Radiogardase 500 mg/1
Prussian blue insoluble capsules · CAPSULE · Heyl Chem.-pharm. Fabrik GmbH & Co. KG
Radiogardase is a capsule containing prussian blue insoluble capsules at 500 mg/1, taken oral. Manufactured by Heyl Chem.-pharm. Fabrik GmbH & Co. KG.
Key Facts
- Brand Name
- Radiogardase
- Generic Name
- Prussian blue insoluble capsules
- NDC Code (Product)
58060-002- Manufacturer
- Heyl Chem.-pharm. Fabrik GmbH & Co. KG
- Strength
- 500 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- NDA021626
- Drug Class
- Decorporation Agent [EPC]
- Marketing Start
- 03/24/2010
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
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 )
Dosage & Administration
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 closel…
Contraindications
4 CONTRAINDICATIONS None None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Based on animal data, co-administration of Radiogardase with other decorporation agents does not affect the efficacy of Radiogardase for treatment of internal contamination with radioactive cesium and/or radioactive or non-radioactive thallium.
Adverse Reactions
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 info@heyl-berlin.de, Fax +49 30 817 4049 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Radiogardase used for?
Radiogardase contains Prussian blue insoluble capsules. It is a capsule taken oral. Consult your doctor for specific uses.
Is Radiogardase a controlled substance?
Radiogardase is not classified as a controlled substance by the DEA.
What is the generic name for Radiogardase?
The generic name for Radiogardase is Prussian blue insoluble capsules. There are no other listed brand versions of Prussian blue insoluble capsules.
What is the NDC code for Radiogardase 500 mg/1?
The NDC (National Drug Code) for Radiogardase 500 mg/1 is 58060-002, listed by Heyl Chem.-pharm. Fabrik GmbH & Co. KG.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)