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Gastrografin
Overview
What is Gastrografin?
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. 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:
What does Gastrografin look like?
What are the available doses of Gastrografin?
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What should I talk to my health care provider before I take Gastrografin?
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How should I use Gastrografin?
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.
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.
What interacts with Gastrografin?
Do not administer to patients with a known hypersensitivity to Gastrografin or any of its components.
What are the warnings of Gastrografin?
Avoid injecting tuberculin subcutaneously. If this occurs, no local reaction develops, but a general febrile reaction and/or acute inflammation around old tuberculous lesions may occur in highly sensitive individuals.
Dehydration: Administration of hypertonic
Gastrografin solutions may lead to hypovolemia and hypotension due
to fluid loss from the intestine. A 1 in 4.6 (1:4.6) dilution of Gastrografin
yields an approximately isotonic 16.5 percent diatrizoate salts solution;
less dilute solutions are hypertonic and may lead to intraluminal
movement of fluid with resulting hypovolemia. In young or debilitated
children and in elderly cachectic persons, the loss of plasma fluid
may be sufficient to cause a shock-like state. If Gastrografin is
used in infants and children (under 10 kg) or in dehydrated or debilitated
patients, the solution must be prepared using the specific dilutions
described in . In
debilitated patients and in patients with electrolyte imbalances,
postprocedural monitoring of hydration, serum osmolarity, electrolytes
and clinical status is essential. In pediatric or severely debilitated
patients, the maintenance of an open intravenous fluid line for rehydration
may be advisable should hypotension or shock supervene. Electrolyte
disturbances must be corrected prior to the administration of any
hypertonic Gastrografin solutions.
Aspiration: Aspiration of Gastrografin into the trachea and airways
may result in serious pulmonary complications including, pulmonary
edema, pneumonitis or death Bronchial entry of any orally administered
contrast medium causes a copious osmotic effusion. Therefore, avoid
use of Gastrografin in patients with esophagotracheal fistula and
minimize risks for pulmonary aspiration in all patients. If Gastrografin
is given by nasogastric tube, the position of the tube in the stomach
must be verified before administration.
Anaphylactic reactions: Anaphylactic reactions, including
fatalities, have been reported with the use of Gastrografin. Patients
at increased risk include those with a history of a previous reaction
to a contrast medium, patients with a known sensitivity to iodine,
and patients with a known clinical hypersensitivity (bronchial asthma,
hay fever, and food allergies). Medical personnel trained in the treatment
of anaphylactic reactions and the necessary drugs and medical equipment
should always be readily available when Gastrografin is used.
What are the precautions of Gastrografin?
General
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 , and ).
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.
Information for the Patient
- 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.
Patients should receive the following information and instructions:
Drug/Laboratory Test Interactions
Array
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 resin uptake and total or free thyroxine (T) assays which are not dependent on iodine estimations.
Array
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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic or mutagenic potential, or possible impairment of fertility in males or females.
Pregnancy Category B
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.
Nursing Mothers
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.
Pediatric Use
See , and .
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 ) were not used; when extemporaneous dosage is elected, the polysorbate 80 level in the dose may be a contributing factor to injury.
What are the side effects of Gastrografin?
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 ). It should be kept in mind
that serious or anaphylactoid reactions that may occur with intravascular
administration of radiopaque contrast agents are theoretically possible
following administration by other routes.
What should I look out for while using Gastrografin?
Do not administer to patients with a known
hypersensitivity to Gastrografin or any of its components.
Dehydration: Administration of hypertonic
Gastrografin solutions may lead to hypovolemia and hypotension due
to fluid loss from the intestine. A 1 in 4.6 (1:4.6) dilution of Gastrografin
yields an approximately isotonic 16.5 percent diatrizoate salts solution;
less dilute solutions are hypertonic and may lead to intraluminal
movement of fluid with resulting hypovolemia. In young or debilitated
children and in elderly cachectic persons, the loss of plasma fluid
may be sufficient to cause a shock-like state. If Gastrografin is
used in infants and children (under 10 kg) or in dehydrated or debilitated
patients, the solution must be prepared using the specific dilutions
described in . In
debilitated patients and in patients with electrolyte imbalances,
postprocedural monitoring of hydration, serum osmolarity, electrolytes
and clinical status is essential. In pediatric or severely debilitated
patients, the maintenance of an open intravenous fluid line for rehydration
may be advisable should hypotension or shock supervene. Electrolyte
disturbances must be corrected prior to the administration of any
hypertonic Gastrografin solutions.
