pharmacopeia

Thiosulfate

AntidotesUS-FDASourced from openFDA
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Mechanism of action

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Exposure to a high dose of cyanide can result in death within minutes due to the inhibition of cytochrome oxidase resulting in arrest of cellular respiration. Specifically, cyanide binds rapidly with cytochrome a3, a component of the cytochrome c oxidase complex in mitochondria.

Indications

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  • Sodium Thiosulfate Injection is indicated for sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potential risks associated with Sodium Thiosulfate Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis.

Contraindications

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  • None None.contraindicated

Dosage & administration

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2. DOSAGE AND ADMINISTRATION If clinical suspicion of cyanide poisoning is high, administer Sodium Thiosulfate Injection without delay and in conjunction with appropriate airway, ventilatory, and circulatory support. ( 2.1 ) The expert advice of a regional poison control center may be obtained by calling 1-800-222-1222. ( 2.1 ) Dosing : Age Intravenous Dose of Sodium Nitrite and Sodium Thiosulfate Adults 1.) Sodium Nitrite -10 mL of sodium nitrite at the rate of 2.5 to 5 mL/minute 2.) Sodium Thiosulfate - 50 mL of sodium thiosulfate immediately following administration of sodium nitrite. Children 1.) Sodium Nitrite - 0.2 mL/kg (6 mg/kg or 6-8 mL/m 2 BSA) of sodium nitrite at the rate of 2.5 to 5 mL/minute not to exceed 10 mL 2.) Sodium Thiosulfate - 1 mL/kg of body weight (250 mg/kg or approximately 30-40 mL/m 2 of BSA) not to exceed 50 mL total dose immediately following administration of sodium nitrite. Redosing : If signs of cyanide poisoning reappear, repeat treatment using one-half the original dose of both sodium nitrite and sodium thiosulfate. ( 2.2 ) Monitoring : Blood pressure must be monitored during treatment. ( 2.2 ) Sodium thiosulfate is chemically incompatible with hydroxocobalamin and should not be administered via the same intravenous line. (2.4) 2.1 Important Dosage and Administration Instructions If clinical suspicion of cyanide poisoning is high, administer Sodium Thiosulfate Injection without delay. Comprehensive treatment of acute cyanide intoxication requires support of vital functions.

Warnings & precautions

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Sulfites: Sodium thiosulfate may contain trace impurities of sodium sulfite ( 5.1 ) 5.1 Sulfites Sodium thiosulfate drug product may contain trace impurities of sodium sulfite. The presence of a trace amount of sulfites in this product should not deter administration of the drug for treatment of emergency situations, even if the patient is sulfite-sensitive.

Adverse reactions

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There have been no controlled clinical trials conducted to systematically assess the adverse events profile of sodium thiosulfate. The medical literature has reported the following adverse events in association with sodium thiosulfate administration. These adverse events were not reported in the context of controlled trials or with consistent monitoring and reporting methodologies for adverse events. Therefore, frequency of occurrence of these adverse events cannot be assessed. Cardiovascular system: hypotension Central nervous system: headache, disorientation Gastrointestinal system: nausea, vomiting Hematological : prolonged bleeding time Body as a Whole: salty taste in mouth, warm sensation over body In humans, rapid administration of concentrated solutions or solutions not freshly prepared, and administration of large doses of sodium thiosulfate have been associated with a higher incidence of nausea and vomiting. However, administration of 0.1 g sodium thiosulfate per pound up to a maximum of 15 g in a 10-15% solution over 10-15 minutes was associated with nausea and vomiting in 7 of 26 patients without concomitant cyanide intoxication. In a series of 11 human subjects, a single intravenous infusion of 50 mL of 50% sodium thiosulfate was associated with increases in clotting time 1-3 days after administration. However, no significant changes were observed in other hematological parameters.

Use in specific populations

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Lactation : Breastfeeding not recommended. ( 8.2 ) Renal impairment : Sodium thiosulfate is substantially excreted by the kidney. The risk of toxic reactions to this drug may be greater in patients with impaired renal function. ( 8.6 ). 8.1 Pregnancy Risk Summary There are no available data on Sodium Thiosulfate Injection use in pregnant women to establish a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are risks to the pregnant woman and fetus associated with untreated cyanide poisoning (see Clinical Considerations ). Therefore, if a pregnant woman has known or suspected cyanide poisoning, Sodium Thiosulfate Injection for sequential use with sodium nitrite is recommended [see Indications and Usage (1) ] . In published animal studies, no evidence of embryotoxicity or malformations was reported when sodium thiosulfate was administered during organogenesis to pregnant mice, rats, hamsters, or rats at 0.2 to 0.9 times the human daily dose of 12.5 g for cyanide poisoning. The studies did not test doses that were comparable to the human dose for cyanide poisoning (see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

Pharmacokinetics

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Metabolism
Sodium Thiosulfate Thiosulfate taken orally is not systemically absorbed. Most of the thiosulfate is oxidized to sulfate or is incorporated into endogenous sulphur compounds; a small proportion is excreted through the kidneys.

Overdosage

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There is limited information about the effects of large doses of sodium thiosulfate in humans. Oral administration of 3 g sodium thiosulfate per day for 1-2 weeks in humans resulted in reductions in room air arterial oxygen saturation to as low as 75%, which was due to a rightward shift in the oxygen hemoglobin dissociation curve. The subjects returned to baseline oxygen saturations 1 week after discontinuation of sodium thiosulfate. A single intravenous administration of 20 mL of 10% sodium thiosulfate reportedly did not change oxygen saturations.

Approval history

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  • Jan 14, 2011NDANDA201444Hope Pharms
  • Feb 14, 2012NDANDA203923Hope Pharms
  • Sep 20, 2022NDANDA212937Fennec Pharms Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
513 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use13326%
  2. 2Calciphylaxis8517%
  3. 3Nausea7615%
  4. 4Drug Ineffective519.9%
  5. 5Vomiting519.9%
  6. 6Metabolic Acidosis295.7%
  7. 7Sepsis224.3%
  8. 8Condition Aggravated214.1%
  9. 9Death173.3%
  10. 10Pruritus173.3%
  11. 11Pain152.9%
  12. 12Erythema142.7%
  13. 13Fatigue142.7%
  14. 14Calcinosis132.5%
  15. 15Dyspnoea132.5%

Literature

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Recent PubMed references pinned to Thiosulfate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 74 ClinicalTrials.gov registrations naming Thiosulfate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Thiosulfate work?
Exposure to a high dose of cyanide can result in death within minutes due to the inhibition of cytochrome oxidase resulting in arrest of cellular respiration. Specifically, cyanide binds rapidly with cytochrome a3, a component of the cytochrome c oxidase complex in mitochondria.
What is Thiosulfate used for?
According to FDA labeling, Thiosulfate carries indications including: Sodium Thiosulfate Injection is indicated for sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potential risks associated with Sodium Thiosulfate Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Thiosulfate?
Thiosulfate is classified as Antidotes.
What are the brand names for Thiosulfate?
Thiosulfate is marketed under brand names including Exoderm, Pedmark, Versiclear.
What are the contraindications for Thiosulfate?
Thiosulfate labeling lists contraindications including: None None.. Always consult the full prescribing information and a clinician.
Note. Data for thiosulfate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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