INDIGO CARMINE injection, solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

INDIGOTINDISULFONATE SODIUM (UNII: D3741U8K7L) (INDIGOTINDISULFONIC ACID - UNII:X7OI7JF73P)

から入手可能:

American Regent, Inc.

INN（国際名）:

INDIGOTINDISULFONATE SODIUM

構図:

INDIGOTINDISULFONATE SODIUM 8 mg in 1 mL

投与経路:

INTRAMUSCULAR

処方タイプ:

PRESCRIPTION DRUG

適応症:

Originally employed as a kidney function test, the chief application of Indigo Carmine at present is localizing ureteral orifices during cystoscopy and ureteral catheterization. Indigo Carmine is contraindicated in patients who have previously experienced an adverse reaction following its use. Indigo Carmine is not a controlled substance listed in any of the Drug Enforcement Administration Schedules. Its use is not known to lead to dependence or abuse.

製品概要:

Indigo Carmine Injection NDC 0517-0375-05        5 mL ampules         packaged in boxes of 5 AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN0375 Rev. 2/17

認証ステータス:

unapproved drug other

製品の特徴

INDIGO CARMINE- INDIGO CARMINE INJECTION, SOLUTION
AMERICAN REGENT, INC.
_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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INDIGO CARMINE INJECTION (INDIGOTINDISULFONATE SODIUM INJECTION, USP)
RX ONLY
DESCRIPTION
Each mL contains: Indigotindisulfonate Sodium 8 mg, Water for
Injection q.s. pH adjusted, when
necessary, with Citric Acid and/or Sodium Citrate. Sterile,
nonpyrogenic.
Sufficient Indigo Carmine is contained in each 5 mL ampule to permit
accurate withdrawal and
administration of the full dose. It gives a deep blue solution when
dissolved in water.
The structural formula is:
CLINICAL PHARMACOLOGY
Indigo Carmine is excreted largely by the kidneys, retaining its blue
color during passage through the
body.
Elimination of the dye begins soon after injection, appearing in the
urine within 10 minutes in average
cases. The biological half-life is 4 to 5 minutes following
intravenous injection. Larger quantities are
necessary when intramuscular injection is employed. Appearance time
and elimination are delayed
following intramuscular injection.
INDICATIONS AND USAGE
Originally employed as a kidney function test, the chief application
of Indigo Carmine at present is
localizing ureteral orifices during cystoscopy and ureteral
catheterization.
CONTRAINDICATIONS
Indigo Carmine is contraindicated in patients who have previously
experienced an adverse reaction
following its use.
WARNINGS
An occasional idiosyncratic drug reaction may occur. A mild pressor
effect may be encountered in
some patients.
PRECAUTIONS
PREGNANCY
Animal Reproduction studies have not been conducted with
indigotindisulfonate sodium injection. It is
also not known whether indigotindisulfonate sodium injection can cause
fetal harm when administered to
a pregnant woman or can affect reproduction capacity.
Indigotindisulfonate sodium injection should be
given to a pregnant woman only if clearly needed.
It is