Ephedrine Sulfate 50 mg/mL
Ephedrine Sulfate · INJECTION · Amneal Pharmaceuticals LLC
Ephedrine Sulfate is a injection containing ephedrine sulfate at 50 mg/mL, taken intravenous. Manufactured by Amneal Pharmaceuticals LLC.
Key Facts
- Brand Name
- Ephedrine Sulfate
- Generic Name
- Ephedrine Sulfate
- NDC Code (Product)
70121-1637- Manufacturer
- Amneal Pharmaceuticals LLC
- Strength
- 50 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA212932
- Marketing Start
- 10/23/2019
Recall History
SCA Pharmaceuticals
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Avella of Deer Valley, Inc. Store 38
Lack of Assurance of Sterility: Potential leakage of bags.
Cantrell Drug Company
Lack of Sterility Assurance.
Pharmakon Pharmaceuticals
Stability data does not support expiry.
Avella of Deer Valley, Inc. Store 38
Lack of Assurance of Sterility: Potential leakage of bags.
Pharmedium Services, LLC
Lack of sterility assurance.
PharMEDium Services, LLC
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Pharmakon Pharmaceuticals, Inc.
Lack of Assurance of Sterility
PharMEDium Services, LLC
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Akorn, Inc.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND 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
2 DOSAGE AND ADMINISTRATION Should be administered by trained healthcare providers ( 2.1 ) Ephedrine sulfate injection, 50 mg/mL, must be diluted before administration as an intravenous bolus dose. ( 2.1 ) Bolus intravenous injection: 5 mg to 10 mg as needed, not to exceed 50 mg. ( 2.1 ) 2.1 General Dosage and Administration Instructions Ephedrine sulfate injection, 50 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. Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 2.2 Dosing for the Treatment of Clinically Important Hypotension in the Setting of Anesthesia Ephedrine sulfate injection should be administered by trained healthcare providers. The recommended dosages 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 Prepare …
Contraindications
4 CONTRAINDICATIONS None None ( 4 )
Drug Interactions
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 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 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 and any of these drugs. 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 ephedrine and any of these drugs. Examples: α-adrenergic antagonists, β-adrenergic receptor antagonists, reserpine, quinidine, mephentermine Other Drug Interactions Guanethidine Clinical Impact: Ephedrine may inhibit the neuron blockage produced by guanethidine, …
Adverse Reactions
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 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 Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Ephedrine Sulfate used for?
Ephedrine Sulfate contains Ephedrine Sulfate. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Ephedrine Sulfate a controlled substance?
Ephedrine Sulfate is not classified as a controlled substance by the DEA.
What is the generic name for Ephedrine Sulfate?
The generic name for Ephedrine Sulfate is Ephedrine Sulfate. There are 6 other brand versions of Ephedrine Sulfate.
What is the NDC code for Ephedrine Sulfate 50 mg/mL?
The NDC (National Drug Code) for Ephedrine Sulfate 50 mg/mL is 70121-1637, listed by Amneal Pharmaceuticals LLC.