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Cholecystographic Agents, Oral (Systemic)

This monograph includes information on the following:

1) Iocetamic Acid 
2) Iopanoic Acid
3) Ipodate 
4) Tyropanoate  


INN:
Tyropanoate— Sodium Tyropanoate

VA CLASSIFICATION
Iocetamic Acid—
Primary: DX102

Iopanoic Acid—
Primary: DX102

Ipodate—
Primary: DX102
Secondary: HS852

Tyropanoate—
Primary: DX102


Commonly used brand name(s): Bilivist3; Bilopaque4; Cholebrine1; Oragrafin Calcium3; Oragrafin Sodium3; Telepaque2.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

Not commercially available in Canada.



Category:

Note: Ipodate and tyropanoate are ionic radiopaque contrast media. {01} {22} {37} {38}



Diagnostic aid, radiopaque (gallbladder disorders)—Iocetamic Acid; Iopanoic Acid; Ipodate; Tyropanoate;

Antihyperthyroid agent—Ipodate;

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Cholecystography, oral—Oral cholecystographic agents are indicated for radiographic delineation of the gallbladder. However, oral cholecystography is no longer the primary test in the evaluation of gallbladder disease. Real-time ultrasonography is the procedure of choice in most patients suspected of having gallbladder disease. Oral cholecystography is being reserved for situations in which the diagnosis is uncertain after ultrasonography, particularly in cases of chronic cholecystitis, or when there is a need to count or measure gallstones for extracorporeal shock wave lithotripsy (ESWL) or pharmacologic dissolution. {01} {07} {22} {28} {37} {38}

[Hyperthyroidism, in Graves' disease (treatment)]—Ipodate salts, and possibly iopanoic acid and tyropanoate, are used as an alternative treatment of Graves' hyperthyroidism, when conventional therapeutic agents are contraindicated or when rapid correction of thyrotoxicosis is needed. However, the efficacy of ipodate salts, and other cholecystographic agents, in other forms of hyperthyroidism, such as toxic multi-nodular goiter, has not been investigated. {02} {03} {04} {05} {06} {22} {27} {32} {34}

—Iopanoic acid and ipodate salts have been used for oral cholangiography to visualize the biliary ducts. However, cholescintigraphy performed after the intravenous injection of radioisotope-labeled substances that are rapidly excreted into the bile (e.g., technetium Tc 99m–labeled iminodiacetic acid derivatives) is the preferred method, especially in patients in whom acute cholecystitis is suspected. {01} {07} {37} {38}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
{01}{37}{38}Molecular weight—
    Iocetamic acid: 613.96
    Iopanoic acid: 570.93
    Ipodate calcium: 1233.99
    Ipodate sodium: 619.94
    Tyropanoate sodium: 663.01

pKa—
    Iocetamic acid: 4.1 and 4.25
    Iopanoic acid: 4.8

Mechanism of action/Effect:

Diagnostic aid (gallbladder disorders; biliary tract disorders) {23}—Organic iodine compounds block x-rays as they pass through the body, thereby allowing body structures containing iodine to be delineated in contrast to those structures that do not contain iodine {40}. The degree of opacity produced by these iodinated organic compounds is directly proportional to their iodine content. Radiopaque oral cholecystographic agents are concentrated in the functioning gallbladder and some may, upon contraction of the gallbladder, provide visualization of the extrahepatic ducts.

Antihyperthyroid agent—Ipodate inhibits peripheral conversion of thyroxine (T 4) to triiodothyronine (T 3). It also decreases the secretion of thyroid hormone in Graves' hyperthyroidism. {02} {03} {22} {33}

Absorption:

Generally well absorbed by passive diffusion across the gastrointestinal mucosa, primarily from the small intestine. However, iopanoic acid is poorly absorbed from the intestine in the absence of bile salts. {01} {09} {25} {35} {37} {38}

Protein binding:

High, to plasma albumin. {01} {09} {35} {37} {38}

Biotransformation:

Hepatic (primarily converted to radiopaque glucuronic acid conjugates). Inorganic iodide is liberated during hepatic metabolism. {01} {02} {37} {38}


Time to peak opacification:


Gallbladder {01} {35} {37} {38}:

Iocetamic acid: 10 to 15 hours.

Iopanoic acid: 14 to 19 hours.

Ipodate: 10 to 12 hours.

