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INSOLUBLE PRUSSIAN BLUE

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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Insoluble Prussian blue, also known as ferric ferrocyanide, is a negligibly absorbable binding agent used for the treatment of radioactive cesium and/or thallium, and nonradioactive thallium contamination.

Specific Substances

    1) Berlin blue
    2) Chinese blue
    3) CI Pigment blue 27
    4) Color Index No 77510
    5) Ferric hexacyanoferrate(II)
    6) Ferric(III) hexacyanoferrate(II)
    7) Ferrate(4-), hexacyano-, iron(3+)
    8) Ferrate(4-), hexakis(cyano-C)-, iron
    9) Ferric ferrocyanoferrate
    10) Ferrihexacyanoferrate
    11) Ferric ferrocyanide
    12) Ferrocin
    13) Ferrotsin
    14) Hamburg blue
    15) Iron blue
    16) Iron cyanide
    17) Iron(3+) ferrocyanide
    18) Iron(III) ferrocyanide
    19) Milori blue
    20) Mineral blue
    21) Paris blue
    22) Potassium ferric hexacyanoferrate
    23) Prussian blue
    24) Tetrairon tris (hexacyanoferrate)
    25) Molecular Formula: C18-Fe3-N18.4Fe (ferric hexacyanoferrate)
    26) CAS 14038-43-8 (ferric hexacyanoferrate)
    27) CAS 12230-15-2 (potassium ferric hexacyanoferrate)
    28) FERRIC HEXACYANOFERRATE
    29) FERRICYANIDE
    30) FERROCYANIDE
    31) PRUSSIAN BLUE, INSOLUBLE
    1.2.1) MOLECULAR FORMULA
    1) C18-Fe3-N18.4Fe

Available Forms Sources

    A) FORMS
    1) Insoluble Prussian blue is available as 0.5 gram blue powder in gelatin capsules for oral administration by prescription. Thirty capsules are packaged in a brown glass bottle (Prod Info Radiogardase(TM), 2003a). Non pharmaceutical-grade Prussian blue (e.g. artists’ dye) is NOT intended for human consumption and should not be used for treatment (Centers for Disease Control, 2004) .
    B) SOURCES
    1) HEYLTEX CORPORATION
    a) The Heyltex Corporation, Katy, Texas, a subsidiary of Heyl Chemisch-pharmazeutische Fabrik, is the only U.S.distributor for Prussian blue (Radiogardase®)
    1) Phone: (281) 395-7040
    2) Fax: (281) 395-2320
    3) Website: www.heyltex.com
    4) Email: info@heyltex.com
    2) CENTERS FOR DISEASE CONTROL
    a) The CDC has included Prussian blue in the U.S. Strategic National Stockpile (SNS) of pharmaceuticals and medical supplies:
    1) Phone: 770-488-7100 (Emergency Operations Center) maintained 24/7 to assist local, state, and federal agencies.
    3) RADIATION EMERGENCY ASSISTANCE CENTER/TRAINING SITE (REAC/TS)
    a) Radiation Emergency Assistance Center/Training Site (REAC/TS), Oak Ridge Institute for Science and Education (ORISE) may serve as a further source of assistance:
    1) Emergency Number: (865) 576-1005
    2) Radiation Emergency Medicine: (865) 576-3131
    3) Website: http://orise.orau.gov/reacts
    4) Email: reacts@orise.orau.gov
    C) USES
    1) Insoluble Prussian blue is used to treat patients with known or suspected internal contamination with radioactive cesium, radioactive thallium, or nonradioactive thallium, to increase the rate of elimination (Prod Info Radiogardase(TM), 2003a). There is a single case report of use in nonradioactive cesium toxicity (Thurgur et al, 2006).

Overview

Life Support

    A) This overview assumes that basic life support measures have been instituted.

