NDC 71863-211 Rezipres

Ephedrine Hydrochloride

NDC Product Code 71863-211

NDC Product Information

Rezipres with NDC 71863-211 is a a human prescription drug product labeled by Eton Pharmaceuticals, Inc.. The generic name of Rezipres is ephedrine hydrochloride. The product's dosage form is injection, solution and is administered via intravenous form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 2560085, 2560090, 2560094, 2560096, 2560100 and 2560102.

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Rezipres Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • WATER (UNII: 059QF0KO0R)
  • NITROGEN (UNII: N762921K75)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • WATER (UNII: 059QF0KO0R)
  • NITROGEN (UNII: N762921K75)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
  • Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)
  • beta-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
  • Adrenergic beta-Agonists - [MoA] (Mechanism of Action)
  • Norepinephrine Releasing Agent - [EPC] (Established Pharmacologic Class)
  • Increased Norepinephrine Activity - [PE] (Physiologic Effect)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Eton Pharmaceuticals, Inc.
Labeler Code: 71863
FDA Application Number: NDA213536 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-14-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Rezipres Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

REZIPRES® is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.

2.1 General Dosage And Administration Instructions

  • REZIPRES® 47 mg/mL must be diluted before administration as an intravenous bolus to achieve the desired concentration. Dilute with normal saline or 5% dextrose in water.REZIPRES® 9.4 mg/mL can be either used as provided at 9.4 mg/mL or it can be diluted, with 5% Dextrose Injection or 0.9% Sodium Chloride Injection, to achieve the desired concentration, before administration as an intravenous bolus.REZIPRES® 4.7 mg/mL is a premixed formulation. Do not dilute prior to use.REZIPRES® is a clear, colorless solution. Discard any unused portion.Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is not clear or if particulate matter is present.

2.2 Dosing 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 4.7 mg to 9.4 mg administered by intravenous bolus. Administer additional boluses as needed, not to exceed a total dosage of 47 mg.Adjust dosage according to the blood pressure goal (i.e., titrate to effect).

2.3 Prepare A 4.7 Mg/Ml Solution For Bolus Intravenous Administration

REZIPRES® 47 mg/mL• Withdraw 47 mg (1 mL of 47 mg/mL) of REZIPRES® 47 mg/mL and dilute with 9 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection.• Withdraw an appropriate dose of the 4.7 mg/mL solution prior to bolus intravenous administration.REZIPRES® 9.4 mg/mL• Withdraw 5 mL of REZIPRES® 9.4 mg/mL and dilute with 5 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection.• Withdraw an appropriate dose of the 4.7 mg/mL solution prior to bolus intravenous administration.

2.4 Direct Administration Of 9.4 Mg/Ml Solution For Bolus Intravenous

REZIPRES® if used as provided at 9.4 mg/ml:• withdraw an appropriate dose of REZIPRES® 9.4 mg/mL solution prior to bolus intravenous administration.

3 Dosage Forms And Strengths

REZIPRES® 47 mg/mLREZIPRES® 47 mg/mL is a clear, colorless solution available in a one point cut clear colorless glass 2 mL single-dose ampule that contains 1 mL of solution, corresponding to 47 mg of ephedrine hydrochloride, equivalent to 38 mg of ephedrine base.REZIPRES® 47 mg/5 mL (9.4 mg/mL)REZIPRES® 47 mg/5mL is a clear, colorless solution available in a one point cut clear colorless glass single-dose ampule equivalent to 38 mg/5 mL ephedrine base (9.4 mg/mL ephedrine hydrochloride, equivalent to 7.7 mg/mL ephedrine base).REZIPRES® 23.5 mg/5 mL (4.7 mg/mL)REZIPRES® 23.5 mg/ 5mL is a clear, colorless solution, available in a one point cut clear colorless glass single-dose ampule, equivalent to 19 mg/5 mL of ephedrine base (4.7 mg/mL ephedrine hydrochloride, equivalent to 3.8 mg/mL of ephedrine base).

4 Contraindications

None

5.1 Pressor 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 REZIPRES® and an oxytocic.

5.2 Tolerance And Tachyphylaxis

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

5.3 Risk 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.

6 Adverse Reactions

The following adverse reactions associated with the use of ephedrine 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, vomitingCardiac disorders: Tachycardia, palpitations (thumping heart), reactive hypertension, bradycardia, ventricular ectopics, R-R variabilityNervous system disorders: DizzinessPsychiatric disorders: Restlessness

7.1 Interactions That Augment Pressor Effect

Interactions that Augment Pressor Effect Oxytocin and oxytocic drugsClinical 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 REZIPRES® and an oxytocic.  Clonidine, propofol, monoamine oxidase inhibitors (MAOIs), atropineClinical Impact: These drugs augment the pressor effect of ephedrine. Intervention: Carefully monitor the blood pressure of individuals who have received both REZIPRES® and any of these drugs.

