sodium nitrite and sodium thiosulfate Intravenous

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

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 .

Commonly used brand name(s)

In the U.S.

• Nithiodote

Available Dosage Forms:

• Solution

Uses For sodium nitrite and sodium thiosulfate

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.

sodium nitrite and sodium thiosulfate is to be given only by or under the direct supervision of a doctor.

Before Using sodium nitrite and sodium thiosulfate

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 sodium nitrite and sodium thiosulfate, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to sodium nitrite and sodium thiosulfate 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.

Pediatric

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.

Geriatric

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 Category	Explanation
All Trimesters	C	Animal 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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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 sodium nitrite and sodium thiosulfate. 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 sodium nitrite and sodium thiosulfate

A nurse or other trained health professional will give you or your child sodium nitrite and sodium thiosulfate in a hospital. sodium nitrite and sodium thiosulfate is given through a needle placed in one of your veins.

Precautions While Using sodium nitrite and sodium thiosulfate

Your doctor will check your or your child's progress closely while you are receiving sodium nitrite and sodium thiosulfate. 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 sodium nitrite and sodium thiosulfate. 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 sodium nitrite and sodium thiosulfate.

sodium nitrite and sodium thiosulfate 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 sodium nitrite and sodium thiosulfate.

sodium nitrite and sodium thiosulfate Side Effects

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.

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