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) USES: Insoluble Prussian blue is used to treat patients with known or suspected internal contamination with radioactive cesium or thallium, or nonradioactive thallium, to increase the rate of elimination. There is one case report of use in nonradioactive cesium toxicity.
    B) PHARMACOLOGY: Insoluble Prussian blue acts via ion-exchange, adsorption, and mechanical trapping within its crystal structure, and has a very high affinity for radioactive and nonradioactive cesium and thallium. Following oral administration, it is negligibly absorbed by the gastrointestinal tract. Insoluble Prussian blue binds ingested cesium and thallium isotopes in the GI tract, reducing absorption. Cesium and thallium isotopes excreted in bile are also bound, limiting reabsorption via enterohepatic circulation. This changes the primary route of isotope elimination from renal to fecal, and increases the rate of elimination of these isotopes.
    C) EPIDEMIOLOGY: Overdose is rare.
    D) WITH THERAPEUTIC USE
    1) ADVERSE EFFECTS: Constipation, gastric distress, and asymptomatic hypokalemia have been reported in patients taking insoluble Prussian blue.
    E) WITH POISONING/EXPOSURE
    1) OVERDOSE: Limited data.
    2) MILD TO MODERATE TOXICITY: Gastrointestinal symptoms including abdominal pain or distension, constipation and obstipation may occur following overdose. Asymptomatic hyponatremia may be observed.
    3) SEVERE TOXICITY: Patients may develop severe symptoms of decreased gastrointestinal motility, abdominal pain or distension, and bowel obstruction. Significant electrolyte imbalances and/or fluid abnormalities may also occur.
    0.2.20) REPRODUCTIVE
    A) Insoluble Prussian blue is classified as US Food and Drug Administration pregnancy category C. The effects of insoluble Prussian blue in human offspring are unknown since there are no studies in pregnant women. Insoluble Prussian blue is negligibly absorbed from the GI tract, and effects on the fetus are not expected. Because both cesium and thallium can cross the placenta and induce fetal toxicity, a risk benefit analysis would support the use of insoluble Prussian blue in significant radioactive or nonradioactive cesium or thallium exposure. Breastfeeding studies have not been conducted with insoluble Prussian blue. Insoluble Prussian blue is not absorbed from the gastrointestinal tract, and subsequent excretion into breast milk is unlikely. Cesium and thallium do pass into breast milk, and mothers exposed to either should not breastfeed.

Laboratory Monitoring

    A) Obstipation, obstruction, hypokalemia or other electrolyte disturbance may occur following overdose. Following a significant exposure, monitor for fluid and electrolyte abnormalities.
    B) Following an ingestion, insoluble Prussian blue is negligibly absorbed through the intact gastrointestinal tract. Therapeutic or toxic blood concentrations have not been established.
    C) Systemic toxicity requiring monitoring of liver, kidney or hematologic function has not been reported.
    D) It may bind to some orally administered therapeutic dugs. Obtain drug concentrations or monitor clinical response of oral medications as needed.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) MANAGEMENT OF MILD TO MODERATE TOXICITY
    1) Treatment is symptomatic and supportive. Obstipation, obstruction, hypokalemia or other electrolyte disturbances may occur following overdose. Correct any significant fluid and/or electrolyte abnormalities. Consider the use of a laxative to prevent constipation. Initially, treat mild constipation with a fiber-based laxative or a high fiber diet. Patients with preexisting cardiac abnormalities and/or electrolyte abnormalities may require closer monitoring.
    B) MANAGEMENT OF SEVERE TOXICITY
    1) Treatment is symptomatic and supportive. Establish IV access. Monitor patient for decreased gastrointestinal motility, abdominal pain or distension, obstipation or bowel obstruction. Use of a laxative to treat constipation. Abdominal decompression with nasogastric suction, and administration of enemas may be needed. Monitor patient for evidence of electrolyte imbalances; correct any electrolyte and/or fluid abnormalities, as needed. Since insoluble Prussian blue may bind with some orally administered therapeutic agents, carefully monitor clinical response to oral medications. NOTE: A patient exposed to radiation requires concomitant monitoring and treatment for radiation toxicity, since insoluble Prussian blue does NOT treat the adverse events related to a radiation exposure (see RADIATION management, as appropriate).
    C) DECONTAMINATION
    1) PREHOSPITAL: Following an oral ingestion, insoluble Prussian blue is negligibly absorbed through the intact gastrointestinal tract. Gastrointestinal decontamination is not needed.
    2) HOSPITAL: Following an oral ingestion, insoluble Prussian blue is negligibly absorbed through the intact gastrointestinal tract. Gastrointestinal decontamination is not needed.
    D) ANTIDOTE
    1) There is no known antidote for insoluble Prussian blue.
    E) ENHANCED ELIMINATION
    1) Insoluble Prussian blue is not systemically bioavailable; therefore, hemodialysis is not beneficial.
    F) PATIENT DISPOSITION
    1) HOME CRITERIA: A patient with an inadvertent exposure, that remains asymptomatic can be managed at home.
    2) OBSERVATION CRITERIA: Patients with a deliberate overdose, and those who are symptomatic, need to monitored for several hours to assess electrolyte and fluid balance and gastrointestinal function. Patients with underlying cardiac abnormalities may require ECG monitoring in addition to electrolyte/fluid analysis. Patients that remain asymptomatic can be discharged.
    3) ADMISSION CRITERIA: Patients with significant gastrointestinal symptoms (eg, signs of obstruction), persistent electrolyte imbalances, ECG abnormalities likely need to be admitted for further treatment and monitoring.
    G) PHARMACOKINETICS
    1) Based on animal data, 99% of a single dose of 40 mg of labeled insoluble Prussian blue was excreted unchanged in feces. It was also not found to be significantly absorbed. Insoluble Prussian blue is not systemically bioavailable; nor does it rely on renal elimination or hepatic metabolism.
    H) DIFFERENTIAL DIAGNOSIS
    1) Patients with a history of decreased gastrointestinal motility due to other causes. Patients with underlying cardiac dysrhythmias or electrolyte imbalance may develop more severe symptoms. If a radiation exposure has occurred, symptoms observed may be related to radiation toxicity (insoluble Prussian blue does NOT treat the complications of radiation exposure).