7.2 Interactions That Antagonize The Pressor Effect

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 REZIPRES® and any of these drugs.Examples: α-adrenergic antagonists, β-adrenergic receptor antagonists, reserpine, quinidine, mephentermine.

7.3 Other Drug Interaction

Other Drug Interaction GuanethidineClinical Impact: REZIPRES® 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.RocuroniumClinical Impact: REZIPRES® 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 anesthesiaClinical Impact: REZIPRES® may decrease the efficacy of epidural blockade by hastening the regression of sensory analgesia.Intervention: Monitor and treat the patient according to clinical practice.TheophyllineClinical Impact: Concomitant use of REZIPRES® may increase the frequency of nausea, nervousness, and insomnia.Intervention: Monitor patient for worsening symptoms and manage symptoms according to clinical practice.Cardiac glycosidesClinical Impact: Giving REZIPRES® with a cardiac glycoside, such as digitalis, may increase the possibility of arrhythmias.Intervention: Carefully monitor patients on cardiac glycosides who are also administered REZIPRES®.

8.1 Pregnancy

Risk SummaryAvailable data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, there are clinical considerations [see Clinical Considerations].In animal reproduction studies, decreased fetal survival and fetal body weights were observed in the presence of maternal toxicity after normotensive pregnant rats were administered 60 mg/kg intravenous ephedrine sulfate (12 times the maximum recommended human dose (MRHD) of 47 mg/day of ephedrine hydrochloride). No malformations or embryofetal adverse effects were observed when pregnant rats or rabbits were treated with intravenous bolus doses of ephedrine sulfate during organogenesis at doses 1.9 and 7.7 times the MRHD, respectively [See data].The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.  In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.Clinical ConsiderationsDisease-associated maternal and/or embryofetal riskUntreated hypotension associated with spinal anesthesia for cesarean section is associated with an increase in maternal nausea and vomiting. A decrease in uterine blood flow due to maternal hypotension may result in fetal bradycardia and acidosis.Fetal/Neonatal Adverse ReactionsCases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature. These reports describe umbilical artery pH of ≤7.2 at the time of delivery [see Clinical Pharmacology 12.3]. Monitoring of the newborn for signs and symptoms of metabolic acidosis may be required. Monitoring of infant’s acid-base status is warranted to ensure that an episode of acidosis is acute and reversible.DataAnimal DataDecreased fetal body weights were observed when pregnant rats were administered intravenous bolus doses of 60 mg/kg ephedrine sulfate (12 times the maximum recommended human dose (MRHD) based on body surface area) from Gestation Day 6-17. This dose was associated with evidence of maternal toxicity (decreased body weight of dams and abnormal head movements). No malformations or fetal deaths were noted at this dose. No effects on fetal body weight were noted at 10 mg/kg (1.9 times the MRHD).No evidence of malformations or embryo-fetal toxicity were noted in pregnant rabbits administered intravenous bolus doses up to 20 mg/kg ephedrine sulfate (7.7 times the MRHD based on body surface area) from Gestation Day 6 to 20. This dose was associated with expected pharmacological maternal effects (increased respiration rate, dilated pupils, piloerection).Decreased fetal survival and body weights in the presence of maternal toxicity (increased mortality) were noted when pregnant dams were administered intravenous bolus doses of 60 mg/kg epinephrine sulfate (approximately 12 times the MRHD based on body surface area) from GD 6 through Lactation Day 20. No adverse effects were noted at 10 mg/kg (1.9 times the MRHD).

8.2 Lactation

Risk SummaryA single published case report indicates that ephedrine is present in human milk. However, no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for REZIPRES® and any potential adverse effects on the breastfed child from REZIPRES® or from the underlying maternal condition.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.Animal Toxicity DataIn a study in which juvenile rats were administered intravenous bolus doses of 2, 10, or 60 mg/kg ephedrine sulfate daily from Postnatal Day 35 to 56, an increased incidence of mortality was noted at the high dose of 60 mg/kg. The no-adverse-effect level was 10 mg/kg (approximately 1.9 times a maximum daily dose of 47 mg ephedrine hydrochloride in a 60 kg person based on body surface area).

