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Sezaby

phenobarbital
Used for Neonatal Seizures
Used for Neonatal Seizures

Sezaby (phenobarbital) is an injectable medication approved in November 2022 to help treat active seizures in newborns that happen within the first 4 weeks of life. It's typically given in the neonatal intensive care unit (NICU) in the hospital by a healthcare provider. Sezaby (phenobarbital) doesn't contain harmful preservatives or inactive ingredients, making it a safe treatment option for newborns.

Last reviewed on January 16, 2023
Sezaby (phenobarbital) is a controlled substance, which means that it's more likely to be misused or cause dependence. There are federal and state laws that limit the amount of medication that can be prescribed or dispensed within a certain period of time.
basics-icon

What is Sezaby (phenobarbital)?

What is Sezaby (phenobarbital) used for?

  • Seizures in newborns (neonatal seizures)

How Sezaby (phenobarbital) works

Are you looking for information on pentobarbital (Nembutal) or phenobarbital tablets or elixir instead?

Drug Facts

Common BrandsSezaby
Drug ClassBarbiturate
Controlled Substance ClassificationSchedule IV
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
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What are the risks and warnings for Sezaby (phenobarbital)?

Sezaby (phenobarbital) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

risk-warning

Not recommended for use with opioids

When Sezaby (phenobarbital) is given with opioids (strong medications for pain or sedation), there's a risk of severe and potentially life-threatening side effects. These side effects include extreme sleepiness, slowed breathing, coma, or even death. The care team will only use this combination of medications if it's clearly needed and for the shortest amount of time possible. If your baby needs to take Sezaby (phenobarbital) and an opioid at the same time, the care team will carefully look for breathing problems and excessive sleepiness while caring for your baby. Look for these signs as well when you spend time with your baby at the bedside, and call for help right away if you do.

risk-warning

Slowed breathing

  • Risk factors: Taking Sezaby (phenobarbital) with medications that cause slowed breathing

    Sezaby (phenobarbital) can potentially cause breathing problems in your baby. Your baby's risk is higher if they're receiving Sezaby (phenobarbital) with other medications that have a slowing or calming effect on the body, such as sedatives and opioids. In some cases, slowed breathing can be life-threatening. Let the care team know if your baby's taking any other medications so they can check for potentially dangerous interactions. They'll closely monitor your baby's breathing while getting treated.

    risk-warning

    Severe allergic and skin reactions

    Severe allergic reactions to Sezaby (phenobarbital) are possible, including rash, fever, and swelling. Additionally, Sezaby (phenobarbital) can cause serious skin reactions like Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and DRESS syndrome. These reactions can appear as severe rash, fever, skin reddening, blisters, skin peeling, or facial swelling. Finally, reactions like pain or swelling can happen near the area where Sezaby (phenobarbital) is infused. The care team will watch your baby for any of these severe reactions. If they occur, they'll likely stop Sezaby (phenobarbital). Let them know right away if you notice any of these symptoms in your baby.

    risk-warning

    Life-threatening abnormal heart rhythm

    • Risk factors: History of heart problems, slow heart rate, or other abnormal heart rhythms (arrhythmias) | Uncontrolled hypothyroidism (low thyroid hormone) | Abnormal electrolytes | Taking other medications that cause QT prolongation

      Sezaby (phenobarbital) can affect your baby's heart rhythm, which can be serious and life-threatening. One example includes affecting the time it takes for the heart to pump and then relax. This is known as QT prolongation. Your baby's risk for QT prolongation is higher if they have certain factors, including abnormal electrolyte levels and heart rhythm problems, among others. The care team will closely monitor your baby's heart rate and heart rhythm while using the medication.

      faqs

      Frequently asked questions about Sezaby (phenobarbital)

      What is Sezaby (phenobarbital) used for?
      Sezaby (phenobarbital) is used to treat seizures that happen within the first 4 weeks (or first month) of life in both term and preterm (early) babies. The medication is given in the neonatal intensive care unit (NICU). Sezaby (phenobarbital) was granted orphan drug status by the FDA, since it's used to treat a rare condition.
      How is Sezaby (phenobarbital) given?
      Sezaby (phenobarbital) is given as an injection into the veins (intravenous or IV) by a healthcare provider. In general, it's injected every 8 or 12 hours for up to 5 days. Your baby's provider will calculate the dose based on your baby's body weight.
      Is Sezaby (phenobarbital) safe for my baby?
      Sezaby (phenobarbital) can be safely used to treat seizures that your newborn baby has. Sezaby (phenobarbital) doesn't contain benzyl alcohol (a preservative) or propylene glycol (an inactive ingredient that helps medication stay in injectable form). These ingredients have both caused serious side effects, including death, in newborns. Phenobarbital is the first-choice treatment option for newborns who have seizures within the first month of life.
      How does Sezaby (phenobarbital) work?
      Sezaby (phenobarbital) is a barbiturate. It works by raising the effects of a chemical in the brain that typically slows brain activity. This is thought to help control brain activity and treat seizures.
      What are possible side effects of Sezaby (phenobarbital)?
      Possible side effects of Sezaby (phenobarbital) include abnormal breathing, sleepiness, feeding problems, and low blood pressure. The care team in the NICU will keep a very close eye on your baby for any side effects. This isn't a complete list of side effects, so be sure to discuss what to expect with your baby's healthcare provider. Ask the care team in the NICU if you have any concerns about Sezaby (phenobarbital) or how your baby is doing.
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      Sezaby (phenobarbital) contraindications

      Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Sezaby (phenobarbital) will not be safe for you to take.

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      References

      Best studies we found

      Centers for Disease Control and Prevention. (1982). Neonatal deaths associated with use of benzyl alcohol -- United States. Morbidity and Mortality Weekly Report.

      Krawiec, C., et al. (2023). Neonatal seizure. StatPearls.

      Lewis, C. B., et al. (2022). Phenobarbital. StatPearls.

      View All References (6)

      Lim, T. Y., et al. (2014). Propylene glycol toxicity in children. The Journal of Pediatric Pharmacology and Therapeutics.

      National Child and Maternal Health Education Program. (2022). Know your terms: Full-term pregnancy.

      National Institute of Diabetes and Digestive and Kidney Diseases. (2020). Porphyria.

      Sun Pharmaceutical Industries, Inc. (2022). Sezaby (phenobarbital sodium) for injection, for intravenous use, CIV [package insert].

      Sun Pharmaceutical Industries Limited. (2022). Sezaby (phenobarbital sodium powder for injection) approved by US FDA for the treatment of neonatal seizures. Reuters.

      World Health Organization. (2011). Guidelines on neonatal seizures.

      GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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