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SODIUM NITRITE is a brand name for Sodium Nitrite, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
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.
); 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.
Page 20 of 22 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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. Page 21 of 22 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). Page 22 of 22 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: Online at MedEffect; By calling 1-866-234-2345 (toll-free); By completing a Consumer Side Effect Reporting Form and sending it by: - Fax to 1-866-678-6789 (toll-free), or - Mail to: Canada Vigilance Program Health Canada, Postal Locator 0701E Ottawa, ON K1A 0K9 Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.
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. ca, or by calling 1-800-755-9595.
This leaflet was prepared by:
Hope Pharmaceuticals, Ltd. 522A Clarke Road, Suite 299 Coquitlam, BC V3J 0A3 Canada Last revised: April 27, 2015