Sodium Thiosulfate
Generic: SODIUM THIOSULFATE
Basic Information
Manufacturer
Hope Pharmaceuticals
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
82f55408-2de9-463d-85e8-b39c3b259f0b
Indications & Usage
1 INDICATIONS AND USAGE 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.
Sodium Thiosulfate Injection, an antidote, is indicated for sequential use with sodium nitrite for treatment of acute cyanide poisoning that is judged to be serious or life-threatening.
( 1 ) Use with caution if the diagnosis of cyanide poisoning is uncertain.
( 1 )
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.
Sodium Thiosulfate Injection, an antidote, is indicated for sequential use with sodium nitrite for treatment of acute cyanide poisoning that is judged to be serious or life-threatening.
( 1 ) Use with caution if the diagnosis of cyanide poisoning is uncertain.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS 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.
Most common adverse reactions are: Hypotension, headache, disorientation ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hope Pharmaceuticals at 1-800-755-9595 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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.
Most common adverse reactions are: Hypotension, headache, disorientation ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hope Pharmaceuticals at 1-800-755-9595 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .