Emerphed
Emerphed is an FDA drug label for the active ingredient EPHEDRINE SULFATE manufactured by Nexus Pharamaceuticals Inc. administered by INTRAVENOUS. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20220930.
- Generic name
- EPHEDRINE SULFATE
- Manufacturer
- Nexus Pharamaceuticals Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAVENOUS
- Dosage form
- N/A
- NDC
- 14789-250
- Application
- NDA213407
- Label effective
- 20220930
Indications & Usage
1. INDICATIONS AND USAGE EMERPHED is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. EMERPHED 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 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 EMERPHED. Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. EMERPHED 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).
Contraindications
4. CONTRAINDICATIONS None None ( 4 )
Warnings
Not available.
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 Nexus Pharmaceuticals at (855) 642-2594 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .