INDIGO CARMINE injection, solution

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

A-S Medication Solutions

Calea de administrare:

INTRAMUSCULAR

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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.

Rezumat produs:

Product: 50090-4520 NDC: 50090-4520-0 5 mL in a AMPULE

Statutul autorizaţiei:

unapproved drug other

Caracteristicilor produsului

INDIGO CARMINE- INDIGO CARMINE INJECTION, SOLUTION
A-S MEDICATION SOLUTIONS
_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.