PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC- phenylephrine hydrochloride solution/ drops
HUB Pharmaceuticals, LLC
PHENYLEPHRINE HYDROCHLORIDE- phenylephrine hydrochloride injection
West-Ward Pharmaceutical Corp.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
WARNING:
PHYSICIANS SHOULD COMPLETELY FAMILIARIZE THEMSELVES WITH THE COMPLETE CONTENTS OF THIS LEAFLET BEFORE PRESCRIBING PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC SOLUTION.
DESCRIPTION:
Phenylephrine Hydrochloride Ophthalmic Solution is a sterile solution used as a vasoconstrictor and mydriatic for use in ophthalmology.
Phenylephrine hydrochloride is a synthetic sympathomimetic compound structurally similar to epinephrine and ephedrine.
(-)-m -Hydroxy-?-[(methylamino)methyl] benzyl alcohol hydrochloride Phenylephrine Hydrochloride Ophthalmic Solution is available in two strengths, 2.5% and 10%.
Each mL of the 2.5% solution contains: Phenylephrine Hydrochloride 2.5%. Dibasic and Monobasic Sodium Phosphates, Boric Acid, with Benzalkonium Chloride as preservative in Water for Injection q.s.
Each mL of the 10% solution contains: Phenylephrine Hydrochloride 10%, Dibasic and Monobasic Sodium Phosphates with Benzalkonium Chloride as preservative in Water for Injection q.s.
Hydrochloric Acid and/or Sodium Hydroxide may have been used to adjust pH of both solutions.
CLINICAL PHARMACOLOGY:
Phenylephrine Hydrochloride Ophthalmic Solution possesses predominantly (?-adrenergic effects. In the eye, phenylephrine acts locally as a potent vasoconstrictor and mydriatic, by constricting ophthalmic blood vessels and radial muscle of the iris.
INDICATIONS AND USAGE
Phenylephrine Hydrochloride is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation, in such settings as septic shock or anesthesia.
2.1 General Administration Instructions
Phenylephrine hydrochloride must be diluted before administration as bolus intravenous infusion or continuous intravenous infusion.
Inspect the solution for particulate matter and discoloration prior to administration. The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions. Discard any unused portion.
During phenylephrine hydrochloride administration:
Correct intravascular volume depletion.
Correct acidosis. Acidosis may reduce the effectiveness of phenylephrine.
2.2 Preparing a 100 mcg/mL Solution of Bolus Intravenous Administration
For bolus intravenous administration, withdraw 10 mg (1 mL of a 10 mg/mL concentration) of phenylephrine injection and dilute with 99 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. This will yield a final concentration of 100 mcg/mL. Withdraw an appropriate dose from the 100 mcg/mL solution prior to bolus intravenous administration.
2.3 Preparing a Solution for Continuous Intravenous Infusion
For continuous intravenous infusion, withdraw 10 mg (1 mL of 10 mg/mL concentration) of phenylephrine hydrochloride injection and add to 500 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP (providing a final concentration of 20 mcg/mL).
2.4 Dosing for Perioperative Setting
In adult patients undergoing surgical procedures with either neuraxial anesthesia or general anesthesia:
50 mcg to 250 mcg by intravenous bolus administration. The most frequently reported initial bolus dose is 50 mcg or 100 mcg.
0.5 mcg/kg/min to 1.4 mcg/kg/min by intravenous continuous infusion, titrated to blood pressure goal.
2.5 Dosing for Septic or Other Vasodilatory Shock
In adult patients with septic or other vasodilatory shock:
No bolus.
0.5 mcg/kg/min to 6 mcg/kg/min by intravenous continuous infusion, titrated to blood pressure goal. Doses above 6 mcg/kg/min do not show significant incremental increase in blood pressure.
3 DOSAGE FORMS AND STRENGTHS
Injection: 10 mg/mL phenylephrine hydrochloride is supplied as a 1 mL single dose vial
Phenylephrine hydrochloride is recommended for use as a decongestant and vasoconstrictor and for pupil dilation in uveitis (posterior synechiae). Wide angle glaucoma, prior to surgery, refraction, ophthalmoscopic examination, and diagnostic procedures.
DOSAGE AND ADMINISTRATION:
Prolonged exposure to air or strong light may cause oxidation and discoloration. Do not use if solution is brown or contains a precipitate.
