Phenylephrine hydrochloride is an α1-adrenergic receptor agonist.140, 141, 501
Phenylephrine hydrochloride is used parenterally in the setting of anesthesia or septic shock to treat clinically important hypotension resulting principally from vasodilation.140, 141, 501 The drug has also been used to treat hypotension due to cardiogenic shock† in certain patients (e.g., patients with aortic or mitral valve stenosis, patients with hypertrophic cardiomyopathy and left ventricular outflow tract obstruction).264 265, 266
Evidence supporting the use of IV phenylephrine is based on studies from the published literature, the majority of which were conducted in the perioperative setting.140, 141, 501 The available data indicate that phenylephrine is effective in increasing and maintaining blood pressure in hypotensive patients.140, 141, 501
Studies performed in a variety of surgical settings have demonstrated that phenylephrine increases systolic and mean arterial blood pressure when administered IV (as a direct “bolus” injection or continuous infusion) following the development of hypotension in patients receiving neuraxial and/or general anesthesia.140, 501 In many of these studies, the drug was used in low-risk pregnant women undergoing cesarean section with neuraxial anesthesia.140, 141, 147, 149, 501 Phenylephrine also has been used for the prevention of hypotension in patients undergoing spinal anesthesia for caesarean section; although prophylactic use of phenylephrine may help reduce the incidence of hypotension in this setting, it has not been shown to eliminate the need for treatment of maternal hypotension in all women.257, 258
Although data are limited, studies have shown that phenylephrine increases mean arterial pressure in patients with septic shock.141, 156 Effects on mean arterial pressure and mortality appear to be similar between phenylephrine and other vasopressors used in the setting of septic shock.259, 260
The American College of Obstetricians and Gynecologists (ACOG) and the American Society of Anesthesiologists (ASA) have published guidelines on obstetric anesthesia that include recommendations regarding vasopressor therapy.261, 262 According to ACOG, approximately 10% of women will develop hypotension with low-dose neuraxial labor analgesia.261 When hypotension occurs, it can be treated with IV vasopressors.261 The ASA guideline states that either IV ephedrine or IV phenylephrine may be used to treat hypotension during neuraxial anesthesia.262 In the absence of maternal bradycardia, phenylephrine should be considered over ephedrine because it has been associated with improved fetal acid-base status in uncomplicated pregnancies.262
The Surviving Sepsis guidelines provide recommendations for management of blood pressure in septic shock.263 In these guidelines, norepinephrine is recommended first-line over other vasopressors; if norepinephrine is not adequate to maintain mean arterial pressure, vasopressin may be added.263 Epinephrine may be added to norepinephrine and vasopressin if mean arterial pressure remains inadequate.263 For adults with septic shock and cardiac dysfunction with persistent hypoperfusion despite adequate volume status and arterial blood pressure, guidelines suggest either adding dobutamine to norepinephrine or using epinephrine alone.263 No recommendations for or against the use of phenylephrine are present in the guideline.263
Phenylephrine has been used via intracavernosal injection† for the treatment of priapism†.268 The American Urological Association recommends intracavernosal phenylephrine and corporal aspiration first line for the treatment of acute ischemic priapism.268 Intracavernosal phenylephrine is also recommended as initial therapy for prolonged erections (<4 hours) that occur following administration of intracavernosal erectile dysfunction therapies.268 Other prolonged erections should be managed with intracavernosal phenylephrine when conservative management is ineffective.268
Dispensing and Administration Precautions
Phenylephrine hydrochloride is administered by IV bolus or continuous IV infusion for the treatment of clinically important hypotension.140, 141, 501 The drug is available as a 10 mg/mL phenylephrine hydrochloride injection concentrate that must be diluted prior to administration and as a ready-to-use phenylephrine hydrochloride 100 mcg/mL (Immphentiv®, Biorphen®) injection.140, 141, 501 Ready-to-use phenylephrine hydrochloride 100 mcg/mL (Immphentiv®, Biorphen®) injection should not be further diluted before IV bolus administration.141, 501
