Akovaz

AKOVAZ- ephedrine sulfate injection
Exela Pharma Sciences, 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), 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 healthcare providers.

The recommended dosages for the treatment of clinically important hypotension in the setting of anesthesia is an initial dose of 5 mg 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.

2.4 Instructions for Use of Prefilled Syringe

1. Perform visual inspection on the syringe by verifying:

Absence of syringe damage
Absence of external particles
Absence of internal particles
Proper drug color
Drug name
Drug strength
Fill volume
Route of administration
Expiration date to be sure the drug has not expired

2. Do not remove tamper evident seal. Push plunger rod slightly in to break the stopper loose while tip cap is still on.

3. Remove tip cap and tamper evident seal by twisting off. (See Figure 1):

Figure 1.

opening syringe pictorial

4. Discard the tip cap.

5. Expel air bubble.

6. Adjust dose into sterile material (if applicable).

7. Connect the syringe to an appropriate intravenous connection.

Before injection, ensure that the syringe is securely attached to the needle or needleless luer access device (NLAD).

8. Depress plunger rod to deliver medication. Ensure that pressure is maintained on the plunger rod during the entire administration.

9. Remove syringe from NLAD (if applicable) and discard into appropriate receptacle.

To prevent needle stick injuries, do not recap needle when needle is connected to syringe.

NOTE: All steps must be done sequentially

Do not re-sterilize syringe
Do not use this product on a sterile field
Do not introduce any other fluid into the syringe at any time
This product is for single dose only

3 DOSAGE FORMS AND STRENGTHS

AKOVAZ (ephedrine sulfate injection) is a clear, colorless, sterile solution for intravenous injection available as:

single-dose 1 mL vial that contains 50 mg/mL ephedrine sulfate, equivalent to 38 mg/mL of ephedrine base

single-dose 5 mL prefilled syringe that contains 25 mg/ 5 mL (5 mg/mL) ephedrine sulfate equivalent to 19 mg/5 mL (3.8 mg/mL) of 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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