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Phenylephrine hydrochloride 10 mg/mL Injection, 1 vial

by Medical Purchasing Solutions, LLC · 1 VIAL, SINGLE-DOSE in 1 BAG (71872-7159-1) / 1 mL in 1 VIAL, SINGLE-DOSE
NDC 71872-7159-01
🏷️ FDA NDC (as labeled) 71872-7159-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 71872-7159-1
Product NDC 71872-7159
11-digit billing NDC 71872715901
RxCUI 1666372
UNII 04JA59TNSJ
UPC 0370121157717
Application # ANDA211079
SPL Set ID 86abb371-3ac9-9f74-e053-2991aa0a66af
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-07-07
Route INTRAVENOUS
Dosage form INJECTION
Substance PHENYLEPHRINE HYDROCHLORIDE
TE code (Orange Book) AP1 · RLD · RS
Why two NDCs? The FDA registers this code as 71872-7159-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 71872-7159-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the alpha-1 Adrenergic Agonist class.

Pharmacologic class alpha-1 Adrenergic Agonist
Drug family (ATC) Sympathomimetics excl. antiglaucoma preparations, Adrenergic and dopaminergic agents, Other agents for treatment of hemorrhoids and anal fissures for topical use
How it works Adrenergic alpha1-Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerMedical Purchasing Solutions, LLC
Application holderAMNEAL EU LTD
FDA applicationANDA211079 (ANDA)
Labeler code71872
First marketedJul 2018
Product typeHuman Prescription Drug
Portfolio249 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Yes, it's the same active ingredient, but used in very different ways depending on the form. The nasal spray delivers a tiny amount directly to the nasal lining to temporarily shri...
  • I see phenylephrine in nasal sprays at the pharmacy AND as an IV drug in the hospital — is it really the same medication?
  • You should check with your doctor first. Phenylephrine constricts blood vessels, which can raise blood pressure and put extra strain on the heart — even from a nasal spray. If you...
  • Can I use the nasal spray if I have high blood pressure or heart disease?
📖 Read our full Phenylephrine guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Phenylephrine Hydrochloride — tap one for details:

Butcher's BroomModerate
🌿 Every supplement checked against Phenylephrine Hydrochloride (1 interactions) — ranked by severity →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 1 mg / 1 mL UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • 3.5 mg / 1 mL UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 2 mg / 1 mL UNII 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
  • 4 mg / 1 mL UNII B22547B95K
    A salt derived from citric acid that helps maintain the proper acid-base balance in the medicine. It's used as a buffer to keep the product stable and at the right pH level.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

