Phenobarbital

SEZABY is indicated for the treatment of neonatal seizures in term and preterm infants. SEZABY is a barbiturate indicated for the treatment of neonatal seizures in term and preterm infants.

The precise mechanism of action for phenobarbital for the treatment of neonatal seizures is not fully understood, but it is thought to involve potentiation of synaptic inhibition through an action on the GABA A receptor.

Loading Dose: 20 mg/kg is administered by intravenous infusion over 15 minutes into a large peripheral vein. If clinically indicated, at least 15 minutes after completion of the initial loading dose, a second loading dose may be administered over the subsequent 15 minutes as 20 mg/kg for term infants or 10 mg/kg or 20 mg/kg for preterm infants. The maximum total loading dose is 40 mg/kg. Maintenance Dosage: starting 8 to 12 hours after first loading dose: 4.5 mg/kg/day given in 2 or 3 divided doses (i.e., 1.5 mg/kg every 8 hours or 2.25 mg/kg every 12 hours) up to 5 days. Must be reconstituted with 10 mL 0.9 % Sodium Chloride Injection, USP prior to administration. See additional preparation and administration instructions in the Full Prescribing Information.

SEZABY is contraindicated in patients with: acute porphyrias, or a history of hypersensitivity reaction to phenobarbital or other barbiturates Acute porphyrias. Hypersensitivity to phenobarbital or other barbiturates

Boxed warning: 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. Respiratory Depression or Insufficiency: Abnormal respiration has been observed, careful respiratory monitoring is recommended during and after treatment. Serious Dermatologic Reactions: Serious and sometimes fatal hypersensitivity reactions, including toxic epidermal necrolysis and Stevens-Johnson syndrome, have been reported. SEZABY should be discontinued at the first sign of a rash, unless the rash is clearly not drug related. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity: DRESS can be fatal or life-threatening.

The following clinically significant adverse reactions are described elsewhere in the labeling: Risks from Concomitant Use with Opioids Dependence and Withdrawal Reactions After Use of SEZABY for a Longer Duration Than Recommended Abuse, Misuse, and Addiction with Unapproved Use in Adolescents and Adults Respiratory Depression or Insufficiency Serious Dermatologic Reactions Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Hypersensitivity Exacerbation of Porphyria Injection Site Reactions QT Prolongation Embryofetal Toxicity with Unapproved Use in Adolescents and Adults Neonatal Adverse Reactions from Unapproved Maternal Phenobarbital Use Sedation, Respiratory Depression, and Withdrawal in Neonates Exposed to Phenobarbital Through Breast Milk Suicidal Behavior and Ideation with Unapproved use in Adolescents and Adults The most common adverse…

CYP2C9, 2C19, 2E1, UGT Inhibitors: Closely monitor and decrease SEZABY dosage, if needed. CYP3A4, 2B6, 2C, UGT Substrates: Substrate dosage adjustment may be needed. CNS depressants: Closely monitor for sedation and respiratory depression. Drugs that Prolong the QT Interval: Avoid concomitant use.

Store unopened vials of SEZABY in original cartons at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Retain in the original carton until use to protect from light. For information on storage of the reconstituted SEZABY, see Dosage and Administration.