Upload
brian-harris
View
236
Download
0
Embed Size (px)
Citation preview
7/30/2019 Phenobarbital Sodium AHFS DI
1/16
/11/2012 Phenobarbi tal Sodi um - Pri nt Versi on
1ww.drugs.com/monograph/phenobarbital-sodium.html?printable=1
Phenobarbital Sodium
Class: Barbiturates
VA Class: CN301CAS Number: 50-06-6Brands: Luminal
Introduction
Barbiturate;abcd anxiolytic, sedative, hypnotic, and anticonvulsant.abf
Uses for Phenobarbital Sodium
Insomnia and Anxiety
Relief of anxiety, tension, and apprehension.cd However, barbiturates used infrequently for routine sedation, since therare few clinical situations in which oral barbiturates provide a safety or efficacy advantage over nonbarbiturate
sedatives/hypnotics.f
Short-term treatment of insomnia.cd However, generally not used orally as a hypnotic because several hours are
required to achieve maximal effectsa and barbiturates have decreased effectiveness for sleep induction and maintenanc
after 2 weeks.d
Drug Withdrawal
Withdrawal of barbiturate or nonbarbiturate hypnotics in patients who are physically dependent on these drugs.a
Surgery
Preoperatively, to produce sedation and relieve anxiety.ac
Seizure Disorders
Management of tonic-clonic seizures and partial seizures; used alone (particularly in infants and young children) or,
more commonly, in combination with phenytoin or other anticonvulsants.b
Prevention of febrile seizures in infants and young children.b
Second-line agent in the termination of status epilepticus; may be useful to prevent seizure recurrence after seizures ainitially terminated with other anticonvulsants (e.g., diazepam, phenytoin) or for termination of status epilepticus that
does not respond to initial therapy with other anticonvulsants.bc Usefulness of parenteral phenobarbital in terminating
acute seizure episodes is limited by its slow onset of action.abd
Prophylactic management of epilepsy.cd
http://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#ra7/30/2019 Phenobarbital Sodium AHFS DI
2/16
/11/2012 Phenobarbi tal Sodi um - Pri nt Versi on
2ww.drugs.com/monograph/phenobarbital-sodium.html?printable=1
Hyperbilirubinemia in Neonates
Prevention and treatment of hyperbilirubinemia in neonates.a
Cholestasis
Has been used to reduce bilirubin concentrations in patients with congenital nonhemolytic unconjugated
hyperbilirubinemia or chronic intrahepatic cholestasis.a
Has been used in the management of hyperlipemia associated with intrahepatic and extrahepatic cholestasis.a
Phenobarbital Sodium Dosage and Administration
General
Adjust dosage carefully and slowly according to individual requirements and response.ab
Following chronic administration, withdraw phenobarbital slowly to avoid the possibility of precipitating withdrawa
symptoms if the patient is physically dependent on the drug.ad
To prevent rebound in rapid eye movement (REM) sleep, withdrawal of a single therapeutic dose over 5 or 6 days(e.g., reducing dosage from 3 to 2 doses daily for 1 week) has been recommended when barbiturates are
discontinued following prolonged use.a
Seizures
23 weeks of therapy may be required to achieve full anticonvulsant effects. b
When transferring a patient to another anticonvulsant drug, reduce phenobarbital dosage gradually over 1 week
while, at the same time, instituting therapy with a low dose of the replacement drug.b
Withdraw phenobarbital or reduce dosage slowly to avoid precipitating seizures or status epilepticus.b
Insomnia
Do not administer for periods >2 weeks.a
Administration
Administer orally or by IM or slow IV injection.abcd Sub-Q injection not recommended.ad
Oral Administration
Frequently administered in 2 or 3 divided doses;a however, there is no advantage in dividing the daily dosage (because
the long half-life).ab
IV Administration
For solution and drug compatibility information, see Compatibility under Stability.
