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FDA approved drugs -> Active ingredient

FDA approved drugs -> Active ingredient

Warning

H315 (100%): Causes skin irritation [Warning Skin corrosion/irritation]

P261, P264, P264+P265, P271, P280, P302+P352, P304+P340, P305+P351+P338, P319, P321, P332+P317, P337+P317, P362+P364, P403+P233, P405, and P501 (click each P-code to see the statement)

The GHS information provided by 1 company from 1 notification to the ECHA C&L Inventory.

Ethanaminium, N-4-4-(diethylamino)phenyl(2,5-disulfophenyl)methylene-2,5-cyclohexadien-1-ylidene-N-ethyl-, inner salt, sodium salt: Does not have an individual approval but may be used as a component in a product covered by a group standard. It is not approved for use as a chemical in its own right.

The Approved Drug Products with Therapeutic Equivalence Evaluations identifies currently marketed prescription drug products, including isosulfan blue, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act.

Isosulfan blue injection 1% upon subcutaneous administration, delineates lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; and lymph node response to therapeutic modalities. /Included in US product label/

SRP: Expired or waste pharmaceuticals shall carefully take into consideration applicable DEA, EPA, and FDA regulations. It is not appropriate to dispose by flushing the pharmaceutical down the toilet or discarding to trash. If possible return the pharmaceutical to the manufacturer for proper disposal being careful to properly label and securely package the material. Alternatively, the waste pharmaceutical shall be labeled, securely packaged and transported by a state licensed medical waste contractor to dispose by burial in a licensed hazardous or toxic waste landfill or incinerator.

TERRESTRIAL FATE: Based on a classification scheme(1), an estimated Koc value of 5.5X10+6(SRC), determined from a structure estimation method(2), indicates that Isosulfan Blue is expected to be immobile in soil(SRC). However, structurally similar Sulfan Blue is an anionic dye(3). Therefore, by analogy, Isosulfan Blue may exist almost entirely in the anion form in the environment and anions generally do not adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(4). Volatilization from moist soil is not expected because the compound exists as an anion and anions do not volatilize. Isosulfan Blue is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 1.9X10-36 mm Hg at 25 °C(SRC), determined from a fragment constant method(5). Biodegradation data in soil were not available(SRC, 2012).

AQUATIC FATE: Based on a classification scheme(1), an estimated Koc value of 5.5X10+6(SRC), determined from a structure estimation method(2), indicates that Isosulfan Blue is expected to adsorb to suspended solids and sediment(SRC). Structurally similar Sulfan Blue is an anionic dye(3); thus, analogous Isosulfan Blue is expected to exist almost entirely in the anion form at pH values of 5 to 9 and therefore volatilization from water surfaces is not expected to be an important fate process. According to a classification scheme(4), an estimated BCF of 3(SRC), from an estimated log Kow of -2.34(5) and a regression-derived equation(6), suggests the potential for bioconcentration in aquatic organisms is low(SRC). Biodegradation data in water were not available(SRC, 2012).

ATMOSPHERIC FATE: According to a model of gas/particle partitioning of semivolatile organic compounds in the atmosphere(1), Isosulfan Blue, which has an estimated vapor pressure of 1.9X10-36 mm Hg at 25 °C(SRC), determined from a fragment constant method(2), is expected to exist solely in the particulate phase in the ambient atmosphere. Particulate-phase Isosulfan Blue may be removed from the air by wet or dry deposition(SRC). Structurally similar Sulfan Blue absorbs light at 635 nm(3); therefore, by analogy, Isosulfan Blue may be susceptible to direct photolysis by sunlight(SRC).

Using a structure estimation method based on molecular connectivity indices(1), the Koc of Isosulfan Blue can be estimated to be 5.5X10+6(SRC). According to a classification scheme(2), this estimated Koc value suggests that Isosulfan Blue is expected to be immobile in soil. Analogous Sulfan Blue is an anionic dye(3). Therefore, by analogy, Isosulfan Blue may exist almost entirely in the anion form in the environment and anions generally do not adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(4).

