SEZABY
Generic: PHENOBARBITAL SODIUM
Basic Information
Manufacturer
Sun Pharmaceutical Industries, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
8c7d0402-4977-4c25-bc4b-11db91339e9a
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.
SEZABY is a barbiturate indicated for the treatment of neonatal seizures in term and preterm infants.
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 Withdrawal in Neonates Exposed to Phenobarbital Through Breast Milk [see Warnings and Precautions (5.13)] Suicidal Behavior and Ideation with Unapproved use in Adolescents and Adults [see Warnings and Precautions (5.14)] The most common adverse reactions (incidence > 5% patients overall) are abnormal respiration, sedation, feeding disorder, and hypotension.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc.
at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The Study 1 was a multicenter, randomized, double-blind, active-controlled study in neonates who were experiencing seizures [see Clinical Studies (14)] .
Patients were infants younger than 14 days of age with gestational ages between 36 and 44 weeks.
Overall, 106 neonates (51 female and 55 male) were randomized to receive either phenobarbital (N=42) or levetiracetam (N=64) as their initial treatment.
Patients received up to two 15-minute infusions of their initially assigned treatment (loading dose(s)) followed by maintenance treatment of up to 5 days.
Mean durations of phenobarbital and levetiracetam treatments were 4.3 and 4 days, respectively.
Table 2 summarizes the adverse reactions that occurred in 2% or more of neonates in Study 1.
Incidences are displayed for neonates who received phenobarbital only and for neonates who received levetiracetam only.
Because patients in Study 1 were neonates, adverse reactions that are verbally reported could not be assessed in this study.
Table 2: Adverse Reactions That Occurred in At Least 2% of Neonates Overall in Study 1 by Treatment Received Phenobarbital (N = 32)* % Levetiracetam (N = 19) % Respiration abnormal 25 5 Sedation 16 5 Feeding disorder 16 5 Hypotension 16 0 Bradycardia 3 0 Hyponatremia 3 0 Sepsis 3 0 * Fifty-five neonates received both phenobarbital and levetiracetam and they had a similar adverse reaction profile as neonates who received only phenobarbital.
6.2 Postmarketing Experience The following adverse reactions associated with the use of phenobarbital in neonates were identified in the literature.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular System : Bradycardia, patent ductus arteriosus Dermatologic Reactions : Eczema Hepatic : Abnormal liver function Musculoskeletal : Hypotonia, absent deep tendon reflexes Nervous System : Impaired consciousness, neurological impairment Renal : Abnormal kidney function Respiratory System : Bronchial secretion, respiratory depression
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc.
at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The Study 1 was a multicenter, randomized, double-blind, active-controlled study in neonates who were experiencing seizures [see Clinical Studies (14)] .
Patients were infants younger than 14 days of age with gestational ages between 36 and 44 weeks.
Overall, 106 neonates (51 female and 55 male) were randomized to receive either phenobarbital (N=42) or levetiracetam (N=64) as their initial treatment.
Patients received up to two 15-minute infusions of their initially assigned treatment (loading dose(s)) followed by maintenance treatment of up to 5 days.
Mean durations of phenobarbital and levetiracetam treatments were 4.3 and 4 days, respectively.
Table 2 summarizes the adverse reactions that occurred in 2% or more of neonates in Study 1.
Incidences are displayed for neonates who received phenobarbital only and for neonates who received levetiracetam only.
Because patients in Study 1 were neonates, adverse reactions that are verbally reported could not be assessed in this study.
Table 2: Adverse Reactions That Occurred in At Least 2% of Neonates Overall in Study 1 by Treatment Received Phenobarbital (N = 32)* % Levetiracetam (N = 19) % Respiration abnormal 25 5 Sedation 16 5 Feeding disorder 16 5 Hypotension 16 0 Bradycardia 3 0 Hyponatremia 3 0 Sepsis 3 0 * Fifty-five neonates received both phenobarbital and levetiracetam and they had a similar adverse reaction profile as neonates who received only phenobarbital.
6.2 Postmarketing Experience The following adverse reactions associated with the use of phenobarbital in neonates were identified in the literature.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular System : Bradycardia, patent ductus arteriosus Dermatologic Reactions : Eczema Hepatic : Abnormal liver function Musculoskeletal : Hypotonia, absent deep tendon reflexes Nervous System : Impaired consciousness, neurological impairment Renal : Abnormal kidney function Respiratory System : Bronchial secretion, respiratory depression