RADIOGARDASE(Heyl Chem.-pharm. Fabrik GmbH & Co. KG)(四)
logical emergencies, the type of elemental exposure may not be known. Prussian blue insoluble may not bind to all radioactive elements and some radioactive elements may not undergo enterohepatic circulation, which is needed for Prussian blue insoluble binding and elimination. Patients contaminated with unknown or multiple radioactive elements may require treatment with other agents in addition to Prussian blue insoluble.
PRECAUTIONSGeneral Gastrointestinal
Prussian blue insoluble can cause constipation. Decreased gastrointestinal motility will slow the transit time of 137 Cs bound to Prussian blue insoluble in the gastrointestinal tract, and may increase the radiation absorbed dose to the gastrointestinal mucosa. Constipation occurring during Prussian blue insoluble treatment may be treated with a fiber based laxative and/or a high fiber diet. Prussian blue insoluble should be used with caution in patients with disorders associated with decreased gastrointestinal motility.
Information for PatientsCesium-137 is excreted in the urine and feces. Appropriate safety measures should be taken to minimize radiation exposure to others. When possible, a toilet should be used instead of a urinal, and it should be flushed several times after each use. Spilled urine or feces should be cleaned up completely, and patients should wash their hands thoroughly. If blood or urine gets onto clothing, such clothing should be washed separately.
Parents and child-care givers should take extra precaution in handling the urine and feces of pediatric patients. Care is intended to prevent re-exposure to the adult and pediatric patient.
In patients with constipation, a fiber based laxative and/or high fiber diet is recommended during treatment with Prussian blue insoluble.
Patients taking Prussian blue insoluble should be informed that their stools might be blue-colored.
In patients who cannot swallow capsules, when the capsules are opened and the contents are mixed with food and eaten, the mouth and teeth might be colored blue.
Laboratory TestsPrussian blue insoluble may bind electrolytes found in the gastrointestinal tract. Asymptomatic hypokalemia, with serum potassium values of 2.5 – 2.9 (normal 3.5 – 5.0), was reported in 3/42 (7%) of patients on treatment with Prussian blue insoluble. Serum electrolytes should be closely monitored during Prussian blue insoluble treatment. Caution should be exercised when treating patients with pre-existing cardiac arrhythmias or electrolyte imbalances.
Prussian blue insoluble may bind some orally administered therapeutic drugs. As appropriate, blood levels or clinical response to oral medications should be monitored.
Drug-Drug InteractionsAdequate and well-controlled drug-drug interaction studies in humans were not identified in the literature. In preliminary studies, animals were contaminated with several different radioisotopes and treated with several different radioeliminators. Based on these animal data, co-administration of Prussian blue with other radioeliminators does not affect the efficacy of Prussian blue for 137 Cs.
Binding to some therapeutic drugs and essential nutrients is possible. The literature contains anecdotal reports of asymptomatic hypokalemia and decreased bioavailability of oral tetracycline. The serum levels and, or clinical response to critical orally administered products should be monitored.
Carcinogenesis, Mutagenesis, Impairment o |
