Phenylephrine Hydrochloride
10 mg/mL · Injection, Solution
- Prescription only
- alpha-1 Adrenergic Agonist
- Active substance
- Phenylephrine Hydrochloride
- Made by
- Sagent Pharmaceuticals
- Source
- Official label
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 · 2020-07-10
alpha-1 Adrenergic Agonist
- Phenylephrine Hydrochloride Injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
40 mcg to 100 mcg every 1 to 2 minutes as needed, not to exceed 200 mcg.
Full directions ↓- 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 Injection is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
- Phenylephrine Hydrochloride Injection is an alpha-1 adrenergic receptor agonist indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.
- ( 1 )
From the official label · 2020-07-10 · DailyMed
How it works
From this product’s own US prescribing label.
Phenylephrine hydrochloride is an α-1 adrenergic receptor agonist.
Phenylephrine is metabolized primarily by monoamine oxidase and sulfotransferase.
After intravenous administration of radiolabeled phenylephrine, approximately 80% of the total dose was eliminated within first 12 h; and approximately 86% of the total dose was recovered in the urine within 48 h.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2020-07-10
Do not take it if
None None ( 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.
- Phenylephrine hydrochloride injection is injected intravenously either as a bolus or in a dilute solution as a continuous infusion.
- Dilute before administration.
- ( 2 ) Dosing for treatment of hypotension during anesthesia Bolus intravenous injection:
- 40 mcg to 100 mcg every 1 to 2 minutes as needed, not to exceed 200 mcg.
- ( 2 ) Intravenous infusion:
- 10 mcg/min to 35 mcg/min, titrating to effect, not to exceed 200 mcg/min.
- ( 2 ) Adjust the dose according to the pressor response (i.e., titrate to effect).
- ( 2 )
- 2.1 General Dosage and Administration Instructions Phenylephrine hydrochloride 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.
- 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.
- 2.2 Dosing for Treatment of Hypotension during Anesthesia 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.
- Additional boluses may be administered every 1 to 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.
- 2.3 Prepare a 100 mcg per mL Solution for Bolus Intravenous Administration For bolus intravenous administration, prepare a solution containing a final concentration of 100 mcg per mL of phenylephrine hydrochloride injection:
- Withdraw 10 mg (1 mL of 10 mg per 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 per mL solution prior to bolus intravenous administration.
- 2.4 Prepare a Solution for Continuous Intravenous Administration For continuous intravenous infusion, prepare a solution containing a final concentration of 20 mcg per 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 per mL) of phenylephrine hydrochloride injection and dilute with 500 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP.
- 2.5 Directions for Dispensing from Pharmacy Bulk Vial 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.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension:
- Phenylephrine hydrochloride can precipitate angina in patients with severe arteriosclerosis or history of angina, exacerbate underlying heart failure, and increase pulmonary arterial pressure.
- ( 5.1 ) Peripheral and Visceral Ischemia:
- Phenylephrine hydrochloride can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs.
- ( 5.2 ) Skin and Subcutaneous Necrosis:
- Extravasation during intravenous administration may cause necrosis or sloughing of tissue.
- ( 5.3 ) Bradycardia:
- Phenylephrine hydrochloride can cause severe bradycardia and decreased cardiac output.
- ( 5.4 )
- 5.1 Exacerbation of Angina, Heart Failure, or Pulmonary Arterial Hypertension Because of its increasing blood pressure 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 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.
- 5.3 Skin and Subcutaneous Necrosis Extravasation of phenylephrine hydrochloride 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.
- 5.4 Bradycardia Phenylephrine hydrochloride can cause severe bradycardia and decreased cardiac output.
- 5.5 Allergic Reactions Phenylephrine hydrochloride 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.
- 5.6 Renal Toxicity Phenylephrine hydrochloride can increase the need for renal replacement therapy in patients with septic shock.
- Monitor renal function.
- 5.7 Risk of Augmented Pressor Affect in Patients with Autonomic Dysfunction The increasing blood pressure response to adrenergic drugs, including phenylephrine hydrochloride, can be increased in patients with autonomic dysfunction, as may occur with spinal cord injuries.
- 5.8 Pressor Effect with Concomitant Oxytocic Drugs Oxytocic drugs potentiate the increasing blood pressure effect of sympathomimetic pressor amines including phenylephrine hydrochloride [see Drug Interactions ( 7.1 )] , with the potential for hemorrhagic stroke.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Risk Summary Data from randomized controlled trials and meta-analyses with phenylephrine hydrochloride use in pregnant women during Cesarean 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 the 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 are 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 to 4% and 15 to 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 rate 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 use in pregnant women during Cesarean 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 the 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 are 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 to 4% and 15 to 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 rate 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 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 and any potential adverse effects on the breastfed infant from phenylephrine hydrochloride 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 B and Class C], dose-response data indicate decreased responsiveness to phenylephrine.
