Phenobarbital Sodium
Generic Name: phenobarbital sodium
Brand Names:
Sezaby
11 DESCRIPTION Phenobarbital is a barbiturate. Chemically, phenobarbital sodium is 2,4,6(1H,3H,5H)-Pyrimidinetrione, 5-ethyl-5-phenyl-, monosodium salt and has the following structural formula: C 12 H 11 N 2 NaO 3 MW 254.22 The sodium salt of phenobarbital occurs as a white, slightly bitter powder, crystalline granules or flaky crystals; it is very soluble in water, soluble in alcohol and practically insoluble in ether or chloroform.
Overview
11 DESCRIPTION Phenobarbital is a barbiturate. Chemically, phenobarbital sodium is 2,4,6(1H,3H,5H)-Pyrimidinetrione, 5-ethyl-5-phenyl-, monosodium salt and has the following structural formula: C 12 H 11 N 2 NaO 3 MW 254.22 The sodium salt of phenobarbital occurs as a white, slightly bitter powder, crystalline granules or flaky crystals; it is very soluble in water, soluble in alcohol and practically insoluble in ether or chloroform.
Uses
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
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.
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Risks from Concomitant Use with Opioids [see Warnings and Precautions (5.1)] Dependence and Withdrawal Reactions After Use of SEZABY for a Longer Duration Than Recommended [see Warnings and Precautions (5.2)] Abuse, Misuse, and Addiction with Unapproved Use in Adolescents and Adults [see Warnings and Precautions (5.3)] Respiratory Depression or Insufficiency [see Warnings and Precautions (5.4)] Serious Dermatologic Reactions [see Warnings and Precautions (5.5)] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.6)] Hypersensitivity [see Warnings and Precautions (5.7)] Exacerbation of Porphyria [see Warnin...
Interactions
7 DRUG INTERACTIONS CYP2C9, 2C19, 2E1, UGT Inhibitors: Closely monitor and decrease SEZABY dosage, if needed. (7.1) CYP3A4, 2B6, 2C, UGT Substrates: Substrate dosage adjustment may be needed. (7.1) CNS depressants: Closely monitor for sedation and respiratory depression. (7.2) Drugs that Prolong the QT Interval : Avoid concomitant use. (7.3) 7.1 Cytochrome P450- or Uridine 5’-diphospho-glucuronosyltransferase (UGT)-Based Interactions The drug interaction information in Table 3 is based upon published literature in non-neonatal populations, in vitro studies, and the mechanistic knowledge of phenobarbital metabolic pathways [see Clinical Pharmacology (12.3)] .
Warnings
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; DEPENDENCE AND WITHDRAWAL REACTIONS AFTER USE OF SEZABY FOR A LONGER DURATION THAN RECOMMENDED; and ABUSE, MISUSE AND 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. 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. 4 CONTRAINDICATIONS SEZABY is contraindicated in patients with: acute porphyrias [see Warnings and Precautions (5.8)], or a history of hypersensitivity reaction to phenobarbital or other barbiturates [see Warnings and Precautions (5.7)] Acute porphyrias (4) Hypersensitivity to phenobarbital or other barbiturates (4)
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied SEZABY (phenobarbital sodium) for injection is supplied as a sterile white to off-white, lyophilized powder in single-dose clear glass vials containing 100 mg of phenobarbital sodium. Carton Contents NDC One 100 mg single-dose vial NDC 62756-301-01 The vial stopper is not made with natural rubber latex.
Frequently Asked Questions
What is Phenobarbital Sodium used for?▼
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.
What are the side effects of Phenobarbital Sodium?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Risks from Concomitant Use with Opioids [see Warnings and Precautions (5.1)] Dependence and Withdrawal Reactions After Use of SEZABY for a Longer Duration Than Recommended [see Warnings and Precautions (5.2)] Abuse, Misuse, and Addiction with Unapproved Use in Adolescents and Adults [see Warnings and Precautions (5.3)] Respiratory Depression or Insufficiency [see Warnings and Precautions (5.4)] Serious Dermatologic Reactions [see Warnings and Precautions (5.5)] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.6)] Hypersensitivity [see Warnings and Precautions (5.7)] Exacerbation of Porphyria [see Warnin...
What are the important warnings for Phenobarbital Sodium?▼
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; DEPENDENCE AND WITHDRAWAL REACTIONS AFTER USE OF SEZABY FOR A LONGER DURATION THAN RECOMMENDED; and ABUSE, MISUSE AND 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. 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. 4 CONTRAINDICATIONS SEZABY is contraindicated in patients with: acute porphyrias [see Warnings and Precautions (5.8)], or a history of hypersensitivity reaction to phenobarbital or other barbiturates [see Warnings and Precautions (5.7)] Acute porphyrias (4) Hypersensitivity to phenobarbital or other barbiturates (4)
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.