NDC 71872-7257-01 — Ephedrine Sulfate 50 mg/mL Injection, 1 vial

🆔 Identity & classification

FDA NDC (as labeled) 71872-7257-1

Product NDC 71872-7257

11-digit billing NDC 71872725701

RxCUI 1116294

UNII U6X61U5ZEG

UPC 0370121163718

Application # ANDA212932

SPL Set ID c8e8ec0e-988b-85a1-e053-2a95a90a2268

Established class (EPC) Norepinephrine Releasing Agent; alpha-Adrenergic Agonist; beta-Adrenergic Agonist

Mechanism of action Adrenergic alpha-Agonists; Adrenergic beta-Agonists

Physiologic effect Increased Norepinephrine Activity

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2019-10-23

Route INTRAVENOUS

Dosage form INJECTION

Substance EPHEDRINE SULFATE

TE code (Orange Book) AP · RLD · RS

Why two NDCs? The FDA registers this code as 71872-7257-1 — 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 → 71872-7257-01. 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-Adrenergic Agonist class.

Pharmacologic class alpha-Adrenergic Agonist, beta-Adrenergic Agonist, Norepinephrine Releasing Agent

Drug family (ATC) Adrenergic and dopaminergic agents, Sympathomimetics, plain, Alpha- and beta-adrenoreceptor agonists

How it works Adrenergic alpha-Agonists, Adrenergic beta-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 applicationANDA212932 (ANDA)

Labeler code71872

First marketedOct 2019

Product typeHuman Prescription Drug

Portfolio250 products on file

🔎 All NDCs from Medical Purchasing Solutions, LLC

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

Some ephedrine-containing asthma tablets, like Bronkaid and Primatene, are available over the counter, but there's an important catch: you should only use them if a doctor has alre...
I have asthma — can I just pick up ephedrine tablets at the pharmacy without a prescription?
The biggest things to watch for are a rapid heartbeat, tremors, severe nervousness, trouble sleeping, or difficulty breathing that isn't improving. Because ephedrine raises your bl...
What should I watch out for when taking the asthma tablets?

📖 Read our full Ephedrine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Ephedrine Sulfate — tap one for details:

EphedraMajor PeyoteMajor Rauvolfia VomitoriaMajor Sida CordifoliaMajor 1,3-dmaaModerate 1,3-dmbaModerate 1,4-dmaaModerate Acacia RigidulaModerate

🌿 Every supplement checked against Ephedrine Sulfate (46 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.

UNII Q40Q9N063P
Acetic acid is a weak organic acid commonly used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level to ensure the drug remains stable and effective in its formulation.
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.
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.

