Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
INDIGOTINDISULFONATE SODIUM (UNII: D3741U8K7L) (INDIGOTINDISULFONIC ACID - UNII:X7OI7JF73P)
American Regent, Inc.
INDIGOTINDISULFONATE SODIUM
INDIGOTINDISULFONATE SODIUM 8 mg in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
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.
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
unapproved drug other
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._ ---------- 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 Lue koko asiakirja