Document
DailyMed Label: Gastrografin
Title
DailyMed Label: Gastrografin
Date
2021
Document type
DailyMed Prescription
Name
Gastrografin
Generic name
diatrizoate meglumine and diatrizoate sodium
Manufacturer
Bracco Diagnostics Inc
Product information
NDC: 0270-0445
Product information
NDC: 0270-0445
Product information
NDC: 0270-0445
Product information
NDC: 0270-0445
Product information
NDC: 0270-0445
Product information
NDC: 0270-0445
Product information
NDC: 0270-0445
Product information
NDC: 0270-0445
Product information
NDC: 0270-0445
Product information
NDC: 0270-0445
Product information
NDC: 0270-0445
Product information
NDC: 0270-0445
Description
Gastrografin (Diatrizoate Meglumine and Diatrizoate
Sodium Solution) is a palatable lemon-flavored water-soluble iodinated
radiopaque contrast medium for oral or rectal administration only.
Each mL contains 660 mg diatrizoate meglumine and 100 mg diatrizoate
sodium; pH has been adjusted to 6.0 to 7.6 with sodium hydroxide. Each mL contains approximately 4.8 mg (0.21 mEq) sodium and
367 mg organically bound iodine. Inactive ingredients: edetate disodium,
flavor, polysorbate 80, purified water, saccharin sodium, simethicone,
and sodium citrate.
Diatrizoate
meglumine is designated chemically as 1-deoxy-1-(methylamino)-D-glucitol
3,5-diacetamido-2,4,6-triiodo-benzoate (salt); diatrizoate sodium
is monosodium 3, 5-diacetamido-2,4,6-triiodobenzoate. Structural formulas:
Gastrografin Structure
Indications
Gastrografin (Diatrizoate Meglumine and
Diatrizoate Sodium Solution) is indicated for radiographic examination
of segments of the gastrointestinal tract (esophagus, stomach, proximal
small intestine, and colon). The preparation is particularly indicated
when a more viscous agent such as barium sulfate, which is not water-soluble,
is not feasible or is potentially dangerous.
Gastrografin may also be used as an adjunct to contrast
enhancement in computed tomography of the torso (body imaging); the
preparation is indicated, in conjunction with intravenous administration
of a radiopaque contrast agent, when unenhanced imaging may not provide
sufficient definition in distinguishing normal loops of bowel from
adjacent organs or areas of suspected pathology.
Dosage
This medium is not to be used for
the preparation of solutions for parenteral administration. Oral or
rectal administration only. Discard any unused portion after procedure.
The routine preparatory measures
employed for barium studies are also appropriate for this agent.
For pediatric and severely cachectic patients
the maintenance of an intravenous fluid line may be advisable.
Oral Administration: Adult oral dosage
may range from 30 to 90 mL (11 to 33 g iodine), depending on the nature
of the examination and the size of the patient. For infants and children
less than 5 years of age, 30 mL (11 g iodine) are usually adequate;
for children 5 to 10 years of age, the suggested dose is 60 mL (22
g iodine). These pediatric doses may be diluted 1:1, if desired, with
water, carbonated beverage, milk, or mineral oil. When used in infants,
the solution may be given in a nursing bottle. Pediatric doses may
also be used in dehydrated and/or debilitated adult patients. A 1:1
dilution is also recommended when the contrast medium is used in elderly
cachectic individuals.
For very
young (under 10 kg) and debilitated children the dose should be diluted:
1 part Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium
Solution) in 3 parts water is recommended.
For Enemas or Enterostomy Instillations: Gastrografin should be diluted when it is used for enemas and enterostomy
instillations. When used as an enema, the suggested dilution for adults
is 240 mL (88 g iodine) in 1,000 mL of tap water. For children under
5 years of age, a 1:5 dilution in tap water is suggested; for children
over 5 years of age, 90 mL (33 g iodine) in 500 mL of tap water is
a suitable dilution.
A usual adult dose is 240 mL of a dilute
Gastrografin solution prepared by diluting 25 mL (9.17 g iodine) to
one liter with tap water. Less dilute solutions [up to 77 mL (28.26
g iodine) diluted to one liter with tap water] may be used when indicated.
The dose is administered orally about 15 to 30 minutes prior to imaging
in order to permit the contrast medium to reach the pelvic loops.
Contraindications
Do not administer to patients with a known
hypersensitivity to Gastrografin or any of its components.
Precautions
Diagnostic procedures
which involve the use of radiopaque contrast agents should be carried
out under the direction of personnel with the prerequisite training
and with a thorough knowledge of the particular procedure to be performed.
Appropriate facilities should be available for coping with any complication
of administration, as well as for treatment of reaction to the contrast
medium (see
ADVERSE REACTIONS
, and
PRECAUTIONS, Information for the Patient
).
Rectal administration
of undiluted Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium
Solution) in any patient, particularly with large doses and/or in
those with overdistention, has been reported to be associated with
mucosal irritation.
Cases of hyperthyroidism
have been reported with the use of oral contrast media. Some of these
patients reportedly had multinodular goiters which may have been responsible
for the increased hormone synthesis in response to excess iodine.
Administration of an intravascular iodinated radiopaque diagnostic
agent to a hyperthyroid patient precipitated thyroid storm; a similar
situation could follow administration of oral preparations of iodides.
