SEZABY

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE 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. Dosage and administration 2 DOSAGE AND ADMINISTRATION 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. (2.1) 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. (2.1). 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. (2.3) 2.1 Recommended Dosage and Administration The recommended dosage of SEZABY in neonates consists of a loading dose(s) followed by maintenance dosage (see Table 1). Administer SEZABY by intravenous infusion (over 15 minutes) into a large peripheral vein to avoid local tissue toxicity [see Warnings and Precautions (5.9)]. SEZABY is for intravenous use only. Table 1: Recommended Dosage of SEZABY for Neonatal Seizures Loading Dose (maximum total loading dose is 40 mg/kg) First loading dose 20 mg/kg Second loading dose (If clinically indicated) 1 Preterm Infants 10 mg/kg or 20 mg/kg [see Clinical Pharmacology (12.3)] Term Infants 20 mg/kg 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 1 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.) 2.2 Reconstitution and Additional Administration Instructions Determine the number of vials to be reconstituted based on the patient’s weight and recommended dose. Aseptically reconstitute the lyophilized powder in the vial using 10 mL of 0.9% Sodium Chloride Injection, USP. Swirl the vial gently until contents are completely dissolved. The reconstituted solution contains 100 mg per 10 mL (10 mg/mL) of phenobarbital sodium. Inspect the vial visually for particulate matter and discoloration prior to administration (the reconstituted solution is clear, colorless, and free from visible particulate matter). Discard the reconstituted solution if it is discolored or contains foreign particles. Withdraw the appropriate volume from the reconstituted vial for intravenous infusion and administer immediately [see Dosage and Administration (2.3)] . Discard any unused portion of the reconstituted solution left in the vial [see Description (11)]. 2.3 Storage of Reconstituted Solution If the reconstituted solution is not administered immediately, place the vial back in the original carton to protect it from light and store at either room temperature at 20°C to 25°C (68°F to 77°F) for a maximum of 8 hours or in the refrigerator at 2°C to 8°C (36°F to 46°F) for a maximum of 24 hours. Discard any unused portion of the reconstituted solution after the recommended storage duration. Warnings and cautions 5 WARNINGS AND PRECAUTIONS Respiratory Depression or Insufficiency: Abnormal respiration has been observed; careful respiratory monitoring is recommended during and after treatment. (5.4) 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. (5.5) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan hypersensitivity : DRESS can be fatal or life-threatening. If signs or symptoms of DRESS are present, evaluate the patient immediately. Discontinue if an alternative etiology cannot be established. (5.6) Infusion Site Reactions : SEZABY may cause tissue damage with necrosis; avoid perivascular extravasation or intra-arterial injection. Stop SEZABY if evidence of pain, swelling, discoloration, or temperature change in limb. (5.9) QT Prolongation : Avoid concomitant use of SEZABY in patients who are at significant risk of developing torsade de pointes and with products that may increase the risk of the QTc interval prolongation or products that may increase concentrations of SEZABY. (5.10) 5.1 Risks from Concomitant Use with Opioids Concomitant use of phenobarbital products, including SEZABY, and opioids may result in profound sedation, respiratory depression, coma,