3 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 system	Per each	Per 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Ephedrine Sulfate 50 mg/mL 00641-6238-25	Hikma	25 vials	—	AP	FDA listed	—
Ephedrine Sulfate 50 mg/mL 00781-3269-95	Sandoz	10 vials	—	AP	FDA listed	—
Ephedrine Sulfate 50 mg/mL 16714-0037-10	NorthStar	10 vials	—	AP	FDA listed	—
Ephedrine Sulfate 50 mg/mL 25021-0836-01	Sagent	25 vials	—	AP	FDA listed	—
Ephedrine Sulfate 50 mg/mL 42023-0216-25	Par	25 vials	—	AP	FDA listed	—
Ephedrine sulfate 50 mg/mL 43598-0725-25	Dr.	25 vials	—	AP	FDA listed	—
Ephedrine Sulfate 50 mg/mL 51662-1325-01	HF	1 ml	—	AP	FDA listed	—
Akovaz 50 mg/mL 51754-4200-04	Exela	25 vials	—	AP3	FDA listed	—
Ephedrine Sulfate 50 mg/mL 55150-0373-25	Eugia	25 vials	—	AP	FDA listed	—
Ephedrine Sulfate 50 mg/mL 65145-0158-25	Caplin	25 vials	—	AP	FDA listed	—
Ephedrine Sulfate 50 mg/mL 65219-0257-01	Fresenius	25 vials	—	AP	FDA listed	—
Ephedrine Sulfate 50 mg/mL 68083-0495-25	Gland	25 vials	—	AP	FDA listed	—
Ephedrine Sulfate 50 mg/mL 70069-0819-10	Somerset	10 vials	—	AP	FDA listed	—
Ephedrine Sulfate 50 mg/mL 70121-1637-05	Amneal	25 vials	—	AP	FDA listed	—
Ephedrine Sulfate 50 mg/mL 70518-4433-00	REMEDYREPACK	10 vials	—	AP	FDA listed	—
Ephedrine Sulfate 50 mg/mL 70700-0249-23	Xiromed,	10 vials	—	AP	FDA listed	—
Ephedrine sulfate 50 mg/mL 70756-0611-25	Lifestar	25 vials	—	AP	FDA listed	—
Ephedrine Sulfate 50 mg/mLthis 71872-7257-01	Medical	1 vial	—	AP	FDA listed	—
Ephedrine Sulfate 50 mg/mL 71872-7269-01	Medical	1 vial	—	AP	FDA listed	—
Ephedrine Sulfate 50 mg/mL 71872-7276-01	Medical	1 vial	—	AP	Discontinued	—
Ephedrine sulfate 50 mg/mL 71872-7302-01	Medical	1 vial	—	AP	FDA listed	—
Ephedrine Sulfate 50 mg/mL 71872-7336-01	Medical	1 vial	—	AP	FDA listed	—
Ephedrine Sulfate 50 mg/mL 72572-0150-10	Civica,	10 vials	—	AP	FDA listed	—
Ephedrine sulfate 50 mg/mL 72603-0203-25	NorthStar	25 vials	—	AP	FDA listed	—
Ephedrine sulfate 50 mg/mL 84549-0611-25	ProPharma	1 ml	—	AP	FDA listed	—
ephedrine sulfate 50 mg/mL 36000-0336-25	Baxter	25 vials	—	AP	FDA listed	—
Ephedrine Sulfate 50 mg/mL 71872-7378-01	Medical	1 vial	—	AP	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

🏛️

2019

On the market since

Oct 2019

📍

2026

Currently FDA-listed

7 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ephedrine Sulfate — the ingredient across all brands.

Top reported reactions

Drug Abuse15

Cardiac Arrest13

Overdose13

Toxicity To Various Agents13

Drug Dependence11

Respiratory Arrest11

Administration Related Reaction10

Age at onset

Neonate1

Adolescent1

Adult21

Elderly8

Reporter sex

Male · 49%

Female · 49%

Unknown · 2%

Serious outcomes

Hospitalization51

Life-threatening15

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
71872-7257-01 You're viewing this	1 VIAL, SINGLE-DOSE in 1 BAG (71872-7257-1) / 1 mL in 1 VIAL, SINGLE-DOSE	2021-07-07	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	✓ Available
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 71872-7257-1, 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: 71872-7257-01, written without dashes as 71872725701. 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 71872-7257-01, the first segment (71872) is the labeler code FDA assigned to Medical Purchasing Solutions, LLC; the middle segment (7257) 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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description

🎯 Indications and Usage 53 words ▾

1 INDICATIONS AND USAGE Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. Ephedrine sulfate injection is an alpha- and beta- adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. (1)

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION Ephedrine sulfate injection, 50 mg/mL, (equivalent to 38 mg ephedrine base) is injected intravenously as a bolus. Dilute before administration. (2) Bolus intravenous injection: 5 mg to 10 mg as needed, not to exceed 50 mg. (2)

2.1General Dosage and Administration Instructions Ephedrine sulfate injection must be diluted before administration as an intravenous bolus to achieve the desired concentration. Dilute with normal saline or 5% dextrose in water. Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard unused portion.

