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Sodium nitrite and sodium thiosulfate (Intravenous route)

Pronunciation:

SOE-dee-um NYE-trite, SOE-dee-um thye-oh-SUL-fate

Brand Names:

  • Nithiodote

Dosage Forms:

  • Solution

Warnings:

Intravenous route(Solution)

Sodium nitrite can cause serious adverse reactions and death from hypotension and methemoglobin formation, even at doses less than twice the recommended therapeutic dose. Hypotension and methemoglobin formation can occur concurrently or separately. 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 and in those at higher risk of developing methemoglobinemia .

Uses of This Medicine:

Sodium nitrite and sodium thiosulfate injection are used together to treat cyanide poisoning. Cyanide poisoning is a life-threatening condition that requires immediate medical attention.

This medicine is to be given only by or under the direct supervision of a doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of sodium nitrite and sodium thiosulfate injection in the pediatric population. However, because cyanide poisoning is a life-threatening condition, it is used in the pediatric population. Recommended doses should not be exceeded, and the patient should be carefully monitored during treatment.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sodium nitrite and sodium thiosulfate injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving sodium nitrite and sodium thiosulfate injection.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Anemia or
  • Carbon monoxide poisoning or
  • Glucose-6-phosphate dehydrogenase (G6PD) deficiency (genetic disorder affecting red blood cells) or
  • Heart disease or
  • Lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease) or
  • Smoke inhalation injury—Use with caution. May cause side effects to become worse.
  • Hypotension (low blood pressure)—Use with caution. May make this condition worse.
  • Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through a needle placed in one of your veins.

Precautions While Using This Medicine:

Your doctor will check your or your child's progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly. Blood tests will also be needed to check for unwanted effects.

Severe hypotension (low blood pressure) may occur with this medicine. It could be life-threatening and requires immediate medical attention. Your doctor will measure your blood pressure and keep it from going too low while you are receiving this medicine.

This medicine may cause a rare, but serious blood problem called methemoglobinemia. Newborn babies and infants may be more likely to have this serious side effect. Your doctor will measure how much methemoglobin is in your blood and keep it from going too high while you are receiving this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known
Bluish color of the fingernails, lips, skin, palms, or nail beds
blurred vision
change in consciousness
confusion
dark urine
difficult or labored breathing
dizziness
dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
drowsiness
fainting
fast, slow, pounding, or irregular heartbeat or pulse
fever
headache
lightheadedness
loss of consciousness
nausea
numbness and tingling sensation
pale skin
rapid heart rate
rapid shallow breathing
seizures
shortness of breath
sore throat
sweating
tightness in the chest
troubled breathing
unusual bleeding or bruising
unusual tiredness or weakness
vomiting
wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
Abdominal or stomach pain
anxiety
confusion about identity, place, and time
headache
hives or welts
increased sweating
itching
redness of the skin
salty taste in your mouth
skin rash
tingling sensation at the injection site
warm sensation over your body

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 4/4/2014

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