For treatment of hypotension during anesthesia, the manufacturers recommend administration of phenylephrine hydrochloride as an IV bolus or continuous infusion; when used in the treatment of septic shock, the drug should be administered as a continuous IV infusion with no initial bolus dose.140, 141, 501 Phenylephrine hydrochloride injection should be stored at 20-25°C, but may be exposed to temperatures ranging from 15-30°C; single-dose and pharmacy bulk vials should be kept in their original carton until time of use and protected from light.140, 141, 501
Commercially available phenylephrine hydrochloride injection concentrate must be diluted with a compatible IV solution prior to administration.140, 141 Diluted solutions may be stored at room temperature for up to 4 hours or under refrigeration for up to 24 hours; any unused portions should be discarded.140, 141, 501
Commercially available phenylephrine hydrochloride bulk vials are intended for use in a pharmacy admixture program for preparation of single doses to be dispensed to multiple patients.140 Each vial should be penetrated only one time with a suitable sterile transfer device or dispensing set.140 Dispensing from a pharmacy bulk vial should be completed within 4 hours after the vial is penetrated.140
Prior to administration, phenylephrine hydrochloride solutions should be inspected visually for particulate matter and discoloration; the drug should be discarded if the solution is colored, cloudy, or contains any particulate matter.140, 141
Care should be taken to avoid extravasation and the infusion site should be checked for free flow.140
Commercially available phenylephrine hydrochloride injection concentrate must be diluted with a compatible IV solution prior to administration as a direct IV (“bolus”) injection or continuous infusion.140, 141 To prepare solutions for IV bolus administration, 1 mL of the commercially available phenylephrine hydrochloride injection containing 10 mg/mL should be withdrawn and diluted with 99 mL of 5% dextrose or 0.9% sodium chloride injection to provide a final concentration of 100 mcg/mL.140, 141 To prepare solutions for continuous IV infusion, 1 mL of the commercially available phenylephrine hydrochloride injection containing 10 mg/mL should be withdrawn and added to 500 mL of 5% dextrose or 0.9% sodium chloride injection to provide a final concentration of 20 mcg/mL.140, 141
Standardized concentrations for phenylephrine have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care. 249, 250Multidisciplinary expert panels were convened to determine recommended standard concentrations .249, 250Because recommendations from the S4S panels may differ from the manufacturer's prescribing information, caution is advised when using concentrations that differ from labeling, particularly when using rate information from the label .249, 250 For additional information on S4S (including updates that may be available), see [Web].249, 250
Patient Population | Concentration Standards | Dosing Units |
|---|---|---|
Adults | 80 mcg/mL | mcg/kg/min |
400 mcg/mL | ||
Pediatric patients (<50 kg) | 80 mcg/mL | mcg/kg/min |
400 mcg/mL |
Dosages currently recommended by the manufacturers are based on information from published studies.140, 141, 501
For the treatment of hypotension during anesthesia in adults, the manufacturers recommend direct IV (“bolus”) doses of phenylephrine hydrochloride ranging from 40-250 mcg; the usual initial dose is 50 or 100 mcg.140, 141, 501 One manufacturer states that additional IV bolus doses may be administered every 1-2 minutes as needed not to exceed a total dosage of 200 mcg; however, if blood pressure is below the target goal, a continuous IV infusion should be initiated.140, 501 If phenylephrine hydrochloride is administered by continuous IV infusion, the manufacturers recommend infusion rates of 10-35 mcg/minute or 0.5-1.4 mcg/kg per minute.140, 141, 501 The infusion generally should be started at a low rate and titrated to effect.142 In all situations, dosage should be titrated to effect and the patient should be closely monitored.140, 141
Some manufacturers state that total dosage of phenylephrine hydrochloride should not exceed 200 mcg (if given by IV bolus) or 200 mcg/minute (if given by continuous IV infusion).140, 501 Higher dosages do not necessarily produce incremental increases in blood pressure and may cause hypertension and reflex bradycardia.140, 142, 148