Tyropanoate: 4 to 10 hours. {30} {37}


Elimination:
    Renal and fecal (primary route of excretion depends on the degree of binding to albumin and existing renal and/or hepatic disease). Most of administered dose is excreted within a week. {01} {09} {35} {37} {38}


Within 24 hours of administration, the following percentage of the dose is eliminated in the urine {02} {22} {23}
        Iocetamic acid: 62%.
        Iopanoic acid: 33%.
        Ipodate: 45%.
        Tyropanoate: 45%.



Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to iodine or other iodinated contrast media may be sensitive to these agents also. {01} {02} {03} {37} {38}

Carcinogenicity/Mutagenicity

Long-term animal studies to evaluate carcinogenic or mutagenic potential of cholecystographic agents have not been performed. {01} {30} {37} {38}

Pregnancy/Reproduction

Pregnancy—
Other organically bound iodine–containing preparations administered near term by intra-amniotic injection {39} have caused hypothyroidism in some newborns. Also, elective contrast radiography of the abdomen is usually not recommended during pregnancy because of the risks to the fetus from radiation exposure. {01} {37} {38}


Iocetamic acid

Studies in humans have not been done.

Teratology studies in rats and rabbits have not shown that iocetamic acid causes adverse effects in the fetus. {01}

FDA Pregnancy Category B.



Ipodate salts, iopanoic acid, and tyropanoate

Studies with ipodate salts, iopanoic acid, and tyropanoate have not been done in either animals or humans. {37} {38}

FDA Pregnancy Category C.


Breast-feeding

Problems in humans have not been documented; however, risk-benefit must be considered since iocetamic acid, iopanoic acid, and tyropanoate are distributed into breast milk and the pharmacologic similarity of the oral cholecystographic agents suggests that the others may be distributed into breast milk also. {01} {09} {35} {37} {38}

Pediatrics


Iocetamic acid and tyropanoate sodium:

Appropriate studies on the relationship of age to the effects of iocetamic acid or tyropanoate sodium have not been performed in the pediatric population. {01} {09} {37} Safety and efficacy have not been established.



Iopanoic acid and ipodate calcium:

Appropriate studies on the relationship of age to the effects of iopanoic acid or ipodate calcium have not been performed in the pediatric population. However, no pediatrics-specific problems have been documented to date. {38}



Ipodate sodium:

Studies performed to date using ipodate sodium in the treatment of neonatal hyperthyroidism due to Graves' disease, and in children up to 15 years of age with toxic ingestion of levothyroxine, have not demonstrated pediatrics-specific problems that would limit the usefulness of ipodate sodium in children. {01} {12} {13} {14} {37} {38}



Geriatrics


Elderly patients may be more sensitive to the toxic effects of oral cholecystographic agents; use of large or repeated doses over a period of several days is not recommended. {01} {37} {38}

Dehydration in elderly patients receiving oral cholecystographic agents may lead to acute renal insufficiency; adequate hydration is recommended before and following administration of these agents. {01} {37} {38}

The elderly may be more sensitive to the effects of cholecystographic agents on thyroid function. Iodine-induced thyrotoxicosis may occur 4 to 12 weeks following contrast radiography. Thyroid function monitoring may be needed in geriatric patients. {43}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

See also Diagnostic interference.

Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Iodipamide meglumine, intravenous    (hepatic excretion of iodipamide meglumine may be blocked after administration of oral cholecystographic agents, increasing the risk of adverse effects; administration of cholecystographic agents is not recommended within 24 hours before or after iodipamide meglumine {01} {09} {35} {37} {38})


Urographic agents, such as diatrizoate salts, iodamide, iothalamate salts, and ioxaglate salts    (risk of renal toxicity may be increased when administration of oral cholecystographic agents is followed by urographic agents, especially in patients with hepatic or biliary function impairment {01} {09} {22} {37} {38})


Diagnostic interference
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With results of this test

Due to other medications
Cholestyramine    (concurrent use with cholecystographic agents may result in poor or non-visualization of gallbladder because of cholestyramine's high affinity for these agents; cholestyramine should be discontinued long enough [12 to 48 hours] to allow its complete evacuation from at least the small bowel prior to cholecystography {01} {09} {22} {35} {37} {38})


Due to medical problems or conditions
Gastrointestinal disorders, such as malabsorptive diseases, inflammatory small bowel disease, and short small intestines    (absorption of cholecystographic agent may be decreased or impaired, resulting in nonvisualization {01} {09} {37} {38})


