INDIUM 111 OXYQUINOLONE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

INDIUM IN-111 OXYQUINOLINE (UNII: LGX9OL562T) (INDIUM IN-111 OXYQUINOLINE - UNII:LGX9OL562T)

Available from:

AnazaoHealth Corporation

INN (International Name):

INDIUM IN-111 OXYQUINOLINE

Composition:

INDIUM IN-111 OXYQUINOLINE 2 mCi in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

This preparation is supplied as a sterile, non-pyrogenic, isotonic aqueous solution with a pH range of 6.5 to 7.5 and is not for direct injection. Each milliliter contains 2 mCi at calibration time, 50μg oxyquinoline, 100μg polysorbate 80, and 6 mg of HEPES (N-2-hydroxyethyl-piperazine-N’-2-ethane sulfonic acid) buffer in 0.75% sodium chloride solution. It is intended for single use only and contains no bacteriostatic agent.

Authorization status:

unapproved drug other

Summary of Product characteristics

INDIUM 111 OXYQUINOLONE - INDIUM 111 OXYQUINOLONE SOLUTION
ANAZAOHEALTH CORPORATION
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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INDIUM 111 OXYQUINOLONE (IN-111 OXINE)
DESCRIPTION
This preparation is supplied as a sterile, non-pyrogenic, isotonic
aqueous solution with a pH range of
6.5 to 7.5 and is not for direct injection. Each milliliter contains 2
mCi at calibration time, 50μg
oxyquinoline, 100μg polysorbate 80, and 6 mg of HEPES
(N-2-hydroxyethyl-piperazine-N’-2-ethane
sulfonic acid) buffer in 0.75% sodium chloride solution. It is
intended for single use only and contains
no bacteriostatic agent.
CLINICAL PHARMACOLOGY
Indium forms a saturated (1:3) complex with oxyquinoline. The complex
is neutral and lipid-soluble,
which enables it to penetrate the cell membrane. Within the cell,
indium becomes firmly attached to
cytoplasmic components; the liberated oxyquinoline is released by the
cell. It is thought that the
mechanism of labeling cells with Indium In-111 Oxyquinoline involves
an exchange reaction between
the oxyquinoline carrier and subcellular components, which chelate
indium more strongly than
oxyquinoline. The low stability constant of the oxyquinoline complex,
estimated at approximately 10,
supports this theory.
Following the recommended leukocyte cell labeling procedure,
approximately 77% of the added Indium
In-111Oxyquinoline is incorporated in the resulting cell pellet (which
represents approximately 3-4 x
10
WBC).
Cell clumping can occur and was found in about one fifth of the
leukocyte preparations examined. The
presence of red blood cells or plasma will lead to reduced leukocyte
labeling efficiency. Transferrin in
plasma competes for Indium In-111 Oxyquinoline.
Chemotaxis of granulocytes deteriorates during storage and loss of
chemotaxis may cause false
negative scans. The spontaneous release of Indium In-111 has been
reported to range from a