Nithiodote

Last updated on RxList: 1/25/2021
Nithiodote Side Effects Center

What Is Nithiodote?

Nithiodote (sodium nitrite injection and sodium thiosulfate injection for intravenous infusion) is an antidote used to treat acute cyanide poisoning that is judged to be serious or life-threatening.

What Are Side Effects of Nithiodote?

Side effects of Nithiodote include:

Dosage for Nithiodote

The adult dose of Nithiodote is 10 mL of sodium nitrite at the rate of 2.5 to 5 mL/minute and 50 mL of sodium thiosulfate immediately following administration of sodium nitrite. The pediatric dose of Nithiodote is 0.2 mL/kg (6 mg/kg or 6-8 mL/m2 BSA) of sodium nitrite at the rate of 2.5 to 5 mL/minute not to exceed 10 mL and 1 mL/kg of body weight (250 mg/kg or approximately 30-40 mL/m2 of BSA) not to exceed 50 mL total dose immediately following administration of sodium nitrite.

Nithiodote In Children

There are case reports in the medical literature of sodium nitrite in conjunction with sodium thiosulfate being administered to pediatric patients with cyanide poisoning; however, there have been no clinical studies to evaluate the safety or efficacy of sodium thiosulfate or sodium nitrite in the pediatric population. As for adult patients, dosing recommendations for pediatric patients have been based on theoretical calculations of antidote detoxifying potential, extrapolation from animal experiments, and a small number of human case reports.

Use sodium nitrite with caution in patients less than 6 months of age because they may be at higher risk of developing severe methemoglobinemia compared to older children and adults. The presence of fetal hemoglobin, which is oxidized to methemoglobin more easily than adult hemoglobin, and lower methemoglobin reductase levels compared to older children and adults may contribute to risk.

What Drugs, Substances, or Supplements Interact with Nithiodote?

Nithiodote may interact with other medicines.

Tell your doctor all medications and supplements you use.

Nithiodote During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Nithiodote; it is unknown how it would affect a fetus. It is unknown if Nithiodote passes into breast milk. Because Nithiodote may be administered in life-threatening situations, breastfeeding is not a contraindication to its use. Because many drugs are excreted in human milk, exercise caution following Nithiodote administration to a nursing woman. Consult your doctor before breastfeeding.

Additional Information

Our Nithiodote (sodium nitrite injection and sodium thiosulfate injection for intravenous infusion) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Nithiodote Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; chest tightness, difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers right away if you have:

  • a light-headed feeling, like you might pass out;
  • a seizure;
  • shortness of breath, tiredness;
  • fast or irregular heart rate, pounding heartbeats or fluttering in your chest; or
  • signs of a blood cell disorder--nausea, vomiting, dizziness, muscle weakness, loss of coordination, blue-colored skin, feeling tired or short of breath.

Common side effects may include:

  • feeling light-headed, loss of consciousness;
  • headache, dizziness, confusion;
  • blurred vision; or
  • fast or pounding heartbeats.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nithiodote (Sodium Nitrite Injection for Intravenous Infusion)

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Nithiodote Professional Information

SIDE EFFECTS

There have been no controlled clinical trials conducted to systematically assess the adverse events profile of sodium nitrite or sodium thiosulfate.

The medical literature has reported the following adverse events in association with sodium nitrite or 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.

Sodium Nitrite

Cardiovascular system: syncope, hypotension, tachycardia, methemoglobinemia, palpitations, dysrhythmia

Hematological: methemoglobinemia

Central nervous system: headache, dizziness, blurred vision, seizures, confusion, coma

Gastrointestinal system: nausea, vomiting, abdominal pain

Respiratory system: tachypnea, dyspnea

Body as a Whole: anxiety, diaphoresis, lightheadedness, injection site tingling, cyanosis, acidosis, fatigue, weakness, urticaria, generalized numbness and tingling

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.

Sodium Thiosulfate

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.

Read the entire FDA prescribing information for Nithiodote (Sodium Nitrite Injection for Intravenous Infusion)

© Nithiodote Patient Information is supplied by Cerner Multum, Inc. and Nithiodote Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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