Range Of Toxicity

    A) TOXIC DOSE: A minimum toxic dose has not been established. Doses up to 10 g/day have been well tolerated.
    B) THERAPEUTIC DOSE: GENERAL DOSING: ADULT or CHILD: Begin treatment as soon as possible after contamination is suspected, and continue for a minimum of 30 days, thereafter, continuation of therapy is based on the level of contamination and clinical judgment. RADIOACTIVE CESIUM OR THALLIUM: ADULTS/ADOLESCENTS (13 years and older): 3 g orally 3 times daily. When internal radioactivity has decreased substantially, the dose may be reduced to 1 or 2 g 3 times daily to improve GI tolerance. PEDIATRIC (2 to 12 years): 1 g orally 3 times daily. Administration of a laxative may be required to prevent obstipation. Safety and efficacy of insoluble Prussian blue in infants and neonates have not been established. CESIUM OR THALLIUM POISONING: ADULT/ADOLESCENTS (13 years and older): 3 g orally 3 times daily. Optimal duration of therapy is not established. CESIUM POISONING: There are no reported cases of the use of Prussian blue in a child for the treatment of cesium poisoning. THALLIUM POISONING: PEDIATRIC (2 to 12 years): 1 g orally 3 times daily. Optimal duration of therapy is not established. Monitor urinary thallium concentrations to determine the need for continued therapy.

Clinical Effects

Summary Of Exposure

    A) USES: Insoluble Prussian blue is used to treat patients with known or suspected internal contamination with radioactive cesium or thallium, or nonradioactive thallium, to increase the rate of elimination. There is one case report of use in nonradioactive cesium toxicity.
    B) PHARMACOLOGY: Insoluble Prussian blue acts via ion-exchange, adsorption, and mechanical trapping within its crystal structure, and has a very high affinity for radioactive and nonradioactive cesium and thallium. Following oral administration, it is negligibly absorbed by the gastrointestinal tract. Insoluble Prussian blue binds ingested cesium and thallium isotopes in the GI tract, reducing absorption. Cesium and thallium isotopes excreted in bile are also bound, limiting reabsorption via enterohepatic circulation. This changes the primary route of isotope elimination from renal to fecal, and increases the rate of elimination of these isotopes.
    C) EPIDEMIOLOGY: Overdose is rare.
    D) WITH THERAPEUTIC USE
    1) ADVERSE EFFECTS: Constipation, gastric distress, and asymptomatic hypokalemia have been reported in patients taking insoluble Prussian blue.
    E) WITH POISONING/EXPOSURE
    1) OVERDOSE: Limited data.
    2) MILD TO MODERATE TOXICITY: Gastrointestinal symptoms including abdominal pain or distension, constipation and obstipation may occur following overdose. Asymptomatic hyponatremia may be observed.
    3) SEVERE TOXICITY: Patients may develop severe symptoms of decreased gastrointestinal motility, abdominal pain or distension, and bowel obstruction. Significant electrolyte imbalances and/or fluid abnormalities may also occur.

Gastrointestinal

    3.8.2) CLINICAL EFFECTS
    A) CONSTIPATION
    1) WITH THERAPEUTIC USE
    a) Insoluble Prussian blue may cause constipation or obstipation. This reduction in GI motility will slow the transit time of radionuclides bound to the drug in the GI tract, and may increase the absorbed radiation dose to the GI mucosa (Prod Info RADIOGARDASE(R) oral insoluble capsules, 2004; Hoffman, 2003; Prod Info Radiogardase(TM), 2003a; Thompson & Church, 2001; Pearce, 1994).
    b) Mild to moderate constipation has been reported in 10 of 42 (24%) patients in the Goiania incident treated with insoluble Prussian blue (Prod Info Radiogardase(TM), 2003a).
    c) Undefined gastric distress has been reported in patients taking 20 g/day of insoluble Prussian blue (Prod Info RADIOGARDASE(R) oral insoluble capsules, 2004).
    d) Insoluble Prussian blue may impart a blue discoloration to the stools, and to the mouth and teeth if the capsules are opened and mixed with food or fluids (Prod Info RADIOGARDASE(R) oral insoluble capsules, 2004). Bluish discoloration of sweat and tears may occur with prolonged therapy (Hoffman, 2003).
    2) WITH POISONING/EXPOSURE
    a) Obstipation, obstruction, and severe decreases in electrolytes may occur following overdose (Prod Info RADIOGARDASE(R) oral insoluble capsules, 2004).

