SOE-dee-um NYE-trite, SOE-dee-um thye-oh-SUL-fate
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 .
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.
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:
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.
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.
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.
|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.|
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.
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.
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:
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.
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.
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:
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:
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.