/HUMAN EXPOSURE STUDIES/ Certain vital dyes are known to cause pulse oximetry (Spo2) desaturation. The authors studied the effect of isosulfan blue (IB) on Spo2. Thirty-three women, aged 34-81 yr, who were undergoing surgery for breast cancer were studied. IB, 5 mL (50 mg), was injected intraparenchymally around the tumor area by the surgeon. A pulse oximeter was used to continuously record Spo2 values up to 130 min after IB injection. Friedman repeated-measures analysis of ranks was used to analyze the baseline Spo2 and values at 5, 10, 20, 30, 40, 50, and 60 min. Spo2 values were significantly different from baseline values at 5, 10, 20, 30, 40, 50, and 60 min (p < 0.05). In a typical patient, a maximum Spo2 decrease of 3% can be anticipated 25 min after injection of IB. After peritumoral administration of IB, 50 mg, a significant interference with Spo2 will occur.

/HUMAN EXPOSURE STUDIES/ Two female patients with breast cancer were evaluated ... after suspected intraoperative anaphylactic episodes during sentinel lymph node biopsies in which they had received isosulfan blue 1% for the purpose of visualization of the lymph vessels. In the first case, the patient suffered hypotension and hypoxia requiring intubation. In the second case, the patient suffered prolonged hypotension. Both patients recovered without sequelae. The patients were /examined/ and skin tests were performed to isosulfan blue in addition to other agents the patients had received during anesthesia. In both cases, the patients demonstrated positive skin tests to isosulfan blue. Neither patient had positive skin tests to any other agent used for skin testing. Isosulfan blue skin tests were performed in nine control subjects and all skin tests in the control subjects were negative. Isosulfan blue may be a cause of anaphylactic reactions and this seems to be an immunoglobulin E-mediated event as confirmed by positive skin tests.

/SIGNS AND SYMPTOMS/ Life-threatening anaphylactic reactions (respiratory distress, shock, angioedema) have occurred after isosulfan blue injection 1% administration. Reactions are more likely to occur in patients with a history of bronchial asthma, allergies, drug reactions or previous reactions to triphenylmethane dyes. Monitor patients closely for at least 60 minutes after administration of isosulfan blue injection 1%. Trained personnel should be available to administer emergency care including resuscitation.

/CASE REPORTS/ Hypersensitivity Reactions: Case series report an overall incidence of hypersensitivity reactions in approximately 2% of patients. Life-threatening anaphylactic reactions have occurred. Manifestations include respiratory distress, shock, angioedema, urticaria, pruritus. A death has been reported following administration of a similar compound employed to estimate the depth of a severe burn. Reactions are more likely to occur in patients with a personal or family history of bronchial asthma, significant allergies, drug reactions or previous reactions to triphenylmethane dyes.

For more Human Toxicity Excerpts (Complete) data for Isosulfan blue (8 total), please visit the HSDB record page.

An estimated BCF of 3 was calculated in fish for Isosulfan Blue(SRC), using an estimated log Kow of -2.34(1) and a regression-derived equation(2). According to a classification scheme(3), this BCF suggests the potential for bioconcentration in aquatic organisms is low(SRC).

Structurally similar Sulfan Blue is an anionic dye(1). Therefore, by analogy, Isosulfan Blue will exist almost entirely in the anion form at pH values of 5 to 9 and therefore volatilization from water surfaces is not expected to be an important fate process. Isosulfan Blue is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 1.9X10-36 mm Hg(SRC), determined from a fragment constant method(3).

Isosulfan Blue may undergo hydrolysis in the environment due to the presence of functional groups that hydrolyze under environmental conditions(1). Analogous Sulfan Blue absorbs light at 635 nm(2); therefore, Isosulfan Blue may be susceptible to direct photolysis by sunlight(SRC).

Occupational exposure to Isosulfan Blue may occur through inhalation and dermal contact with this compound at workplaces where Isosulfan Blue is produced or used. Exposure to Isosulfan Blue among the general population may be limited to those administered the drug, a diagnostic contrast agent. (SRC)

While data specific to Isosulfan Blue were not located(SRC, 2012), the literature suggests that some pharmaceutically active compounds originating from human and veterinary therapy are not eliminated completely in municipal sewage treatment plants and are therefore discharged into receiving waters(1). Wastewater treatment processes often were not designed to remove them from the effluent(2). Selected organic waste compounds may be degrading to new and more persistent compounds that may be released instead of or in addition to the parent compound(2).