2.2Dosing for the Treatment of Clinically Important Hypotension in the Setting of Anesthesia The recommended dosages for the treatment of clinically important hypotension in the setting of anesthesia is an initial dose of 5 mg to 10 mg administered by intravenous bolus. Administer additional boluses as needed, not to exceed a total dosage of 50 mg. Adjust dosage according to the blood pressure goal (i.e., titrate to effect).

2.3Prepare a 5 mg/mL Solution for Bolus Intravenous Administration For bolus intravenous administration, prepare a solution containing a final concentration of 5 mg/mL of ephedrine sulfate injection: Withdraw 50 mg (1 mL of 50 mg/mL) of ephedrine sulfate injection and dilute with 9 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection. Withdraw an appropriate dose of the 5 mg/mL solution prior to bolus intravenous administration.

💊 Dosage Forms and Strengths 39 words ▾

3 DOSAGE FORMS AND STRENGTHS Ephedrine sulfate injection, USP is available as a single-dose 1 mL vial that contains 50 mg/mL ephedrine sulfate USP, equivalent to 38 mg ephedrine base. Injection: 50 mg/mL ephedrine sulfate in single-dose vial (3)

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None None (4)

⚠️ Warnings and Cautions 166 words ▾

5 WARNINGS AND PRECAUTIONS Pressor Effects with Concomitant Use with Oxytocic Drugs : Pressor effect of sympathomimetic pressor amines is potentiated (5.1) Tachyphylaxis and Tolerance : Repeated administration of ephedrine may cause tachyphylaxis (5.2)

5.1Pressor Effect with Concomitant Oxytocic Drugs Serious postpartum hypertension has been described in patients who received both a vasopressor (i.e., methoxamine, phenylephrine, ephedrine) and an oxytocic (i.e., methylergonovine, ergonovine) [see Drug Interactions (7) ] . Some of these patients experienced a stroke. Carefully monitor the blood pressure of individuals who have received both ephedrine and an oxytocic.

5.2Tolerance and Tachyphylaxis Data indicate that repeated administration of ephedrine can result in tachyphylaxis. Clinicians treating anesthesia-induced hypotension with ephedrine sulfate injection should be aware of the possibility of tachyphylaxis and should be prepared with an alternative pressor to mitigate unacceptable responsiveness.

5.3Risk of Hypertension When Used Prophylactically When used to prevent hypotension, ephedrine has been associated with an increased incidence of hypertension compared with when ephedrine is used to treat hypotension.

🤒 Adverse Reactions 101 words ▾

6 ADVERSE REACTIONS The following adverse reactions associated with the use of ephedrine sulfate 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. Gastrointestinal disorders: Nausea, vomiting Cardiac disorders: Tachycardia, palpitations (thumping heart), reactive hypertension, bradycardia, ventricular ectopics, R-R variability Nervous system disorders: Dizziness Psychiatric disorders: Restlessness Most common adverse reactions during treatment: nausea, vomiting, and tachycardia.

(6) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Interactions that Augment the Pressor Effect Oxytocin and oxytocic drugs Clinical Impact: Serious postpartum hypertension has been described in patients who received both a vasopressor (i.e., methoxamine, phenylephrine, ephedrine) and an oxytocic (i.e., methylergonovine, ergonovine). Some of these patients experienced a stroke. Intervention: Carefully monitor the blood pressure of individuals who have received both ephedrine and an oxytocic.

Clonidine, propofol, monoamine oxidase inhibitors (MAOIs), atropine Clinical Impact: These drugs augment the pressor effect of ephedrine. Intervention: Carefully monitor the blood pressure of individuals who have received both ephedrine and any of these drugs. Interactions that Antagonize the Pressor Effect Clinical Impact: These drugs antagonize the pressor effect of ephedrine.

Intervention: Carefully monitor the blood pressure of individuals who have received both ephedrine and any of these drugs. Examples: α-adrenergic antagonists, β-adrenergic receptor antagonists, reserpine, quinidine, mephentermine Other Drug Interactions Guanethidine Clinical Impact: Ephedrine may inhibit the neuron blockage produced by guanethidine, resulting in loss of antihypertensive effectiveness. Intervention: Clinician should monitor patient for blood pressor response and adjust the dosage or choice of pressor accordingly.

Rocuronium Clinical Impact: Ephedrine may reduce the onset time of neuromuscular blockade when used for intubation with rocuronium if administered simultaneously with anesthetic induction. Intervention: Be aware of this potential interaction. No treatment or other interventions are needed.

Epidural anesthesia Clinical Impact: Ephedrine may decrease the efficacy of epidural blockade by hastening the regression of sensory analgesia. Intervention: Monitor and treat the patient according to clinical practice. Theophylline Clinical Impact: Concomitant use of ephedrine may increase the frequency of nausea, nervousness, and insomnia.

Intervention: Monitor patient for worsening symptoms and manage symptoms according to clinical practice. Cardiac glycosides Clinical Impact: Giving ephedrine with a cardiac glycoside, such as digitalis, may increase the possibility of arrhythmias. Intervention: Carefully monitor patients on cardiac glycosides who are also administered ephedrine.

Interactions that Augment Pressor Effect : clonidine, oxytocin and oxytocic drugs, propofol, monoamine oxidase inhibitors (MAOIs), and atropine. Monitor blood pressure. (7) Interactions that Antagonize the Pressor Effect : Antagonistic effects with α-adrenergic antagonists, β-adrenergic antagonists, reserpine, quinidine, mephentermine.

Monitor blood pressure. (7) Guanethidine : Ephedrine may inhibit the neuron blockage produced by guanethidine, resulting in loss of antihypertensive effectiveness. Monitor blood pressure and adjust the dosage of pressor accordingly.

Rocuronium : Ephedrine may reduce the onset time of neuromuscular blockade when used for intubation with rocuronium if administered simultaneously with anesthetic induction. Be aware of this potential interaction. No treatment or other interventions are needed.

Epidural anesthesia : Ephedrine may decrease the efficacy of epidural blockade by hastening the regression of sensory analgesia. Monitor and treat the patient according to clinical practice. Theophylline : Concomitant use of ephedrine may increase the frequency of nausea, nervousness, and insomnia.

Monitor patient for worsening symptoms and manage symptoms according to clinical practice. Cardiac glycosides : Giving ephedrine with a cardiac glycoside, such as digitalis, may increase the possibility of arrhythmias. Carefully monitor patients on cardiac glycosides who are also administered ephedrine.

🆘 Overdosage 48 words ▾

10 OVERDOSAGE Overdose of ephedrine can cause a rapid rise in blood pressure. In the case of an overdose, careful monitoring of blood pressure is recommended. If blood pressure continues to rise to an unacceptable level, parenteral antihypertensive agents can be administered at the discretion of the clinician.

🧬 Clinical Pharmacology ~1 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ephedrine sulfate is a sympathomimetic amine that directly acts as an agonist at α- and ß-adrenergic receptors and indirectly causes the release of norepinephrine from sympathetic neurons. Pressor effects by direct alpha- and beta-adrenergic receptor activation are mediated by increases in arterial pressures, cardiac output, and peripheral resistance. Indirect adrenergic stimulation is caused by norepinephrine release from sympathetic nerves.

12.2Pharmacodynamics Ephedrine stimulates heart rate and cardiac output and variably increases peripheral resistance; as a result, ephedrine usually increases blood pressure. Stimulation of the α-adrenergic receptors of smooth muscle cells in the bladder base may increase the resistance to the outflow of urine. Activation of ß-adrenergic receptors in the lungs promotes bronchodilation.

The overall cardiovascular effect from ephedrine is the result of a balance among α-1 adrenoceptor-mediated vasoconstriction, ß-2 adrenoceptor-mediated vasoconstriction, and ß-2 adrenoceptor-mediated vasodilatation. Stimulation of the ß-1 adrenoceptors results in positive inotrope and chronotrope action. Tachyphylaxis to the pressor effects of ephedrine may occur with repeated administration [see Warnings and Precautions (5.2) ] .