8.5 Geriatric Use

Clinical studies of ephedrine 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. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

8.6 Renal Impairment

Ephedrine and its metabolite are excreted in urine. In patients with renal impairment, excretion of ephedrine is likely to be affected with a corresponding increase in elimination half-life, which will lead to slow elimination of ephedrine and consequently prolonged pharmacological effect and potentially adverse reactions. Monitor patients with renal impairment carefully after the initial bolus dose for adverse events.

10 Overdosage

Overdose of REZIPRES® 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.

11 Description

REZIPRES® is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent. Ephedrine Hydrochloride Injection, 4.7 mg/mL is a clear, colorless, sterile solution for intravenous injection. The chemical name of ephedrine hydrochloride is (1R,2S)-(-)-2-methylamino-1-phenyl-1-propanol hydrochloride, and the molecular weight is 201.7 g/mol. Its structural formula is depicted below:Ephedrine hydrochloride is freely soluble in water, soluble in ethanol and stable in aqueous solution.REZIPRES® 47 mg/mLREZIPRES® 47 mg/ml is a clear, colorless, sterile solution for intravenous injection. It must be diluted before intravenous administration. Each mL contains ephedrine hydrochloride 47 mg (equivalent to 38 mg ephedrine base) in water for injection. The pH is adjusted with sodium hydroxide and hydrochloric acid if necessary. The pH range is 5.0 to 6.5.REZIPRES® 47 mg/5 mL (9.4 mg/mL)REZIPRES® 9.4 mg/ml is a clear, colorless, sterile solution for intravenous injection. It can either be used as provided or diluted at 4.7 mg/mL, before intravenous administration. Each mL contains ephedrine hydrochloride 9.4 mg (equivalent to 7.7 mg ephedrine base) and sodium chloride 6.0 mg in water for injection. The pH is adjusted with sodium hydroxide and hydrochloric acid if necessary. The pH range is 5.0 to 6.5.REZIPRES® 23.5 mg/5 mL (4.7 mg/mL)REZIPRES® 4.7 mg/ml is a clear, colorless, sterile solution for intravenous injection. It must not be diluted prior to use. Each mL contains ephedrine hydrochloride 4.7 mg (equivalent to 3.8 mg ephedrine base) and sodium chloride 7.5 mg in water for injection. The pH is adjusted with sodium hydroxide and hydrochloric acid if necessary. The pH range is 5.0 to 6.5.

12.1 Mechanism Of Action

Ephedrine is a sympathomimetic amine that directly acts as an agonist at α- and β-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.

12.2 Pharmacodynamics

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 β- 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, β-2 adrenoceptor-mediated vasoconstriction, and β-2 adrenoceptor-mediated vasodilatation. Stimulation of the β-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].

12.3 Pharmacokinetics

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 IV 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].

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenesis: Two-year feeding studies in rats and mice conducted under the National Toxicology Program (NTP) demonstrated no evidence of carcinogenic potential with ephedrine sulfate at doses up to 10 mg/kg/day and 27 mg/kg/day (approximately 2 times and 3 times the maximum human recommended dose on a mg/m2 basis, respectively).Mutagenesis: Ephedrine sulfate tested negative in the in vitro bacterial reverse mutation assay, the in vitro mouse lymphoma assay, the in vitro sister chromatid exchange, the in vitro chromosomal aberration assay, and the in vivo rat bone marrow micronucleus assay.Impairment of Fertility: there was no impact on fertility or early embryonic development in a study in which male rats were administered intravenous bolus doses of 0, 2, 10, or 60 mg/kg ephedrine sulfate (up to 12 times the MRHD of 47 mg of ephedrine hydrochloride based on body surface area) for 28 days prior to mating and through gestation and females were treated for 14 days prior to mating through Gestation Day 7.

14 Clinical Studies

The evidence for the efficacy of REZIPRES® is derived from the published literature. Increases in blood pressure following administration of ephedrine were observed in 14 studies, including 9 where ephedrine was used in pregnant women undergoing neuraxial anesthesia during Cesarean delivery, 1 study in non-obstetric surgery under neuraxial anesthesia, and 4 studies in patients undergoing surgery under general anesthesia. Ephedrine has been shown to raise systolic and mean blood pressure when administered as a bolus dose following the development of hypotension during anesthesia.

