Prescription Drug Information: Akovaz

AKOVAZ- ephedrine sulfate injection
BluePoint Laboratories

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.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk 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.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

Cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported in the literature. These reports describe umbilical artery pH of ≤7.2 at the time of delivery [see Clinical Pharmacology 12.3] . Monitoring of the newborn for signs and symptoms of metabolic acidosis may be required. Monitoring of infant’s acid-base status is warranted to ensure that an episode of acidosis is acute and reversible.

8.2 Lactation

Risk Summary

Limited published literature reports that ephedrine is present in human milk. However, no information is available on the effects of the drug on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AKOVAZ (ephedrine sulfate injection) and any potential adverse effects on the breastfed child from AKOVAZ (ephedrine sulfate injection) or from the underlying maternal condition.

8.4 Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5 Geriatric Use

Clinical studies of ephedrine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. This drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Page 1 of 2 1 2

RxDrugLabels.com provides trustworthy package insert and label information about marketed prescription drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by RxDrugLabels.com. Every individual prescription drug label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

As a leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. RxDrugLabels.com provides the full prescription-only subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.