pharmacopeia

Pentetate

Plutonium Chelating ActivityUS-FDASourced from openFDA
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Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Plutonium Chelating Activity.

Indications

Sourced from openFDA
  • Pentetate Indium Disodium In 111 is recommended for use in radionuclide cisternography.

Contraindications

Sourced from openFDA
  • None known.contraindicated

Dosage & administration

Sourced from openFDA

Extreme care must be exercised to assure aseptic conditions in intrathecal injections. The maximum recommended intrathecal dose in the average patient (70 kg) is 18.5 MBq, 500 µ Ci. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Warnings & precautions

Sourced from openFDA

The contents of the vial are radioactive. Adequate shielding of the preparation must be maintained at all times. Since the drug is excreted by the kidneys, caution should be exercised in patients with severely impaired renal function.

Adverse reactions

Sourced from openFDA

Aseptic meningitis and pyrogenic reactions have been rarely (less than 0.4%) observed following cisternography with Pentetate lndium Disodium In 111. One death has been reported to have occurred within 20 minutes following the administration of Pentetate Indium Disodium In 111 and appears to be drug related. In addition, two cases of septic meningitis have also been reported. There have also been reports of skin reactions and vomiting following administration of Pentetate lndium Disodium In 111. Relationship of the drug to these latter occurrences has not been established.

Use in specific populations

Sourced from openFDA

Pregnancy Category C Animal reproduction studies have not been conducted with GE Healthcare (Medi-Physics, Inc.) Indium DTPA In 111. Also, it is not known whether Pentetate Indium Disodium In 111 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pentetate Indium Disodium In 111 should be given to a pregnant woman only if clearly needed. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.

Approval history

Sourced from openFDA
  • Feb 18, 1982NDANDA017707Ge Healthcare
  • Dec 29, 1989NDANDA018511Jubilant
  • Mar 26, 2025ANDAANDA215146Curium

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
27 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective1452%
  2. 2No Adverse Event1348%
  3. 3Radioisotope Scan Abnormal311%
  4. 4Dyspnoea27.4%
  5. 5False Positive Investigation Result27.4%
  6. 6Product Ineffective27.4%
  7. 7Blood Pressure Increased13.7%
  8. 8Cns Ventriculitis13.7%
  9. 9Confusional State13.7%
  10. 10Erythema13.7%
  11. 11Feeling Hot13.7%
  12. 12Foetal Heart Rate Deceleration Abnormality13.7%
  13. 13Headache13.7%
  14. 14Hypersensitivity13.7%
  15. 15Incorrect Route Of Product Administration13.7%

Literature

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Recent PubMed references pinned to Pentetate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 282 ClinicalTrials.gov registrations naming Pentetate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Pentetate work?
Mechanism-of-action class: Plutonium Chelating Activity.
What is Pentetate used for?
According to FDA labeling, Pentetate carries indications including: Pentetate Indium Disodium In 111 is recommended for use in radionuclide cisternography.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Pentetate?
Pentetate is classified as Plutonium Chelating Activity.
What are the contraindications for Pentetate?
Pentetate labeling lists contraindications including: None known.. Always consult the full prescribing information and a clinician.
Note. Data for pentetate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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