Aspiration: Aspiration of Gastrografin into the trachea and airways
may result in serious pulmonary complications including, pulmonary
edema, pneumonitis or death Bronchial entry of any orally administered
contrast medium causes a copious osmotic effusion. Therefore, avoid
use of Gastrografin in patients with esophagotracheal fistula and
minimize risks for pulmonary aspiration in all patients. If Gastrografin
is given by nasogastric tube, the position of the tube in the stomach
must be verified before administration.
Anaphylactic reactions: Anaphylactic reactions, including
fatalities, have been reported with the use of Gastrografin. Patients
at increased risk include those with a history of a previous reaction
to a contrast medium, patients with a known sensitivity to iodine,
and patients with a known clinical hypersensitivity (bronchial asthma,
hay fever, and food allergies). Medical personnel trained in the treatment
of anaphylactic reactions and the necessary drugs and medical equipment
should always be readily available when Gastrografin is used.
What might happen if I take too much Gastrografin?
See regarding potential hypovolemia, hypotension, or shock. The
maintenance of an open intravenous fluid line for rehydration may
be advisable. See for appropriate doses and dilutions. Treatment of an overdose
should be directed toward the support of all vital functions, and
prompt institution of symptomatic therapy.
How should I store and handle Gastrografin?
Store Megestrol acetate oral suspension, USP between 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from heat.p15701179Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP)p15701179Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP)
Clinical Information
Chemical Structure
No Image foundClinical 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 ).
Non-Clinical Toxicology
Do not administer to patients with a known hypersensitivity to Gastrografin or any of its components.Dehydration: Administration of hypertonic Gastrografin solutions may lead to hypovolemia and hypotension due to fluid loss from the intestine. A 1 in 4.6 (1:4.6) dilution of Gastrografin yields an approximately isotonic 16.5 percent diatrizoate salts solution; less dilute solutions are hypertonic and may lead to intraluminal movement of fluid with resulting hypovolemia. In young or debilitated children and in elderly cachectic persons, the loss of plasma fluid may be sufficient to cause a shock-like state. If Gastrografin is used in infants and children (under 10 kg) or in dehydrated or debilitated patients, the solution must be prepared using the specific dilutions described in . In debilitated patients and in patients with electrolyte imbalances, postprocedural monitoring of hydration, serum osmolarity, electrolytes and clinical status is essential. In pediatric or severely debilitated patients, the maintenance of an open intravenous fluid line for rehydration may be advisable should hypotension or shock supervene. Electrolyte disturbances must be corrected prior to the administration of any hypertonic Gastrografin solutions.
Aspiration: Aspiration of Gastrografin into the trachea and airways may result in serious pulmonary complications including, pulmonary edema, pneumonitis or death Bronchial entry of any orally administered contrast medium causes a copious osmotic effusion. Therefore, avoid use of Gastrografin in patients with esophagotracheal fistula and minimize risks for pulmonary aspiration in all patients. If Gastrografin is given by nasogastric tube, the position of the tube in the stomach must be verified before administration.
Anaphylactic reactions: Anaphylactic reactions, including fatalities, have been reported with the use of Gastrografin. Patients at increased risk include those with a history of a previous reaction to a contrast medium, patients with a known sensitivity to iodine, and patients with a known clinical hypersensitivity (bronchial asthma, hay fever, and food allergies). Medical personnel trained in the treatment of anaphylactic reactions and the necessary drugs and medical equipment should always be readily available when Gastrografin is used.
Intravenous adenosine has been effectively administered in the presence of other cardioactive drugs, such as quinidine, beta-adrenergic blocking agents, calcium channel blocking agents, and angiotensin converting enzyme inhibitors, without any change in the adverse reaction profile. Digoxin and verapamil use may be rarely associated with ventricular fibrillation when combined with adenosine (see ). Because of the potential for additive or synergistic depressant effects on the SA and AV nodes, however, adenosine should be used with caution in the presence of these agents. The use of adenosine in patients receiving digitalis may be rarely associated with ventricular fibrillation (see ).
The effects of adenosine are antagonized by methylxanthines such as caffeine and theophylline. In the presence of these methylxanthines, larger doses of adenosine may be required or adenosine may not be effective. Adenosine effects are potentiated by dipyridamole. Thus, smaller doses of adenosine may be effective in the presence of dipyridamole. Carbamazepine has been reported to increase the degree of heart block produced by other agents. As the primary effect of adenosine is to decrease conduction through the A-V node, higher degrees of heart block may be produced in the presence of carbamazepine.
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 , and ).
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.
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 ). It should be kept in mind that serious or anaphylactoid reactions that may occur with intravascular administration of radiopaque contrast agents are theoretically possible following administration by other routes.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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