PHENYLEPHRINE HYDROCHLORIDE- phenylephrine hydrochloride injection
Phenylephrine hydrochloride Injection, 10 mg/mL is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
Phenylephrine hydrochloride Injection, 10 mg/mL 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.
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. 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 injection administration:
- Correct intravascular volume depletion.
- Correct acidosis. Acidosis may reduce the effectiveness of phenylephrine.
The following are the recommended dosages for the treatment of hypotension during anesthesia.
- The recommended initial dose is 40 to 100 mcg administered by intravenous bolus. May administer additional boluses every 1-2 minutes as needed; not to exceed a total dosage of 200 mcg.
- If blood pressure is below the target goal, start a continuous intravenous infusion with an infusion rate of 10 to 35 mcg/minute; not to exceed 200 mcg/minute.
- Adjust dosage according to the blood pressure goal.
For bolus intravenous administration, prepare a solution containing a final concentration of 100 mcg/mL of Phenylephrine hydrochloride injection :
- Withdraw 10 mg (1 mL of 10 mg/mL) of Phenylephrine hydrochloride 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.
For continuous intravenous infusion, prepare a solution containing a final concentration of 20 mcg/mL of Phenylephrine hydrochloride injection in 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP:
- Withdraw 10 mg (1 mL of 10 mg/mL) of Phenylephrine hydrochloride injection and dilute with 500 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP.
The Pharmacy Bulk Vial is intended for dispensing of single doses to multiple patients in a pharmacy admixture program and is restricted to the preparation of admixtures for infusion. Each closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set that allows measured dispensing of the contents. The Pharmacy Bulk Vial is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). Dispensing from a pharmacy bulk vial should be completed within 4 hours after the vial is penetrated.
Phenylephrine hydrochloride Injection, 10 mg/mL is available in three vial sizes:
- Injection: 10 mg/mL in a single dose 1 mL vial (10 mg of phenylephrine hydrochloride per vial)
- Injection: 10 mg/mL in Pharmacy Bulk Package 5 mL vial (50 mg of phenylephrine hydrochloride per vial) that will provide five 1 mL single doses
- Injection: 10 mg/mL in Pharmacy Bulk Package 10 mL vial (100 mg of phenylephrine hydrochloride per vial) that will provide ten 1 mL single doses
Because of its increasing blood pressure effects, Phenylephrine hydrochloride injection can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.
Phenylephrine hydrochloride injection can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease.
Extravasation of Phenylephrine hydrochloride injection can cause necrosis or sloughing of tissue. The infusion site should be checked for free flow. Care should be taken to avoid extravasation of Phenylephrine hydrochloride injection.
Phenylephrine hydrochloride injection can cause severe bradycardia and decreased cardiac output.
Phenylephrine hydrochloride injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Phenylephrine hydrochloride injection can increase the need for renal replacement therapy in patients with septic shock. Monitor renal function.
The increasing blood pressure response to adrenergic drugs, including Phenylephrine hydrochloride injection, can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries.
Oxytocic drugs potentiate the increasing blood pressure effect of sympathomimetic pressor amines including Phenylephrine hydrochloride injection [ see Drug Interactions ( 7.1)] , with the potential for hemorrhagic stroke.
Adverse reactions to Phenylephrine hydrochloride injection are primarily attributable to excessive pharmacologic activity. Adverse reactions reported in published clinical studies, observational trials, and case reports of Phenylephrine hydrochloride injection are listed below by body system. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Cardiac disorders: Reflex bradycardia, lowered cardiac output, ischemia, hypertension, arrhythmias
Gastrointestinal disorders: Epigastric pain, vomiting, nausea
Nervous system disorders: Headache, blurred vision, neck pain, tremors
Vascular disorders: Hypertensive crisis
Respiratory, Thoracic and Mediastinal Disorders: Dyspnea
Skin and subcutaneous tissue disorders: Pruritis
The increasing blood pressure effect of Phenylephrine hydrochloride injection is increased in patients receiving:
Monoamine oxidase inhibitors (MAOI)
Oxytocin and oxytocic drugs
Steroids, such as hydrocortisone
Norepinephrine transporter inhibitors, such as atomoxetine
Ergot alkaloids, such as methylergonovine maleate
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.