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Phenylephrine Hydrochloride Injection, Solution

80 ug/mL · Injection, Solution

  • Prescription only
  • alpha-1 Adrenergic Agonist
Made by
Dr. Reddy's Laboratories Inc.

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-03-31

What it is

alpha-1 Adrenergic Agonist

Used for
  • Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for increasing blood pressure in
The label’s usual adult dose

50 mcg to 250 mcg ( 2.2 ) Intravenous continuous infusion:

Full directions ↓
Do not take it if

The use of Phenylephrine Hydrochloride Injection, 80 mcg/mL is contraindicated in patients with:

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection is indicated for increasing blood pressure in
  • adults with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
  • Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection is an alpha-1 adrenergic receptor agonist indicated for increasing blood pressure in
  • adults with clinically important hypotension resulting primarily from vasodilation, in the setting of anesthesia ( 1 )

From the official label · 2026-03-31 · DailyMed

How it works

From this product’s own US prescribing label.

Phenylephrine hydrochloride is an α-1 adrenergic receptor agonist.

Half-life5 min
Mostly cleared after≈ 25 minfive half-lives — our arithmetic
How the body breaks it down

A mass balance study showed that phenylephrine is extensively metabolized by the liver with only 12% of the dose excreted unchanged in the urine.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-03-31

Do not take it if

  • The use of Phenylephrine Hydrochloride Injection, 80 mcg/mL is contraindicated in patients with:
  • Hypersensitivity to the product or any of its components Hypersensitivity to it or any of its components ( 4 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • Do NOT dilute prior to administration ( 2.1 ) Dosing for Perioperative Hypotension Intravenous bolus administration:
  • 50 mcg to 250 mcg ( 2.2 ) Intravenous continuous infusion:
  • 0.5 mcg/kg/minute to 1.4 mcg/kg/minute titrated to effect ( 2.2 )
  • 2.1 General Administration Instructions During Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection, 80 mcg/mL (20 mg/250 mL) administration:
  • Correct intravascular volume depletion.
  • Correct acidosis.
  • Acidosis may reduce the effectiveness of phenylephrine Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection, 80 mcg/mL (20 mg/250 mL) is supplied as a premixed, ready to administer product that requires no further dilution prior to infusion.
  • Parenteral drug products should be inspected for particulate matter and discoloration prior to administration.
  • Do not use if the solution is coloured or cloudy, or if it contains particulate matter.
  • Discard any unused portion.
  • 2.2 Recommended Dosage 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.
  • Do not exceed 200 mcg/min.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • Severe bradycardia and decreased cardiac output ( 5.2 ) Extravasation :
  • during intravenous administration may cause necrosis or sloughing of tissue ( 5.4 ) Concomitant use with oxytocic drugs :
  • pressor effect of sympathomimetic pressor amines is potentiated ( 5.5 )
  • 5.1 Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension Because of its pressor effects, phenylephrine hydrochloride can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.
  • 5.2 Bradycardia Phenylephrine hydrochloride can cause severe bradycardia and decreased cardiac output.
  • 5.3 Risk in Patients with Autonomic Dysfunction The pressor response to adrenergic drugs, including phenylephrine, can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries.
  • 5.4 Skin and Subcutaneous Necrosis Extravasation of phenylephrine can cause necrosis or sloughing of tissue.
  • Avoid extravasation by checking infusion site for free flow.
  • 5.5 Pressor Effect with Concomitant Oxytocic Drugs Oxytocic drugs potentiate the pressor effect of sympathomimetic pressor amines including phenylephrine hydrochloride [ see Drug Interactions (7.1) ], with the potential for hemorrhagic stroke.
  • 5.6 Peripheral and Visceral Ischemia Phenylephrine hydrochloride can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease.
  • 5.7 Renal Toxicity Phenylephrine hydrochloride can increase the need for renal replacement therapy in patients with septic shock.
  • Monitor renal function.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

