Akovaz 5 mg/mL

ephedrine sulfate · INJECTION · Exela Pharma Sciences, LLC

No Recall History

Plain English

Akovaz is a injection containing ephedrine sulfate at 5 mg/mL, taken intravenous. Manufactured by Exela Pharma Sciences, LLC.

Key Facts

Brand Name: Akovaz
Generic Name: ephedrine sulfate
NDC Code (Product): 51754-4250
Manufacturer: Exela Pharma Sciences, LLC
Strength: 5 mg/mL
Dosage Form: INJECTION
Route: INTRAVENOUS
Marketing Status
Application #: NDA208289
Marketing Start: 05/10/2021

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective25 reports

drug abuse14 reports

cardiac arrest13 reports

toxicity to various agents13 reports

overdose12 reports

respiratory arrest11 reports

administration related reaction10 reports

hypotension10 reports

no adverse event10 reports

off label use10 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE AKOVAZ (ephedrine sulfate injection) is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. AKOVAZ injection 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 • Should be administered by trained healthcare providers ( 2.1 ) • AKOVAZ injection, 50 mg/mL, must be diluted before administration as an intravenous bolus dose. ( 2.1 ) • AKOVAZ injection, 5 mg/mL in a pre-filled syringe, is a premixed formulation. Do not dilute prior to use. ( 2.1 ) • Bolus intravenous injection: 5 mg to 10 mg as needed, not to exceed 50 mg. ( 2.1 ) 2.1 General Dosage and Administration Instructions AKOVAZ (ephedrine sulfate injection), 50 mg/mL must be diluted before administration as an intravenous bolus to achieve the desired concentration. Dilute with normal saline or 5% dextrose in water. AKOVAZ (ephedrine sulfate injection), 25 mg/5 mL (5 mg/mL) in a prefilled syringe, is a premixed formulation. Do not dilute prior to use. The single-dose prefilled syringe is intended for use in one patient during one surgical procedure. Discard any unused portion. 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 AKOVAZ should be administered by trained he…

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 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, …

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 Exela Pharma Sciences, LLC at 1-888-451-4321 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Frequently Asked Questions

What is Akovaz used for?

Akovaz contains ephedrine sulfate. It is a injection taken intravenous. Consult your doctor for specific uses.

Is Akovaz a controlled substance?

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

What is the generic name for Akovaz?

The generic name for Akovaz is ephedrine sulfate. There are 12 other brand versions of ephedrine sulfate.

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

The NDC (National Drug Code) for Akovaz 5 mg/mL is 51754-4250, listed by Exela Pharma Sciences, LLC.

Product NDC

51754-4250

Package NDC

51754-4250-3

Other Ephedrine Brands

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

Data from openFDA · Public domain (CC0 1.0)