Thiosulfate: Difference between revisions

Jump to navigation Jump to search
Ammu Susheela (talk | contribs)
No edit summary
Ammu Susheela (talk | contribs)
No edit summary
Line 1: Line 1:
{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{Ammu}}
|authorTag={{Ammu}}
|genericName=sodium thiosulfate
|aOrAn=a
|aOrAn=a
|hasBlackBoxWarning=Yes
|drugClass=antidote
|adverseReactions=<!--Black Box Warning-->
|indicationType=treatment
|indication= for sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be life-threatening
|adverseReactions=hypotension, prolonged bleeding time
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
Line 12: Line 15:


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult=1.1 Indication
Sodium Thiosulfate Injection is indicated for sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be 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.


* Dosing Information
1.2 Identifying Patients with Cyanide Poisoning
Cyanide poisoning may result from inhalation, ingestion, or dermal exposure to various cyanide-containing compounds, including smoke from closed-space fires. Sources of cyanide poisoning include hydrogen cyanide and its salts, cyanogenic plants, aliphatic nitriles, and prolonged exposure to sodium nitroprusside.


:* Dosage
The presence and extent of cyanide poisoning are often initially unknown. There is no widely available, rapid, confirmatory cyanide blood test. Treatment decisions must be made on the basis of clinical history and signs and symptoms of cyanide intoxication. If clinical suspicion of cyanide poisoning is high, Sodium Thiosulfate Injection and Sodium Nitrite Injection should be administered without delay.
: [[File:Thiosulphate 01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
In some settings, panic symptoms including tachypnea and vomiting may mimic early cyanide poisoning signs. The presence of altered mental status (e.g., confusion and disorientation) and/or mydriasis is suggestive of true cyanide poisoning although these signs can occur with other toxic exposures as well.


=====Condition2=====
The expert advice of a regional poison control center may be obtained by calling 1-800-222-1222.


* Dosing Information
Smoke Inhalation


:* Dosage
Not all smoke inhalation victims will have cyanide poisoning and may present with burns, trauma, and exposure to other toxic substances making a diagnosis of cyanide poisoning particularly difficult. Prior to administration of Sodium Thiosulfate Injection smoke-inhalation victims should be assessed for the following:


=====Condition3=====
Exposure to fire or smoke in an enclosed area
Presence of soot around the mouth, nose, or oropharynx
Altered mental status
Although hypotension is highly suggestive of cyanide poisoning, it is only present in a small percentage of cyanide-poisoned smoke inhalation victims. Also indicative of cyanide poisoning is a plasma lactate concentration greater than or equal to 10 mmol/L (a value higher than that typically listed in the table of signs and symptoms of isolated cyanide poisoning because carbon monoxide associated with smoke inhalation also contributes to lactic acidemia). If cyanide poisoning is suspected, treatment should not be delayed to obtain a plasma lactate concentration.


* Dosing Information
1.3 Use with Other Cyanide Antidotes
 
Caution should be exercised when administering cyanide antidotes, other than sodium nitrite, simultaneously with Sodium Thiosulfate Injection, as the safety of co-administration has not been established. If a decision is made to administer another cyanide antidote, other than sodium nitrite, with Sodium Thiosulfate Injection, these drugs should not be administered concurrently in the same IV line.
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
:* Dosage


<!--Off-Label Use and Dosage (Adult)-->


<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport======Condition1=====


Line 123: Line 124:
<!--Clinical Trials Experience-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====




<!--Drug Interactions-->
|postmarketing=* 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.
|drugInteractions=* Drug
|drugInteractions=* Drug
:* Description
:* Description

Revision as of 17:51, 22 January 2015

Thiosulfate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Thiosulfate is a antidote that is FDA approved for the treatment of for sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be life-threatening. Common adverse reactions include hypotension, prolonged bleeding time.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

1.1 Indication Sodium Thiosulfate Injection is indicated for sequential use with sodium nitrite for the treatment of acute cyanide poisoning that is judged to be 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.

1.2 Identifying Patients with Cyanide Poisoning Cyanide poisoning may result from inhalation, ingestion, or dermal exposure to various cyanide-containing compounds, including smoke from closed-space fires. Sources of cyanide poisoning include hydrogen cyanide and its salts, cyanogenic plants, aliphatic nitriles, and prolonged exposure to sodium nitroprusside.

The presence and extent of cyanide poisoning are often initially unknown. There is no widely available, rapid, confirmatory cyanide blood test. Treatment decisions must be made on the basis of clinical history and signs and symptoms of cyanide intoxication. If clinical suspicion of cyanide poisoning is high, Sodium Thiosulfate Injection and Sodium Nitrite Injection should be administered without delay.

This image is provided by the National Library of Medicine.

In some settings, panic symptoms including tachypnea and vomiting may mimic early cyanide poisoning signs. The presence of altered mental status (e.g., confusion and disorientation) and/or mydriasis is suggestive of true cyanide poisoning although these signs can occur with other toxic exposures as well.

The expert advice of a regional poison control center may be obtained by calling 1-800-222-1222.

Smoke Inhalation

Not all smoke inhalation victims will have cyanide poisoning and may present with burns, trauma, and exposure to other toxic substances making a diagnosis of cyanide poisoning particularly difficult. Prior to administration of Sodium Thiosulfate Injection smoke-inhalation victims should be assessed for the following:

Exposure to fire or smoke in an enclosed area Presence of soot around the mouth, nose, or oropharynx Altered mental status Although hypotension is highly suggestive of cyanide poisoning, it is only present in a small percentage of cyanide-poisoned smoke inhalation victims. Also indicative of cyanide poisoning is a plasma lactate concentration greater than or equal to 10 mmol/L (a value higher than that typically listed in the table of signs and symptoms of isolated cyanide poisoning because carbon monoxide associated with smoke inhalation also contributes to lactic acidemia). If cyanide poisoning is suspected, treatment should not be delayed to obtain a plasma lactate concentration.

1.3 Use with Other Cyanide Antidotes Caution should be exercised when administering cyanide antidotes, other than sodium nitrite, simultaneously with Sodium Thiosulfate Injection, as the safety of co-administration has not been established. If a decision is made to administer another cyanide antidote, other than sodium nitrite, with Sodium Thiosulfate Injection, these drugs should not be administered concurrently in the same IV line.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Thiosulfate in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Thiosulfate in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Thiosulfate in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Thiosulfate in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Thiosulfate in pediatric patients.

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Thiosulfate in the drug label.

Postmarketing Experience

  • 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.

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Thiosulfate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Thiosulfate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Thiosulfate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Thiosulfate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Thiosulfate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Thiosulfate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Thiosulfate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Thiosulfate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Thiosulfate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Thiosulfate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Thiosulfate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Thiosulfate in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Thiosulfate in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Thiosulfate in the drug label.

Pharmacology

There is limited information regarding Thiosulfate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Thiosulfate01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Thiosulfate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Thiosulfate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Thiosulfate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Thiosulfate in the drug label.

How Supplied

Storage

There is limited information regarding Thiosulfate Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Thiosulfate |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Thiosulfate |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Thiosulfate in the drug label.

Precautions with Alcohol

  • Alcohol-Thiosulfate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. Empty citation (help)
  2. "http://www.ismp.org". External link in |title= (help)

{{#subobject:

 |Label Page=Thiosulfate
 |Label Name=Thiosulfate11.png

}}

{{#subobject:

 |Label Page=Thiosulfate
 |Label Name=Thiosulfate11.png

}}