Hepatic or cystic duct obstruction    (flow of cholecystographic agent to the gallbladder may be blocked, resulting in nonvisualization {01} {09} {37} {38})


Hepatic function impairment, severe, advanced    (bilirubin concentration of more than 5 mg per 100 mL may result in nonvisualization {01})

With other diagnostic test results
Hepatic function determinations    (use of these agents may increase sulfobromophthalein [BSP] retention; BSP test should not be performed for at least 2 days following oral cholecystography {01} {09} {35} {37} {38})


Thyroid function determinations and
Thyroid imaging    (cholecystographic agents may cause a decrease in radioactive iodine or pertechnetate ion uptake for a period varying from 1 week to several months; these agents may also depress total T 3 and elevate total T 4 and TSH values due to enzyme inhibition; other thyroid function tests not based on measurement of iodine are not affected {01} {05} {09} {29} {35} {37} {38})


Urinalysis    (use of these agents may produce false-positive results for up to 3 days following oral cholecystography. Pseudoalbuminuria may be present if sulfosalicylic acid and nitric acid ring tests are used; heat and acetic acid or colorimetric dip-strip method may be used to verify positive reactions {09} {35})

With physiology/laboratory test values
Bilirubin, serum and
BSP, urine    (concentrations may be increased for a few days {01})


Uric acid, serum and urinary    (rate of excretion of uric acid may be increased, resulting in a decrease of uric acid serum concentration and an increase of urinary excretion values for a few days {01} {22} {26} {35} {37} {38})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).

See also Diagnostic interference.

Except under special circumstances, this medication should not be used when the following medical problems exist:
» Hepatorenal disease, advanced or
» Renal function impairment, severe    (use of cholecystographic agents may precipitate acute renal insufficiency {01} {35} {37} {38})


Risk-benefit should be considered when the following medical problems exist
Allergic reaction (anaphylaxis) to penicillins or to skin allergens, previous    (increased risk of anaphylactoid reaction in patients who have had a previous reaction to penicillins or to skin allergens {41} {42})


Allergies or asthma, history of    (increased risk of hypersensitivity reactions {01} {37} {38})


Coronary artery disease    (increased risk of hypotension, bradycardia, and acute coronary insufficiency {01} {05} {06} {35} {37} {38})


Dehydration, all patients, especially the elderly and/or those with pre-existing renal or hepatic disease    (increased risk of acute renal insufficiency {01} {09} {37} {38})


» Hepatic function impairment, severe, advanced    (increased risk of renal toxicity and damage because of increased load of unchanged drug to the kidneys {01} {09} {35} {37} {38})


Hyperthyroidism    (thyroid storm may be precipitated {01} {09} {37} {38})


Hyperuricemia    (administration of cholecystographic agents may increase risk of developing uric acid stones and decreased renal function; adequate hydration and alkalinization of the urine is recommended in these patients {01} {09} {37} {38})


» Renal function impairment    (increased risk of acute renal insufficiency {01} {09} {37} {38})


» Sensitivity to iodinated contrast media{01}{35}{37}{38}

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Blood pressure determinations    (recommended after administration of oral cholecystographic agent in patients with cardiovascular disease {35})


Blood urea nitrogen (BUN) determinations and
Creatinine determinations, serum and
Hepatic function monitoring and
Urinary output monitoring    (may be required after cholecystography in patients with liver disease {03})


Renal function determinations    (recommended before cholecystography in patients with liver disease, because of the possibility of acute renal insufficiency)


Thyroid function determinations    (iodine-induced thyrotoxicosis may occur 4 to 12 weeks following contrast radiography in geriatric patients; thyroid function monitoring may be needed {43})




Side/Adverse Effects

Note: Acute renal insufficiency has been reported following oral administration of cholecystographic agents, especially when these agents were used in large doses or with other agents, or in dehydrated patients or those with hepatic disease. {01} {09} {37} {38}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
    
Pseudo-allergic reaction{01}{08}{10}{37}{38} (itching, skin rash or hives, swelling of skin)
    
unusual bleeding or bruising —with iopanoic acid{01}

Symptoms of overdose
—reported only with iopanoic acid{01}    
Severe diarrhea
    
severe nausea and vomiting
    
problems with urination



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent {01} {24} {37} {38}
    
Mild diarrhea
    
mild to moderate nausea and vomiting

Incidence less frequent or rare {01} {24} {37} {38}
    
Abdominal or stomach spasms or cramps
    
severe diarrhea
    
difficult or painful urination
    
dizziness
    
frequent urge to urinate
    
headache
    
heartburn
    
severe or continuing nausea and vomiting





Overdose

Treatment of overdose
Since there is no specific antidote for overdose with cholecystographic agents, treatment is symptomatic and supportive with possible utilization of the following:

To decrease absorption—Gastric lavage and administration of enema are recommended.

