Indigotindisulfonate sodium injection should be given to a pregnant woman only if clearly needed. Indigo Carmine solution is injected either by the intravenous or intramuscular route, and its appearance at the ureteral orifices is watched with the cystoscope in place. -. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. There is no FDA guidance on the use of Indigo carmine in pediatric settings. In Meyler's Side Effects of Drugs (Sixteenth Edition), 2016. Find NCBI SARS-CoV-2 literature, sequence, and clinical content: https://www.ncbi.nlm.nih.gov/sars-cov-2/. Anaesthesist. J Turk Ger Gynecol Assoc. 1. ScienceDirect ® is a registered trademark of Elsevier B.V. ScienceDirect ® is a registered trademark of Elsevier B.V. Options to Evaluate Ureter Patency at Cystoscopy in a World Without Indigo Carmine, https://doi.org/10.1016/j.jmig.2016.06.009. It is not known whether this drug is excreted in human milk.  |  Evaluating ureteral patency in the post-indigo carmine era: a randomized controlled trial. The unavailability of indigo carmine may be a permanent reality that forces gynecologists to examine alternatives for the evaluation of ureteral integrity.  |  Detailed information related to Indigo Carmine's uses, side-effects, reviews, questions, interactions, and precautions is as follows: Elderly. Time of ureteral ejection of sodium fluorescein in the cystoscopic assessment of ureteral patency in patients undergoing total laparoscopic hysterectomy. The authors declare that they have no conflict of interest. The color of the urine was graded by the operator as being clear (negative) or bright yellow (positive), indicating ureteric patency and that no indigo carmine was required. There is limited information regarding Indigo carmine Patient Counseling Information in the drug label. There is no FDA guidance on the use of Indigo carmine in women of reproductive potentials and males. Given intravenously at a dose of 5 mL (8 mg/mL solution; total dose 40 mg), it generally takes 5–10 minutes to be detected during cystoscopy . There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Indigo carmine in women who are pregnant. 2004 Jul;11(7):475-7 Get the latest public health information from CDC: https://www.coronavirus.gov. Confirmation of ureteric patency during cystoscopy using phenazopyridine HCl: a low-cost approach. Alternative dye for cystoscopy; Dose (amnio instillation) 2-5 mL 10% (200 – 500mg) 1-4 ml 5% (50-200 mg) has been suggested as sufficient; While there are potential IV side effects such as yellowing of sclera/palms, nausea, emesis and allergic reaction, no adverse events have been reported with amnio instillation CONTRAINDICATIONS Indigo Carmine is contraindicated in patients who have previously experienced an adverse reaction following its use. Jelovsek et al 30 reported the results of intraoperative cystoscopy with intravenous indigo carmine in 126 patients undergoing total laparoscopic hysterectomy. This review will equip practicing gynecologists to choose an alternative method for assessing ureteral integrity that is tailored to their specific needs. A lesser dosage in infants, children and underweight patients will prevent skin coloration. Indigo Carmine is contraindicated in patients who have previously experienced an adverse reaction following its use. The contents of this FDA label are provided by the National Library of Medicine. It gives a deep blue solution when dissolved in … By continuing you agree to the use of cookies. The time of administration, time of operation, and time of cystoscopy were recorded. There is limited information regarding Indigo carmine Clinical Studies in the drug label. There is no FDA guidance on use of Indigo carmine during labor and delivery. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. NDC 0517-0375-10 5 mL ampules packaged in boxes of 10, This page was last edited 21:10, 6 March 2015 by wikidoc user. In patients with a clearance of creatinine < 10 mL/min, Indigo carmine should not be used (see section 4.4). In light of the worldwide shortage of indigo carmine, this video outlines various other methods to detect ureteric patency during intraoperative cystoscopy. Larger quantities are necessary when intramuscular injection is employed. 2017 Nov;217(5):601.e1-601.e10. National Center for Biotechnology Information, Unable to load your collection due to an error, Unable to load your delegates due to an error. 1989 Mar;38(3):136-9. supports HTML5 video, Authors: The intravenous method is preferred because a 5 mL injection is sufficient. There is limited information regarding Indigo carmine How Supplied in the drug label. There is no FDA guidance on the use of Indigo carmine in patients with hepatic impairment. Sufficient Indigo Carmine is contained in each 5 mL ampule to permit accurate withdrawal and administration of the full dose. Please read our full disclaimer here. Each mL contains: Indigotindisulfonate Sodium 8 mg, Water for Injection q.s. This review provides an evidence-based review of the various methods available for evaluating ureteral patency, with specific information on dosing, adverse effects, and contraindications. [2]. Lea Luketic, Prim Care Companion J Clin Psychiatry. Indigo Carmine (indigotindisulfonate) solution is injected either by the intravenous or intramuscular route, and its appearance at the ureteral orifices is watched with the cystoscope in place. This site needs JavaScript to work properly. There is limited information regarding Indigo carmine Storage in the drug label. We use cookies to help provide and enhance our service and tailor content and ads. There is no FDA guidance on the use of Indigo carmine with respect to specific gender populations. Talk to your doctor about the effects of taking alcohol with this medication. Options to Evaluate Ureter Patency at Cystoscopy in a World Without Indigo Carmine. -, Eur J Neurol. Indigo Carmine solution is injected either by the intravenous or intramuscular route, and its appearance at the ureteral orifices is watched with the cystoscope in place. There is limited information regarding Indigo carmine Clinical Trials Experience in the drug label. The majority of published studies investigating intraoperative cystoscopy have used indigo carmine to dye the urine to allow visualization of ureteral jets; unfortunately, however, this dye is currently not available in North America. Since precipitation of indigotindisulfonate sodium may occur, Indigo Carmine Solution must not be diluted prior to injection or injected with infusion assemblies which were used with other solutions. Epub 2017 Jul 18. Indigo carmine was used in only two cases (2.9%). 2009 Sep;31(9):845-849. doi: 10.1016/S1701-2163(16)34303-1. The excretion of Indigo carmine … This would have advantages in reducing the cost and toxicity of intravenous indigo carmine administration.