Radiogardase

Radiogardase is an FDA-registered drug product whose active ingredient is PRUSSIAN BLUE INSOLUBLE CAPSULES. It is labelled by Heyl Chem.-pharm. Fabrik GmbH & Co. KG taken by oral and marketed as a human prescription drug product. Identifiers on file: NDC 58060-002, application NDA021626, label effective 20211007. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing PRUSSIAN BLUE INSOLUBLE CAPSULES are most often described in connection with: radiogardase indicated, treatment patients, known suspected, internal contamination, radioactive cesium, non-radioactive thallium, rates elimination, order increase. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE Radiogardase is indicated for treatment of patients with known or suspected internal contamination with radioactive cesium and/or radioactive or non-radioactive thallium, in order to increase their rates of elimination. Radiogardase is indicated for treatment of patients with known or suspected internal contamination with radioactive cesium and/or radioactive or non-radioactive thallium to increase their rates of elimination. ( 1 )

2 DOSAGE AND ADMINISTRATION Adults and Adolescents: 3 grams orally three times a day ( 2.3 ) Pediatrics (2 – 12 years): 1 gram orally three times a day ( 2.3 ) Administer as soon as possible after internal contamination with cesium or thallium is suspected ( 2.1 ) 2.1 Important Administration Instructions Obtain quantitative baseline of the internalized contamination by radioactive cesium (137Cs) and/or thallium by appropriate whole-body counting and/or by bioassay (e.g., biodosimetry), or feces/urine samples, whenever possible prior to Radiogardase treatment. Initiate treatment with Radiogardase as soon as possible after contamination is suspected. Even when delayed, treatment with Radiogardase is effective and should not be withheld. Take Radiogardase capsules with food to stimulate excretion of cesium or thallium. In patients who cannot tolerate swallowing large numbers of capsules, open the capsules and mix with bland food or liquids. 2.2 Decontamination Procedures for Radioactive Cesium or Thallium Contamination Prior to initiating treatment with Radiogardase, follow radioactive decontamination safety procedures including: Use appropriate radiation protective attire and closely monitor personnel and treatment area for radiation levels using radiation detection, indication, and computation devices (RADIAC) or thermal luminescent devices (TLD). Control spread of radiation contamination through the establishment of a patient decontamination area and a contaminated material disposal site (with proper labeling, handling, and disposal of contaminated material). 2.3 Recommended Dosage Adults and Adolescents : 3 grams (6 capsules) taken orally three times a day (a total daily dose of 9 grams) Pediatric Patients (2 – 12 years) : 1 gram (2 capsules) taken orally three times a day (a total daily dose of 3 grams) 2.4 Treatment of Radioactive Cesium Contamination Anticipate that treatment with Radiogardase may last 30 days or longer. Base duration of Radiogardase treatment on weekly measurements of radioactivity in urine and fecal samples to monitor cesium elimination rate. Obtain weekly laboratory evaluations (complete blood count, serum chemistry and electrolytes). 2.5 Treatment of Radioactive and Non-radioactive Thallium Contamination Anticipate that treatment with Radiogardase may last 30 days or longer. For radioactive thallium: Base duration of Radiogardase treatment on weekly measurements of radioactivity inurine and fecal samples to monitor thallium elimination rate. Continue Radiogardase treatment until a 24-hour urine thallium test is normal (less than 5 micrograms per liter) and radiation level is acceptable. For non-radioactive thallium: Continue Radiogardase treatment until a 24-hour urine thallium test is normal (less than 5 micrograms per liter). Obtain weekly laboratory evaluations (complete blood count, serum chemistry and electrolytes). In cases of severe thallium intoxication, additional types of treatment may be necessary, such as: Induced emesis, followed by gastric intubation and lavage Forced diuresis until urinary thallium excretion is less than 1 mg/24 hours Charcoal hemoperfusion may be useful during the first 48 hours after thallium ingestion (biodistribution phase). Hemodialysis has also been reported to be effective in thallium intoxication.

4 CONTRAINDICATIONS None None ( 4 )

6 ADVERSE REACTIONS Constipation was reported in 10 (24%) of 42 patients treated with Radiogardase. Severity of constipation was mild in 7 patients and moderate in 3 patients [see Warnings and Precautions (5.2) ]. Most common adverse reaction (incidence >24%) was constipation ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact [email protected], Fax +49 30 817 4049 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What is Radiogardase used for?
1 INDICATIONS AND USAGE Radiogardase is indicated for treatment of patients with known or suspected internal contamination with radioactive cesium and/or radioactive or non-radioactive thallium, in order to increase their rates of elimination. Radiogardase is indicated for treatment of patients with known or suspected internal contamination with radioactive cesium and/or radioactive or …

Who makes Radiogardase?
Heyl Chem.-pharm. Fabrik GmbH & Co. KG is the labeler of record for Radiogardase.

What form does Radiogardase come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Radiogardase prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Radiogardase been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.