7 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Phenylephrine Hydrochloride 10 mg/mL 00404-9931-99 Henry 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00641-6142-25 Hikma 25 vials — — FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00641-6229-25 Hikma 25 vials — — FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00781-3422-92 Sandoz 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00781-9226-92 Sandoz 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 14335-0440-01 Hainan 25 vials — AP1 FDA listed —
phenylephrine hydrochloride 10 mg/mL 23155-0620-41 Heritage 25 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 25021-0315-01 Sagent 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 31722-0343-32 Camber 10 vials — AP1 FDA listed —
phenylephrine hydrochloride 10 mg/mL 36000-0358-25 Baxter 25 vials — AP1 FDA listed —
Biorphen 10 mg/mL 43598-0199-10 Dr. 10 ampules — AP FDA listed —
Phenylephrine Hci 10 mg/mL 51662-1249-01 HF 1 ml — — FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 51662-1576-01 HF 1 ml — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 55150-0300-25 Eugia 25 vials — AP2 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 55154-8226-05 Cardinal 5 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 58657-0851-26 Method 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 63323-0751-13 Fresenius 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 65145-0115-25 Caplin 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 65219-0388-01 Fresenius 25 vials — AP2 FDA listed —
Phenylephrine Hydrochloride Phenylephrine Hydrochloride 10 mg/mL 68083-0465-25 Gland 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 70069-0801-25 Somerset 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 70069-0811-25 Somerset 25 vials — AP1 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 70121-1577-05 Amneal 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 70594-0063-02 Xellia 25 vials — AP1 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 70756-0621-25 Lifestar 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71288-0807-02 Meitheal 25 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71839-0127-25 BE 25 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71872-7043-01 Medical 1 vial — — FDA listed —
Phenylephrine hydrochloride 10 mg/mLthis 71872-7159-01 Medical 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71872-7267-01 Medical 1 vial — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71872-7273-01 Medical 1 vial — AP1 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 71872-7303-01 Medical 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71872-7343-01 Medical 1 vial — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71872-7348-01 Medical 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 72205-0264-25 Novadoz 25 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 72485-0504-25 Armas 25 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 72572-0571-25 Civica, 25 vials — — FDA listed —
Phenylephrine hydrochloride 10 mg/mL 81284-0211-25 Provepharm 25 vials — AP1 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 84549-0621-25 ProPharma 1 ml — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00781-9227-95 Sandoz 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00781-9228-70 Sandoz 1 vial — AP1 FDA listed —
phenylephrine hydrochloride 10 mg/mL 68083-0338-10 Gland 10 vials — AP1 FDA listed —
phenylephrine hydrochloride 10 mg/mL 68083-0339-01 Gland 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71288-0808-76 Meitheal 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 55150-0301-10 Eugia 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 55150-0302-01 Eugia 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71839-0128-10 BE 10 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 71839-0129-10 BE 10 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 31722-0344-31 Camber 10 vials — AP1 FDA listed —
phenylephrine hydrochloride 10 mg/mL 36000-0362-05 Baxter 5 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00641-6188-10 Hikma 10 vials — — FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00781-3458-95 Sandoz 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 72205-0265-07 Novadoz 10 vials — AP2 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 14335-0442-01 Hainan 1 vial — AP1 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 42023-0215-01 Par 1 vial — — FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 58657-0853-01 Method 10 ml — AP1 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 70121-1578-07 Amneal 10 vials — AP1 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 70121-1579-01 Amneal 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 58657-0852-11 Method 10 vials — AP1 FDA listed —
phenylephrine hydrochloride 10 mg/mL 36000-0360-10 Baxter 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00781-3466-70 Sandoz 1 vial — AP1 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 42023-0214-10 Par 10 vials — — FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 72205-0266-07 Novadoz 10 vials — AP2 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 81284-0212-10 Provepharm 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 31722-0345-10 Camber 1 vial — AP1 FDA listed —
Phenylephrine hydrochloride 10 mg/mL 81284-0213-01 Provepharm 1 vial — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 00641-6189-10 Hikma 10 vials — — FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 14335-0441-01 Hainan 10 vials — AP1 FDA listed —
Phenylephrine Hydrochloride 10 mg/mL 72572-0570-10 Civica, 10 vials — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71872-7159-01 You're viewing this 1 VIAL, SINGLE-DOSE in 1 BAG (71872-7159-1) / 1 mL in 1 VIAL, SINGLE-DOSE 2019-04-09 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 71872-7159-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71872-7159-01, written without dashes as 71872715901. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71872-7159-01, the first segment (71872) is the labeler code FDA assigned to Medical Purchasing Solutions, LLC; the middle segment (7159) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Medical Purchasing Solutions, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Medical Purchasing Solutions, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 61 words ▾

1 INDICATIONS AND USAGE Phenylephrine hydrochloride injection, 10 mg/mL is an alpha-1 adrenergic receptor agonist 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 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Phenylephrine hydrochloride injection, 10 mg/mL, 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 ) The dose should be adjusted according to the pressor response (i.e. titrate to effect). ( 2 )

2.1General Dosage and Administration Instructions Phenylephrine hydrochloride injection, 10 mg/mL must be diluted before administration as an intravenous bolus or continuous intravenous infusion to achieve the desired concentration: Bolus : Dilute with normal saline or 5% dextrose in water. Continuous infusion : Dilute with normal saline or 5% dextrose in water. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Do not use if the solution is colored or cloudy, or if it contains particulate matter. The diluted solution should not be held for more than 4 hours at room temperature or for more than 24 hours under refrigerated conditions. Discard any unused portion.

During phenylephrine hydrochloride injection administration: Correct intravascular volume depletion. Correct acidosis. Acidosis may reduce the effectiveness of phenylephrine.

2.2Dosing 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. May administer additional boluses 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.

2.3Prepare a 100 mcg/mL Solution for Bolus Intravenous Administration For bolus intravenous administration, prepare a solution containing a final concentration of 100 mcg/mL of phenylephrine hydrochloride injection: Withdraw 10 mg (1 mL of 10 mg/mL) of phenylephrine hydrochloride and dilute with 99 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP. Withdraw an appropriate dose from the 100 mcg/mL solution prior to bolus intravenous administration.

2.4Prepare a Solution for Continuous Intravenous Administration For continuous intravenous infusion, prepare a solution containing a final concentration of 20 mcg/mL of phenylephrine hydrochloride in 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP: Withdraw 10 mg (1 mL of 10 mg/mL) of phenylephrine hydrochloride and dilute with 500 mL of 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP.

