LEVOPHED INJECTION 1 mg/ml

1 INDICATIONS AND USAGE

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

4 CONTRAINDICATIONS

None.

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

Correct Hypovolemia

Address hypovolemia before initiation of LEVOPHED therapy. If the patient does not respond to therapy, suspect occult hypovolemia [see Warnings and Precautions (5.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

Administration

Dilute LEVOPHED prior to use [see Dosage and Administration (2.3)].

Infuse LEVOPHED into a large vein. Avoid infusions into the veins of the leg in the elderly or in patients with occlusive vascular disease of the legs [see Warnings and Precautions (5.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Avoid using a catheter-tie-in technique.

Discontinuation

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

2.2 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.

2.3 Preparation of Diluted Solution

Visually inspect LEVOPHED for particulate matter and discoloration prior to administration (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.

Add the content of one LEVOPHED vial or ampule (4 mg in 4 mL) to 1,000 mL of 5% Dextrose Injection, USP or Sodium Chloride Injection solutions that contain 5% dextrose to produce a 4 mcg per mL dilution. Dextrose reduces loss of potency due to oxidation. Administration in saline solution alone is not recommended.

Use higher concentration solutions in patients requiring fluid restriction.

2.4 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.