nithiodote
Nithiodote is a combination medicine containing Sodium Nitrite and Sodium Thiosulfate.
Sodium Nitrite and Sodium Thiosulfate · by Hope Pharms
Key facts
- Active ingredient
- Sodium Nitrite and Sodium Thiosulfate
- Form
- Kit
- Strength
- Sodium Nitrite 300MG/10ML(30MG/ML)
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Hope Pharms
- FDA application
- NDA201444
- FDA boxed warning
- Yes — see the boxed warning
What is Nithiodote?
From the FDA label:Sodium nitrite, one of the active ingredients in NITHIODOTE has the chemical name nitrous acid sodium salt. The chemical formula is NaNO 2 and the molecular weight is 69.0. Sodium thiosulfate, the second active ingredient in NITHIODOTE has the chemical name thiosulfuric acid, disodium salt, pentahydrate. The chemical formula is Na 2 S 2 O 3 ∙ 5H 2 O and the molecular weight is 248.17. The structural formulae are: Structure of Sodium Nitrite Structure of Sodium Thiosulfate Pentahydrate NITHIODOTE is a cyanide antidote which contains one 10 mL glass vial of a 3% solution of sodium nitrite injection and one 50 mL glass vial containing a 25% solution of sodium thiosulfate 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. Sodium thiosulfate injection is a sterile aqueous solution and is intended for intravenous injection. Each vial contains 12.5 grams of sodium thiosulfate in 50 mL solution (250 mg/mL). Each mL also contains 2.8 mg boric acid and 4.4 mg of potassium chloride. The pH of the solution is adjusted with boric acid and/or sodium hydroxide. Sodium thiosulfate injection is a clear solution with a pH between 7.5 and 9.0. Chemical Structure Chemical Structure
How to use
If clinical suspicion of cyanide poisoning is high, administer NITHIODOTE 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 ) NITHIODOTE 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 NITHIODOTE without delay. Comprehensive treatment of…
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. Most common adverse reactions are: Sodium nitrite : syncope, hypotension, tachycardia, palpitations, dysrhythmia, methemoglobinemia, headache, dizziness, blurred vision, seizures, confusion, coma ( 6 ) Sodium thiosulfate : 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 . S odium 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,…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
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 . [See Warnings and Precautions (5.1 and 5.2) ] WARNING: LIFE-THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION See full prescribing information for complete boxed warning . Sodium nitrite can cause serious adverse reactions and death from: Hypotension ( 5.1 ) Methemoglobin formation ( 5.2 ) Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with sodium nitrite.
Warnings
Important safety information
Methemoglobinemia: Sodium nitrite reacts with hemoglobin to form methemoglobin and should be used with caution in patients known to have anemia. Monitor oxyhemoglobin and methemoglobin levels by pulse co-oximetry or other measurements. Optimally, the sodium nitrite dose should be reduced in proportion to the oxygen carrying capacity. ( 5.2 ) Smoke inhalation: Carbon monoxide contained in smoke can result in the formation of carboxyhemoglobin that can reduce the oxygen carrying capacity of the blood. Sodium nitrite should be used with caution in patients with smoke inhalation injury because of the potential for worsening hypoxia due to methemoglobin formation. Carboxyhemoglobin and oxyhemoglobin levels should be monitored by pulse oximetry or other measurements in patients that present with evidence of smoke inhalation. Optimally, the sodium nitrite dose should be reduced in proportion to the oxygen carrying capacity. ( 5.4 ) 5.1 Hypotension 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). 5.2 Methemoglobinemia Supportive care alone may be sufficient treatment without administration of antidotes for many cases of cyanide intoxication, particularly in conscious patients without signs of severe toxicity. Monitor patients closely to ensure adequate perfusion and oxygenation during treatment with sodium nitrite. Monitor methemoglobin levels and administer oxygen during treatment with sodium nitrite whenever possible. When sodium nitrite is administered to humans a wide range of methemoglobin concentrations occur. Methemoglobin concentrations as high as 58% have been reported after two 300-mg doses of sodium nitrite administered to an adult. Sodium nitrite should be used with caution in the presence of other drugs that may cause methemoglobinemia such as procaine and nitroprusside. Use sodium nitrite with caution in patients who may be particularly susceptible to injury from vasodilation and its related hemodynamic sequelae. Monitor hemodynamics closely during and after administration of sodium nitrite and sodium thiosulfate, and reduce infusion rates if hypotension occurs. 5.3 Anemia Use sodium nitrite with caution in patients with known anemia. Patients with anemia will form more methemoglobin (as a percentage of total hemoglobin) than persons with normal red blood cell (RBC) volumes. Optimally, these patients should receive a sodium nitrite dose that is reduced in proportion to their oxygen carrying capacity. 5.4 Smoke Inhalation Injury Use sodium nitrite with caution in persons with smoke inhalation injury or carbon monoxide poisoning because of the potential for worsening hypoxia due to methemoglobin formation. 5.5 Neonates and Infants Neonates and infants may be more susceptible than adults and older pediatric patients to severe methemoglobinemia when sodium nitrite is administered. Follow reduced dosing guidelines in pediatric patients. 5.6 G6PD Deficiency Because patients with G6PD deficiency are at increased risk of a hemolytic crisis with sodium nitrite administration, consider alternative therapeutic approaches in these patients. Monitor patients with known or suspected G6PD deficiency for an acute drop in hematocrit. Exchange transfusion may be needed for patients with G6PD deficiency who receive sodium nitrite. 5.7 Use with Other Drugs Use sodium nitrite with caution in the presence of concomitant antihypertensive medications, diuretics or volume depletion due to diuretics, or drugs known to increase vascular nitric oxide, such as PDE5 inhibitors. 5.8 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.
Who should not take Nithiodote
None None. ( 4 )
Overdose — what happens if you 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.…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Formal drug interaction studies have not been conducted with NITHIODOTE.
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- Is there a coupon or discount for Nithiodote?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Nithiodote. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Nithiodote?
- Nithiodote is marketed by Hope Pharms. You can see Hope Pharms's full profile, rating, and other products on pharmaranks.
- Is Nithiodote a brand-name or generic drug?
- Nithiodote is a brand-name product with the active ingredient Sodium Nitrite and Sodium Thiosulfate.
- Is Nithiodote available over the counter?
- No. Nithiodote is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Nithiodote come in?
- Nithiodote is currently marketed as kit, per the FDA's National Drug Code Directory.
- Is Nithiodote FDA-registered?
- Nithiodote is on record with the U.S. FDA under application number NDA201444. You can verify this on its official FDA label.
- Is Nithiodote safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Nithiodote. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Nithiodote?
- Nithiodote's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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