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Sodium Nitrite
Overview
What is Sodium Nitrite?
Sodium nitrite has the chemical name nitrous acid sodium salt. The chemical formula is NaNO and the molecular weight is 69.0. The structural formula is:
Structure of Sodium Nitrite
Sodium Nitrite Injection is a cyanide antidote which contains one 10 mL glass vial of a 3% solution of sodium nitrite injection.
Sodium nitrite injection is a sterile aqueous solution and is intended for intravenous injection. Each vial contains 300 mg of sodium nitrite in 10 mL solution (30 mg/mL). Sodium nitrite injection is a clear solution with a pH between 7.0 and 9.0.
What does Sodium Nitrite look like?
What are the available doses of Sodium Nitrite?
Sodium Nitrite Injection consists of:
What should I talk to my health care provider before I take Sodium Nitrite?
How should I use Sodium Nitrite?
Sodium Nitrite Injection is indicated for sequential use with sodium thiosulfate 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 potentially life-threatening risks associated with Sodium Nitrite Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis.
If clinical suspicion of cyanide poisoning is high, administer Sodium Nitrite Injection without delay and in conjunction with appropriate airway, ventilatory, and circulatory support. ()
The expert advice of a regional poison control center may be obtained by calling 1-800-222-1222. ()
What interacts with Sodium Nitrite?
Sorry No Records found
What are the warnings of Sodium Nitrite?
Sorry No Records found
What are the precautions of Sodium Nitrite?
Sorry No Records found
What are the side effects of Sodium Nitrite?
Sorry No records found
What should I look out for while using Sodium Nitrite?
None
Sodium nitrite can cause serious adverse reactions and death in humans, even at doses less than twice the recommended therapeutic dose. Sodium nitrite causes hypotension and methemoglobin formation, which diminishes oxygen carrying capacity. Hypotension and methemoglobin formation can occur concurrently or separately. Because of these risks, sodium nitrite should be used to treat acute life-threatening cyanide poisoning and be used with caution in patients where the diagnosis of cyanide poisoning is uncertain
Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with sodium nitrite. Alternative therapeutic approaches should be considered in patients known to have diminished oxygen or cardiovascular reserve (e.g., smoke inhalation victims, pre-existing anemia, cardiac or respiratory compromise), and those at higher risk of developing methemoglobinemia (e.g., congenital methemoglobin reductase deficiency) as they are at greater risk for potentially life-threatening adverse events related to the use of sodium nitrite
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What might happen if I take too much Sodium Nitrite?
Large doses of sodium nitrite result in severe hypotension and toxic levels of methemoglobin which may lead to cardiovascular collapse.
Sodium nitrite administration has been reported to cause or significantly contribute to mortality in adults at oral doses as low as 1 g and intravenous doses as low as 600 mg. A death attributed to sodium nitrite has been reported following administration of an adult dose (300 mg IV followed by a second dose of 150 mg) to a 17-month old child.
Cyanosis may become apparent at a methemoglobin level of 10-20%. Other clinical signs and symptoms of sodium nitrite toxicity (anxiety, dyspnea, nausea, and tachycardia) can be apparent at methemoglobin levels as low as 15%. More serious signs and symptoms, including cardiac dysrhythmias, circulatory failure, and central nervous system depression are seen as methemoglobin levels increase, and levels above 70% are usually fatal.
Treatment of overdose involves supplemental oxygen and supportive measures such as exchange transfusion. Treatment of severe methemoglobinemia with intravenous methylene blue has been described in the medical literature; however, this may also cause release of cyanide bound to methemoglobin. Because hypotension appears to be mediated primarily by an increase in venous capacitance, measures to increase venous return may be most appropriate to treat hypotension.
How should I store and handle Sodium Nitrite?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAEach Sodium Nitrite carton (NDC 60267-311-10) consists of the following:
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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. Inhibition of cytochrome a3 prevents the cell from using oxygen and forces anaerobic metabolism, resulting in lactate production, cellular hypoxia and metabolic acidosis. In massive acute cyanide poisoning, the mechanism of toxicity may involve other enzyme systems as well.
The synergy resulting from treatment of cyanide poisoning with the combination of sodium nitrite and sodium thiosulfate is the result of differences in their primary mechanisms of action as antidotes for cyanide poisoning.
Non-Clinical Toxicology
NoneSodium nitrite can cause serious adverse reactions and death in humans, even at doses less than twice the recommended therapeutic dose. Sodium nitrite causes hypotension and methemoglobin formation, which diminishes oxygen carrying capacity. Hypotension and methemoglobin formation can occur concurrently or separately. Because of these risks, sodium nitrite should be used to treat acute life-threatening cyanide poisoning and be used with caution in patients where the diagnosis of cyanide poisoning is uncertain
Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with sodium nitrite. Alternative therapeutic approaches should be considered in patients known to have diminished oxygen or cardiovascular reserve (e.g., smoke inhalation victims, pre-existing anemia, cardiac or respiratory compromise), and those at higher risk of developing methemoglobinemia (e.g., congenital methemoglobin reductase deficiency) as they are at greater risk for potentially life-threatening adverse events related to the use of sodium nitrite
[see and ]
Caution is advised if Primaquine is used concomitantly with other drugs that prolong the QT interval (see PRECAUTIONS, ADVERSE REACTIONS, and OVERDOSAGE).
Sodium nitrite has been associated with severe hypotension, methemoglobinemia, and death at doses less than twice recommended therapeutic doses. Hypotension may occur concurrently or separately. Sodium nitrite should be used to treat life-threatening cyanide poisoning. When the diagnosis of cyanide poisoning is uncertain and/or the patient is not in extremis, special consideration should be given to administration of sodium nitrite if the patient is known or suspected to have diminished oxygen or cardiovascular reserve (e.g., smoke inhalation victims, pre-existing anemia, substantial blood loss, cardiac or respiratory compromise) or to be at higher risk of developing methemoglobinemia (e.g., congenital methemoglobin reductase deficiency).
There have been no controlled clinical trials conducted to systematically assess the adverse events profile of sodium nitrite.
The medical literature has reported the following adverse events in association with sodium nitrite 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:
Hematological:
Central nervous system:
Gastrointestinal system:
Respiratory system:
Body as a Whole
Severe hypotension, methemoglobinemia, cardiac dysrhythmias, coma and death have been reported in patients without life-threatening cyanide poisoning but who were treated with injection of sodium nitrite at doses less than twice those recommended for the treatment of cyanide poisoning.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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