Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED EPHEDRINE SULFATE INJECTIONS, USP is supplied in the following dosage forms. NDC 51662-1325-1 EPHEDRINE SULFATE INJECTIONS, USP 50 mg/mL 1mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Ephedrine Sulfate Injection, USP, 50 mg/mL, is supplied as follows: Vial stoppers are not manufactured with natural rubber latex. Store ephedrine sulfate injection, 50 mg/mL, at 20° to 25°C (68° to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature.] Protect from light. Store in carton until time of use. For single use only. Discard unused portion. HOW SUPPLIED; PRINCIPAL DISPLAY PANEL, VIAL LABEL Ephedrine Sulfate Injection, USP 50 mg/mL, 1 mL Single-Dose Vial VIAL LABEL; PRINCIPAL DISPLAY PANEL, SERIALIZED LABEL RFID LABEL SERIALIZED LABEL
- 16 HOW SUPPLIED EPHEDRINE SULFATE INJECTIONS, USP is supplied in the following dosage forms. NDC 51662-1325-1 EPHEDRINE SULFATE INJECTIONS, USP 50 mg/mL 1mL VIAL HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Ephedrine Sulfate Injection, USP, 50 mg/mL, is supplied as follows: Vial stoppers are not manufactured with natural rubber latex. Store ephedrine sulfate injection, 50 mg/mL, at 20° to 25°C (68° to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature.] Protect from light. Store in carton until time of use. For single use only. Discard unused portion. HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL, VIAL LABEL Ephedrine Sulfate Injection, USP 50 mg/mL, 1 mL Single-Dose Vial VIAL LABEL
- PRINCIPAL DISPLAY PANEL, SERIALIZED LABEL RFID LABEL SERIALIZED LABEL
Overview
Ephedrine sulfate 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. Each mL contains ephedrine sulfate 50 mg in water for injection as a single-dose product. The pH range is 4.5 to 7.0. The drug product must be diluted before intravenous administration. The chemical name of ephedrine sulfate is (1R,2S)-(-)-2-methylamine-1-phenylpropan-1-ol sulfate (2:1) (salt). Its molecular weight is 428.54. The structural formula is: Image 1 Ephedrine sulfate darkens on exposure to light. It is freely soluble in water and ethanol, very slightly soluble in chloroform, and practically insoluble in ether. STRUCTURE
Indications & Usage
INDICATIONS & USAGE Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
Dosage & Administration
DOSAGE & ADMINISTRATION 2.1 General Dosage and Administration Instructions Ephedrine sulfate injection must be diluted before administration to achieve the desired concentration as an intravenous bolus or intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is colored or cloudy, or if it contains particulate matter. 2.2 Dosing for the Treatment of Clinically Important Hypotension in the Setting of Anesthesia The recommended dosage for the treatment of clinically important hypotension in the setting of anesthesia is an initial dose of 5 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). 2.3 Preparation of 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 Sodium Chloride Injection. Withdraw an appropriate dose of the 5 mg/mL solution prior to bolus intravenous administration.
Warnings & 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) 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. 5.2 Tolerance 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. 5.3 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.
Contraindications
None
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 For medical advice about adverse reactions, contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
DRUG INTERACTIONS
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