Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Ephedrine sulfate injection, USP is a clear, colorless solution available as a single-dose vial that contains 50 mg/10 mL (5 mg/mL) ephedrine sulfate, equivalent to 38 mg/10 mL (3.8 mg/mL) ephedrine base and is supplied as follows: NDC Presentation 68083-610-10 10 mL clear glass, single-dose vials; strength 50 mg/10 mL (5 mg/mL) packaged in a carton of 10 Ephedrine Sulfate Injection, USP 50 mg/10 mL (5 mg/mL) is not made with natural rubber latex. Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 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: Gland Pharma Limited D.P.Pally, Dundigal Post Hyderabad-500 043, India. Revised: 06/2024; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Carton Label NDC 68083-610-10 Rx only Ephedrine Sulfate Injection, USP 50 mg/10 mL (5 mg/mL) (equivalent to 38 mg/10 mL ephedrine base) Premixed formulation – Do not dilute For Intravenous Use Only 10 x 10 mL Single-dose Vials Container Label NDC 68083-610-01 Rx only Ephedrine Sulfate Injection, USP 50 mg/10 mL (5 mg/mL) (equivalent to 38 mg/10 mL ephedrine base) Premixed formulation – Do not dilute For Intravenous Use Only 10 mL Single-dose Vial ephedrine-spl-container-carton ephedrine-spl-container-label
- 16 HOW SUPPLIED/STORAGE AND HANDLING Ephedrine sulfate injection, USP is a clear, colorless solution available as a single-dose vial that contains 50 mg/10 mL (5 mg/mL) ephedrine sulfate, equivalent to 38 mg/10 mL (3.8 mg/mL) ephedrine base and is supplied as follows: NDC Presentation 68083-610-10 10 mL clear glass, single-dose vials; strength 50 mg/10 mL (5 mg/mL) packaged in a carton of 10 Ephedrine Sulfate Injection, USP 50 mg/10 mL (5 mg/mL) is not made with natural rubber latex. Store at 20º to 25ºC (68º to 77ºF); excursions permitted to 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: Gland Pharma Limited D.P.Pally, Dundigal Post Hyderabad-500 043, India. Revised: 06/2024
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Carton Label NDC 68083-610-10 Rx only Ephedrine Sulfate Injection, USP 50 mg/10 mL (5 mg/mL) (equivalent to 38 mg/10 mL ephedrine base) Premixed formulation – Do not dilute For Intravenous Use Only 10 x 10 mL Single-dose Vials Container Label NDC 68083-610-01 Rx only Ephedrine Sulfate Injection, USP 50 mg/10 mL (5 mg/mL) (equivalent to 38 mg/10 mL ephedrine base) Premixed formulation – Do not dilute For Intravenous Use Only 10 mL Single-dose Vial ephedrine-spl-container-carton ephedrine-spl-container-label
Overview
Ephedrine sulfate is a sympathomimetic amine. Ephedrine Sulfate Injection, USP is a clear, colorless, sterile solution for intravenous injection. The chemical name of ephedrine sulfate is benzenemethanol, α-[1-(methylamino) ethyl]-, [R-(R*, S*)]-, sulfate (2:1) (salt), and the molecular weight is 428.5 g/mol. Its structural formula is depicted below: Ephedrine sulfate is freely soluble in water and ethanol, very slightly soluble in chloroform, and practically insoluble in ether. Each mL contains ephedrine sulfate, USP 5 mg (equivalent to 3.8 mg ephedrine base), 0.9% sodium chloride, USP in water for injection.The pH range is 4.5 to 7.0. ephedrine-spl-structure
Indications & 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 & Administration
• This is a pre-mixed formulation. Do not dilute before administration. ( 2 ) • 5 mg to 10 mg administered by intravenous bolus. Additional boluses as needed, not to exceed a total dose of 50 mg. ( 2 ) 2.1 General Dosage and Administration Instructions • This is a premixed formulation. Do not dilute prior to use. • Discard any unused portion of Ephedrine sulfate injection. • Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. • Ephedrine sulfate injection is a clear, colorless solution. 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 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).
Warnings & 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 sulfate injection may cause tachyphylaxis ( 5.2 ) 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 sulfate injection and an oxytocic. 5.2 Tolerance and Tachyphylaxis Data indicate that repeated administration of ephedrine can result in tachyphylaxis. Be aware of this possibility when treating anesthesia-induced hypotension with ephedrine sulfate injection and 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 None ( 4 )
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 Gland Pharma Limited at 609-250‐7990 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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 sulfate injection 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 sulfate injection and any of these drugs. Drugs that Antagonize the Pressor Effect α-adrenergic antagonists, β-adrenergic receptor antagonists, reserpine, quinidine, mephentermine Clinical Impact: These drugs antagonize the pressor effect of ephedrine. Intervention: Carefully monitor the blood pressure of individuals who have received both ephedrine sulfate injection and any of these drugs. Other Drug Interactions Guanethidine Clinical Impact: Ephedrine sulfate injection 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 sulfate injection 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 sulfate injection 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 sulfate injection 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 sulfate injection 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 sulfate injection 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 sulfate injection 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 sulfate injection 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 sulfate injection 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 sulfate injection with a cardiac glycoside, such as digitalis, may increase the possibility of arrhythmias. Carefully monitor patients on cardiac glycosides who are also administered ephedrine sulfate injection.
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