SODIUM NITROPRUSSIDE BAXTER sodium nitroprusside 50 mg/2 mL concentrated injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium nitroprusside, Quantity: 50 mg

Available from:

Baxter Healthcare Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: water for injections

Administration route:

Intravenous

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

SODIUM NITROPRUSSIDE BAXTER concentrated injection is indicated for:,1. Immediate reduction of blood pressure in patients with hypertensive crises. Concomitant oral antihypertensive medication should be started while the hypertensive emergency is being brought under control with sodium nitroprusside.,2. Producing controlled hypotension during anaesthesia in order to reduce bleeding in surgical procedures where surgeon and anaesthetist deem it appropriate.,3. Short term therapy of cardiac failure, to enhance cardiac output and lower myocardial oxygen requirements. Patients should be commenced on oral therapy as soon as possible.

Product summary:

Visual Identification: SODIUM NITROPRUSSIDE BAXTER concentrated injection is a clear, reddish brown colour solution available in 2 mL amber coloured, rubber stoppered vial. The product is practically free from visible particles.; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2023-05-16

Patient Information leaflet

SODIUM NITROPRUSSIDE BAXTER
1
SODIUM NITROPRUSSIDE BAXTER
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING SODIUM NITROPRUSSIDE BAXTER?
SODIUM NITROPRUSSIDE BAXTER contains the active ingredient Sodium
nitroprusside. SODIUM NITROPRUSSIDE BAXTER is
used for;
•
Immediate reduction of blood pressure in patients with hypertensive
crises
•
Producing controlled hypotension during anaesthesia in order to reduce
bleeding in surgical procedures
•
Short term therapy of cardiac failure, to enhance cardiac output and
lower myocardial oxygen requirements
For more information, see Section 1. Why am I using SODIUM
NITROPRUSSIDE BAXTER? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SODIUM NITROPRUSSIDE BAXTER?
Do not use if you have ever had an allergic reaction to SODIUM
NITROPRUSSIDE BAXTER or any of the ingredients listed at the
end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
SODIUM NITROPRUSSIDE BAXTER?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with SODIUM NITROPRUSSIDE BAXTER and
affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE SODIUM NITROPRUSSIDE BAXTER?
•
SODIUM NITROPRUSSIDE BAXTER should only be used as an infusion with
sterile 5% Glucose in water. It should not be
administered by direct injection.
•
This medicinal product must not be mixed with other medicinal
products. SODIUM NITROPRUSSIDE BAXTER is for single use
in one patient only. Discard any residue.
More instructions can be found in Section 4. How do I use SODIUM
NITROPRUSSIDE BAXTER?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SODIUM NITROPRUSSIDE BAXTER?
THINGS YOU
SHOULD DO
•
Tell

Summary of Product characteristics

Version 2.0 Page 1 of 15
AUSTRALIAN
PRODUCT
INFORMATION
–
SODIUM NITROPRUSSIDE BAXTER 50 MG/2 ML
CONCENTRATED
INJECTION
VIAL
(SODIUM
NITROPRUSSIDE)
1.
NAME OF THE MEDICINE
Sodium nitroprusside
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
SODIUM NITROPRUSSIDE BAXTER concentrated injection is a sterile
solution containing
the
equivalent
of
50
milligram
of
sodium
nitroprusside
dihydrate
[sodium
nitrosylpentacyanoferrate (III)] per 2 mL.
For the full list of excipients see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
SODIUM NITROPRUSSIDE BAXTER concentrated injection is a clear, reddish
brown color
solution available in amber glass vials containing the equivalent of
50 mg sodium nitroprusside
dihydrate in 2 mL solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SODIUM NITROPRUSSIDE BAXTER concentrated injection is indicated for:
1.
Immediate reduction of blood pressure in patients with hypertensive
crises. Concomitant
oral antihypertensive medication should be started while the
hypertensive emergency is
being brought under control with sodium nitroprusside.
2.
Producing controlled hypotension during anaesthesia in order to reduce
bleeding in surgical
procedures where surgeon and anaesthetist deem it appropriate.
3.
Short term therapy of cardiac failure, to enhance cardiac output and
lower myocardial
oxygen requirements. Patients should be commenced on oral therapy as
soon as possible.
4.2
DOSE AND METHOD OF ADMINISTRATION
SODIUM NITROPRUSSIDE IS ONLY TO BE USED AS AN INFUSION WITH
STERILE 5% GLUCOSE IN WATER.
IT SHOULD NOT BE ADMINISTERED BY
DIRECT INJECTION.
Product is for single use in one patient only. Discard any residue.
Version 2.0 Page 2 of 15
DOSAGE
_DILUTION TO PROPER STRENGTH FOR INFUSION: _
Depending on the desired concentration, SODIUM NITROPRUSSIDE BAXTER
concentrated
injection containing 50 mg/2 mL sodium nitroprusside must be further
diluted in 500-1000 mL
of sterile 5% glucose injection. The diluted solution should be
protected from light, using the
supplied opaque sleeve, alumini