Akovaz

Name: Akovaz

Akovaz Dosage

The recommended dose range of Akovaz for the treatment of low blood pressure is 5 mg to 10 mg into the vein as needed, not to exceed 50 mg.

 

Commonly used brand name(s)

In the U.S.

  • Akovaz
  • Corphedra

Available Dosage Forms:

  • Solution

Therapeutic Class: Vasopressor

Pharmacologic Class: Adrenergic

Chemical Class: Alkylarylamine

Contraindications

None

Overdosage

Overdose of ephedrine can cause a rapid rise in blood pressure. In the case of an overdose, careful monitoring of blood pressure is recommended. If blood pressure continues to rise to an unacceptable level, parenteral antihypertensive agents can be administered at the discretion of the clinician.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis: Two-year feeding studies in rats and mice conducted under the National Toxicology Program (NTP) demonstrated no evidence of carcinogenic potential with ephedrine sulfate at doses up to 10 mg/kg/day and 27 mg/kg/day (approximately 2 times and 3 times the maximum human recommended dose on a mg/m2 basis, respectively).

Mutagenesis: Ephedrine sulfate tested negative in the in vitro bacterial reverse mutation assay, the in vitro mouse lymphoma assay, the in vitro sister chromatid exchange, and the in vitro chromosomal aberration assay.

Impairment of Fertility: Studies to evaluate the effect of ephedrine on fertility have not been conducted.

Clinical Studies

The evidence for the efficacy of ephedrine injection is derived from the published literature. Increases in blood pressure following administration of ephedrine were observed in 14 studies, including 9 where ephedrine was used in pregnant women undergoing neuraxial anesthesia during Cesarean delivery, 1 study in non-obstetric surgery under neuraxial anesthesia, and 4 studies in patients undergoing surgery under general anesthesia. Ephedrine has been shown to raise systolic and mean blood pressure when administered as a bolus dose following the development of hypotension during anesthesia.

PRINCIPAL DISPLAY PANEL - NDC 76014-005-25 - Alternate 25-count Carton Label (Éclat Pharmaceuticals)


Akovaz 
ephedrine sulfate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76014-005
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EPHEDRINE SULFATE (EPHEDRINE) EPHEDRINE SULFATE 50 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
ACETIC ACID  
SODIUM HYDROXIDE  
Packaging
# Item Code Package Description
1 NDC:76014-005-25 25 VIAL, SINGLE-DOSE in 1 CARTON
1 NDC:76014-005-30 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208289 08/01/2016
Labeler - Avadel Legacy Pharmaceuticals, LLC (965538205)
Revised: 05/2017   Avadel Legacy Pharmaceuticals, LLC

For the Consumer

Applies to ephedrine: intravenous solution

Along with its needed effects, ephedrine (the active ingredient contained in Akovaz) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking ephedrine:

Incidence not known
  • Blurred vision
  • dizziness
  • fast, pounding, or irregular heartbeat or pulse
  • headache
  • nervousness
  • pounding in the ears
  • slow or fast heartbeat

Some side effects of ephedrine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Nausea or vomiting
  • restlessness

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