When used in the treatment of septic shock, phenylephrine hydrochloride is administered by continuous IV infusion without an initial bolus dose.141 For the treatment of septic shock or other vasodilatory shock in adults, the manufacturer recommends that phenylephrine hydrochloride therapy be initiated at an infusion rate of 0.5-6 mcg/kg per minute; the rate of infusion should be adjusted to maintain the target blood pressure goal.141 Infusion rates higher than 6 mcg/kg per minute do not appear to provide substantial incremental increases in blood pressure.141
Patients with hepatic cirrhosis may have a reduced response to phenylephrine, potentially requiring higher dosages of the drug.140, 141, 501 Some manufacturers recommended initiating dosing within the recommended dosage range, although higher dosages may ultimately be warranted.140, 501
Patients with end-stage renal disease may have an increased response to phenylephrine, potentially requiring lower dosages of the drug.140, 141 Some manufacturers suggest initiating dosing at the lower end of the dosage range, and titrating to target blood pressure goals.140, 141
If phenylephrine is used in geriatric patients, dosage should be selected carefully, usually starting at the low end of the dosage range, since renal, hepatic, and cardiovascular dysfunction and concomitant disease or other drug therapy are more common in this age group.140, 141
Phenylephrine can cause severe bradycardia and decreased cardiac output.140, 141, 501 Because of its potent vasoconstricting effects, phenylephrine may also precipitate angina in patients with a history of the condition or with severe atherosclerosis, exacerbate underlying heart failure, and increase pulmonary arterial pressure.140, 141, 501
Peripheral and Visceral Ischemia
Phenylephrine can cause severe peripheral and visceral vasoconstriction and ischemia, reducing blood flow to vital organs.140, 141, 501 Severe vasoconstrictive effects may be more likely to occur in patients with substantial peripheral vascular disease.140, 141, 501
Renal Toxicity in Septic Shock
In patients with septic shock, phenylephrine may increase the need for renal replacement therapy.140, 141, 501
Because of possible renal toxicity in patients with septic shock, renal function should be monitored during phenylephrine use in such patients.140, 141, 501
In patients with autonomic dysfunction (e.g., those with spinal cord injuries), the blood pressure response to phenylephrine may be increased.140, 141, 501
When a vasopressor (e.g., phenylephrine) is used in conjunction with oxytocic drugs, the pressor effect is potentiated, increasing the risk of hemorrhagic stroke.140, 141, 501
Because phenylephrine can cause necrosis of the skin and subcutaneous tissue, care should be taken to avoid extravasation of the drug during IV administration and the infusion site should be checked for free flow.140, 501
Commercially available formulations of phenylephrine hydrochloride injection may contain sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylaxis and life-threatening or less severe asthmatic episodes, in certain susceptible individuals.140, 141 Sulfite sensitivity appears to occur more frequently in asthmatic than non-asthmatic individuals.140, 141
Data from randomized trials and meta-analyses with phenylephrine injection in pregnant women undergoing Cesarean section have not established a drug-associated risk of major birth defects or miscarriage.140, 501 Additionally, the data did not identify adverse effects on maternal outcomes or infant Apgar scores.140, 501 At recommended doses, phenylephrine does not appear to significantly affect fetal heart rate or fetal heart rate variability.140, 501 Data are not available on phenylephrine use during the first or second trimester.140, 501
Untreated hypotension in pregnant women undergoing Cesarean delivery with neuraxial anesthesia has been associated with increased maternal nausea and vomiting.140, 501 A sustained decrease in uterine blood flow caused by maternal hypotension has also been associated with fetal bradycardia and acidosis.140, 501
No data are available on the safety of phenylephrine injection during the period of organogenesis; therefore, conclusions cannot be drawn regarding the risk of birth defects from drug exposure.140, 501 In addition, no data are available on the risk of miscarriage following fetal exposure to phenylephrine injection.140, 501
In animal studies, fetal malformations were observed following phenylephrine infusion over 1 hour during the period of organogenesis at a dosage of 1.2 times the human daily dosage.140, 501 Decreased pup weight was also observed in offspring of pregnant rats who received 2.9 times the human daily dose of phenylephrine.140, 501
