Pronunciation:

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

Brand Names:

• Nithiodote

Dosage Forms:

• Solution

Warnings:

Sodium nitrite can cause serious adverse reactions and death from hypotension and methemoglobin formation. Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with sodium nitrite .

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. It is more likely to occur if you breathe smoke from closed-space household and industrial fires, or you have swallowed or breathe cyanide (a chemical poison), or your skin is exposed to cyanide.

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.

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 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 doctor or an emergency care provider 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 to make sure 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. Check with your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly, sweating, or unusual tiredness or weakness.

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. Check with your doctor right away if you or your child has bluish-colored lips, fingernails, or palms, dark urine, difficulty breathing, fever, headache, pale skin, rapid heart rate, sore throat, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

sore throat

sweating

tightness in the chest

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

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

Anxiety

confusion about identity, place, and time

headache

hives or welts, itching, skin rash

increased sweating

redness of the skin

salty taste in your mouth

stomach pain

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.