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 INFORMATIONThese 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 ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGEEphedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
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2 DOSAGE AND ADMINISTRATION2.1 General Dosage and Administration Instructions - Ephedrine sulfate injection must be diluted before administration as an intravenous bolus to achieve the desired concentration. Dilute with ...
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3 DOSAGE FORMS AND STRENGTHSEphedrine 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.
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4 CONTRAINDICATIONSNone
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5 WARNINGS AND PRECAUTIONS5.1 Pressor Effect with Concomitant Oxytocic Drugs - Serious postpartum hypertension has been described in patients who received both a vasopressor (i.e., methoxamine, phenylephrine, ephedrine ...
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6 ADVERSE REACTIONSThe 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 ...
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7 DRUG INTERACTIONSInteractions that Augment the Pressor Effect - Oxytocin and oxytocic drugs - Clinical Impact: Serious postpartum hypertension has been described in patients who received both ...
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8 USE IN SPECIFIC POPULATIONS8.1 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 ...
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10 OVERDOSAGEOverdose 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 ...
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11 DESCRIPTIONEphedrine 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 ...
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12 CLINICAL PHARMACOLOGY12.1 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 ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis: Two-year feeding studies in rats and mice conducted under the National Toxicology Program (NTP) demonstrated no ...
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14 CLINICAL STUDIESThe 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 ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGEphedrine 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 ...
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SPL UNCLASSIFIED SECTIONManufactured by: Gland Pharma Limited - D.P.Pally, Dundigal Post - Hyderabad - 500 043, India - Distributed by: Somerset Therapeutics, LLC - Somerset NJ 08873 - Revised: 03/2024
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PACKAGE LABEL.PRINCIPAL DISPLAY PANELVial 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 ...
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INGREDIENTS AND APPEARANCEProduct Information