Announcing the only FDA-approved and preservative-free phenobarbital for neonatal seizures1,2
SEZABY™ (phenobarbital sodium) is indicated for the treatment of neonatal seizures in term and preterm infants.
SEZABY does not add to potential burden of critically ill neonates.1,3-5
NO alcohol: no known safe level of exposure to ethanol in neonates6
NO propylene glycol: no safe dose established for neonates less than 14 days of age (high levels may result in toxicity)7
NO benzyl alcohol: exposure to high levels associated with developmental delay, cerebral palsy, and fatal cases of “gasping syndrome”4,6
Respiratory Depression or Insufficiency: Abnormal respiration has been observed; careful respiratory monitoring is needed during and after the administration of SEZABY. The most common adverse reactions (incidence > 5% patients overall) are abnormal respiration, sedation, feeding disorder, and hypotension. Please see the full Prescribing Information for reconstitution and additional administration instructions.
The only phenobarbital with FDA-APPROVED DOSING for neonates1,2
SEZABY Loading Dose (maximum total loading dose is 40 mg/kg)
First loading dose
20 mg/kg
Second loading dose (If clinically indicated)*
Preterm Infants
10 mg/kg or 20 mg/kg
Term Infants
20 mg/kg
SEZABY Maintenance Dosage (total daily dose is 4.5 mg/kg/day and the total duration is up to 5 days). Initiate 8 to 12 hours after first loading dose.
Option 1
1.5 mg/kg every 8 hours
Option 2
2.25 mg/kg every 12 hours
*If seizures persist or recur any time 15 minutes after completion of the initial loading dose, administer a second loading dose. (Administer the second loading dose no sooner than 15 minutes after completion of the first loading dose.)
The most common adverse reactions (incidence > 5% patients overall) are abnormal respiration, sedation, feeding disorder, and hypotension. Please see full Prescribing Information for Boxed Warning, Contraindications, and other important Warnings and Precautions.
INDICATIONS AND USAGE
SEZABY™ (phenobarbital sodium) is indicated for the treatment of neonatal seizures in term and preterm infants.
CONTRAINDICATIONS
SEZABY is contraindicated in patients with:
acute porphyrias
a history of hypersensitivity reaction to phenobarbital or other barbiturates
WARNINGS AND PRECAUTIONS
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; DEPENDENCE AND WITHDRAWAL REACTIONS AFTER USE OF SEZABY FOR A LONGER DURATION THAN RECOMMENDED; and ABUSE, MISUSE, ADDICTION WITH UNAPPROVED USE IN ADOLESCENTS AND ADULTS
Risks from Concomitant Use with Opioids
Concomitant use of phenobarbital products, including SEZABY, and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. If a decision is made for concomitant use of these drugs, limit dosages and durations to the minimum required, and follow patients for signs and symptoms of respiratory depression and sedation.
Dependence and Withdrawal Reactions After Use of SEZABY for a Longer Duration than Recommended
The continued use of phenobarbital may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although SEZABY is indicated only for short-term use, if used for a longer duration than recommended, abrupt discontinuation or rapid dosage reduction of SEZABY may precipitate acute withdrawal reactions, which can be life-threatening. For patients receiving SEZABY for longer duration than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue SEZABY.
Abuse, Misuse, and Addiction with Unapproved Use in Adolescents and Adults
SEZABY is not approved for use in adolescents or adults. The unapproved use of SEZABY, in adolescents and adults exposes them to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of phenobarbital commonly involve concomitant use of other drugs, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes.
Respiratory Depression or Insufficiency: Abnormal respiration has been observed; careful respiratory monitoring is needed during and after the administration of SEZABY.
Serious Dermatologic Reactions: Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported with the use of phenobarbital. SEZABY should be discontinued at the first sign of drug-related rash, unless the rash is clearly not drug related.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity: DRESS, also known as multiorgan hypersensitivity, has been reported in patients taking antiepileptic drugs, including phenobarbital. Some of these events have been fatal or life-threatening.
SEZABY should be discontinued if an alternative etiology for the signs or symptoms cannot be established.
