Sezaby Injection Dosage

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. SEZABY is for intravenous use only.

Table 1: Recommended Dosage of SEZABY for Neonatal Seizures

1If 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.)

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.
• Discard any unused portion of the reconstituted solution left in the vial.

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.