If a vasopressor is used in conjunction with oxytocic drugs, the vasopressor effect is potentiated and may result in serious adverse effects.140
There are no data on whether phenylephrine or its metabolite is distributed into human or animal milk following parenteral administration.140, 501 The effects on the breast-fed infant and milk production are not known.140, 501
The developmental and health benefits of breast-feeding should be weighed along with the mother's clinical need for the drug and any potential adverse effects on the breast-fed infant from phenylephrine or from the underlying maternal condition.140, 501
The manufacturers state that safety and efficacy of parenteral preparations of phenylephrine hydrochloride have not been established in pediatric patients.140, 141, 501
Clinical studies of phenylephrine hydrochloride did not include sufficient numbers of patients ≥65 years of age to determine whether geriatric patients respond differently than younger patients.140, 141, 501 Clinical experience to date has not identified any differences in response between geriatric and younger patients.140, 141, 501
If phenylephrine is used in geriatric patients, dosage should be selected carefully, usually starting at the low end of the dosage range, since renal, hepatic, and cardiovascular dysfunction and concomitant disease or other drug therapy are more common in this age group.140, 141, 501
Patients with hepatic cirrhosis may have a reduced response to phenylephrine.140, 141, 501
Patients with end-stage renal disease may have an increased response to phenylephrine.140, 141
The most commonly reported adverse effects in patients receiving IV phenylephrine hydrochloride were nausea, vomiting, and headache.140, 501
- and Beta-Adrenergic Blocking Agents
The effects of both phenylephrine and α-adrenergic blocking agents may be blocked when these drugs are administered concomitantly.141 Phenothiazine drugs (e.g., chlorpromazine) and amiodarone also have some α-adrenergic blocking effects and can reduce the pressor effect of phenylephrine.141 Mixed α- and β-adrenergic blocking agents can also antagonize the hypertensive effects of phenylephrine.140, 501
The pressor effects of phenylephrine may be increased with concomitant administration of β-adrenergic blocking drugs.141
Angiotensin and aldosterone potentiate the pressor effects of phenylephrine.140, 501 Therefore, concomitant use of angiotensin-II converting enzyme inhibitors may antagonize the hypertensive effect of phenylephrine.140, 501
Use of calcium channel blockers (e.g., nifedipine) may also antagonize the pressor effects of phenylephrine.140, 501
Concomitant use of α2-adrenergic agonists (e.g., clonidine) can potentiate the pressor effect of phenylephrine.141
When a vasopressor (e.g., phenylephrine) is used in conjunction with oxytocin and oxytocic drugs, the pressor effect is potentiated, increasing the risk of hemorrhagic stroke.140, 141, 501
The pressor effects of phenylephrine are potentiated in patients receiving monoamine oxidase (MAO) inhibitors (e.g., selegiline).140, 141, 501
Concomitant use of atropine sulfate may potentiate the pressor effect of phenylephrine.140, 141
Other drugs that may potentiate the pressor effect of phenylephrine include tricyclic antidepressants, corticosteroids (e.g., hydrocortisone), norepinephrine-reuptake inhibitors (e.g., atomoxetine), and ergot alkaloids (e.g., methylergonovine maleate).140, 141, 501 Other drugs that can antagonize the pressor effect of phenylephrine include phosphodiesterase (PDE) type 5 inhibitors, benzodiazepines, and centrally-active sympatholytics (e.g., guanfacine, reserpine).140, 501
The phenylephrine activation of α1-adrenergic receptors on vascular smooth muscle cells results in vasoconstriction.140, 501 Following IV administration of phenylephrine hydrochloride, systolic and diastolic blood pressure, mean arterial blood pressure, and total peripheral vascular resistance are increased.140, 141, 501 Vasoconstriction occurs in most vascular beds, including renal, pulmonary, and splanchnic arteries, but minimal to no effect is observed on cerebral blood vessels.140, 141, 152 Hepatic vascular beds are also affected.141 In some patients, phenylephrine can substantially reduce cardiac output, presumably due to increased afterload; however, the exact effects of the drug on global cardiac output depend on the dose and contributory effects of the arterial and venous vasculature.152 Although phenylephrine reduces venous compliance and can potentially increase venous return, accompanying increases in arterial and venous resistance can negate this potential benefit.152 With increased blood pressure following IV administration, there is increased vagal activity, resulting in reflex bradycardia.140, 141, 501 Phenylephrine constricts both arterial and venous blood vessels, although its effects on arterial vessels are more pronounced.152 At clinically relevant dosages, phenylephrine increases myocardial work and oxygen requirements.152