- Start dosing in the recommended dose range, but more phenylephrine may be needed in this population.
- 8.7 Renal Impairment In patients with end stage renal disease (ESRD), dose-response data indicate increased responsiveness to phenylephrine.
- Consider starting at the lower end of the recommended dose range, and adjusting dose based on the target blood pressure goal.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Other medicines
- Agonistic effects (increase in phenylephrine hydrochloride blood pressure effect) can occur with monoamine oxidase inhibitors (MAOI), oxytocin and oxytocic drugs, tricyclic antidepressants, angiotensin and aldosterone, atropine, steroids, norepinephrine transporter inhibitors, ergot alkaloids.
- ( 7.1 ) Antagonistic effects (decrease in phenylephrine hydrochloride blood pressure effect) can occur with α-adrenergic antagonists, phosphodiesterase Type 5 inhibitors, mixed α- and β-receptor antagonists, calcium channel blockers, benzodiazepines and ACE inhibitors, centrally acting sympatholytic agents.
- ( 7.2 )
- 7.1 Interactions that Augment Pressor Effect The increasing blood pressure effect of phenylephrine hydrochloride is increased in patients receiving:
- Monoamine oxidase inhibitors (MAOI) Oxytocin and oxytocic drugs Tricyclic antidepressants Angiotensin, aldosterone Atropine Steroids, such as hydrocortisone Norepinephrine transporter inhibitors, such as atomoxetine Ergot alkaloids, such as methylergonovine maleate
- 7.2 Interactions that Antagonize the Pressor Effect The increasing blood pressure effect of phenylephrine hydrochloride is decreased in patients receiving:
- α-adrenergic antagonists Phosphodiesterase Type 5 inhibitors Mixed α- and β-receptor antagonists Calcium channel blockers, such as nifedipine Benzodiazepines ACE inhibitors Centrally acting sympatholytic agents, such as reserpine, guanfacine
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 can cause a rapid rise in blood pressure.
- Symptoms of overdose include headache, vomiting, hypertension, reflex bradycardia, a sensation of fullness in the head, tingling of the extremities, and cardiac arrhythmias including ventricular extrasystoles and ventricular tachycardia.
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
- Adverse reactions to phenylephrine hydrochloride are primarily attributable to excessive pharmacologic activity.
- Adverse reactions reported in published clinical studies, observational trials, and case reports of phenylephrine hydrochloride 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 Most common adverse reactions during treatment:
- nausea, vomiting, and headache.
- ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals, Inc. at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
- If applicable, inform patient, family member, or caregiver that certain medical conditions and medications might influence how Phenylephrine Hydrochloride Injection works.
- SAGENT ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2020 Sagent Pharmaceuticals, Inc.
- July 2020 SAGENT Pharmaceuticals ®
Quoted from the official label, section “Patient Counseling Information”.
Strengths and forms
- FORMS AND STRENGTHS Phenylephrine Hydrochloride Injection, USP 10 mg per mL, for intravenous use, is available in three vial sizes:
- Injection:
- 10 mg per mL as a clear, colorless solution in a single-dose 1 mL vial (10 mg of phenylephrine hydrochloride per vial) Injection:
- 10 mg per mL as a clear, colorless solution 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 per mL as a clear, colorless solution in Pharmacy Bulk Package 10 mL vial (100 mg of phenylephrine hydrochloride per vial) that will provide ten 1 mL single doses Phenylephrine Hydrochloride Injection ( 3 ) 1 mL single-dose vials containing 10 mg phenylephrine hydrochloride (10 mg per mL) ( 3 ) 5 mL pharmacy bulk package vials containing 50 mg phenylephrine hydrochloride (10 mg per mL) ( 3 ) 10 mL pharmacy bulk package vials containing 100 mg phenylephrine hydrochloride (10 mg per mL) ( 3 )
Quoted from the official label, section “Dosage Forms & Strengths”.
What it looks like and how it is packed
- Phenylephrine Hydrochloride Injection, USP is supplied as follows:
- NDC Phenylephrine Hydrochloride Injection, USP (10 mg per mL) Package Factor 25021-315-01 10 mg per mL Single-Dose Vial 25 vials per carton 25021-315-99 50 mg per 5 mL Pharmacy Bulk Package Vial 10 vials per carton 25021-315-98 100 mg per 10 mL Pharmacy Bulk Package Vial 1 vial per carton Phenylephrine Hydrochloride Injection, USP is a clear, colorless solution.
