PHENYLEPHRINE HYDROCHLORIDE injection

PHENYLEPHRINE HYDROCHLORIDE by

Drug Labeling and Warnings

PHENYLEPHRINE HYDROCHLORIDE by is a Prescription medication manufactured, distributed, or labeled by Novadoz Pharmaceuticals LLC, MSN LABORATORIES PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE


    Phenylephrine Hydrochloride Injection 10 mg/mL is indicated for increasing blood pressure in adults with clinically important hypotension resulting primarily from vasodilation in the settings of anesthesia and septic shock.

  • 2 DOSAGE AND ADMINISTRATION

    2.1 General Administration Instructions

    • Phenylephrine Hydrochloride Injection 10 mg/mL formulation (10 mg/mL, 50 mg/5mL, and 100 mg/10 mL) MUST BE DILUTED before administration as an intravenous bolus or for continuous intravenous infusion. The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions (2°C – 8°C).

    Parenteral drug products should be inspected for particulate matter and discoloration prior to administration. Discard any unused portion.
    During Phenylephrine Hydrochloride Injection 10 mg/mL administration:

    • Correct intravascular volume depletion.
    • Correct acidosis. Acidosis may reduce the effectiveness of phenylephrine.

    2.2 Preparation of Phenylephrine Hydrochloride Injection

    Preparing a 100 mcg/mL Solution for Intravenous Bolus Administration
    For intravenous bolus administration, withdraw 10 mg (1 mL of a 10 mg/mL concentration) of Phenylephrine Hydrochloride Injection 10 mg/mL 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 intravenous bolus administration.
    Preparing a 20 mcg/mL Solution for Continuous Intravenous Infusion
    For continuous intravenous infusion, withdraw 10 mg (1 mL of 10 mg/mL concentration) of phenylephrine hydrochloride injection 10 mg/mL 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).
    Directions for Dispensing from Phenylephrine Hydrochloride Injection 10 mg/mL 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.
    Dosing for Perioperative Setting
    In adult patients undergoing surgical procedures with either neuraxial anesthesia or general anesthesia:

    • Phenylephrine Hydrochloride Injection 10 mg/mL (diluted to 20 mcg/mL): 0.5 mcg/kg/min to 1.4 mcg/kg/min by intravenous continuous infusion, titrated to blood pressure goal.
       

    Dosing for Septic or Other Vasodilatory Shock (Phenylephrine Hydrochloride Injection 10 mg/mL only)
    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

    Phenylephrine Hydrochloride Injection, USP: 10 mg/mL phenylephrine hydrochloride is a clear, colorless, essentially free of visible foreign matter sterile parenteral solution, available in three vial sizes:

    • 10 mg in 1 mL (10 mg/mL) of Phenylephrine hydrochloride in a single-dose vial
    • 50 mg in 5 mL (10 mg/mL) of Phenylephrine hydrochloride in a pharmacy bulk package vial
    • 100 mg in 10 mL (10 mg/mL) of Phenylephrine hydrochloride in a pharmacy bulk package vial
  • 4 CONTRAINDICATIONS

    The use of Phenylephrine Hydrochloride Injection 10 mg/mL is contraindicated in patients with:

    • Hypersensitivity to the products or any of their components
  • 5 WARNINGS AND PRECAUTIONS

    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 Injection 10 mg/mL 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.

    5.5 Pressor Effect with Concomitant Oxytocic Drugs


    Oxytocic drugs potentiate the pressor effect of sympathomimetic pressor amines including Phenylephrine Hydrochloride Injection 10 mg/mL [see Drug Interactions (7.1)], with the potential for hemorrhagic stroke.

    5.6 Allergic Reactions


    Phenylephrine Hydrochloride Injection 10 mg/mL 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.

    5.7 Peripheral and Visceral Ischemia


    Phenylephrine Hydrochloride Injection 10 mg/mL can cause excessive peripheral and visceral vasoconstriction and ischemia to vital organs, particularly in patients with extensive peripheral vascular disease.

    5.8 Renal Toxicity


    Phenylephrine Hydrochloride Injection 10 mg/mL can increase the need for renal replacement therapy in patients with septic shock. Monitor renal function.

  • 6 ADVERSE REACTIONS


    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
    Immune system disorders: Sulfite sensitivity
    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

  • 7 DRUG INTERACTIONS

    7.1 Agonists

    The pressor effect of phenylephrine hydrochloride is increased in patients receiving:

    • Monoamine oxidase inhibitors (MAOI), such as selegiline.
    • 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.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy


    Risk Summary
    In animal reproductive and developmental studies, decreased fetal body weights were noted at 0.4 times the human daily dose (HDD) of 10 mg. No malformations were reported, however, an increased incidence of agenesis of the intermediate lobe of the lung, a visceral variation, was reported at levels as low as 0.08 times the HDD.
    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 to 4% and 15 to 20%, respectively.
    Data
    Animal Data
    No malformations were noted when normotensive pregnant rats were treated with a single daily intravenous bolus dose of 50 mcg, 150 mcg, or 300/200 mcg/kg phenylephrine hydrochloride from Gestation Day 6 to 17 (high dose is 0.3/0.2 times the human daily dose (HDD) of 10 mg/day based on body surface area). Evidence of maternal toxicity, including mortality, was noted at the highest tested dose of 300/200 mcg/kg.
    Decreased fetal body weights but no clear treatment-related malformations were reported when normotensive pregnant rabbits were treated with a single daily intravenous bolus dose of 40 mcg, 100 mcg and 200 mcg/kg (0.08, 0.2, and 0.4 times the HDD based on body surface area) phenylephrine hydrochloride from Gestation Day 7 to 19. Maternal toxicity, as manifested by decreased food consumption and body weight gain at all doses. An increased incidence of agenesis of the intermediate lobe of the lung, a visceral variation, was noted in all treatment groups compared to controls.
    No adverse effects on the offspring were reported when pregnant rats were treated via a single daily intravenous bolus dose of up to 200 mcg/day phenylephrine hydrochloride (0.2 times the HDD based on body surface area) from Gestation Day 6 to Lactation Day 20.

    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, doseresponse data indicates increased responsiveness to phenylephrine. Consider using lower doses of phenylephrine hydrochloride in ESRD patients.

  • 10 OVERDOSAGE


    Overdose of phenylephrine hydrochloride injection 10 mg/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. Consider using an α-adrenergic antagonist.

  • 11 DESCRIPTION


    Phenylephrine Hydrochloride Injection contains 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:

    phenyl-inj-structure

    Phenylephrine hydrochloride is freely soluble in water and alcohol. Phenylephrine hydrochloride is sensitive to light.
    Phenylephrine Hydrochloride Injection, USP, 10 mg/mL:
    Phenylephrine Hydrochloride injection, USP is a clear, colorless, aqueous solution that is essentially free of visible foreign matter. It MUST BE DILUTED before administration as bolus intravenous infusion or continuous intravenous infusion.
    Each mL contains: 10 mg of Phenylephrine Hydrochloride (equivalent to 8.2 mg of phenylephrine base); 3.5 mg of Sodium Chloride USP as tonicity agent; 1 mg of Citric Acid Monohydrate USP and 4 mg of Sodium Citrate Dihydrate USP, as buffering agents; 2 mg of Sodium Metabisulfite USP, as antioxidant, and Sodium Hydroxide NF and Hydrochloric Acid NF, as pH adjusters in Water for Injection.
    Phenylephrine Hydrochloride injection pH range is 3.0 to 6.5.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action


    Phenylephrine hydrochloride is an α-1 adrenergic receptor agonist.

    12.2 Pharmacodynamics


    Phenylephrine is the active moiety. Metabolites are inactive at both the α-1 and α-2 adrenergic receptors. Following parenteral administration of phenylephrine hydrochloride, increases in systolic blood pressure, diastolic blood pressure, mean arterial blood pressure, and total peripheral vascular resistance are observed. The onset of blood pressure increase following an intravenous bolus phenylephrine hydrochloride administration is rapid and the effect may persist for up to 20 minutes. As mean arterial pressure increases following parenteral doses, vagal activity also increases, resulting in reflex bradycardia.
    Most vascular beds are constricted, including renal, splanchnic, and hepatic.

    12.3 Pharmacokinetics


    Following an intravenous infusion of phenylephrine hydrochloride, the effective half-life was approximately 5 minutes. The steady-state volume of distribution (340 L) exceeded the body volume by a factor of 5, suggesting a high distribution into certain organ compartments. The average total serum clearance (2095 mL/min) was close to one-third of the cardiac output.
    A mass balance study showed that phenylephrine is extensively metabolized by the liver with only 12% of the dose excreted unchanged in the urine. Deamination by monoamino oxidase is the primary metabolic pathway resulting in the formation of the major metabolite (m-hydroxymandelic acid) which accounts for 57% of the total administered dose.

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility


    Carcinogenesis:
    Long-term animal studies that evaluated the carcinogenic potential of orally administered phenylephrine hydrochloride in F344/N rats and B6C3F1 mice were completed by the National Toxicology Program using the dietary route of administration. There was no evidence of carcinogenicity in mice administered approximately 270 mg/kg/day (131-times the human daily dose (HDD) of 10 mg/day based on body surface area) or rats administered approximately 50 mg/kg/day (48-times the HDD based on body surface area comparisons).
    Mutagenesis:
    Phenylephrine hydrochloride tested negative in the in vitro bacterial reverse mutation assay (S. typhimurium strains TA98, TA100, TA1535 and Ta1537), the in vitro chromosomal aberrations assay, the in vitro sister chromatid exchange assay, and the in vivo rat micronucleus assay. Positive results were reported in only one of two replicates of the in vitro mouse lymphoma assay.
    Impairment of Fertility:
    No adverse effects on fertility or early embryonic development were noted when phenylephrine hydrochloride was administered at doses of 50 mcg, 100 mcg, or 200 mcg/kg/day (up to 0.2 times HDD of 10 mg/60 kg/day based on body surface area) via single daily bolus injection for 28 days prior to mating to male rats or for 14 days prior to mating through Gestation Day 7 to female rats.