💊 Dosage Forms and Strengths 50 words ▾

3 DOSAGE FORMS AND STRENGTHS Phenylephrine hydrochloride injection, USP is a sterile, clear, colorless solution and supplied in 1 mL single-dose glass vials. Each mL contains phenylephrine hydrochloride USP, 10 mg . Injection. ( 3 ) 1 mL single-dose vials containing 10 mg phenylephrine hydrochloride (10 mg/mL). ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None None. ( 4 )

⚠️ Warnings and Cautions ~1 min read ▾

5 WARNINGS AND PRECAUTIONS Extravasation during intravenous administration may cause necrosis or sloughing of tissue. ( 5.3 ) Severe bradycardia and decreased cardiac output. ( 5.4 ) Allergic-type reactions : Sulfite. ( 5.5 ) Concomitant use with oxytocic drugs: Pressor effect of sympathomimetic pressor amines is potentiated. ( 5.8 )

5.1Exacerbation 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.

5.2Peripheral 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.

5.3Skin 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.

5.4Bradycardia Phenylephrine hydrochloride can cause severe bradycardia and decreased cardiac output.

5.5Allergic 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.

5.6Renal Toxicity Phenylephrine hydrochloride can increase the need for renal replacement therapy in patients with septic shock. Monitor renal function.

5.7Risk 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.

5.8Pressor 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.

🤒 Adverse Reactions 138 words ▾

6 ADVERSE REACTIONS 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 Amneal Biosciences at 1-855-266-3251 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 153 words ▾

7 DRUG INTERACTIONS Agonistic effects 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 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 )

7.1Interactions 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

7.2Interactions 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.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 )

8.1Pregnancy Pregnancy Category C Risk Summary There are no adequate or well-controlled studies with phenylephrine hydrochloride injection in pregnant women, nor have animal reproduction studies been conducted. Published studies in normotensive pregnant rabbits report early onset labor, increased fetal lethality, and adverse placental effects with subcutaneous phenylephrine administration during gestation at doses approximately 1.9-times the total daily human dose. Published studies in normotensive pregnant sheep report decreased uterine blood flow and decreased PaO 2 in the fetus with intravenous phenylephrine administration during late gestation at doses less than and similar to the human dose.

It is not known whether phenylephrine hydrochloride, can cause fetal harm when administered to a pregnant woman. Phenylephrine hydrochloride, should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus. Clinical Considerations Labor and Delivery The most common maternal adverse reactions reported in published studies of phenylephrine use during neuraxial anesthesia during Cesarean delivery include nausea and vomiting, bradycardia, reactive hypertension, and transient arrhythmias.

Phenylephrine, when administered during labor or delivery, does not appear to alter either neonatal Apgar scores or umbilical artery blood-gas status. Data Animal Data Studies in the published literature evaluating subcutaneously administered phenylephrine (0.33 mg/kg, TID) in normotensive pregnant rabbits reported fetal deaths, adverse histopathology findings in the placenta (necrosis, calcification and thickened vascular walls with narrowed lumen) and possible teratogenic effects (one incidence of clubbed feet, partial development of the intestine) when treatment was initiated during the first trimester or later; and premature labor when treatment was initiated at the second trimester or later.

The doses administered were 1.9- times the total daily human dose of 10 mg/day based on a body surface area comparison. Published studies in pregnant normotensive sheep demonstrate that intravenous phenylephrine (4 mcg/kg/min for 30 minutes, equivalent to 3.6 to 4.1 mcg/kg/min human equivalent dose based on body surface area) administered during the third trimester of pregnancy decreased uterine blood flow by 42%. This dose is 1.1- to 1.2-times the human bolus dose of 200 mcg/60 kg person based on body surface area.

Mean fetal blood pressure and heart rate fluctuated above and below controls by about 7% during the infusion. Fetal PaO 2 was significantly decreased by approximately 26% of control during the infusion. Likewise, PaCO 2 was increased and pH was decreased.

The clinical significance of these findings is not clear; however, the results suggest the potential for cardiovascular effects on the fetus when phenylephrine is used during pregnancy.

8.3Nursing Mothers It is not known whether phenylephrine is present in human milk. 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 child from the drug or from the underlying maternal condition. Exercise caution when phenylephrine hydrochloride injection is administered to a nursing woman.

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric 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…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Category C Risk Summary There are no adequate or well-controlled studies with phenylephrine hydrochloride injection in pregnant women, nor have animal reproduction studies been conducted. Published studies in normotensive pregnant rabbits report early onset labor, increased fetal lethality, and adverse placental effects with subcutaneous phenylephrine administration during gestation at doses approximately 1.9-times the total daily human dose. Published studies in normotensive pregnant sheep report decreased uterine blood flow and decreased PaO 2 in the fetus with intravenous phenylephrine administration during late gestation at doses less than and similar to the human dose.

It is not known whether phenylephrine hydrochloride, can cause fetal harm when administered to a pregnant woman. Phenylephrine hydrochloride, should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus. Clinical Considerations Labor and Delivery The most common maternal adverse reactions reported in published studies of phenylephrine use during neuraxial anesthesia during Cesarean delivery include nausea and vomiting, bradycardia, reactive hypertension, and transient arrhythmias.