16 How Supplied/Storage And Handling

REZIPRES® is a clear, colorless solution supplied as follows: NDC NumberStrengthPresentation 71863-212-01  47 mg/ml 2 mL clear glass, single-dose ampule filled with 1 mL 71863-212-02 2 mL ampules filled with 1 mL packaged in a carton of 10 71863-211-05  47 mg/5 mL   (9.4 mg/ml) 5 mL clear glass, single-dose ampule 71863-211-06 5 mL ampules packaged in a carton of 10 71863-210-05  23.5 mg/5 mL   (4.7 mg/ml) 5 mL clear glass, single-dose ampule 71863-210-06 5 mL ampules packaged in a carton of 10Store REZIPRES® 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].For single-dose only. 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.

17 Patient Counseling Information

If applicable, inform patient, family member, or caregiver that certain medical conditions and medications might influence how REZIPRES® works.Manufactured for:Eton Pharmaceuticals, Inc.Deer Park, IL 60010USARev. 06/2021

Rezipres® 47 Mg / Ml - Label

NDC 71863-212-01  Rx OnlyREZIPRES®Ephedrine Hydrochloride Injection47 mg/ 1 mL equivalent to 38 mg ephedrine baseMust Be Diluted1 mL Single Dose Ampule For Intravenous Use OnlyStore at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].Does not contain preservatives or sulfites.Discard unused portion.

Rezipres® 47 Mg / Ml - Carton

STERILE INJECTION NDC 71863-212-02 10 Single Dose Ampules 1 mL EachREZIPRES®Ephedrine Hydrochloride Injection47 mg / mLequivalent to 38 mg ephedrine baseMust Be DilutedFor Intravenous Use OnlyPreservative Free- Contains no Sulfites Rx Only 10 Single Dose Ampules x 1 mLEach mL contains:47 mg Ephedrine Hydrochloride (equivalent to 38 mg ephedrine base), Sodium Chloride, Water for Injection. pH may be adjusted with Sodium Hydroxide and/or Hydrochloric Acid. Recommended Dosage and Directions: See Prescribing Information.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Discard Unused Portion.

Rezipres® 9.4 Mg / Ml - Label

NDC 71863-211-05 5 mL single-dose ampuleREZIPRES®Ephedrine Hydrochloride Injection47 mg/ 5 mL (9.4 mg/ mL)(equivalent to 38 mg/5 mL ephedrine base)Premixed Formulation - Can Be DilutedStore at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Does not contain preservatives or sulfites. Rx OnlyDiscard unused portion.For Intravenous Use Only

Rezipres® 9.4 Mg / Ml - Carton

STERILE INJECTION NDC 71863-211-06 10 Single Dose Ampules 5 mL EachREZIPRES®Ephedrine Hydrochloride Injection47 mg / 5 mL (9.4 mg/ mL)(equivalent to 38 mg/5 mL ephedrine base)Premixed Formulation- Can Be DilutedFor Intravenous Use Only Rx Only 10 Single Dose Ampules x 5 mLPreservative Free- Contains no Sulfites Each mL contains:9.4 mg Ephedrine Hydrochloride (equivalent to 7.7 mg ephedrine base), Sodium Chloride, Water for Injection. pH may be adjusted with Sodium Hydroxide and/or Hydrochloric Acid. Recommended Dosage and Directions: See Prescribing Information.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Discard Unused Portion

Rezipres® 4.7 Mg / Ml - Label

NDC 71863-210-05 5 mL single-dose ampuleREZIPRES®Ephedrine Hydrochloride Injection23.5 mg/ 5 mL (4.7 mg/ mL)(equivalent to 19 mg/5 mL ephedrine base)Premixed Formulation - Do Not DiluteStore at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Does not contain preservatives or sulfites. Rx OnlyDiscard unused portion.For Intravenous Use Only

Rezipres® 4.7 Mg / Ml - Carton

STERILE INJECTION NDC 71863-210-06 10 Single Dose Ampules 5 mL EachREZIPRES®Ephedrine Hydrochloride Injection23.5 mg / 5 mL (4.7 mg/ mL)(equivalent to 19 mg/5 mL ephedrine base)Premixed Formulation - Do Not DiluteFor Intravenous Use Only Rx Only 10 Single Dose Ampules x 5 mLPreservative Free- Contains no SulfitesEach mL contains:4.7 mg Ephedrine Hydrochloride (equivalent to 3.8 mg ephedrine base), Sodium Chloride, Water for Injection. pH may be adjusted with Sodium Hydroxide and/or Hydrochloric Acid.Recommended Dosage and Directions: See Prescribing Information.Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Discard Unused Portion

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