Reserve IV administration for emergency treatment of acute seizure states; however, usefulness in these conditions is
limited.ab (See Seizure Disorders under Uses.)
http://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#unlbl-usehttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#unlbl-usehttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#unlbl-usehttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#unlbl-use7/30/2019 Phenobarbital Sodium AHFS DI
3/16
/11/2012 Phenobarbi tal Sodi um - Pri nt Versi on
3ww.drugs.com/monograph/phenobarbital-sodium.html?printable=1
Patient should be hospitalized and under close supervision.a
To minimize the risk of irritation and thrombosis, do not use small veins (e.g., those on the dorsum of the hands or
wrist).d
Avoid intra-arterial injection.b (See Intra-arterial Injection under Cautions.)
Rate of Administration
60 mg/minute.abd
IM Administration
Maximum volume of single injections is 5 mL; administer deeply into a large muscle to avoid tissue irritation. d
Dosage
Available as phenobarbital sodium; dosage expressed in terms of the salt.d
Pediatric Patients
Anxiety
Oral
6 mg/kg daily or 180 mg/m2 daily, in 3 equally divided doses.ac
Surgery
Oral
13 mg/kg preoperatively.ad
IM
16100 mg administered 6090 minutes before surgery;a alternatively, 13 mg/kg preoperatively.ad
Drug Withdrawal
Oral
Infants: 310 mg/kg daily.a After symptoms are relieved, decrease dosage gradually and withdraw drug completely ove
a 2-week period.a
Seizure Disorders
Oral
1550 mg 2 or 3 times daily.c Alternatively, 35 mg/kg or 125 mg/m2 daily.b
IV or IM
46 mg/kg daily for 710 days to reach therapeutic blood concentrations; alternatively, 1015 mg/kg daily. d
http://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#ra7/30/2019 Phenobarbital Sodium AHFS DI
4/16
/11/2012 Phenobarbi tal Sodi um - Pri nt Versi on
4
Prevention of Febrile Seizures
Oral
34 mg/kg daily.b
Status Epilepticus
IV or IM
1520 mg/kg IV over 1015 minutes.d Alternatively 100400 mg IM or IV; allow up to 30 minutes for maximum
anticonvulsant effect before administering additional doses (to prevent overdosage).b
Hyperbilirubinemia in Neonates
Oral
7 mg/kg per day from the first to fifth day of life.a
IM, then Oral
5 mg/kg IM on the first day of life, followed by 5 mg/kg orally on the second to seventh day.a
Cholestasis
Oral
Children
7/30/2019 Phenobarbital Sodium AHFS DI
5/16
/11/2012 Phenobarbi tal Sodi um - Pri nt Versi on
5ww.drugs.com/monograph/phenobarbital-sodium.html?printable=1
After withdrawal symptoms are relieved, gradually decrease dosage and withdraw completely over a 2-week period.a
Surgery
IM
100200 mg given 6090 minutes before surgery.ad
Seizure Disorders
Oral
100300 mg daily,bc usually at bedtime.b
Status Epilepticus
IV or IM
20320 mg; repeat in 6 hours, if necessary.d Alternatively, 200600 mg; allow up to 30 minutes for maximum
anticonvulsant effect before administering additional doses (to prevent overdosage).b
Some clinicians administer phenobarbital sodium IV until seizures stop or a total dose of 20 mg/kg has been given.ab
Discontinue IV injections as soon as the desired effect is obtained.b
Cholestasis
Oral
Dosages of 90180 mg daily in 2 or 3 divided doses have been used. a
Special Populations
Hepatic Impairment
Dosage reduction recommended in patients with hepatic impairment;cde avoid use in patients with marked hepatic
impairment.cd
Renal Impairment
Dosage reduction recommended.de
Geriatric Patients
Dosage reduction recommended.def
Cautions for Phenobarbital Sodium
Contraindications
Known hypersensitivity to any barbiturates.cd
Respiratory disease in which dyspnea or obstruction is evident.cd
http://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rehttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rehttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rehttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#unlbl-usehttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rahttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#ra7/30/2019 Phenobarbital Sodium AHFS DI
6/16
Marked impairment of hepatic function.cd
History of manifest or latent porphyriacd (due to potential for exacerbation of acute intermittent porphyria or
porphyria variegata).f
Previous addiction to sedative and/or hypnotic drugs.cd
Warnings/Precautions
Warnings
Pain Reaction
Potential for paradoxical excitement and/or euphoria, restlessness, or delirium in patients with severe pain.f Barbiturate
could mask important symptoms in patients with acute or chronic pain.df Use with caution in such patients.df Should
not be used to relieve pain or to produce sedation or sleep in the presence of uncontrolled pain.cf
Abuse Potential
Possible tolerance, psychologic dependence, and physical dependence.cd (See Contraindications under Cautions.)