Specific treatment—

Administration of oral fluids to avoid concentration and possible precipitation or crystallization of the cholecystographic agent or uric acid in the kidneys.

Alkalinization of the urine to solubilize the glucoronide complex formed and the uric acid.

Use of cholestyramine to reduce absorption of the cholecystographic agent.

Monitoring—Frequent monitoring of blood pressure.


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Cholecystographic Agents, Oral (Diagnostic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Description of use
Action in the body: Accumulation in gallbladder; visualization of radiopacity in gallbladder and extrahepatic ducts possible with x-rays

Before having this test
»   Conditions affecting use, especially:
Sensitivity to iodine or other iodinated contrast media

Pregnancy—Not recommended, because of possibility of hypothyroidism in newborn; risk to the fetus from radiation exposure





Breast-feeding—Distributed into breast milk





Use in the elderly—Increased sensitivity to toxic effects; importance of adequate hydration to prevent acute renal insufficiency; increased risk of thyrotoxicosis
Other medical problems, especially renal function impairment or severe hepatic function impairment

Preparation for this test
Taking medication with water after dinner the evening(s) before test; also, adequate intake of fluids to prevent dehydration

Not eating or drinking anything, except water, after taking medication; not smoking or chewing gum

Special diet and/or preparatory instructions may apply; patient should inquire in advance

Precautions after having this test
Possible interference with later thyroid tests


Side/adverse effects
Signs of possible side effects, especially pseudo-allergic reaction (for all cholecystographic agents) or unusual bleeding or bruising (for iopanoic acid)


General Dosing Information
The manufacturer's literature should be consulted for specific techniques and procedures for administration of contrast media.

Pretreatment with corticosteroids and/or antihistamines is recommended to minimize the incidence and severity of reactions in patients with a history of severe reactions to contrast media or with other high-risk conditions (e.g., asthma or history of allergies, positive allergy history to skin allergens or penicillin, dehydration). {01} {10} {15} {16} {17} {18} {19} {20} {21} {37} {38}

As a preparatory measure for cholecystography, it is recommended that the patient ingest a fatty meal on the day prior to the initial oral dose of the cholecystographic agent, regardless of the nature of the agent. This will induce gallbladder contractions and elimination of the contents of the gallbladder. Whether or not the evening meal immediately prior to the administration of the cholecystographic agent should contain fat is dependent on the nature of the contrast medium used. When using iopanoic acid as the contrast agent, it has been shown that a reasonable amount of dietary fat enhances gastrointestinal absorption of the agent, and thus, better opacification of the gallbladder is obtained. Conversely, ingestion of a fatty meal with other cholecystographic agents decreases their absorption. {01} {07} {22} {24} {25} {29} {37} {38}

The fatty meal is being replaced, in some cases, by a commercially available oral fat emulsion, which is usually administered 20 minutes before diagnostic imaging of the gallbladder. {31}

During the interval between ingestion of the cholecystographic agent and the time of the examination, the patient should not take anything by mouth except water. Also, smoking or chewing gum is not recommended since the resulting increase in gastric acidity may affect intestinal motility and absorption of the agent. {01} {07} {09} {22} {37} {38}

Adequate hydration is important in all patients, especially in those with renal or hepatic disease and in the elderly. Additional fluid intake is recommended after ingestion of the cholecystographic agent. {01} {09} {37} {38}

IOCETAMIC ACID


Oral Dosage Forms

Note: The dosing and strengths of the dosage forms available are expressed in terms of iocetamic acid (not the iodine content).

IOCETAMIC ACID TABLETS USP

Usual adult and adolescent dose
Cholecystography—Oral, 3 to 4.5 grams.

Note: For repeat examination, on the same day as the initial cholecystography, the above dose may be given again.
In current practice, to avoid false positive diagnosis of gallbladder disease, the dose of the cholecystographic agent is administered on two consecutive evenings prior to cholecystography. {29}
The use of large or repeated doses over several days is not recommended, especially in geriatric patients.


