Biorphen Dosage

General Dosage and Administration Instructions

During BIORPHEN administration:

• Correct intravascular volume depletion.
• Correct acidosis. Acidosis may reduce the effectiveness of phenylephrine.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if the solution is colored or cloudy, or if it contains particulate matter. Discard any unused portion.

BIORPHEN 0.1 mg/mL and 10 mg/mL Injection have important differences in administration instructions:

Administration Instructions for BIORPHEN 0.1 mg/mL Injection:

BIORPHEN 0.1 mg/mL injection MUST NOT BE DILUTED before administration as an intravenous bolus. It is supplied as READY-TO-USE formulation.

Administration Instructions for BIORPHEN 10 mg/mL Injection:

BIORPHEN 10 mg/mL injection MUST BE DILUTED before administration as an intravenous bolus or continuous intravenous infusion to achieve the desired concentration:

• Bolus: Dilute with normal saline or 5% dextrose in water.
• Continuous infusion: Dilute with normal saline or 5% dextrose in water.

The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions.

Dosing for Treatment of Hypotension during Anesthesia

The following are the recommended dosages for the treatment of hypotension during anesthesia.

BIORPHEN 0.1 mg/mL Injection:

• The recommended initial dose is 40 mcg to 100 mcg administered by intravenous bolus. Additional boluses up to 200 mcg may be administered every 1 to 2 minutes as needed.
• Adjust dosage according to the blood pressure goal.

BIORPHEN 10 mg/mL Injection:
• The recommended initial dose is 40 mcg to 100 mcg administered by intravenous bolus. Additional boluses up to 200 mcg may be administered every 1 to 2 minutes as needed.
• If blood pressure is below the target goal, start a continuous intravenous infusion with an infusion rate of 10 mcg/minute to 35 mcg/minute; not to exceed 200 mcg/minute.
• Adjust dosage according to the blood pressure goal.

2.3 Preparation of a 100 mcg/mL Solution for Bolus Intravenous Administration from BIORPHEN
10 mg/mL Injection

For bolus intravenous administration, prepare a solution containing a final concentration of 100 mcg/mL of BIORPHEN 10 mg/mL Injection:

• Withdraw 10 mg i.e. 1 mL of BIORPHEN 10 mg/mL Injection and dilute with 99 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP.
• Withdraw an appropriate dose from the 100 mcg/mL solution prior to bolus intravenous administration.

2.4 Preparation of Solution for Continuous Intravenous Administration from BIORPHEN
10 mg/mL Injection

For continuous intravenous infusion, prepare a solution containing a final concentration of 20 mcg/mL of BIORPHEN 10 mg/mL Injection in 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP.

• Withdraw 10 mg i.e. 1 mL of BIORPHEN 10 mg/mL Injection and dilute with 500 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP.