Phenobarbital

Overview

A barbituric acid derivative that acts as a nonselective central nervous system depressant. It promotes binding to inhibitory gamma-aminobutyric acid subtype receptors, and modulates chloride currents through receptor channels. It also inhibits glutamate induced depolarizations.

Indication

For the treatment of all types of seizures except absence seizures.

Associated Conditions

Alcohol Withdrawal Syndrome
Anxiety
Febrile Convulsions
Hyperbilirubinemia
Insomnia
Menopausal Symptoms
Partial-Onset Seizures
Seizures, Generalized
Withdrawal Symptoms

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Antiseizure Medication in Seizure Networks at Early Acute Brain Injury	2023/10/13	NCT06081283	Phase 4	Active, not recruiting	University of North Carolina, Chapel Hill
A Dose Escalation Study of Levetiracetam in the Treatment of Neonatal Seizures	2022/11/09	NCT05610085	Phase 2	Recruiting	University of California, San Diego
Lacosamide in Neonatal Status Epilepticus	2022/03/22	NCT05291455	Phase 3	UNKNOWN	Sherief Abd-Elsalam
Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures	2020/03/25	NCT04320940	Phase 3	Terminated	NEMA Research, Inc.
Phenobarbital vs Ativan for Alcohol Withdrawal in the Intensive Care Unit	2019/11/07	NCT04156464	Phase 4	UNKNOWN	OSF Healthcare System
Alcohol Withdrawal Syndrome Treated With Adjunctive Phenobarbital or Ketamine	2018/12/28	NCT03788889	Phase 4	Withdrawn	Santa Barbara Cottage Hospital
Selective Treatment According to Molecular Subtype of Prostate Cancer	2018/10/04	NCT03696186	Phase 2	UNKNOWN	Tianjin Medical University Second Hospital
Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome	2018/09/13	NCT03670160	Phase 2	Completed	University of Tennessee Medical Center
Childhood Convulsive Status Epilepticus Management In A Resource Limited Setting	2018/08/28	NCT03650270	Phase 3	Completed	University of Cape Town
Pharmacokinetics of Antiepileptics in Patients on CRRT	2018/08/16	NCT03632915	N/A	Completed	University of Maryland, Baltimore

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Phenobarbital	Bryant Ranch Prepack	72162-1582	ORAL	30 mg in 1 1	10/6/2023
Phenobarbital	Bryant Ranch Prepack	72162-1167	ORAL	64.8 mg in 1 1	10/25/2023
PHENOBARBITAL WITH BELLADONNA ALKALOIDS	ATLANTIC BIOLOGICALS CORP.	17856-0162	ORAL	16.2 mg in 5 mL	6/15/2018
Phenobarbital	Bryant Ranch Prepack	63629-2400	ORAL	16.2 mg in 1 1	11/12/2020
Phenobarbital	Par Pharmaceutical, Inc.	0603-5167	ORAL	64.8 mg in 1 1	8/14/2021
Phenohytro	Winder Laboratories, LLC	75826-118	ORAL	16.2 mg in 1 1	12/27/2019
FIDOQUEL-CA1	Genus Lifesciences	64950-543	ORAL	64.8 mg in 1 1	3/25/2025
PHENOBARBITAL	QUAGEN PHARMACEUTICALS LLC	70752-164	ORAL	97.2 mg in 1 1	2/16/2023
Phenobarbital	Bryant Ranch Prepack	72162-1268	ORAL	20 mg in 5 mL	8/29/2023
Phenobarbital Sodium	Bryant Ranch Prepack	72162-1330	INTRAMUSCULAR	130 mg in 1 mL	9/27/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
PHENOBARBITONE TABLET 60 mg	PT ACTAVIS INDONESIA	SIN03709P	TABLET	60 mg	10/6/1989
PHENOBARBITONE TABLET 10 mg	PT ACTAVIS INDONESIA	SIN02457P	TABLET	10 mg	2/10/1989

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Sodium Phenobarbital Injection	重庆药友制药有限责任公司	国药准字H50021536	化学药品	注射剂	9/30/2020
Sodium Phenobarbital Injection	广东邦民制药厂有限公司	国药准字H44021888	化学药品	注射剂	11/13/2019
Sodium Phenobarbital Injection	哈药集团三精制药有限公司	国药准字H23021166	化学药品	注射剂	2/28/2023
Sodium Phenobarbital Injection	津药和平（天津）制药有限公司	国药准字H12020381	化学药品	注射剂	7/27/2020
Sodium Phenobarbital Injection	遂成药业股份有限公司	国药准字H41025613	化学药品	注射剂	5/14/2020
Sodium Phenobarbital Injection	重庆药友制药有限责任公司	国药准字H50021537	化学药品	注射剂	9/30/2020
Sodium Phenobarbital Injection	哈药集团三精制药有限公司	国药准字H23021167	化学药品	注射剂	2/28/2023
Phenobarbital Sodium for Injection	上海上药新亚药业有限公司	国药准字H31020532	化学药品	注射剂	7/17/2020
Phenobarbital Sodium for Injection	上海上药新亚药业有限公司	国药准字H31020502	化学药品	注射剂	7/17/2020
Phenobarbital Sodium for Injection	上海上药新亚药业有限公司	国药准字H31020501	化学药品	注射剂	7/17/2020

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
NOUMED PHENOBARBITONE phenobarbital 30 mg tablet blister pack	407691	NOUMED PHARMACEUTICALS PTY LTD	Medicine	A	4/14/2023
PHENOBARBITONE INJECTION	175471	Aspen Pharmacare Australia Pty Ltd	Medicine	A	11/4/2011
PHENOBARB phenobarbital 30mg tablet bottle	19758	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	10/14/1991
ORION PHENOBARBITAL ELIXIR phenobarbital 15mg/5mL oral liquid bottle	21187	Orion Laboratories Pty Ltd T/A Evaris Pharma	Medicine	A	10/8/1991
NOUMED PHENOBARBITONE phenobarbital 15 mg tablet blister pack	410797	NOUMED PHARMACEUTICALS PTY LTD	Medicine	A	6/19/2023

Related News

FDA-Approved Sezaby Shows Superior Efficacy Over Levetiracetam for Neonatal Seizures

5 months ago

Sezaby, a preservative-free phenobarbital formulation by Sun Pharmaceutical Industries, has been approved as the first FDA-sanctioned treatment specifically for neonatal seizures in both term and preterm infants.

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