Infusion Site Reactions: SEZABY is highly alkaline. Therefore, extreme care should be taken to avoid perivascular extravasation or intra-arterial injection. Extravascular injection may cause local tissue damage with subsequent necrosis; consequences of intra-arterial injection may vary from transient pain to gangrene of the limb. Any evidence of pain, swelling, discoloration, or temperature change in the limb warrants stopping the injection.
QT Prolongation: SEZABY may prolong the QT interval. Avoid use of SEZABY in patients who are at significant risk of developing torsade de pointes. If use cannot be avoided in these patients, collect ECGs during treatment at specified intervals as clinically indicated, and monitor serum electrolytes and correct abnormalities.
Avoid the concomitant use of products that may increase the risk of QTc interval prolongation that may increase concentrations of phenobarbital.
ADVERSE REACTIONS
The most common adverse reactions (incidence > 5% patients overall) are abnormal respiration, sedation, feeding disorder, and hypotension.
DRUG INTERACTIONS
CYP2C9, 2C19, 2E1, UGT Inhibitors: Closely monitor for adverse reactions (e.g., over sedation, prolonged QTc interval, etc.) when used concomitantly with inhibitors of these enzymes and reduced efficacy (e.g., breakthrough seizure); when used with inducers of these enzymes. Consider titration of the SEZABY maintenance dosage accordingly if concomitant use is unavoidable and decrease SEZABY dosage, if needed.
CYP3A4, 2B6, 2C, UGT Substrates: Closely monitor neonates when SEZABY is used concurrently with substrates of these enzymes and consider increasing the dosage of the substrate accordingly, unless otherwise advised in its Prescribing Information, if concomitant use is unavoidable.
CNS depressants: Closely monitor for sedation and respiratory depression with concomitant use of SEZABY with other CNS depressants, including opioids.
Drugs that Prolong the QT Interval: Avoid concomitant use of SEZABY and these products.
To Report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
Please see full Prescribing Information for Boxed Warning, Contraindications, and other important Warnings and Precautions.
SEZABY™ (phenobarbital sodium) is indicated for the treatment of neonatal seizures in term and preterm infants.
CONTRAINDICATIONS
SEZABY is contraindicated in patients with:
acute porphyrias
a history of hypersensitivity reaction to phenobarbital or other barbiturates
WARNINGS AND PRECAUTIONS
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; DEPENDENCE AND WITHDRAWAL REACTIONS AFTER USE OF SEZABY FOR A LONGER DURATION THAN RECOMMENDED; and ABUSE, MISUSE, ADDICTION WITH UNAPPROVED USE IN ADOLESCENTS AND ADULTS
SEZABY Ordering Info
NDC: 62756-301-01
Supplied: One 100 mg single dose vial (lyophilized powder)
Reconstituted: 10 mg/mL phenobarbital sodium, for intravenous use only
References:
1. SEZABY [prescribing information]. Sun Pharmaceutical Industries, Inc.; November 2022.
2. Sharpe C, Reiner GE, Davis SL, et al. Levetiracetam versus phenobarbital for neonatal seizures: a randomized controlled trial. Pediatrics. 2020;145:e20193182.
3. Salunke S, Brandys B, Giacoia G, Tuleu C. The STEP (Safety and Toxicity of Excipients for Paediatrics) database: Part 2-the pilot version. Int J Pharmaceut. 2013;457:310-22.
4. LeBel M, Ferron L, Masson M, et al. Benzyl alcohol metabolism and elimination in neonates. Dev Pharmacol Ther. 1988;11:347-56.
5. Sridharan K, Hasan MSN, Al Jufairi M, et al. Possible effects of excipients used in the parenteral drugs administered in critically ill adults, children, and neonates. Expert Opin Drug Safety. 2020:19;1625-40. doi.or g/10.1080/14740338.2020.1805431.
6. Akinmboni TO, Davis NL, Falck AJ, Bearer CF, Mooney SM. Excipient exposure in very low birth weight preterm neonates. J Perinatol. 2018;38:169-74. doi:10.1038/jp.2017.165.
7. Food and Drug Administration. Drug Safety Communication. Serious health problems seen in premature babies given Kaletra (lopinavir/ritonavir) oral solution. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-serious-health-problems-seen-premature-babies-given-kaletra. Accessed November 2022.
