히드록소코발라민아세트산염

is indicated for the treatment of known or suspected cyanide poisoning. CYANOKIT is indicated for the treatment of known or suspected cyanide poisoning. ( 1 )

None None ( 4 )

Risk of Anaphylaxis and Other Hypersensitivity Reactions : Consider alternative therapies, if available, in patients with known anaphylactic reactions to hydroxocobalamin or cyanocobalamin. ( 5.2 ) Risk of Renal Injury : Acute renal failure with acute tubular necrosis, renal impairment and urine calcium oxalate crystals have been reported following CYANOKIT therapy. Monitor renal function for 7 days following CYANOKIT therapy. ( 5.3 ) Risk of Increased Blood Pressure : Substantial increases in blood pressure may occur following CYANOKIT therapy. Monitor blood pressure during treatment. ( 5.4 ) 5.1 Emergency Patient Management In conjunction with CYANOKIT, treatment of cyanide poisoning must include immediate attention to airway patency, adequacy of oxygenation and hydration, cardiovascular support, and management of seizures. Consideration should be given to decontamination measures based on the route of exposure. 5.2 Risk of Anaphylactic and Other Hypersensitivity Reactions Use caution in the management of patients with known anaphylactic reactions to hydroxocobalamin or cyanocobalamin. Consider alternative therapies, if available. Allergic reactions may include: anaphylaxis, chest tightness, edema, urticaria, pruritus, dyspnea, and rash. Allergic reactions including angioneurotic edema have also been reported in postmarketing experience. 5.3 Risk of Renal Injury Cases of acute renal failure with acute tubular necrosis, renal impairment, and urine calcium oxalate crystals …

8.1 Pregnancy Risk Summary Available data from cases reported in the published literature and postmarketing surveillance with CYANOKIT use in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal and fetal outcomes. There are risks to the pregnant woman and fetus associated with untreated cyanide poisoning (see Clinical Considerations) . In animal studies, hydroxocobalamin administered to pregnant rats and rabbits during the period of organogenesis caused skeletal and soft tissue abnormalities, including alterations in the central nervous system, at exposures similar to human exposures at the therapeutic dose (see Data) …