Brand names: Phenobarbital Sodium
FDA Black Box Warning
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. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. If a decision is made for concomitant use of these drugs, limit dosages and durations to the minimum required, and follow patients for signs and symptoms of respiratory depression and sedation [see Warnings and Precautions (5.1) and Drug Interactions (7.3)]. Dependence and Withdrawal Reactions After Use of SEZABY for a Longer Duration than Recommended The continued use of phenobarbital may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although SEZABY is indicated only for short-term use [see Indications and Usage (1) and Dosage and Administration (2)], if used for a longer duration than recommended, abrupt discontinuation or rapid dosage reduction of SEZABY may precipitate acute withdrawal reactions, which can be life-threatening. For patients receiving SEZABY for longer duration than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue SEZABY [see Warnings and Precautions (5.2)]. Abuse, Misuse, and Addiction with Unapproved Use in Adolescents and Adults SEZABY is not approved for use in adolescents or adults. The unapproved use of SEZABY, in adolescents and adults exposes them to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of phenobarbital commonly involve concomitant use of other drugs, alcohol, and/or illicit substances, which is associated with an increa
2 interactions on record
Doxycycline Phenobarbital has been shown to shorten the half-life of doxycycline for as long as 2 weeks after barbiturate therapy is discontinued. If phenobarbital and doxycycline are administered concurrently, the clinical response to doxycycline should be monitored closely.
Source: FDA drug label - phenobarbital sodium
Estradiol, Estrone, Progesterone and Other Steroidal Hormones Pretreatment with or concurrent administration of phenobarbital may decrease the effect of estradiol by increasing its metabolism.
Source: FDA drug label - phenobarbital sodium