Akovaz

AKOVAZ- ephedrine sulfate injection
Avadel Legacy Pharmaceuticals, LLC

1 INDICATIONS AND USAGE

AKOVAZ (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

AKOVAZ (ephedrine sulfate injection) 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

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 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 AKOVAZ (ephedrine sulfate injection):

  • Withdraw 50 mg (1 mL of 50 mg/mL) of AKOVAZ (ephedrine sulfate injection) and dilute with 9 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection.
  • Withdraw an appropriate dose of the 5 mg/mL solution prior to bolus intravenous administration.

3 DOSAGE FORMS AND STRENGTHS

AKOVAZ (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 AKOVAZ (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

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, resulting in loss of antihypertensive effectiveness.
Intervention: Clinician should monitor patient for blood pressor response and adjust the dosage or choice of pressor accordingly.
Rocuronium
Clinical Impact: Ephedrine may reduce the onset time of neuromuscular blockade when used for intubation with rocuronium if administered simultaneously with anesthetic induction.
Intervention: Be aware of this potential interaction. No treatment or other interventions are needed.
Epidural anesthesia
Clinical Impact: Ephedrine may decrease the efficacy of epidural blockade by hastening the regression of sensory analgesia.
Intervention: Monitor and treat the patient according to clinical practice.
Theophylline
Clinical Impact: Concomitant use of ephedrine may increase the frequency of nausea, nervousness, and insomnia.
Intervention: Monitor patient for worsening symptoms and manage symptoms according to clinical practice.
Cardiac glycosides
Clinical Impact: Giving ephedrine with a cardiac glycoside, such as digitalis, may increase the possibility of arrhythmias.
Intervention: Carefully monitor patients on cardiac glycosides who are also administered ephedrine.
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