Details for: SODIUM NITRITE INJECTION, USP
Company: HOPE PHARMACEUTICALS LTD
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02440466 | SODIUM NITRITE INJECTION, USP | SODIUM NITRITE | 30 MG / ML | SOLUTION | INTRAVENOUS |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
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.
What it does
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
What dosage form it comes in
Each 10 mLvial of Sodium Nitrite Injection contains 300 mg of the active ingredientsodium 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)
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.
Proper use of this medication
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.
Side effects and what to do about them
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
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 anyside effects, or they become troublesome, talk to yourdoctor or pharmacist. This includes any possible side effects not listed in thisleaflet.
How to store
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:
- 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
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.
More information
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
Last revised: April 27, 2015