Reproductive

    3.20.1) SUMMARY
    A) Insoluble Prussian blue is classified as US Food and Drug Administration pregnancy category C. The effects of insoluble Prussian blue in human offspring are unknown since there are no studies in pregnant women. Insoluble Prussian blue is negligibly absorbed from the GI tract, and effects on the fetus are not expected. Because both cesium and thallium can cross the placenta and induce fetal toxicity, a risk benefit analysis would support the use of insoluble Prussian blue in significant radioactive or nonradioactive cesium or thallium exposure. Breastfeeding studies have not been conducted with insoluble Prussian blue. Insoluble Prussian blue is not absorbed from the gastrointestinal tract, and subsequent excretion into breast milk is unlikely. Cesium and thallium do pass into breast milk, and mothers exposed to either should not breastfeed.
    3.20.3) EFFECTS IN PREGNANCY
    A) PREGNANCY CATEGORY
    1) Insoluble Prussian blue is classified as US Food and Drug Administration pregnancy category C (Prod Info RADIOGARDASE oral insoluble capsules, 2014)
    B) RISK SUMMARY
    1) The effects of insoluble Prussian blue in human offspring are unknown since there are no studies in pregnant women. Insoluble Prussian blue is negligibly absorbed from the GI tract, and effects on the fetus are not expected (Prod Info RADIOGARDASE oral insoluble capsules, 2014). Because both cesium and thallium can cross the placenta and induce fetal toxicity, a risk benefit analysis would support the use of insoluble Prussian blue in significant radioactive or nonradioactive cesium or thallium exposure. The decision not to use insoluble Prussian blue in one patient exposed to cesium-137 during her 4th month of pregnancy resulted in a neonatal cesium-137 concentration at birth identical to that of the mother (Prod Info RADIOGARDASE oral insoluble capsules, 2014).
    2) A female exposed to a thallium rodenticide during her 13th week of pregnancy had a 24 hour urine thallium concentration of 3400 mcg/L (normal <5 mcg/L) 6 weeks after the exposure. Chelation with Prussian blue improved her clinical status and she was discharged from the hospital. Approximately 11 to 12 weeks after the thallium exposure she spontaneously aborted a child with normal external morphology for its estimated gestational age (Hoffman, 2000).
    3.20.4) EFFECTS DURING BREAST-FEEDING
    A) BREAST MILK
    1) Breastfeeding studies have not been conducted with insoluble Prussian blue. Insoluble Prussian blue is not absorbed from the gastrointestinal tract, and subsequent excretion into breast milk is unlikely (Prod Info RADIOGARDASE oral insoluble capsules, 2014). Cesium and thallium do pass into breast milk, and mothers exposed to either should not breastfeed (Prod Info Radiogardase(TM), 2003a).

Carcinogenicity

    3.21.1) IARC CATEGORY
    A) IARC Carcinogenicity Ratings for CAS14038-43-8 (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004):
    1) Not Listed

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) Obstipation, obstruction, hypokalemia or other electrolyte disturbance may occur following overdose. Following a significant exposure, monitor for fluid and electrolyte abnormalities.
    B) Following an ingestion, insoluble Prussian blue is negligibly absorbed through the intact gastrointestinal tract. Therapeutic or toxic blood concentrations have not been established.
    C) Systemic toxicity requiring monitoring of liver, kidney or hematologic function has not been reported.
    D) It may bind to some orally administered therapeutic dugs. Obtain drug concentrations or monitor clinical response of oral medications as needed.
    4.1.2) SERUM/BLOOD
    A) Obstipation, obstruction, hypokalemia or other electrolyte disturbance may occur following overdose. Following a significant exposure, monitor for fluid and electrolyte abnormalities.
    4.1.4) OTHER
    A) OTHER
    1) Insoluble Prussian blue may bind some orally administered therapeutic dugs. As appropriate, blood concentrations or clinical response to oral medications should be monitored (Prod Info RADIOGARDASE(R) oral insoluble capsules, 2004).
    2) Insoluble Prussian blue may cause stool to become blue-colored. In addition, patients that are unable to swallow the capsules, and mix the content of the capsules in food, may develop a blue-colored mouth and teeth (Prod Info RADIOGARDASE(R) oral insoluble capsules, 2004).