  • 14 CLINICAL STUDIES


    Increases in systolic and mean blood pressure following administration of phenylephrine were observed in 42 literature-based studies in the perioperative setting, including 26 studies where phenylephrine was used in low-risk (ASA 1 and 2) pregnant women undergoing neuraxial anesthesia during cesarean delivery, 3 studies in non-obstetric surgery under neuraxial anesthesia, and 13 studies in patients undergoing surgery under general anesthesia. Mean arterial blood pressure increases were also observed in two double-blind, active-controlled studies in patients with septic shock.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING


    Phenylephrine Hydrochloride injection, USP, 10 mg/mL, is a clear colorless
    solution, free from visible particulate matter and supplied as follows:

     NDC No.
    		 Strength
    		How Supplied
    NDC: 72205-264-2510 mg/mL 1 mL Single-dose vials packaged in cartons containing 25 vials per
    carton
    NDC: 72205-265-0750 mg/5 mL (10 mg/mL)
    		 5 mL Pharmacy Bulk Package vials packed in cartons containing
    10 vials per carton
    NDC: 72205-266-07100 mg/10 mL (10 mg/mL)
    		 10 mL Pharmacy Bulk Package vials packed in cartons containing
    10 vials per carton

    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]. Protect from light. Keep covered in carton until time of use.
    The 1 mL vials are for single-dose only. Discard any unused portion.
    The 5 mL 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 (2°C – 8°C). Discard any unused portion.

  • 17 PATIENT COUNSELING INFORMATION

    Inform patients, families, or caregivers that the primary side effect of phenylephrine is hypertension and, rarely, hypertensive crisis. Patients may experience bradycardia (slow heart rate), which in some cases may produce heart block or other cardiac arrhythmias, extra ventricular beats, myocardial ischemia in patients with underlying cardiac disease, and pulmonary edema (fluid in the lungs) or rales.
    Common, less serious symptoms include the following:

    • chest pain
    • skin or tissue damage if the drug leaks out of the venous catheter into the surrounding tissue
    • headache, nervousness, tremor, numbness/tingling (paresthesias) in hands or feet
    • nausea, vomiting
    • excitability, dizziness, sweating, flushing

    Manufactured by:
    MSN Laboratories Private Limited
    Telangana – 509 228,
    INDIA
    Distributed by:
    Novadoz Pharmaceuticals LLC
    Piscataway, NJ 08854-3714
    Revised: December 2023

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

     

    Phenylephrine Hydrochloride Injection, USP 10 mg/mL - Vial Label

    phenyl-inj-10mg-cntr-lable

    Phenylephrine Hydrochloride Injection, USP 10 mg/mL - Carton Label

    phenyl-inj-10mg-crtn-lable

    Phenylephrine Hydrochloride Injection, USP 50 mg/5 mL (10 mg/mL) - Vial Label

    phenyl-inj-50mg-cntr-lable

    Phenylephrine Hydrochloride Injection, USP 50 mg/5 mL (10 mg/mL) - Carton Label

    phenyl-inj-50mg-crtn-lable

    Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL) - Vial Label

    phenyl-inj-100mg-cntr-lable

    Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL) - Carton Label

    phenyl-inj-100mg-crtn-lable

  • INGREDIENTS AND APPEARANCE
    PHENYLEPHRINE HYDROCHLORIDE 
    phenylephrine hydrochloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 72205-264
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 3.5 mg  in 1 mL
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) 4 mg  in 1 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 1 mg  in 1 mL
    SODIUM METABISULFITE (UNII: 4VON5FNS3C) 2 mg  in 1 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 72205-264-2525 in 1 CARTON05/04/2024
    1NDC: 72205-264-011 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21752107/10/2023
    PHENYLEPHRINE HYDROCHLORIDE 
    phenylephrine hydrochloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 72205-265
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 3.5 mg  in 1 mL
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) 4 mg  in 1 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 1 mg  in 1 mL
    SODIUM METABISULFITE (UNII: 4VON5FNS3C) 2 mg  in 1 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 72205-265-0710 in 1 CARTON05/04/2024
    1NDC: 72205-265-015 mL in 1 VIAL, PHARMACY BULK PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21752107/10/2023
    PHENYLEPHRINE HYDROCHLORIDE 
    phenylephrine hydrochloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 72205-266
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 3.5 mg  in 1 mL
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) 4 mg  in 1 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 1 mg  in 1 mL
    SODIUM METABISULFITE (UNII: 4VON5FNS3C) 2 mg  in 1 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 72205-266-0710 in 1 CARTON05/04/2024
    1NDC: 72205-266-0110 mL in 1 VIAL, PHARMACY BULK PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21752107/10/2023
    Labeler - Novadoz Pharmaceuticals LLC (081109687)
    Establishment
    NameAddressID/FEIBusiness Operations
    MSN LABORATORIES PRIVATE LIMITED650786952ANALYSIS(72205-264, 72205-265, 72205-266) , MANUFACTURE(72205-264, 72205-265, 72205-266)
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