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In-111 DTPA Package Insert

Status:
Prescription (Rx) Facts
Strength:
3.75 mCi/1.5 mL
Drug class:
Active ingredient:
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Prescribing information (package insert) - In-111 DTPA

DESCRIPTION

In-111 DTPA is supplied as a sterile, pyrogen-free, isotonic, aqueous solution that is buffered to pH 7 to 8. At calibration time, each milliliter contains 2.5 mCi of Pentetate Indium Disodium In-111 (no carrier-added) and sodium bicarbonate for pH adjustment.

CHARACTERISTICS

Indium 111 decays by electron capture with a physical half-life of 67.9 hour. The energies of the photons that are useful for detection and imaging studies are:

Radiation Mean % Disintegration Mean Energy (keV)

Gamma-2 90.2 171.3

Gamma-3 94.0 245.4

INDICATIONS AND USAGE

In-111 DTPA is indicated for use in radionuclide cisternography

CLINICAL PHARMACOLOGY

After intrathecal administration, the In-111 DTPA is absorbed from the subarachnoid space and the remainder flows superiorly to the basal cisterns within 2 to 4 hours and subsequently will be apparent in the Sylvian cisterns, the interhemispheric cisterns, and over the cerebral convexities. In normal individuals, the it will have ascended to the parasagittal region within 24 hours with simultaneous partial or complete clearance of activity from the basal cisterns and Sylvian regions. In contrast to air, In-111 DTPA does not normally enter the cerebral ventricles

CONTRAINDICATIONS

There are no known contraindications

DOSAGE AND ADMINISTRATION

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

Storage and Handling

Store vial in its lead shield at a temperature of 5-30º C. Do not freeze

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

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Drug information for In-111 DTPA

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Lead Chelator
Active ingredient Indium In-111 pentetate disodium 3.75 mCi/1.5 mL
Dosage form Solution
Route Intrathecal
Marketing status not in the current FDA NDC Directory
Company (applicant) AnazaoHealth Corporation
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
3.75 mCi/1.5 mL – 1.5 ml in 1 vial NDC 51808-125-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.