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Patient Disposition

    6.3.1) DISPOSITION/ORAL EXPOSURE
    6.3.1.1) ADMISSION CRITERIA/ORAL
    A) Patients with significant gastrointestinal symptoms (eg, signs of obstruction), persistent electrolyte imbalances, ECG abnormalities likely need to be admitted for further treatment and monitoring.
    6.3.1.2) HOME CRITERIA/ORAL
    A) A patient with a minor inadvertent exposure, that remains asymptomatic can be managed at home.
    6.3.1.5) OBSERVATION CRITERIA/ORAL
    A) Patients with a deliberate overdose, and those with symptoms, need to monitored for several hours to assess electrolyte and/or fluid balance and gastrointestinal function. Patients with underlying cardiac abnormalities may require ECG monitoring in addition to electrolyte/fluid analysis. Patients that remain asymptomatic can be discharged.

Monitoring

    A) Obstipation, obstruction, hypokalemia or other electrolyte disturbance may occur following overdose. Following a significant exposure, monitor for fluid and electrolyte abnormalities.
    B) Following an ingestion, insoluble Prussian blue is negligibly absorbed through the intact gastrointestinal tract. Therapeutic or toxic blood concentrations have not been established.
    C) Systemic toxicity requiring monitoring of liver, kidney or hematologic function has not been reported.
    D) It may bind to some orally administered therapeutic dugs. Obtain drug concentrations or monitor clinical response of oral medications as needed.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) Significant toxicity is unlikely. Following an oral ingestion, insoluble Prussian blue is negligibly absorbed through the intact gastrointestinal tract. Gastrointestinal decontamination is generally not needed.
    6.5.2) PREVENTION OF ABSORPTION
    A) Significant toxicity is unlikely. Following an ingestion, insoluble Prussian blue is negligibly absorbed through the intact gastrointestinal tract. Gastrointestinal decontamination is generally not needed.
    6.5.3) TREATMENT
    A) SUPPORT
    1) Treatment is symptomatic and supportive. Obstipation, obstruction, hypokalemia or other electrolyte disturbances may occur following overdose. Correct any fluid and/or electrolyte abnormalities. Monitor patient for abdominal pain or distension, obstipation or bowel obstruction. Consider use of a laxative to prevent constipation. For severe symptoms, abdominal decompression with nasogastric suction, and administration of enemas may be necessary.
    B) MONITORING OF PATIENT
    1) Obstipation, obstruction, or electrolytes abnormalities may occur following overdose. Monitor for any fluid and/or electrolyte abnormalities.
    2) Systemic toxicity requiring monitoring of other liver, kidney or hematologic factors has not been reported.

Range Of Toxicity

Summary

    A) TOXIC DOSE: A minimum toxic dose has not been established. Doses up to 10 g/day have been well tolerated.
    B) THERAPEUTIC DOSE: GENERAL DOSING: ADULT or CHILD: Begin treatment as soon as possible after contamination is suspected, and continue for a minimum of 30 days, thereafter, continuation of therapy is based on the level of contamination and clinical judgment. RADIOACTIVE CESIUM OR THALLIUM: ADULTS/ADOLESCENTS (13 years and older): 3 g orally 3 times daily. When internal radioactivity has decreased substantially, the dose may be reduced to 1 or 2 g 3 times daily to improve GI tolerance. PEDIATRIC (2 to 12 years): 1 g orally 3 times daily. Administration of a laxative may be required to prevent obstipation. Safety and efficacy of insoluble Prussian blue in infants and neonates have not been established. CESIUM OR THALLIUM POISONING: ADULT/ADOLESCENTS (13 years and older): 3 g orally 3 times daily. Optimal duration of therapy is not established. CESIUM POISONING: There are no reported cases of the use of Prussian blue in a child for the treatment of cesium poisoning. THALLIUM POISONING: PEDIATRIC (2 to 12 years): 1 g orally 3 times daily. Optimal duration of therapy is not established. Monitor urinary thallium concentrations to determine the need for continued therapy.