Isosulfan Blue's production and use as a diagnostic contrast agent may result in its release to the environment through various waste streams. If released to air, an estimated vapor pressure of 1.9X10-36 mm Hg at 25 °C indicates Isosulfan Blue will exist solely in the particulate phase in the atmosphere. Particulate-phase Isosulfan Blue will be removed from the atmosphere by wet or dry deposition. Sulfan Blue, which is strucrually similar to Isosulfan Blue, absorbs light at 635 nm. Therefore, by analogy, Isosulfan Blue may be susceptible to direct photolysis by sunlight. If released to soil, Isosulfan Blue is expected to be immobile based upon an estimated Koc of 5.5X10+6. However, by analogy to Sulfan Blue which is an anionic dye, Isosulfan Blue may exist almost entirely in the anion form in the environment and anions generally do not adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts. Volatilization from moist soil is not expected because the compound exists as an anion and anions do not volatilize. Isosulfan Blue may not volatilize from dry soil surfaces based upon its vapor pressure. Biodegradation data in soil or water were not available. If released into water, Isosulfan Blue is expected to adsorb to suspended solids and sediment based upon the estimated Koc. Isosulfan Blue is expected to exist almost entirely in the anion form at pH values of 5 to 9 and, therefore, volatilization from water surfaces is not expected to be an important fate process. An estimated BCF of 3 suggests the potential for bioconcentration in aquatic organisms is low. Hydrolysis may be an important environmental fate process since this compound contains functional groups that hydrolyze under environmental conditions (pH 5 to 9). Occupational exposure to Isosulfan Blue may occur through inhalation and dermal contact with this compound at workplaces where Isosulfan Blue is produced or used. Exposure to Isosulfan Blue among the general population may be limited to those administered the drug, a diagnostic contrast agent. (SRC)

/SRP:/ Immediate first aid: Ensure that adequate decontamination has been carried out. If patient is not breathing, start artificial respiration, preferably with a demand valve resuscitator, bag-valve-mask device, or pocket mask, as trained. Perform CPR if necessary. Immediately flush contaminated eyes with gently flowing water. Do not induce vomiting. If vomiting occurs, lean patient forward or place on the left side (head-down position, if possible) to maintain an open airway and prevent aspiration. Keep patient quiet and maintain normal body temperature. Obtain medical attention. /Poisons A and B/

/SRP:/ Basic treatment: Establish a patent airway (oropharyngeal or nasopharyngeal airway, if needed). Suction if necessary. Watch for signs of respiratory insufficiency and assist ventilations if needed. Administer oxygen by nonrebreather mask at 10 to 15 L/min. Monitor for pulmonary edema and treat if necessary ... . Monitor for shock and treat if necessary ... . Anticipate seizures and treat if necessary ... . For eye contamination, flush eyes immediately with water. Irrigate each eye continuously with 0.9% saline (NS) during transport ... . Do not use emetics. For ingestion, rinse mouth and administer 5 mL/kg up to 200 mL of water for dilution if the patient can swallow, has a strong gag reflex, and does not drool ... . Cover skin burns with dry sterile dressings after decontamination ... . /Poisons A and B/

/SRP:/ Advanced treatment: Consider orotracheal or nasotracheal intubation for airway control in the patient who is unconscious, has severe pulmonary edema, or is in severe respiratory distress. Positive-pressure ventilation techniques with a bag valve mask device may be beneficial. Consider drug therapy for pulmonary edema ... . Consider administering a beta agonist such as albuterol for severe bronchospasm ... . Monitor cardiac rhythm and treat arrhythmias as necessary ... . Start IV administration of D5W /SRP: "To keep open", minimal flow rate/. Use 0.9% saline (NS) or lactated Ringer's if signs of hypovolemia are present. For hypotension with signs of hypovolemia, administer fluid cautiously. Watch for signs of fluid overload ... . Treat seizures with diazepam or lorazepam ... . Use proparacaine hydrochloride to assist eye irrigation ... . /Poisons A and B/

The Approved Drug Products with Therapeutic Equivalence Evaluations identifies currently marketed prescription drug products, including isosulfan blue, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act.

Intradermal and parenchymal injections of vital blue dyes, such as isosulfan blue, can lead to systemic absorption through lymphatic channels and vascular beds near tumor sites.

Excreted unchanged in the urine

Not available

Up to 10% of the subcutaneously administered dose of isosulfan blue 1% is excreted in 24 hours in human.

Following subcutaneous administration, isosulfan blue injection 1% binds to serum proteins and is picked up by the lymphatic vessels. Thus, the lymphatic vessels are delineated by the blue dye.

It is not known whether this drug is excreted in human milk.

Coloring medicinal products; dyeing and printing wool, silk.

MEDICATION