12.3Pharmacokinetics Publications studying pharmacokinetics of oral administration of (-)-ephedrine support that (-)-ephedrine is metabolized into norephedrine. However, the metabolism pathway is unknown. Both the parent drug and the metabolite are excreted in urine.

Limited data after intravenous administration of ephedrine support similar observations of urinary excretion of drug and metabolite. The plasma elimination half-life of ephedrine following oral administration was about 6 hours. Ephedrine crosses the placental barrier [see Use in Specific Populations (8.1) ] .

🧬 Mechanism of Action 63 words ▾

12.1Mechanism of Action Ephedrine sulfate is a sympathomimetic amine that directly acts as an agonist at α- and ß-adrenergic receptors and indirectly causes the release of norepinephrine from sympathetic neurons. Pressor effects by direct alpha- and beta-adrenergic receptor activation are mediated by increases in arterial pressures, cardiac output, and peripheral resistance. Indirect adrenergic stimulation is caused by norepinephrine release from sympathetic nerves.

📦 How Supplied / Storage and Handling 140 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Ephedrine Sulfate Injection USP, 50 mg/mL is a clear, colorless sterile solution and supplied in 1 mL single-dose glass vials. Each mL contains 50 mg of ephedrine sulfate USP, equivalent to 38 mg ephedrine base. It is available as follows: 50 mg/mL (1 mL) 1 mL Single-dose Vial: NDC 70121-1637-1 10 Vials in a Carton: NDC 70121-1637-7 25 Vials in a Carton: NDC 70121-1637-5 Vial stoppers are not manufactured with natural rubber latex.

Store ephedrine sulfate injection USP, 50 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]. Store in carton until time of use. For single-dose only.

Discard unused portion. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd.

Parenteral Unit Ahmedabad 382213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 05-2020-01

📋 Description 128 words ▾

11 DESCRIPTION Ephedrine is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. Ephedrine sulfate injection, USP is a clear, colorless, sterile solution for intravenous injection. It must be diluted before intravenous administration.

The chemical name of ephedrine sulfate is (1R,2S)-(-)-2-methylamine-1-phenylpropan-1-ol sulfate, and the molecular weight is 428.5 g/mol. Its molecular formula is (C 10 H 15 NO) 2 .H 2 SO 4 and structural formula is depicted below: Ephedrine sulfate, USP is a white to off-white powder; it is freely soluble in water and slightly soluble in alcohol. Each mL contains ephedrine sulfate, USP 50 mg (equivalent to 38 mg ephedrine base) in water for injection.

The pH is adjusted with sodium hydroxide and/or glacial acetic acid if necessary. The pH range is 4.5 to 7.0. l

Glossary — plain-language definitions of medical terms used in this label:

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agonist: A substance that switches on a specific target in the body to produce an effect, the way a key turns a lock.

bolus: A single dose given all at once, often as a quick push into a vein.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

bronchodilation: A widening of the airways in the lungs, which makes breathing easier.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

parenteral: Given by injection or drip into the body rather than swallowed by mouth.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

postpartum: The period of time right after a woman gives birth.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

restlessness: An inability to stay calm or still, with a constant feeling of needing to move.

single-dose vial: A small container holding one dose of medicine, meant to be used once and then thrown away.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

tachyphylaxis: A rapid drop in a medicine's effect after repeated doses given close together, so it quickly stops working as well.

tolerance: When the body gets used to a medicine over time, so a larger dose is needed to get the same effect.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

vasoconstriction: Narrowing of blood vessels, which reduces blood flow through them and can raise blood pressure.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

🔗 Related NDC lookups

🧪 All Ephedrine Sulfate NDCsSame ingredient 🏭 All Medical labeler NDCsLabeler code 71872 📚 All Norepinephrine Releasing Agent NDCsDrug class