Therapeutic Dose

    7.2.1) ADULT
    A) RADIOACTIVE CESIUM OR THALLIUM
    1) ADULTS AND ADOLESCENTS 13 YEARS OF AGE OR OLDER: 3 grams orally 3 times a day (Prod Info RADIOGARDASE oral insoluble capsules, 2014); treatment should be initiated as soon as possible after contamination is suspected, and should be continued for a minimum of 30 days, and continued thereafter based on the level of contamination and the judgment of the clinician. When internal radioactivity has decreased substantially, the dose may be reduced to 1 or 2 grams 3 times a day to improve gastrointestinal tolerance (Prod Info RADIOGARDASE oral insoluble capsules, 2014).
    2) If swallowing large numbers of capsules is not tolerated, capsules may be opened and mixed with bland food or liquids . However, breaking open the capsules will cause the mouth and teeth to become blue during the time of treatment. May be taken with food to stimulate excretion of cesium or thallium (Prod Info RADIOGARDASE oral insoluble capsules, 2014).
    3) Lactulose, sorbitol, or mannitol may be added to insoluble Prussian blue to prevent obstipation (Thompson & Callen, 2004; Thompson & Church, 2001; Malbrain et al, 1997). A high fiber diet is recommended (Blanusa et al, 2005).
    B) CESIUM POISONING
    1) ADULTS AND ADOLESCENTS 13 YEARS OF AGE OR OLDER - 3 grams orally 3 times a day for 30 days or more (Prod Info RADIOGARDASE oral insoluble capsules, 2014). Optimal duration of therapy is not established. Monitor electrocardiogram for resolution of QTc interval prolongation to determine the need for continued therapy. The dose may be reduced to 1 or 2 grams three times a day to improve gastrointestinal tolerance in patients requiring prolonged treatment (Prod Info RADIOGARDASE oral insoluble capsules, 2014).
    2) If swallowing large numbers of capsules is not tolerated, capsules may be opened and mixed with bland food or liquids (Prod Info RADIOGARDASE oral insoluble capsules, 2014). Breaking open the capsules will cause the mouth and teeth to become blue during the time of treatment. May be taken with food to stimulate excretion of cesium or thallium.
    3) Lactulose, sorbitol, or mannitol may be added to insoluble Prussian blue to prevent obstipation (Thompson & Callen, 2004; Thompson & Church, 2001; Malbrain et al, 1997). A high fiber diet is recommended (Blanusa et al, 2005).
    C) THALLIUM POISONING
    1) ADULTS AND ADOLESCENTS 13 YEARS OF AGE OR OLDER: 3 grams orally 3 times a day for 30 days or more (Prod Info RADIOGARDASE oral insoluble capsules, 2014). Optimal duration of therapy is not established. Monitor urinary thallium concentration to determine the need for continued therapy; some authors recommend continuing therapy until urinary thallium elimination is below 0.5 milligram/day (Hoffman, 2003). The dose may be reduced to 1 or 2 grams 3 times a day to improve gastrointestinal tolerance in patients requiring prolonged treatment (Prod Info Radiogardase(TM), 2003).
    2) If swallowing large numbers of capsules is not tolerated, capsules may be opened and mixed with bland food or liquids. However, breaking open the capsules will cause the mouth and teeth to become blue during the time of treatment. May be taken with food to stimulate excretion of thallium (Prod Info Radiogardase(TM), 2003).
    3) Lactulose, sorbitol, or mannitol may be added to insoluble Prussian blue to prevent obstipation (Thompson & Callen, 2004; Thompson & Church, 2001; Malbrain et al, 1997). A high fiber diet is recommended (Blanusa et al, 2005).
    7.2.2) PEDIATRIC
    A) RADIOACTIVE CESIUM OR THALLIUM
    1) CHILDREN (2 TO 12 YEARS): 1 gram orally 3 times a day (Prod Info RADIOGARDASE oral insoluble capsules, 2014); treatment should be initiated as soon as possible after contamination is suspected, and should be continued for a minimum of 30 days, and continued thereafter based on the level of contamination and the judgment of the clinician. Administration of a laxative may be required to prevent obstipation. Safety and efficacy of insoluble Prussian blue in infants and neonates have not been established (Prod Info Radiogardase(TM), 2003).
    2) If swallowing large numbers of capsules is not tolerated, capsules may be opened and mixed with bland food or liquids. However, breaking open the capsules will cause the mouth and teeth to become blue during the time of treatment. May be taken with food to stimulate excretion of cesium or thallium (Prod Info RADIOGARDASE oral insoluble capsules, 2014).
    B) CESIUM POISONING
    1) CHILDREN (2 TO 12 YEARS): 1 gram orally 3 times a day for 30 days or more (Prod Info RADIOGARDASE oral insoluble capsules, 2014).
    C) THALLIUM POISONING
    1) CHILDREN (2 TO 12 YEARS): 1 gram orally 3 times a day for 30 days or more (Prod Info RADIOGARDASE oral insoluble capsules, 2014). Optimal duration of therapy is not established. Monitor urinary thallium concentration to determine the need for continued therapy; some authors recommend continuing therapy until urinary thallium elimination is below 0.5 milligram/day (Hoffman, 2003). Administration of a laxative may be required to prevent obstipation. Safety and efficacy of insoluble Prussian blue in infants and neonates patients have not been established (Prod Info Radiogardase(TM), 2003).
    2) If swallowing large numbers of capsules is not tolerated, capsules may be opened and mixed with bland food or liquids. However, breaking open the capsules will cause the mouth and teeth to become blue during the time of treatment. May be taken with food to stimulate excretion of thallium (Prod Info Radiogardase(TM), 2003).