  • Risk Summary Data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection use in pregnant women during caesarean section have not established a drug-associated risk of major birth defects and miscarriage.
  • These studies have not identified an adverse effect on maternal outcomes or infant Apgar scores [see Data].
  • There are no data on the use of phenylephrine during the first or second trimester.
  • In animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine was administered during organogenesis via a 1-hour infusion at 1.2 times a human daily dose (HDD) of 10 mg/60 kg/day.
  • Decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the HDD [See Data].
  • The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
  • All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
  • Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk Untreated hypotension associated with spinal anesthesia for cesarean section is associated with an increase in maternal nausea and vomiting.
  • A sustained decrease in uterine blood flow due to maternal hypotension may result in fetal bradycardia and acidosis.
  • Data Human Data Published randomized controlled trials over several decades, which compared the use of phenylephrine injection to other similar agents in pregnant women during cesarean section, have not identified adverse maternal or infant outcomes.
  • At recommended doses, phenylephrine does not appear to affect fetal heart rate or fetal heart variability to a significant degree.
  • There are no studies on the safety of phenylephrine injection exposure during the period of organogenesis, and therefore, it is not possible to draw any conclusions on the risk of birth defects following exposure to phenylephrine injection during pregnancy.
  • In addition, there are no data on the risk of miscarriage following fetal exposure to phenylephrine injection.
  • Animal Data No clear malformations or fetal toxicity were reported when normotensive pregnant rabbits were treated with phenylephrine via continuous intravenous infusion over 1 hour (0.5 mg/kg/day; approximately equivalent to a HDD based on body surface area) from Gestation Day 7 to 19.
  • At this dose, which demonstrated no maternal toxicity, there was evidence of developmental delay (altered ossification of sternebra).
  • In a non-GLP dose range-finding study in normotensive pregnant rabbits, fetal lethality and cranial, paw, and limb malformations were noted following treatment with 1.2 mg/kg/day of phenylephrine via continuous intravenous infusion over 1 hour (2.3-times the HDD).
  • This dose was clearly maternally toxic (increased mortality and significant body weight loss).
  • An increase in the incidence of limb malformation (hyperextension of the forepaw) coincident with high fetal mortality was noted in a single litter at 0.6 mg/kg/day (1.2-times the HDD) in the absence of maternal toxicity.
  • No malformations or embryo-fetal toxicity were reported when normotensive pregnant rats were treated with up to 3 mg/kg/day phenylephrine via continuous intravenous infusion over 1 hour (2.9-times the HDD) from Gestation Day 6 to 17.
  • This dose was associated with some maternal toxicity (decreased food consumption and body weights).
  • Decreased pup weights were reported in a pre- and postnatal development toxicity study in which normotensive pregnant rats were administered phenylephrine via continuous intravenous infusion over 1 hour (0.3, 1.0, or 3.0 mg/kg/day; 0.29, 1, or 2.9 times the HDD) from Gestation Day 6 through Lactation Day 21).
  • No adverse effects on growth and development (learning and memory, sexual development, and fertility) were noted in the offspring of pregnant rats at any dose tested.
  • Maternal toxicities (mortality late in gestation and during lactation period, decreased food consumption and body weight) occurred at 1 and 3 mg/kg/day of phenylephrine (equivalent to and 2.9 times the HDD, respectively).
  • IN SPECIFIC POPULATIONS
  • 8.1 Pregnancy Risk Summary Data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride injection use in pregnant women during caesarean section have not established a drug-associated risk of major birth defects and miscarriage.
  • These studies have not identified an adverse effect on maternal outcomes or infant Apgar scores [see Data].
  • There are no data on the use of phenylephrine during the first or second trimester.
  • In animal reproduction and development studies in normotensive animals, evidence of fetal malformations was noted when phenylephrine was administered during organogenesis via a 1-hour infusion at 1.2 times a human daily dose (HDD) of 10 mg/60 kg/day.
  • Decreased pup weights were noted in offspring of pregnant rats treated with 2.9 times the HDD [See Data].
  • The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
  • All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
  • In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
  • Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk Untreated hypotension associated with spinal anesthesia for cesarean section is associated with an increase in maternal nausea and vomiting.
  • A sustained decrease in uterine blood flow due to maternal hypotension may result in fetal bradycardia and acidosis.
  • Data Human Data Published randomized controlled trials over several decades, which compared the use of phenylephrine injection to other similar agents in pregnant women during cesarean section, have not identified adverse maternal or infant outcomes.
  • At recommended doses, phenylephrine does not appear to affect fetal heart rate or fetal heart variability to a significant degree.
  • There are no studies on the safety of phenylephrine injection exposure during the period of organogenesis, and therefore, it is not possible to draw any conclusions on the risk of birth defects following exposure to phenylephrine injection during pregnancy.
  • In addition, there are no data on the risk of miscarriage following fetal exposure to phenylephrine injection.
  • Animal Data No clear malformations or fetal toxicity were reported when normotensive pregnant rabbits were treated with phenylephrine via continuous intravenous infusion over 1 hour (0.5 mg/kg/day; approximately equivalent to a HDD based on body surface area) from Gestation Day 7 to 19.
  • At this dose, which demonstrated no maternal toxicity, there was evidence of developmental delay (altered ossification of sternebra).
  • In a non-GLP dose range-finding study in normotensive pregnant rabbits, fetal lethality and cranial, paw, and limb malformations were noted following treatment with 1.2 mg/kg/day of phenylephrine via continuous intravenous infusion over 1 hour (2.3-times the HDD).
  • This dose was clearly maternally toxic (increased mortality and significant body weight loss).
  • An increase in the incidence of limb malformation (hyperextension of the forepaw) coincident with high fetal mortality was noted in a single litter at 0.6 mg/kg/day (1.2-times the HDD) in the absence of maternal toxicity.
  • No malformations or embryo-fetal toxicity were reported when normotensive pregnant rats were treated with up to 3 mg/kg/day phenylephrine via continuous intravenous infusion over 1 hour (2.9-times the HDD) from Gestation Day 6 to 17.
  • This dose was associated with some maternal toxicity (decreased food consumption and body weights).
  • Decreased pup weights were reported in a pre- and postnatal development toxicity study in which normotensive pregnant rats were administered phenylephrine via continuous intravenous infusion over 1 hour (0.3, 1.0, or 3.0 mg/kg/day; 0.29, 1, or 2.9 times the HDD) from Gestation Day 6 through Lactation Day 21).
  • No adverse effects on growth and development (learning and memory, sexual development, and fertility) were noted in the offspring of pregnant rats at any dose tested.
  • Maternal toxicities (mortality late in gestation and during lactation period, decreased food consumption and body weight) occurred at 1 and 3 mg/kg/day of phenylephrine (equivalent to and 2.9 times the HDD, respectively).
  • 8.2 Lactation Risk Summary There are no data on the presence of Phenylephrine Hydrochloride Injection or its metabolite in human or animal milk, the effects on the breastfed infant, or the effects on milk production.
  • The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for phenylephrine hydrochloride injection and any potential adverse effects on the breastfed infant from phenylephrine hydrochloride injection or from the underlying maternal condition.
  • 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
  • 8.5 Geriatric Use Clinical studies of phenylephrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
  • Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
  • In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
  • 8.6 Hepatic Impairment In patients with liver cirrhosis [Child Pugh Class A (n=3), Class B (n=5) and Class C (n=1)], dose-response data indicate decreased responsiveness to phenylephrine.
  • Consider using larger doses than usual in hepatic impaired subjects.
  • 8.7 Renal Impairment In patients with end stage renal disease (ESRD) undergoing hemodialysis, dose-response data indicates increased responsiveness to phenylephrine.
  • Consider using lower doses of phenylephrine hydrochloride in ESRD patients.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

