Indications
Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
Contraindications
None
Warnings and precautions
5.1Pressor 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.
5.2Tolerance 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.
5.3Risk 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.
Interactions
DRUG INTERACTIONS
Pregnancy and breastfeeding
8.1Pregnancy
R isk Summary Limited published data on the use of ephedrine sulfate are insufficient to determine a drug associated risk of major birth defects or miscarriage. However, there are clinical considerations [ see Clinical Considerations ] . Animal reproduction studies have not been conducted with ephedrine sulfate. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
At a glance
- Brand name
- Corphedra
- Active substance
- ephedrine sulfate
- Route
- Intravenous
- Dosage form
- Solution
- Applicant
- PH Health
- Status
- Prescription
- FDA approval
- 27 Jan 2017
- Application
- NDA208943-001



