NOREPINEPHRINE SCIGEN CONCENTRATE FOR SOLUTION FOR INFUSION 4 MG/4ML [SIN17453P]

Product Info

NOREPINEPHRINE SCIGEN CONCENTRATE FOR SOLUTION FOR INFUSION 4 MG/4ML

[SIN17453P]

Indication

INDICATIONS AND USAGE

Norepinephrine SciGen is indicated to raise blood pressure in adult patients with severe, acute hypotension.

Dosing

DOSAGE AND ADMINISTRATION

Extravasation of drug solution may cause necrosis and sloughing of surrounding tissue. To reduce the risk of extravasation, infuse into a large vein, check the infusion site frequently for free flow, and monitor for signs of extravasation.
Visually inspect the product for particulate matter and discoloration prior to use (the solution is colorless). Do not use the solution if its color is pinkish or darker than slightly yellow or if it contains a precipitate.

Preparation of Diluted Solution
Use 5% Dextrose Injection or Sodium Chloride Injection solutions that contain 5% dextrose as diluent to produce 4 mcg per ml dilution. Dextrose reduces loss of potency due to oxidation. Administration in saline solution alone is not recommended.
The degree of dilution depends on clinical fluid volume requirements. Use higher concentration solutions in patients requiring fluid restriction.

Chemical and physical in-use stability has been demonstrated for 24 hours at 25 °C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.

Correct Hypovolemia
Address hypovolemia before initiation of Norepinephrine SciGen therapy. If the patient does not respond to therapy, suspect occult hypovolemia.

Dosage
After an initial dosage of 8 to 12 mcg per minute via intravenous infusion, assess patient response and adjust dosage to maintain desired hemodynamic effect. Monitor blood pressure every two minutes until the desired hemodynamic effect is achieved, and then monitor blood pressure every five minutes for the duration of the infusion. Typical maintenance intravenous dosage is 2 to 4 mcg per minute.

Discontinuation
When discontinuing the infusion, reduce the flow rate gradually. Avoid abrupt withdrawal.

Drug Incompatibilities
Avoid contact with iron salts, alkalis, or oxidizing agents.
Whole blood or plasma, if indicated to increase blood volume, should be administered separately.

Contraindications

CONTRAINDICATIONS

None.