Maximum Tolerated Exposure

    A) Doses up to 10 g/day have been well tolerated (Thompson & Church, 2001). Doses of 20 g/day have also been reported (Thompson & Callen, 2004).

Workplace Standards

    A) ACGIH TLV Values for CAS14038-43-8 (American Conference of Governmental Industrial Hygienists, 2010):
    1) Not Listed

    B) NIOSH REL and IDLH Values for CAS14038-43-8 (National Institute for Occupational Safety and Health, 2007):
    1) Not Listed

    C) Carcinogenicity Ratings for CAS14038-43-8 :
    1) ACGIH (American Conference of Governmental Industrial Hygienists, 2010): Not Listed
    2) EPA (U.S. Environmental Protection Agency, 2011): Not Listed
    3) IARC (International Agency for Research on Cancer (IARC), 2016; International Agency for Research on Cancer, 2015; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2010a; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2008; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2007; IARC Working Group on the Evaluation of Carcinogenic Risks to Humans, 2006; IARC, 2004): Not Listed
    4) NIOSH (National Institute for Occupational Safety and Health, 2007): Not Listed
    5) MAK (DFG, 2002): Not Listed
    6) NTP (U.S. Department of Health and Human Services, Public Health Service, National Toxicology Project ): Not Listed

    D) OSHA PEL Values for CAS14038-43-8 (U.S. Occupational Safety, and Health Administration (OSHA), 2010):
    1) Not Listed

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) LD50- (INTRAPERITONEAL)MOUSE:
    1) 2 g/kg; toxic effects: somnolence, dyspnea (RTECS, 2003).
    B) LD50- (INTRAPERITONEAL)RAT:
    1) 2100 mg/kg; toxic effects: somnolence, dyspnea (RTECS, 2003)

