Sodium nitrite and sodium thiosulfate

• Tell all of your health care providers that you take sodium nitrite and sodium thiosulfate. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have your blood pressure checked often. Talk with your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of methemoglobinemia like a blue or gray color of the lips, nails, or skin; a heartbeat that does not feel normal; seizures; very bad dizziness or passing out; very bad headache; feeling very sleepy; feeling tired or weak; or shortness of breath.
• Very bad dizziness or passing out.
• A fast heartbeat.
• Feeling confused.
• Blurred eyesight.
• Numbness and tingling.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, solution [combination package]:

Nithiodote: Sodium nitrite 300 mg/10 mL (10 mL) and sodium thiosulfate 12.5 g/50 mL (50 mL)

• Nithiodote

Refer to adult dosing; use with caution due to the likelihood of decreased renal function.

Administer via slow IV injection as soon as possible after diagnosis of acute, life-threatening cyanide poisoning. Administer sodium nitrite first at a rate of 2.5-5 mL/minute, followed immediately by sodium thiosulfate over 10-30 minutes (Howland, 2015). Decrease the rate of infusion in the event of significant hypotension.

Frequency not defined.

Sodium nitrite:

Cardiovascular: Cardiac arrhythmia, flushing, hypotension, palpitations, syncope, tachycardia

Central nervous system: Anxiety, coma, confusion, dizziness, fatigue, headache, numbness, paresthesia, seizure, tingling of skin (injection site)

Dermatologic: Diaphoresis, urticaria

Endocrine & metabolic: Acidosis

Gastrointestinal: Abdominal pain, nausea, vomiting

Hematologic & oncologic: Methemoglobinemia

Neuromuscular & skeletal: Weakness

Ophthalmic: Blurred vision

Respiratory: Cyanosis, dyspnea, tachypnea

Sodium thiosulfate:

Cardiovascular: Hypotension

Central nervous system: Disorientation, flushing sensation, headache, salty taste

Gastrointestinal: Nausea, vomiting

Hematologic & oncologic: Prolonged bleeding time

Teratogenic effects have been observed following maternal exposure to high concentrations of sodium nitrite in drinking water. Teratogenic effects were not observed in animal reproduction studies of sodium nitrite or sodium thiosulfate. Embryotoxic and nonteratogenic effects were observed in animal reproduction studies of sodium nitrite. Methemoglobin reductase is lower in the fetus compared to adults and may result in adverse effects due to nitrite-induced prenatal hypoxia. There are no adequate and well-controlled studies of Nithiodote in pregnant women. In general, medications used as antidotes should take into consideration the health and prognosis of the mother; antidotes should be administered to pregnant women if there is a clear indication for use and should not be withheld because of fears of teratogenicity (Bailey 2003).

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience flushing, headache, bad taste, vomiting, or nausea. Have patient report immediately to prescriber severe dizziness, passing out, tachycardia, confusion, blurred vision, numbness or tingling, or signs of methemoglobinemia (blue or gray color of the lips, nails, or skin; arrhythmia; seizures; severe dizziness or passing out; severe headache; fatigue; loss of strength and energy; or shortness of breath) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Redosing: If signs of cyanide poisoning reappear, repeat treatment using one-half the original dose of both sodium nitrite and sodium thiosulfate.