Label: EPHEDRINE SULFATE injection

  • NDC Code(s): 70069-819-10
  • Packager: Somerset Therapeutics, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 14, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use EPHEDRINE SULFATE INJECTION safely and effectively. See full prescribing information for EPHEDRINE SULFATE INJECTION - EPHEDRINE ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
  • 2 DOSAGE AND ADMINISTRATION
    2.1 General Dosage and Administration Instructions - Ephedrine sulfate injection must be diluted before administration as an intravenous bolus to achieve the desired concentration. Dilute with ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Ephedrine Sulfate Injection, USP is a clear, colorless sterile solution and single-dose 1 mL vial that contains 50 mg/mL ephedrine sulfate, equivalent to 38 mg/mL of ephedrine base.
  • 4 CONTRAINDICATIONS
    None
  • 5 WARNINGS AND PRECAUTIONS
    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 ...
  • 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 ...
  • 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 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Available data from randomized studies, case series, and reports of ephedrine sulfate use in pregnant women have not identified a drug-associated risk of major ...
  • 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 ...
  • 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 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism 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 ...
  • 13 NONCLINICAL TOXICOLOGY
    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 ...
  • 14 CLINICAL STUDIES
    The evidence for the efficacy of ephedrine injection is derived from the published literature. Increases in blood pressure following administration of ephedrine were observed in 14 studies ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Ephedrine Sulfate Injection USP, 50 mg/mL is a clear, colorless solution and supplied in 1 mL single-dose glass vials. Each mL contains 50 mg of ephedrine sulfate USP, equivalent to 38 mg of ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Gland Pharma Limited - D.P.Pally, Dundigal Post - Hyderabad - 500 043, India - Distributed by: Somerset Therapeutics, LLC - Somerset NJ 08873 - Revised: 03/2024
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Vial label: NDC 70069-819-01 - Ephedrine Sulfate Injection, USP - 50 mg/mL - Must Be Diluted - For Intravenous Use - 1 mL Single-Dose Vial - Discard unused portion - Rx only - Carton Label: NDC ...
  • INGREDIENTS AND APPEARANCE
    Product Information