Details for: SODIUM NITROPRUSSIDE FOR INJECTION
Company: MARCAN PHARMACEUTICALS INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02479109 | SODIUM NITROPRUSSIDE FOR INJECTION | SODIUM NITROPRUSSIDE | 25 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
- 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)
- 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 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 the non-medicinal ingredients are
Water for injection
What dosage form 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
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.
Missed Dose
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.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and get immedia te medical help |
|---|---|---|---|
| Common | |||
| Feeling dizzy and faint or your blood pressure is too low. | ✔ | ||
| Difficulty breathing | ✔ | ||
| Swelling in the arms or legs | ✔ | ||
| Uncommon | |||
| Feeling an irregular heart beat | ✔ | ||
| Rash or other skin irritation | ✔ | ||
| Weakness | ✔ | ||
| Chest pain | ✔ | ||
| Confusion and somnolence (a strong desire for sleep) | ✔ | ||
| Methemoglobine mia, Symptoms include: Shortness of breath, blueness at mouth and finger tips, headache, fatigue dizziness and loss of consciousness. | ✔ | ||
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
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 adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
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.
This leaflet was prepared by:
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite #112
Ottawa, ON K2E 1A2
Date of Preparation: July 19, 2018