Emerphed 5 mg/mL

Ephedrine Sulfate · INJECTION · Nexus Pharamaceuticals Inc.

No Recall History

Plain English

Emerphed is a injection containing ephedrine sulfate at 5 mg/mL, taken intravenous. Manufactured by Nexus Pharamaceuticals Inc..

Key Facts

Brand Name: Emerphed
Generic Name: Ephedrine Sulfate
NDC Code (Product): 14789-250
Manufacturer: Nexus Pharamaceuticals Inc.
Strength: 5 mg/mL
Dosage Form: INJECTION
Route: INTRAVENOUS
Marketing Status
Application #: NDA213407
Marketing Start: 05/15/2020

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective15 reports

cardiac arrest13 reports

toxicity to various agents13 reports

drug abuse12 reports

overdose12 reports

respiratory arrest11 reports

administration related reaction10 reports

hypotension10 reports

off label use10 reports

drug hypersensitivity9 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1. INDICATIONS AND USAGE EMERPHED and EMERPHED-PFS is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. EMERPHED and EMERPHED-PFS 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 premixed formulation. Do not dilute prior to use. Discard any unused portion of EMERPHED or EMERPHED-PFS. Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. EMERPHED and EMERPHED-PFS is a clear, colorless solution. Do not use if the solution is not clear or if particulate matter is present. The single-dose prefilled syringe is intended for use in one patient during one surgical procedure. 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. The single-dose prefilled syringe is intended for use in one patient during one surgical procedure. 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 impor…

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 EMERPHED and EMERPHED-PFS 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 EMERPHED and EMERPHED-PFS 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 EMERPHED and EMERPHED-PFS and any of these drugs. Other Drug Interactions Guanethidine Clinical Impact: EMERPHED and EMERPHED-PFS may inhib…

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 .

Frequently Asked Questions

What is Emerphed used for?

Emerphed contains Ephedrine Sulfate. It is a injection taken intravenous. Consult your doctor for specific uses.

Is Emerphed a controlled substance?

Emerphed is not classified as a controlled substance by the DEA.

What is the generic name for Emerphed?

The generic name for Emerphed is Ephedrine Sulfate. There are 12 other brand versions of Ephedrine Sulfate.

What is the NDC code for Emerphed 5 mg/mL?

The NDC (National Drug Code) for Emerphed 5 mg/mL is 14789-250, listed by Nexus Pharamaceuticals Inc..

Product NDC

14789-250

Package NDC

14789-250-10

Other Ephedrine Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)