Patient Medication Information: uses, side effects, how to take - Sodium Nitrite Injection, USP
ABOUT THIS MEDICATION
What the medication is used for:
Sodium Nitrite Injection is used as an antidote for cyanide poisoning. Cyanide poisoning is a condition that develops when you inhale, touch, or swallow cyanide. Cyanide is a poisonous chemical that prevents your body from absorbing oxygen. The lack of oxygen can damage your organs and be life-threatening.
How does sodium nitrite injection work?:
Sodium Nitrite Injection works by helping to prevent cyanide from binding to important enzymes in the cells of your body, allowing you to continue breathing.
What the medicinal ingredient is:
Sodium nitrite
What the non-medicinal ingredients are:
Water
Sodium Nitrite Injection comes in the following dosage form:
Each 10 mL vial of Sodium Nitrite Injection contains 300 mg of the active ingredient sodium nitrite (30 mg/mL).
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions:
Sodium nitrite can cause serious adverse reactions and death in humans, even at doses less than twice the recommended therapeutic dose. Sodium nitrite causes low blood pressure and methemoglobin formation in blood, which reduces the ability of blood to carry oxygen. Low blood pressure and methemoglobin formation can occur at the same time or separately and can cause harm. Due to these risks, the healthcare professional will decide whether to use this antidote.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you are administered Sodium Nitrite Injection. Talk about any health conditions you may have including if you:
- have kidney problems;
are pregnant or breast-feeding;
- have low blood pressure;
- have a condition called anemia (This is a reduction in number of red blood cells in the bloodstream. Anemia can make the skin appear pale and can cause weakness or breathlessness);
- suffer from Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency (This may result in anemia.);
- have a history of elevated levels of methemoglobin (This is a modified form of hemoglobin that reduces the amount of oxygen in the bloodstream and can cause weakness or breathlessness.);
- have inhaled smoke from a fire;
INTERACTIONS WITH THIS MEDICATION
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements, or alternative medicines.
The following medicines have side effects that are similar to the side effects that may occur with sodium nitrite.
- Other cyanide antidotes;
- Medicines used to treat high blood pressure such as beta blockers, diuretics, and nitrates;
- Medicines that can increase methemoglobin levels such as procaine (used as a local anesthetic) and nitroprusside (used to reduce blood pressure)
It may be necessary for your doctor to adjust the dose of sodium nitrite or one of your other medications.
Sodium nitrite should not be taken at the same time as hydroxocobalamin through the same intravenous line as compatibility of the products is not known.
HOW SODIUM NITRITE INJECTION IS ADMINISTERED
Usual dose:
Sodium nitrite will be given by injection into a vein by a doctor or nurse. Your doctor will choose the dose that is right for you and may monitor your blood pressure after injection. If signs of cyanide poisoning reappear, your doctor will decide if you should receive more sodium nitrite. Your doctor will monitor your condition 24-48 hours after injection and may run blood tests.
Overdose:
Overdosing is unlikely. If it does happen, your doctor will treat any symptoms that follow.
| If you think you have taken too much sodium nitrite, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms. |
WHAT ARE THE POSSIBLE SIDE EFFECTS FROM USING SODIUM NITRITE
INJECTION?
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects of sodium nitrite include:
- Cardiovascular: reduced blood pressure, rapid heart rate, irregular pulse, fainting, palpitations
- Blood disorder: oxygen deprivation in tissues (methemoglobinemia)
- Central nervous system: headache, dizziness, blurred vision, seizures, confusion, coma
- Psychiatric: anxiety
- Gastrointestinal: nausea, vomiting, abdominal pain
- Respiratory: rapid breathing, shortness of breath
- Skin: urticaria (skin rash notable for pale, red, raised, itchy bumps)
- Body as a whole: sweating, light headedness, injection site tingling, fatigue, weakness, generalized numbness and tingling, blue or purple colored skin
The frequencies at which the above reactions occur are not known yet.
Death was reported after administration of a dose of sodium nitrite that was higher than the recommended therapeutic dose, but less than twice the recommended therapeutic dose.
These are not all the possible side effects you may feel when taking Sodium Nitrite Injection. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.
If you get any side effects, or they become troublesome, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
HOW TO STORE IT
The healthcare professional will store the product at room temperature 15° to 30°C (59 to 86°F).
Reporting Side Effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information. 3 ways to report:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
If you want more information about Sodium Nitrite:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website www.nitrite.ca, or by calling 1-800-755-9595.
Hope Pharmaceuticals, Ltd.
522A Clarke Road, Suite 299
Coquitlam, BC V3J 0A3
Canada