumex 32909-927-03 bottle