Following an IV bolus of phenylephrine hydrochloride, blood pressure increase is rapid, typically occurring within minutes.140, 501 Blood pressure effects from a phenylephrine bolus may persist for up to 20 minutes.141 Phenylephrine is widely distributed into organs and peripheral tissues.140, 501 It is not known if phenylephrine or its metabolite are distributed into human or animal milk following parenteral administration.140, 501
Phenylephrine is extensively metabolized in the liver.141 Phenylephrine primarily undergoes metabolism by sulfotransferase and monoamine oxidase (MAO) to pharmacologically inactive metabolites.140, 501 The 2 major metabolites are m-hydroxymandelic acid and sulfate conjugates.140, 501
Following IV administration of phenylephrine, approximately 86% of the dose is excreted in urine within 48 hours, principally as metabolites; approximately 16% of the dose is excreted in urine as unchanged drug.140, 501 The terminal elimination half-life of phenylephrine averages 2.5 hours following IV administration.140, 501 The observed effective half-life is approximately 5 minutes following IV infusion of the drug.140, 501
Patients with hepatic cirrhosis may have a reduced response to phenylephrine, potentially requiring higher dosages of the drug.140, 141 Patients with end-stage renal disease may have an increased response to phenylephrine, potentially requiring lower dosages of the drug.140, 141
Additional Information
The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection | 500 mcg/5 mL | Biorphen® (single dose ampule) | |
Immphentiv® (ready-to-use vial) | ||||
1000 mcg/10 mL | Immphentiv® (ready-to-use vial) | |||
10 mg/mL* | Biorphen® (single-dose ampule and vial) | |||
Vazculep® (single-dose vial) | Exela Pharma Sciences | |||
Phenylephrine Hydrochloride Injection (single-dose vial) | ||||
50 mg/5 mL* | Vazculep® (bulk package vial) | |||
Phenylephrine Hydrochloride Injection (bulk package vial) | ||||
100 mg/10 mL* | Vazculep® (bulk package vial) | |||
Phenylephrine Hydrochloride Injection (bulk package vial) |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Only references cited for selected revisions after 1984 are available electronically.
140. Eclat Pharmaceuticals. Vazculep® (phenylephrine hydrochloride injection) prescribing information. Chesterfield, MO; 2021 Mar.
141. Hikma Pharmaceuticals. Immphentiv® (phenylephrine hydrochloride injection) prescribing information. Berkeley Heights, NJ; 2024 Apr.
142. Food and Drug Administration. Summary review for regulatory action: NDA#204300/S-000. From FDA website. [Web]
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250. ASHP. Standardize 4 Safety: adult continuous infusion standard. Updated 2025 Mar. From ASHP website. Updates may be available at ASHP website. [Web]
251. Institute for Safe Medication Practices (ISMP). ISMP List of High-Alert Medications in Acute Care Settings. ISMP; 2024.
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259. Gamper G, Havel C, Arrich J, Losert H, Pace NL, Müllner M, Herkner H. Vasopressors for hypotensive shock. Cochrane Database Syst Rev. 2016 Feb 15;2(2):CD003709.
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263. Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Hylander Møller M, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. Crit Care Med. 2021 Nov 1;49(11):e1063-e1143.
264. van Diepen S, Katz JN, Albert NM, Henry TD, Jacobs AK, Kapur NK, Kilic A, Menon V, Ohman EM, Sweitzer NK, Thiele H, Washam JB, Cohen MG; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Quality of Care and Outcomes Research; and Mission: Lifeline. Contemporary Management of Cardiogenic Shock: A Scientific Statement From the American Heart Association. Circulation. 2017 Oct 17;136(16):e232-e268.
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501. Dr. Reddy's Laboratories. Biorphen® injection prescribing information. Princeton, NJ; 2024 April.