Peringatan Keamanan

Toxicity information regarding indigotindisulfonic acid is not readily available. Patients experiencing an overdose are at an increased risk of severe adverse effects such as cardiac arrest, arrhythmia, asystole, second degree atrioventricular block, hypotension, elevation in blood pressure, bradycardia, and tachycardia.L42600 Symptomatic and supportive measures are recommended.

The use of indigotindisulfonate sodium in pregnant women has not been associated with a higher risk of adverse maternal and fetal adverse effects. The use of this dye in the first trimester is rare; therefore, data are insufficient to evaluate the risk of major birth defects and miscarriage associated with the use of indigotindisulfonate sodium.L42600 It is not known whether this drug is excreted in human breastmilk. Fertility studies with indigotindisulfonate sodium using the intravenous route of administration have not been conducted.L42600

Carcinogenicity studies evaluating the effects of the intravenous administration of indigotindisulfonate sodium have not been performed. In mice, the long term subcutaneous administration of indigotindisulfonate sodium did not have carcinogenic effects.L42600 Indigotindisulfonate sodium was not genotoxic in Ames assays. The in vitro mutagenicity of this dye was inconclusive, and in vivo studies suggest that orally administered indigotindisulfonate was not mutagenic.L42600 The oral LD50 of indigotindisulfonate sodium in rats is 2000 mg/kg.L42635

Indigotindisulfonic acid

DB11577

small molecule approved investigational

Deskripsi

Indigotindisulfonic acid is a blue-colored dye with a variety of uses.A32490,A32491,A32492,L2222 Its salt form, indigotindisulfonate sodium, is also known as indigo carmine, indigotine or FD&C Blue #2. This compound is an acid-base indicator and is used in the production of food colorants and pH tests.A251405 Indigotindisulfonic acid is used in clinical medicine to determine patency of the urinary collecting system, and to assist in specific surgical procedures such as cystourethroscopy.A32490,A32491,A32492 In 2022, the FDA approved the intravenous use of indigotindisulfonate sodium to aid in visualizing ureter integrity in cystoscopic assessments.L42600

Struktur Molekul 2D

Berat 422.389
Wujud solid

Peta Jejaring Molekuler
Legenda: Obat • Target • Gen • Enzim • (Panah → menunjukkan arah efek / relasi) • Transporter • Carrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) In healthy adults given 5 ml of indigotindisulfonate sodium, the elimination half-life was 12 minutes.[L42600]
Volume Distribusi The volume of distribution of indigotindisulfonate sodium is 10.7 L.[L42600]
Klirens (Clearance) In healthy adults given 5 ml of indigotindisulfonate sodium, the mean urinary clearance was 7.08 L/hour, and the mean total clearance was 40.2 L/hour.[L42600]

Absorpsi

In healthy adults given 5 ml of indigotindisulfonate sodium (salt form of indigotindisulfonic acid), the Cmax and AUC0-INF were 6.33 ?g/mL and 1.15 ?g·h/mL, respectively.L42600 Studies evaluating the pharmacokinetic properties of intravenous indigotindisulfonate sodium in patients with renal impairment have not been performed. Based on subgroup analyses in a randomized clinical trial, patients with mild to moderate renal impairment or an estimated glomerular filtration rate (eGFR) from 30 to 89 mL/min do not require dose adjustments. Indigotindisulfonate sodium is not recommended in patients with eGFR lower than 30 mL/min.L42600

Metabolisme

Indigotindisulfonate sodium is mainly oxidized via primary metabolic pathways.L42600 An in vivo study done in rats showed that the breakdown of indigotindisulfonate sodium (FD&C Blue No. 2) generated two products: isatin-5-sulphonic acid and 5-sulphoanthranilic acid.A251390 Clinical studies evaluating indigotindisulfonate sodium metabolism products have not been performed.

Rute Eliminasi

Indigotindisulfonic acid is excreted largely by the kidneys, retaining its blue color during passage through the body. Approximately 16% of the unchanged drug is excreted in urine, and less than 2% is excreted in feces.L42600 The elimination of this dye begins rapidly after injection, appearing in the urine within 5 minutes.A251410

