SEZABY 100 mg/1
phenobarbital sodium · INJECTION · Sun Pharmaceutical Industries, Inc.
SEZABY is a injection containing phenobarbital sodium at 100 mg/1, taken intravenous. Manufactured by Sun Pharmaceutical Industries, Inc..
Key Facts
- Brand Name
- SEZABY
- Generic Name
- phenobarbital sodium
- NDC Code (Product)
62756-301- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Strength
- 100 mg/1
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- DEA Schedule
- Schedule IV (Controlled)
- Application #
- NDA215910
- Marketing Start
- 12/25/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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 & 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 Dosag…
Contraindications
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)
Drug 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)] . Although the data from the published literature regarding these drug interactions are from non-neonatal populations and the magnitude of the potential drug interactions in neonates have not been characterized, this information still warrants consideration given the potential impact of these possible drug interactions on the safety and efficacy of phenobarbital and CYP2B6, 2C9, 2C19, or UGT substrates in neonates. Table 3: Drug Interactions with SEZABY Effects of Other Drugs on SEZABY CYP2C9, 2C19, 2E1, Uridine 5'-diphospho-gluc…
Adverse Reactions
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 Warnings and Precautions (5.8)] Injection Site Reactions [see Warnings and Precautions (5.9)] QT Prolongation [see Warnings and Precautions (5.10)] Embryofetal Toxicity with Unapproved Use in Adolescents and Adults [see Warnings and Precautions (5.11)] Neonatal Adverse Reactions from Unapproved Maternal Phenobarbital Use [see Warnings and Precautions (5.12)] Sedation, Respiratory Depression, and Withdra…
Frequently Asked Questions
What is SEZABY used for?
SEZABY contains phenobarbital sodium. It is a injection taken intravenous. Consult your doctor for specific uses.
Is SEZABY a controlled substance?
Yes, SEZABY is classified as CIV under the DEA Controlled Substances Act.
What is the generic name for SEZABY?
The generic name for SEZABY is phenobarbital sodium. There are 11 other brand versions of phenobarbital sodium.
What is the NDC code for SEZABY 100 mg/1?
The NDC (National Drug Code) for SEZABY 100 mg/1 is 62756-301, listed by Sun Pharmaceutical Industries, Inc..
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)