Therefore, caution should be exercised when administering enteral
gastrointestinal radiopaque agents to hyperthyroid and euthyroid goiterous
patients.
Consideration should
be given to the potential for precipitation of water-soluble contrast
agents under conditions that may promote hyperacidity (i.e., fasting,
emotional upset, or stress). Harmful effects directly attributable
to precipitate formation have not been reported. However, the possibility
of interpreting the precipitate radiologically as an anatomical abnormality
(i.e., ulceration of the stomach or small intestine) or injury, should
be kept in mind.
Patients should receive the following information and
instructions:
This drug has been prescribed to perform an x-ray of the
gastrointestinal tract.
Inform the physician if pregnant or if allergic to iodine,
any foods, or x-ray materials.
The iodine in diatrizoate salts may interfere with some
thyroid tests if these are needed in the future. Inform the attending
physician at that time about this gastrointestinal study.
This drug may cause abdominal cramping, nausea, vomiting,
diarrhea, skin rashes, itching, heartburn, dizziness, or headache
in some patients, but most reactions are mild and pass quickly.
The results
of protein bound iodine (PBI) and radioactive iodine uptake studies,
which depend on iodine estimations, will not accurately reflect thyroid
function for six months, and possibly as long as one year, following
the administration of diagnostic enteral radiopaque media.
Thyroid function tests, if indicated, generally
should be performed prior to the administration of any iodinated agent.
However, thyroid function can be evaluated after use of these agents
by using T 3 resin uptake and total or free
thyroxine (T 4 ) assays which are not dependent
on iodine estimations.
Small quantities of
contrast medium in the intestinal tract may cause false low trypsin
values when determined spectrophotometrically. Therefore, duodenal
instillation should not precede pancreatic function tests involving
spectrophotometric trypsin assays.
Any test which might be affected by contrast media should be performed
prior to administration of the contrast medium.
Long-term studies in animals have not been performed to evaluate
carcinogenic or mutagenic potential, or possible impairment of fertility
in males or females.
When administered
intravenously, diatrizoate salts cross the placenta and are evenly
distributed in fetal tissues.
No teratogenic effects attributable to diatrizoate meglumine or diatrizoate
sodium have been observed in teratology studies performed in animals.
There are, however, no adequate and well-controlled studies in pregnant
women. Because small amounts of these agents may be absorbed, and
animal teratology studies are not always predictive of human response,
these agents should be used during pregnancy only when clearly needed.
Procedures including radiation involve a
certain risk related to the exposure of the fetus.
Diatrizoate meglumine is excreted in breast
milk following intravascular administration.
Because small amounts of enteral gastrointestinal radiopaque
agents may be absorbed following oral or rectal administration, caution
should be exercised when they are administered to a nursing woman.
See
WARNINGS
, and
PRECAUTIONS, General
.
Local injury to the colonic
mucosa, particularly in the presence of underlying disease which interferes
with intestinal viability, has been reported in cases where recommended
doses and dilutions (see
DOSAGE AND ADMINISTRATION
) were not used; when extemporaneous dosage is elected, the
polysorbate 80 level in the dose may be a contributing factor to injury.
Adverse reactions
Most adverse reactions to enteral diagnostic
radiopaque agents are mild and transitory. Nausea, vomiting and/or
diarrhea, urticaria with erythema, hypoxia, acute dyspnea, tachyarrhythmia,
and anaphylaxis have occurred following ingestion of the contrast
medium, particularly when high concentrations of large volumes of
solution are administered. Severe changes in serum osmolarity and
electrolyte concentrations may produce shock-like states (see
How supplied
Gastrografin (Diatrizoate Meglumine
and Diatrizoate Sodium Solution USP) is available in packages
of: Twenty-four 30 mL single dose bottles (NDC 0270-0445-35). Twelve 120 mL single dose bottles (NDC 0270-0445-40).
Protect from light. Store at 20-25°C (68-77°F)
[See USP]; avoid excessive heat.
Clinical pharmacology
The most important characteristic of contrast media is the iodine
content. The relatively high atomic weight of iodine contributes sufficient
radiodensity for radiographic contrast with surrounding tissues.
Diagnostic enteral radiopaque agents have
few known pharmacological effects. Diatrizoate meglumine and diatrizoate
sodium exert a mild laxative effect attributable to their high osmolarity.
Diatrizoate meglumine and diatrizoate sodium
are sparingly absorbed from the intact gastrointestinal tract, and
therefore permit gastrointestinal opacification and delineation after
oral or rectal administration. Oral administration is used for radiographic
evaluation of the esophagus, stomach and proximal small intestine.
Rectal administration is used for examination of the colon; however,
visualization of the distal small bowel is generally unsatisfactory,
since the hypertonicity of the medium causes intraluminal diffusion
of water with subsequent dilution of the medium. Enough absorption
from the gastrointestinal tract to permit incidental visualization
of the urinary tract has been reported; this should also be considered
when thyroid testing is being contemplated, since iodine-mediated
thyrotropic effects may occur (see
PRECAUTIONS
).
Package label
Gastrografin ® 120 mL Label NDC 0270-0445-40
Gastrografin label 120ml
1 organization
2 products
Organization
Bracco Diagnostics IncProduct
Gastrografin