Pharmacology Toxicology

Pharmacologic Mechanism

    A) Insoluble Prussian blue acts via ion-exchange, adsorption, and mechanical trapping within its crystal structure, and has a very high affinity for radioactive and non-radioactive cesium and thallium. Following oral administration, it is negligibly absorbed by the gastrointestinal tract. Insoluble Prussian blue binds ingested cesium and thallium isotopes in the GI tract, reducing absorption. Cesium and thallium isotopes excreted in bile are also bound, limiting reabsorption via enterohepatic circulation. This changes the primary route of isotope elimination from renal to fecal, and increases the rate of elimination of these isotopes (Prod Info Radiogardase(TM), 2003). It has also been reported that potassium is exchanged for cesium on the surface of the crystal lattice (Thompson & Callen, 2004). Prussian blue with a smaller crystal size has both higher adsorption capacity and antidotal efficacy for thallium (Kravzov et al, 1993).
    B) Two different forms of Prussian blue exist – 'soluble' (colloidal) and insoluble (non-colloidal). Insoluble Prussian blue has been most widely used in human radioactive cesium poisoning. In vitro studies found that Insoluble Prussian blue had three times the binding capacity of soluble Prussian blue at pH 7.5 (optimal pH for cesium-137 adsorption). In vivo experiments showed that soluble Prussian blue broke down to an unbound form which complexed with cesium and was incapable of excretion (Thompson & Callen, 2004). Another in vivo study showed a slight superiority to soluble Prussian blue (Dresow et al, 1993). Soluble Prussian blue was used in the majority of human thallium cases in a recent review, and it seems to be more effective for thallium poisoning, possibly because of its higher potassium concentration (Hoffman, 2003; Thompson & Callen, 2004).
    C) CESIUM TOXICITY
    1) Non-radioactive cesium chloride is used as an alternative therapy by cancer patients (Pinter et al, 2002; Thurgur et al, 2006). Radioactive cesium is a primary component of radioactive fallout, radioactive waste, radiotherapy devices, mining and milling of pollucite, and nuclear power plant operations. The physical half-life of cesium-137 (Cs-137) is approximately 30 years, and that of cesium-134 (Cs-134) is 2 years, making both isotopes a long-term radiological hazard (Agency for Toxic Substances and Disease Registry, 2004). Cesium contamination may occur via ingestion, inhalation, or dermal penetration.
    a) High levels of non-radioactive cesium are arrythmogenic and may produce prolongation of the QTc interval and torsades de pointes (Pinter et al, 2002).
    2) Once absorbed, radioactive cesium follows the same biochemical pathways as potassium. The biological and effective half-life of Cs-137 is 110 days. It is uniformly distributed, with higher concentrations in the liver, skeletal muscle, and erythrocytes. Dermal exposure causes conditions ranging from mild skin irritation to necrotizing lesions. Gastrointestinal complaints are common, including severe nausea, vomiting and diarrhea. Eventually, bone marrow depression occurs, leading to infection, hemorrhage, and death. It is well absorbed orally, and is eliminated primarily through the kidneys. Cs-137 crosses the placenta, and yielded a neonatal Cs-137 concentration at birth identical to that of a mother exposed during her 4th month of pregnancy (Prod Info Radiogardase(TM), 2003). Cesium can be found in the breast milk of mothers with an internal cesium burden(Agency for Toxic Substances and Disease Registry, 2004).
    3) Since Insoluble Prussian blue binds cesium in the gastrointestinal tract, systemic exposure is significantly decreased and fecal excretion is increased (Prod Info Radiogardase(TM), 2003; Thompson & Callen, 2004).
    4) According to the manufacturer’s data, 65 patients and 7 normal human volunteers received Insoluble Prussian blue in literature reports after internal contamination with Cs-137 (Prod Info Radiogardase(TM), 2003). A literature review by Thompson and Callen (2004) noted 83 patients and 3 human volunteers (Thompson & Callen, 2004).
    a) In the 1987 incident in Goiania, Brazil, 46 patients were extensively contaminated with internal Cs-137. Insoluble Prussian blue treatment (doses up to 10 grams/day) reduced the mean whole-body half-life of Cs-137 by 69% in adults, 46% in adolescents, and 43% in children (Prod Info Radiogardase(TM), 2003).
    b) In 2 human volunteers, pretreatment with 1 gram Insoluble Prussian blue reduced absorption of food contaminated with Cs-134 in by 93.6% (Dresow et al, 1993).
    D) THALLIUM TOXICITY
    1) Non-radioactive thallium is used in industry and as a rodenticide. Environmental release occurs from coal combustion, cement plants, and smelting operations. Radioactive Thallium-201 (Tl-201) is widely used medically as a diagnostic agent in myocardial scintigraphy. Thallium-205 (Tl-205) has been used in nuclear magnetic resonance research.
    2) Thallium is rapidly and completely absorbed from either the gastrointestinal or respiratory tract, or through the skin. Water-soluble thallium salts are widely distributed into organs and tissues, including the brain, heart, kidney, skeletal muscle, and testis, which are the principal targets of thallium toxicity. Thallium freely crosses the placenta and may produce fetal toxicity, abnormalities, and demise (Hoffman, 2003). Alopecia and nail growth abnormalities, gastrointestinal distress and constipation, and painful sensory and motor neuropathies may occur (Andersen, 1984; Moore et al, 1993; Mulkey & Oehme, 1993). Due to the similarity of its charge and ionic radius to potassium, thallium distributes in the same manner, and may disrupt potassium-dependent and sulfhydryl-dependent functions, including those required for energy production and utilization (Hoffman, 2003; Moore et al, 1993; Mulkey & Oehme, 1993).
    3) In data provided by the manufacturer, 34 patients with non-radioactive thallium poisoning treated with Insoluble Prussian blue were reported in the literature. In these cases, the drug reduced the mean serum biologic half-life of thallium from 8 days to 3 days (Prod Info Radiogardase(TM), 2003).
    4) In a small case series, 11 patients with thallium intoxication were successfully treated with Prussian blue after ingesting various amounts of thallium. Patients presented from 1 to 151 days after thallium exposure, and all had classic symptoms of thallium poisoning to varying degrees. After 3 to 20 days of Prussian blue therapy, resolution of symptoms was observed, and elimination of thallium excretion in urine, feces, and blood was noted (Stevens et al, 1974). Other similar cases of the use of Prussian blue following thallium exposure have been reported (Pau, 2000; Atsmon et al, 2000; Malbrain et al, 1997; Pai, 1987; Ghezzi & Bozza Marrubini, 1979).
    5) Adsorption of Tl-201 to Prussian blue is a pH-dependent process, with the most uptake at pH 8 (Bhardwaj et al, 2006).
    6) In one patient, Prussian blue reduced whole body radioactivity from Tl-201 myocardial scintigraphy by 30% at 48 hours compared to no Prussian blue treatment (Bhardwaj et al, 2006).

Physicochemical

Physical Characteristics

    A) Insoluble Prussian blue (ferric(III) hexacyanoferrate(II)) is a cubic lattice with the Fe(II) and Fe(III) atoms occupying the corners of the cube and the cyanide groups positioned on the sides. The Prussian blue powder may be uniformly fine, dark granules or coarse light and dark-colored granules (Prod Info Radiogardase(TM), 2003).

Molecular Weight

    A) 859.3 (Prod Info Radiogardase(TM), 2003)

References

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