Sodium Nitroprusside for Injection (Marcan Pharmaceuticals): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• The immediate reduction of blood pressure of

  patients in hypertensive crises who have not responded adequately to standard treatment.

• Producing controlled hypotension (low blood

  pressure) in order to reduce bleeding during surgery when both the surgeon and anaesthesiologist decide it is necessary.

What it does:

Sodium Nitroprusside for Injection is a vasodilator that works by relaxing the muscles in your blood vessels to help them dilate (widen). This lowers blood pressure.

When it should not be used:

Sodium Nitroprusside for Injection should not be used if you:

• Are allergic to Sodium Nitroprusside;

• Are a physically poor risk patient being

  treated for compensatory hypertension (mechanism to correct high blood pressure);

• Have low brain circulation;

• Have anemia (a reduction of red blood cells)

  If you are going to receive this drug in surgery, please tell your doctor if you:

• Have liver disease
• Have severe kidney disease
• Have hereditary vision loss (Leber’s disease)

• Have vision problems caused by smoking

  • Have a history of blood clot in your brain
  • Have vitamin B₁₂ deficiency.

What the nonmedicinal ingredient is: Water for injection

What the medicinal ingredient is:

Sodium Nitroprusside

Sodium Nitroprusside for Injection is available as a sterile, clear, reddish-brown solution, free from visible particulates. Each 2 mL vial contains the equivalent of 50 mg Sodium Nitroprusside dihydrate in sterile water for injection.

What dosage forms it comes in:

Sodium Nitroprusside for Injection is a solution available in single-use amber glass vials in 50 mg / 2 mL format (25 mg / mL), containing Sodium Nitroprusside, in water for injection.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• Sodium Nitroprusside for Injection is only to be used as an intravenous infusion with 5% Dextrose. Not for direct injection.
• Sodium Nitroprusside for Injection can cause rapid decreases in blood pressure. In patients not properly monitored, these decreases can lead to irreversible injuries or death related to poor blood supply. Sodium Nitroprusside for Injection should be used only when available equipment and personnel allow blood pressure to be continuously monitored.
• Except when used briefly or at low infusion rates, Sodium Nitroprusside for Injection gives rise to important quantities of cyanide ion which can cause death.

BEFORE receiving Sodium Nitroprusside for Injection tell your doctor if:

• You have liver disease, kidney disease, anemia (a reduction of red blood cells), a seizure disorder, or a history of head injury or

brain tumor, hypothyroidism (you do not produce enough thyroid hormone), difficulty breathing;

• You have an existing severe disease that may

  make you a poor candidate to undergo surgery;

• You are pregnant, plan to become pregnant or

  are breastfeeding;

• Geriatrics: you may experience a stronger

  lower blood pressure when you receive Sodium Nitroprusside for Injection, please tell your doctor your age.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with Sodium Nitroprusside for Injection include: medications to help lower your blood pressure (specifically, hydralazine or hexamethonium)

PROPER USE OF THIS MEDICATION

Sodium Nitroprusside for Injection is only given in hospital with adequate equipment and trained personnel who can monitor you frequently for changes to your blood pressure. It is only given using an infusion pump, micro-drip regulator or any similar device that would allow precise measurement of the flow rate of the intravenous.

Sodium Nitroprusside for Injection is only to be used as an intravenous infusion with 5% Dextrose. Sodium Nitroprusside for Injection is not for direct injection.

The infusion fluid used for administration of Sodium Nitroprusside for Injection should not be employed as a vehicle for simultaneous administration of any other drug.

Usual dose:

Your health care professionals will decide the best dose for you. Sodium Nitroprusside for Injection must be diluted in 500 to 1000 ml of 5% Dextrose Injection. No other diluents should be used. The diluted solution should be protected from light, using the supplied opaque sleeve, aluminum foil or other opaque materials. The infusion solution should be freshly prepared and

any unused portion discarded. The freshly prepared solution for infusion has a very faint brownish tint. If it is highly coloured, it should be discarded.

Storage period from the time of reconstitution to the completion of intravenous administration should not exceed 24 hours.

As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitate, discolouration and leakage prior to administration whenever solution and container permit. Solutions showing haziness, particulate matter, precipitate, discolouration or leakage should not be used. Discard unused portion.

Tell your health care practitioner right away if you think that your IV has come out of the vein, or if it becomes sore, red or swollen.

Overdose:

If you think you have taken too much Sodium Nitroprusside for Injection, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Seek emergency medical attention if you think you have received too much of this medicine. Symptoms of Sodium Nitroprusside for Injection overdose may include low blood pressure, shortness of breath, shallow breathing, nausea, vomiting, stomach pain, sweating, severe dizziness, headache, muscle twitching, fast or pounding heartbeat, restless feeling, loss of consciousness, and chest or back pain.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its needed effects, a medicine may cause some unwanted effects. These are referred to as “side effects.” Although not all of these side effects may occur, if they do occur they may need medical attention.

Nausea, retching, vomiting, sweating,

apprehension, headache, restlessness, agitation, muscle twitching, abdominal pain, have been noted with too rapid reduction in blood pressure. However, these symptoms rapidly disappear with slowing of the rate of the infusion or temporary discontinuation of the infusion. Your doctor will decide the best rate of infusion for you.

Irritation of the injection site may occur.

This is not a complete list of side effects. For any unexpected effects while taking Sodium Nitroprusside Injection, contact your doctor or pharmacist.

HOW TO STORE IT

Store at room temperature (15°C- 30°C), protect from light and freezing.

Keep out of the reach and sight of children

Protect from light, using the supplied opaque sleeve, aluminum foil, or other opaque material. It is not necessary to cover the infusion drip chamber or the tubing.

The storage period from the time of reconstitution to the completion of intravenous administration should not exceed 24 hours.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse

  Reaction Reporting

  https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html for information on how to report online, by mail or by fax; or

• Calling toll-free at 1-866-234-2345.

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. I

MORE INFORMATION

For more information, please contact your healthcare professionals or pharmacist first, or Marcan Pharmaceuticals Inc. at: 1-855-627-2261 or visit the website at www.marcanpharma.com

The information in this document is current as of the last revision date shown below. For the most current information please visit our website or

contact us directly.

Marcan Pharmaceuticals Inc. 2 Gurdwara Road, Suite #112 Ottawa, ON K2E 1A2

Date of Preparation: July 19, 2018