Akovaz

Serious side effects have been reported with Akovaz. See the “Akovaz Precautions” section.

Common side effects of Akovaz include the following:

• nausea and vomiting
• tachycardia
• palpitations (thumping heart)
• reactive hypertension
• bradycardia
• irregular heartbeat
• dizziness
• restlessness

This is not a complete list of Akovaz side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking Akovaz, tell your doctor about all of your medical conditions. Especially tell your doctor if you are allergic to Akovaz or to any of its ingredients.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Limited published data on the use of ephedrine sulfate are insufficient to determine a drug associated risk of major birth defects or miscarriage. Animal reproduction studies have not been conducted with Akovaz. Cases of potential metabolic acidosis in newborns at delivery with maternal ephedrine exposure have been reported.
 

Akovaz is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.

Hypertension (high blood pressure) may occur after receiving this medicine. It is very important that your doctor check your blood pressure after receiving this medicine. If you notice any changes to your normal blood pressure, call your doctor right away.

Using this medicine repeatedly may cause a rapid decrease of response to the drug.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine 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:

• Blurred vision
• dizziness
• fast, pounding, or irregular heartbeat or pulse
• headache
• nervousness
• pounding in the ears
• slow or fast heartbeat

Some side effects 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:

• Nausea or vomiting
• restlessness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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.

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.

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.

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

Akovaz (ephedrine sulfate injection), 50 mg/mL, is supplied as follows:

Vial stoppers are not manufactured with natural rubber latex. Store Akovaz (ephedrine sulfate injection), 50 mg/mL, at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Store in carton until time of use. For single use only. Discard unused portion.

Manufactured for:

Avadel

Avadel Legacy Pharmaceuticals, LLC

Chesterfield, MO 63005

Rev. 04/17