Neulumex 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 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. 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.
Neulumex - 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.
Indications and Usage for Neulumex
For use in Computed Tomography to opacify the GI tract.
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.
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
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
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.
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.
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.
Nursing Mothers:
Barium sulfate products may be used during
lactation.
Adverse Reactions/Side Effects
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.
Related/similar drugs
ALLERGIC
REACTIONS:
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,
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 cc 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 the 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.
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.
Neulumex 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 – 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 BaSO4. 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 NeuLumEX administered up to 1,800 mL or four (4)
bottles.
Storage and Handling
USP controlled room temperature, 20° to 25°C
(68° to 77°F). Protect from freezing.
How is Neulumex 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
NeuLumEx Carton
NDC 32909-927-03
NeuLumEx Bottle
NDC 32909-927-03