Phenylephrine, when administered during labor or delivery, does not appear to alter either neonatal Apgar scores or umbilical artery blood-gas status. Data Animal Data Studies in the published literature evaluating subcutaneously administered phenylephrine (0.33 mg/kg, TID) in normotensive pregnant rabbits reported fetal deaths, adverse histopathology findings in the placenta (necrosis, calcification and thickened vascular walls with narrowed lumen) and possible teratogenic effects (one incidence of clubbed feet, partial development of the intestine) when treatment was initiated during the first trimester or later; and premature labor when treatment was initiated at the second trimester or later.

The doses administered were 1.9- times the total daily human dose of 10 mg/day based on a body surface area comparison. Published studies in pregnant normotensive sheep demonstrate that intravenous phenylephrine (4 mcg/kg/min for 30 minutes, equivalent to 3.6 to 4.1 mcg/kg/min human equivalent dose based on body surface area) administered during the third trimester of pregnancy decreased uterine blood flow by 42%. This dose is 1.1- to 1.2-times the human bolus dose of 200 mcg/60 kg person based on body surface area.

Mean fetal blood pressure and heart rate fluctuated above and below controls by about 7% during the infusion. Fetal PaO 2 was significantly decreased by approximately 26% of control during the infusion. Likewise, PaCO 2 was increased and pH was decreased.

The clinical significance of these findings is not clear; however, the results suggest the potential for cardiovascular effects on the fetus when phenylephrine is used during pregnancy.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 83 words ▾

8.5Geriatric 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.

🆘 Overdosage 43 words ▾

10 OVERDOSAGE 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.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Phenylephrine hydrochloride is an α-1 adrenergic receptor agonist.

12.2Pharmacodynamics Interaction of phenylephrine with α1-adrenergic receptors on vascular smooth muscle cells causes activation of the cells and results in vasoconstriction. Following phenylephrine hydrochloride intravenous administration, increases in systolic and diastolic blood pressures, 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, typically within minutes.

As blood pressure increases following intravenous administration, vagal activity also increases, resulting in reflex bradycardia. Phenylephrine has activity on most vascular beds, including renal, pulmonary, and splanchnic arteries.

12.3Pharmacokinetics Following an intravenous infusion of phenylephrine hydrochloride, the observed effective half-life was approximately 5 minutes. The steady-state volume of distribution of approximately 340 L suggests a high distribution into organs and peripheral tissues. The average total serum clearance is approximately 2100 mL/min.

The observed phenylephrine plasma terminal elimination half-life was 2.5 hours. 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 hours; and approximately 86% of the total dose was recovered in the urine within 48 hours.

The excreted unchanged parent drug was 16% of the total dose in the urine at 48 hours post intravenous administration. There are two major metabolites, with approximately 57 and 8% of the total dose excreted as m -hydroxymandelic acid and sulfate conjugates, respectively. The metabolites are considered not pharmacologically active.

🧬 Mechanism of Action 12 words ▾

12.1Mechanism of Action Phenylephrine hydrochloride is an α-1 adrenergic receptor agonist.

📦 How Supplied / Storage and Handling 126 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Phenylephrine Hydrochloride Injection, USP is a sterile, clear, colorless solution and supplied in 1 mL single-dose glass vials. Each mL contains phenylephrine hydrochloride USP, 10 mg . 10 mg/mL (1 mL) 1 mL Single - dose Vial: NDC 70121-1577-1 25 Vials in a Carton: NDC 70121-1577-5 Store phenylephrine hydrochloride injection USP, 10 mg/mL at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Protect from light. Store in carton until time of use. Vial stoppers are not manufactured with natural rubber latex.

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.

📋 Description 155 words ▾

11 DESCRIPTION Phenylephrine is an alpha-1 adrenergic receptor agonist. Phenylephrine hydrochloride injection USP, 10 mg/mL is a 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 its structural formula is depicted below: Phenylephrine hydrochloride, USP is a white or practically white crystals with a molecular formula of C 9 H 13 NO 2 • HCl and a molecular weight of 203.67. It is freely soluble in water and in alcohol. Phenylephrine hydrochloride injection USP, 10 mg/mL is sensitive to light.

Each mL contains: phenylephrine hydrochloride, USP 10 mg, sodium chloride 3.5 mg, trisodium 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.

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💬 Information for Patients 46 words ▾

17 PATIENT COUNSELING INFORMATION If applicable, inform patients, family member, or caregiver that certain medical conditions and medications might influence how phenylephrine hydrochloride injection works. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit Ahmedabad 382213, INDIA Distributed by: Amneal Biosciences LLC Bridgewater, NJ 08807 Rev. 04-2018-00

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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