Ephedrine Sulfate

EPHEDRINE SULFATE- ephedrine sulfate injection, solution
Par Pharmaceutical, Inc.

1 INDICATIONS AND USAGE

Ephedrine sulfate injection is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.

2 DOSAGE AND ADMINISTRATION

2.1 General Dosage and Administration Instructions

Ephedrine sulfate injection must be diluted before administration to achieve the desired concentration as an intravenous bolus or intravenous infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is colored or cloudy, or if it contains particulate matter.

2.2 Dosing for the Treatment of Clinically Important Hypotension in the Setting of Anesthesia

The recommended dosage 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 Preparation of a 5 mg/mL Solution for Bolus Intravenous Administration

For bolus intravenous administration, prepare a solution containing a final concentration of 5 mg/mL of ephedrine sulfate injection.

  • Withdraw 50 mg (1 mL of 50 mg/mL) of ephedrine sulfate injection and dilute with 9 mL of 5% Dextrose Injection or Sodium Chloride Injection.
  • Withdraw an appropriate dose of the 5 mg/mL solution prior to bolus intravenous administration.

3 DOSAGE FORMS AND STRENGTHS

Ephedrine sulfate injection is available as a single-dose 1 mL vial that contains 50 mg/mL ephedrine sulfate, equivalent to 38 mg ephedrine base.

4 CONTRAINDICATIONS

None

5 WARNINGS AND PRECAUTIONS

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 and an oxytocic.

5.2 Tolerance 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.

5.3 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.

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

For medical advice about adverse reactions, contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

7 DRUG INTERACTIONS

I nteractions that Augment the Pressor Effect

Oxytocin and oxytocic drugs

C linical 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.

I ntervention:

Carefully monitor the blood pressure of individuals who have received both ephedrine and an oxytocic.

Clonidine, propofol, monoamine oxidase inhibitors (MAOIs), atropine

C linical Impact:

These drugs augment the pressor effect of ephedrine.

I ntervention:

Carefully monitor the blood pressure of individuals who have received both ephedrine and any of these drugs.

I nteractions that Antagonize the Pressor Effect

C linical Impact:

These drugs antagonize the pressor effect of ephedrine.

I ntervention:

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

G u anethidine

C linical Impact:

Ephedrine may inhibit the neuron blockage produced by

guanethidine, resulting in loss of antihypertensive effectiveness.

I ntervention:

Clinician should monitor patient for blood pressor response and adjust the dosage or choice of pressor accordingly.

Rocuronium

C linical Impact:

Ephedrine may reduce the onset time of neuromuscular blockade when used for intubation with rocuronium if administered simultaneously with anesthetic induction.

I ntervention:

Be aware of this potential interaction. No treatment or other interventions are needed.

Ep idural anesthesia

C linical Impact:

Ephedrine may decrease the efficacy of epidural blockade by hastening the regression of sensory analgesia.

I ntervention:

Monitor and treat the patient according to clinical practice.

Th e ophylline

C linical Impact:

Concomitant use of ephedrine may increase the frequency of nausea, nervousness, and insomnia.

I ntervention:

Monitor patient for worsening symptoms and manage symptoms according to clinical practice.

Cardiac glycosides

C linical Impact:

Giving ephedrine with a cardiac glycoside, such as digitalis, may increase the possibility of arrhythmias.

I ntervention:

Carefully monitor patients on cardiac glycosides who are also administered ephedrine.


Page 1 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2019. All Rights Reserved.