- Storage Conditions
- Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] The 1 mL vials are for single-dose only; the 5 and 10 mL vials are pharmacy bulk packages.
- The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions.
- Protect from light.
- Retain in carton until time of use.
- Discard unused portion.
- Sterile, Nonpyrogenic, Preservative - free.
- The container closure is not made with natural rubber latex.
Quoted from the official label, section “How Supplied”.
How to store it
- Conditions
- Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] The 1 mL vials are for single-dose only; the 5 and 10 mL vials are pharmacy bulk packages.
- The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions.
- Protect from light.
- Retain in carton until time of use.
- Discard unused portion.
- Sterile, Nonpyrogenic, Preservative - free.
- The container closure is not made with natural rubber latex.
Quoted from the official label, section “Storage and Handling”.
What is in it
- Phenylephrine is an alpha-1 adrenergic receptor agonist.
- Phenylephrine Hydrochloride Injection, USP 10 mg per mL, is a clear, colorless, sterile, nonpyrogenic solution for intravenous use.
- It must be diluted before administration as an intravenous bolus or continuous intravenous infusion.
- The chemical name of phenylephrine hydrochloride is (-)- m -hydroxy-α[(methylamino)methyl]benzyl alcohol hydrochloride and is chemically designated as C 9 H 14 ClNO 2 with a molecular weight of 203.66 g/mol.
- Its structural formula is depicted below:
- Phenylephrine hydrochloride is soluble in water and ethanol, and insoluble in chloroform and ethyl ether.
- Phenylephrine Hydrochloride Injection, USP 10 mg per mL, is sensitive to light.
- Each mL contains:
- phenylephrine hydrochloride 10 mg, sodium chloride 3.5 mg, sodium citrate dihydrate 4 mg, citric acid monohydrate 1 mg, and sodium metabisulfite 2 mg in water for injection.
- The pH is adjusted with sodium hydroxide and/or hydrochloric acid if necessary.
- The pH range is 3.5 to 5.5.
- Structural Formula
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.
Every version of this medicine (32)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 32 of 32
- Phenylephrine HydrochlorideThis onePrescription onlySagent PharmaceuticalsNo ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyAmneal Pharmaceuticals LLCNo ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyArmas Pharmaceuticals Inc.No ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyBaxter Healthcare CorporationNo ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyBE Pharmaceuticals Inc.No ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyCamber Pharmaceuticals, Inc.No ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyCaplin Steriles LimitedNo ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyCardinal Health 107, LLCNo ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyCivica, Inc.No ingredient list on the stored label
- BiorphenPrescription onlyDr. Reddy's Laboratories Inc.No ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyEugia US LLCNo ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyFresenius Kabi USA, LLCNo ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyGland Pharma LimitedNo ingredient list on the stored label
- Phenylephrine Hydrochloride Phenylephrine HydrochloridePrescription onlyGland Pharma LimitedNo ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyHainan Poly Pharm. Co., Ltd.No ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyHenry Schein, Inc.No ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.No ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyHF Acquisition Co LLC, DBA HealthFirstNo ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyHikma Pharmaceuticals USA Inc.No ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyLifestar Pharma LLCNo ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyMedical Purchasing Solutions, LLCNo ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyMedical Purchasing Solutions, LLC.No ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyMedical Purhasing Solutions, LLCNo ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyMeitheal Pharmaceuticals Inc.No ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyMethod Pharmaceuticals, LLCNo ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyNovadoz Pharmaceuticals LLCNo ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyPar Health USA, LLCNo ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyProPharma DistributionNo ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyProvepharm Inc.No ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlySandoz IncNo ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlySomerset Therapeutics, LLCNo ingredient list on the stored label
- Phenylephrine HydrochloridePrescription onlyXellia Pharmaceuticals USA LLCNo ingredient list on the stored label
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
CanadaNo exact match for this strength and form
Details
| Made by | Sagent Pharmaceuticals |
|---|---|
| Active substance | Phenylephrine Hydrochloride |
| Strength | 10 mg/mL |
| Form | Injection, Solution |
| Route | Intravenous |
| Packs | 25 VIAL in 1 CARTON / 1 mL in 1 VIAL · 1 VIAL in 1 CARTON / 10 mL in 1 VIAL |
| NDC | 25021-315 |
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).
Other strengths and forms
62 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Injection39 products
50 mg/5mL5
100 mg/10mL5
- Solution/ Drops17 products
- Solution3 products
- Tablet2 products
10 mg2
10 mg · 2 companies
Show all forms · 5 forms
- Injection, Solution1 products
- 10 mg/mL
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.