  • Agonistic effects with monoamine oxidase inhibitors (MAOI), β-adrenergic blocking agents, α-2 adrenergic agonists, steroids, tricyclic antidepressants, norepinephrine transport inhibitors, ergot alkaloids, centrally-acting sympatholytic agents and atropine sulfate ( 7.1 ) Antagonistic effects on and by α-adrenergic blocking agents ( 7.2 )
  • 7.1 Agonists The pressor effect of phenylephrine hydrochloride is increased in patients receiving:
  • Monoamine oxidase inhibitors (MAOI), such as selegiline.
  • Oxytocin and oxytocic drugs β-adrenergic blockers α-2 adrenergic agonists, such as clonidine Steroids Tricyclic antidepressants Norepinephrine transport inhibitors, such as atomoxetine Ergot alkaloids, such as methylergonovine maleate Centrally-acting sympatholytic agents, such as guanfacine or reserpine Atropine sulfate
  • 7.2 Antagonists α-adrenergic blocking agents, including phenothiazines (e.g., chlorpromazine) and amiodarone block phenylephrine and are in turn blocked by phenylephrine.

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • Overdose of Phenylephrine Hydrochloride Injection, 80 mcg/mL (20 mg/250 mL) can cause a rapid rise in blood pressure.
  • Symptoms of overdose include headache, vomiting, hypertension, reflex bradycardia, and cardiac arrhythmias including ventricular extrasystoles and ventricular tachycardia, and may cause a sensation of fullness in the head and tingling of the extremities.
  • Consider using an α-adrenergic antagonist.

Quoted from the official label, section “Overdosage”.

Use in children

Safety and effectiveness in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

  • Clinical studies of phenylephrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
  • Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
  • In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Quoted from the official label, section “Geriatric Use”.

Side effects

  • The following adverse reactions associated with the use of phenylephrine hydrochloride were identified in the literature.
  • 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:
  • Bradycardia, AV block, ventricular extrasystoles, myocardial ischemia Gastrointestinal disorders :
  • Nausea, vomiting General disorders and administrative site conditions:
  • Chest pain, extravasation Nervous system disorders :
  • Headache, nervousness, paresthesia, tremor Psychiatric disorders:
  • Excitability Respiratory :
  • Pulmonary edema, rales Skin and subcutaneous tissue disorders:
  • Diaphoresis, pallor, piloerection, skin blanching, skin necrosis with extravasation Vascular disorders:
  • Hypertensive crisis Most common adverse reactions:
  • nausea and vomiting, headache, nervousness ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Dr.
  • Reddy’s Laboratories Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Quoted from the official label, section “Adverse Reactions”.

Strengths and forms

  • FORMS AND STRENGTHS Injection:
  • 20 mg in 250 mL (80 mcg/mL) of phenylephrine hydrochloride in 0.9% Sodium Chloride, supplied as a ready-to-use, clear, colorless solution in a single-dose 250-mL intravenous solution bag. njection:
  • 20 mg in 250 mL (80 mcg/mL) of phenylephrine hydrochloride (equivalent to 16.4 mg of phenylephrine base per 250 mL) in 0.9% Sodium Chloride, supplied in a ready-to-use, single-dose intravenous solution bag (3, 11, 16)

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

  • Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection is a clear, colorless solution supplied in a readyto- use single dose 250 mL infusion bag as follows:
  • Unit of Sale Strength Each NDC 43598-182-05 Pack of 5 intravenous solution bags in a cardboard box (20 mg/250 mL) 80 mcg/mL NDC 43598-182-50 250 mL intravenous solution bag
  • Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
  • Discard any unused portion.

Quoted from the official label, section “How Supplied”.

What is in it

  • Phenylephrine Hydrochloride in 0.9% Sodium Chloride Injection, 80 mcg/mL (20 mg/250 mL), an alpha-1 adrenergic receptor agonist, contains the active pharmaceutical ingredient phenylephrine in the form of hydrochloride salt.
  • Phenylephrine is a synthetic sympathomimetic agent in sterile form for parenteral injection.
  • Phenylephrine hydrochloride chemical name is (-)-m-Hydroxy-α-[(methylamino) methyl]benzyl alcohol hydrochloride and has the following structural formula:
  • Phenylephrine hydrochloride is very soluble in water, freely soluble in ethanol, and insoluble in chloroform and ethyl ether.
  • Phenylephrine hydrochloride is sensitive to light.
  • Phenylephrine Hydrochloride Injection, USP 80 mcg/mL (20 mg/250 mL, equivalent to 16.4 mg of phenylephrine base per 250 ml) is a clear and colorless sterile aqueous solution, essentially free of visible foreign matter.
  • It is a ready-to-use solution intended for intravenous administration.
  • Each mL contains:
  • 0.08 mg of Phenylephrine Hydrochloride and 9.04 mg of Sodium Chloride in Water for Injection.
  • Phenylephrine Hydrochloride Injection, USP 80 mcg/mL.
  • Hydrochloric acid is added as needed to adjust pH (pH range is 3.0 to 5.0).

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Details

Made byDr. Reddy's Laboratories Inc.
Active substancePhenylephrine Hydrochloride Injection, Solution
Strength80 ug/mL
FormInjection, Solution
RouteIntravenous
Packs5 BAG in 1 CARTON / 250 mL in 1 BAG
NDC43598-182

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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