Usual pediatric dose
Safety and efficacy have not been established.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


750 mg with 62% of iodine (Rx) [Cholebrine (scored)]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. {36}


IOPANOIC ACID


Oral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling. The dosing and strengths of the dosage forms available are expressed in terms of iopanoic acid (not the iodine content).

IOPANOIC ACID TABLETS USP

Usual adult and adolescent dose
Cholecystography
Oral, 3 grams.

Note: For repeat examination, on the same day as the initial cholecystography, the above dose may be given again.
In current practice, to avoid false positive diagnosis of gallbladder disease, the dose of the cholecystographic agent is administered on two consecutive evenings prior to cholecystography. {29}
The use of large or repeated doses over several days is not recommended, especially in geriatric patients.


[Antihyperthyroidism (Graves' disease)]1
Oral, 500 mg to 1 gram once a day. {06} {22}


Usual adult prescribing limits
Up to 6 grams in a twenty-four-hour period.

Usual pediatric dose
Cholecystography
Children weighing up to 13 kg: Oral, 150 mg per kg of body weight.

Children weighing 13 to 23 kg: Oral, 2 grams.

Children weighing 23 kg or more: Oral, 3 grams.


Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


500 mg with 66.68% of iodine (Rx) [Telepaque (scored)]

Canada—


500 mg with 66.68% of iodine (Rx) [Telepaque (scored)]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. {36}

1 Not included in Canadian product labeling.

IPODATE


Oral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling. The dosing and strengths of the dosage forms available are expressed in terms of ipodate (not the iodine content).

IPODATE CALCIUM FOR ORAL SUSPENSION USP

Usual adult and adolescent dose
Cholecystography
Oral, 3 grams.

Note: For repeat examination, on the same day as the initial cholecystography, the above dose may be given again.
In current practice, to avoid false positive diagnosis of gallbladder disease, the dose of the cholecystographic agent is administered on two consecutive evenings prior to cholecystography. {29}
The use of large or repeated doses over several days is not recommended, especially in geriatric patients.


[Antihyperthyroidism (Graves' disease)]
Oral, 500 mg once a day.


Usual adult prescribing limits
Up to 6 grams in a twenty-four-hour period.

Usual pediatric dose
Cholecystography—Oral, 450 to 900 mg per kg of body weight.

Note: For infants, dose should be diluted in 50 mL of water and given in baby bottle.


Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


3 grams with 61.7% of iodine (Rx) [Oragrafin Calcium]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer. {36}

Preparation of dosage form:
Granules should be mixed by vigorous stirring in about 60 mL of water.

Stability:
Suspension should be ingested immediately after preparation.


IPODATE SODIUM CAPSULES USP

Usual adult and adolescent dose
Cholecystography
Oral, 3 grams, taken with as little water as possible (capsules may be swallowed in rapid succession or over a period of about 30 minutes).

Note: For repeat examination, on the same day as the initial cholecystography, the above dose may be given again.
In current practice, to avoid false positive diagnosis of gallbladder disease, the dose of the cholecystographic agent is administered on two consecutive evenings prior to cholecystography. {29}
The use of large or repeated doses over several days is not recommended, especially in geriatric patients.


[Antihyperthyroidism (Graves' disease)]
Oral, 500 mg to 1 gram once a day or 3 grams every third day. {02} {22}


Usual adult prescribing limits
Up to 6 grams in a twenty-four-hour period.

Usual pediatric dose
Safety and efficacy have not been established.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


500 mg with 61.4% of iodine (Rx) [Bilivist] [Oragrafin Sodium]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.


TYROPANOATE


Oral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling. The dosing and strengths of the dosage forms available are expressed in terms of tyropanoate (not the iodine content).

TYROPANOATE SODIUM CAPSULES USP

Usual adult and adolescent dose
Cholecystography
Oral, 3 grams.

Note: For repeat examination, on the day after the initial cholecystography, the above dose may be given again.
In current practice, to avoid false positive diagnosis of gallbladder disease, the dose of the cholecystographic agent is administered on two consecutive evenings prior to cholecystography. {29}
The use of large or repeated doses over several days is not recommended, especially in geriatric patients.


[Antihyperthyroidism (Graves' disease)]
Oral, 1.5 grams once a day. {22} {27}


Usual pediatric dose
Safety and efficacy have not been established.

Usual geriatric dose
See Usual adult and adolescent dose .

Strength(s) usually available
U.S.—


750 mg with 57.4% of iodine (Rx) [Bilopaque]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. {36}



Revised: 06/29/1995



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