Interaksi Obat

727 Data
Cyclosporine Cyclosporine may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Icosapent Icosapent may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefotiam Cefotiam may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Mesalazine Mesalazine may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefmenoxime Cefmenoxime may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefmetazole Cefmetazole may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Pamidronic acid Pamidronic acid may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Tenofovir disoproxil Tenofovir disoproxil may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Indomethacin Indomethacin may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cidofovir Cidofovir may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefpiramide Cefpiramide may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Ceftazidime Ceftazidime may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Loracarbef Loracarbef may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefalotin Cefalotin may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Nabumetone Nabumetone may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Ketorolac Ketorolac may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Tenoxicam Tenoxicam may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Celecoxib Celecoxib may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefotaxime Cefotaxime may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Tolmetin Tolmetin may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Foscarnet Foscarnet may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Rofecoxib Rofecoxib may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Piroxicam Piroxicam may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Methotrexate Methotrexate may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cephalexin Cephalexin may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Fenoprofen Fenoprofen may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Valaciclovir Valaciclovir may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Valdecoxib Valdecoxib may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Diclofenac Diclofenac may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Sulindac Sulindac may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Bacitracin Bacitracin may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Amphotericin B Amphotericin B may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cephaloglycin Cephaloglycin may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Flurbiprofen Flurbiprofen may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Adefovir dipivoxil Adefovir dipivoxil may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Pentamidine Pentamidine may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Etodolac Etodolac may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Mefenamic acid Mefenamic acid may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Acyclovir Acyclovir may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Naproxen Naproxen may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Sulfasalazine Sulfasalazine may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Phenylbutazone Phenylbutazone may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Meloxicam Meloxicam may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Carprofen Carprofen may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefaclor Cefaclor may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Diflunisal Diflunisal may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Tacrolimus Tacrolimus may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Ceforanide Ceforanide may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Salicylic acid Salicylic acid may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Meclofenamic acid Meclofenamic acid may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Acetylsalicylic acid Acetylsalicylic acid may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Carboplatin Carboplatin may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Oxaprozin Oxaprozin may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Ketoprofen Ketoprofen may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Balsalazide Balsalazide may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Ibuprofen Ibuprofen may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefditoren Cefditoren may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Atazanavir Atazanavir may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Colistimethate Colistimethate may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefuroxime Cefuroxime may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefapirin Cefapirin may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefadroxil Cefadroxil may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefprozil Cefprozil may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Ceftriaxone Ceftriaxone may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Olsalazine Olsalazine may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Lumiracoxib Lumiracoxib may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefamandole Cefamandole may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefazolin Cefazolin may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefonicid Cefonicid may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefoperazone Cefoperazone may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefotetan Cefotetan may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefoxitin Cefoxitin may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Ceftizoxime Ceftizoxime may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefradine Cefradine may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Magnesium salicylate Magnesium salicylate may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Salsalate Salsalate may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Choline magnesium trisalicylate Choline magnesium trisalicylate may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefepime Cefepime may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefacetrile Cefacetrile may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Ceftibuten Ceftibuten may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cefpodoxime Cefpodoxime may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Antrafenine Antrafenine may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Aminophenazone Aminophenazone may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Antipyrine Antipyrine may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Tiaprofenic acid Tiaprofenic acid may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Lopinavir Lopinavir may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Etoricoxib Etoricoxib may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Hydrolyzed Cephalothin Hydrolyzed Cephalothin may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cephalothin Group Cephalothin Group may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Oxyphenbutazone Oxyphenbutazone may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Latamoxef Latamoxef may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Nimesulide Nimesulide may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Benoxaprofen Benoxaprofen may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Metamizole Metamizole may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Zomepirac Zomepirac may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Ceftobiprole Ceftobiprole may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Cimicoxib Cimicoxib may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Ceftaroline fosamil Ceftaroline fosamil may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Lornoxicam Lornoxicam may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.
Aceclofenac Aceclofenac may decrease the excretion rate of Indigotindisulfonic acid which could result in a higher serum level.

Target Protein

Alpha adrenergic receptor ADRA1A

Referensi & Sumber

Synthesis reference: Sayah, B., et al. (2020). Process for preparing indigo carmine (U.S. Patent No. 2020/0283632 A1). U.S. Patent and Trademark Office. Available at: https://patentimages.storage.googleapis.com/09/ec/73/46479d1a875d0e/US20200283632A1.pdf
Artikel (PubMed)
  • PMID: 933277
    Ng TY, Datta TD, Kirimli BI: Reaction to indigo carmine. J Urol. 1976 Jul;116(1):132-3.
  • PMID: 8567045
    Chang KS, Zhong MZ, Davis RF: Indigo carmine inhibits endothelium-dependent and -independent vasodilation. Hypertension. 1996 Feb;27(2):228-34.
  • PMID: 28729014
    Grimes CL, Patankar S, Ryntz T, Philip N, Simpson K, Truong M, Young C, Advincula A, Madueke-Laveaux OS, Walters R, Ananth CV, Kim JH: Evaluating ureteral patency in the post-indigo carmine era: a randomized controlled trial. Am J Obstet Gynecol. 2017 Nov;217(5):601.e1-601.e10. doi: 10.1016/j.ajog.2017.07.012. Epub 2017 Jul 18.
  • PMID: 2005716
    Monson FC, Wein AJ, McKenna BA, Whitmore K, Levin RM: Indigocarmine as a quantitative indicator of urothelial integrity. J Urol. 1991 Apr;145(4):842-5.
  • PMID: 22148095
    Kim SH, Suk EH, Kil SH, Hahm KD, Hwang JH: Hypotension in patients administered indigo carmine containing impurities -A case report-. Korean J Anesthesiol. 2011 Nov;61(5):435-8. doi: 10.4097/kjae.2011.61.5.435. Epub 2011 Nov 23.
  • PMID: 5922998
    Lethco EJ, Webb JM: The fate of FD&C blue no. 2 in rats. J Pharmacol Exp Ther. 1966 Nov;154(2):384-9.
  • PMID: 26404013
    Amchova P, Kotolova H, Ruda-Kucerova J: Health safety issues of synthetic food colorants. Regul Toxicol Pharmacol. 2015 Dec;73(3):914-22. doi: 10.1016/j.yrtph.2015.09.026. Epub 2015 Sep 25.
  • PMID: 4436890
    Deture FA, Drylie DM: Evaluation of indigo carmine as an indicator of renal function. J Urol. 1974 Dec;112(6):693-6. doi: 10.1016/s0022-5347(17)59830-4.

Contoh Produk & Brand

Produk: 6 • International brands: 1
Produk
  • Bludigo
    Injection • 8 mg/1mL • Intravenous • US • Approved
  • Indigo Carmine
    Injection, solution • 8 mg/1mL • Intramuscular; Intravenous • US
  • Indigo Carmine
    Injection, solution • 8 mg/1mL • Intramuscular; Intravenous • US
  • Indigo Carmine
    Injection, solution • 8 mg/1mL • Intramuscular; Intravenous • US
  • Indigo Carmine
    Injection, solution • 8 mg/1mL • Intramuscular; Intravenous • US
  • Indigo Carmine
    Solution • 0.8 % • Intramuscular; Intravenous • Canada • Approved
International Brands
  • Bludigo — Provepharm

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