WIthdrawal Effects
Abrupt cessation after prolonged use in dependent individuals may result in withdrawal symptoms (e.g., delirium,
convulsions) and potentially be fatal.cd Drug must be withdrawn gradually in patients receiving excessive dosages over
extended periods of time.d
CNS Depression
Performance of activities requiring mental alertness and physical coordination may be impaired.cd
Concurrent use of other CNS depressants may potentiate CNS depression.cd (See Specific Drugs under Interactions.)
Res piratory and Cardiovascular Effects
Possible respiratory depression, apnea, laryngospasm, hypertension, or vasodilation and hypotension, particularly if
phenobarbital is administered IV too rapidly.df Administer slowly; personnel and equipment should be readily available
for administration of artificial respiration.df
Sensitivity Reactions
Dermatologic Effects and Hypersensitivity Reactions
Exfolative dermatitis (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes fatal, reported rarely.bd Because skin eruptions can precede potentially fatal reactions, discontinue phenobarbital whenever dermatologic
reactions occur.df
Hypersensitivity reactions (e.g., localized swelling, particularly of the eyelids, cheeks, or lips; erythematous dermatitis
may occur, particularly in patients with a history of asthma, urticaria, or angioedema.c
General Precautions
Intra-arterial Injection
http://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rc7/30/2019 Phenobarbital Sodium AHFS DI
7/16
/11/2012 Phenobarbi tal Sodi um - Pri nt Versi on
7ww.drugs.com/monograph/phenobarbital-sodium.html?printable=1
Inadvertent intra-arterial administration can cause spasm and severe pain along the affected artery, resulting in local
reactions varying in severity from transient pain to gangrene.d
Discontinue injection if the patient complains of pain or if signs of inadvertent intra-arterial injection (e.g., patches of
discolored skin, a white hand with cyanosed skin, delayed onset of action) occur.bd Appropriate therapy for such
inadvertent injection has not been fully established; consult manufacturers labeling for current recommendations.bd
Suicide
Use with caution, if at all, in depressed patients; potential for suicidal tendencies.cdf Prescribe drug in the smallest
feasible quantity.c
Concomitant Diseases
Use parenterally with extreme caution in debilitated patients or patients with severe hepatic impairment, pulmonary or
cardiac disease, status asthmaticus, uremia, or shock.df
Specific Populations
Pregnancy
Tablets: Category B.c Injection: Category D.d
Barbiturates have caused postpartum hemorrhage and hemorrhagic disease in neonates; readily reversible with vitamin
K therapy.fi
Possible withdrawal symptoms in neonates born to women who received barbiturates throughout the last trimester of
pregnancy.f Premature neonates are particularly susceptible to the depressant effects of barbiturates. f
Lactation
Distributed into milk; use with caution.cd
Pediatric Use
May produce paradoxical excitement and hyperactivity or exacerbate existing hyperactivity; if severe, substitute anothe
barbiturate or therapeutic agent.b
Possible behavioral (e.g., hyperactivity, fussiness, lethargy, disturbed sleep, irritability, disobedience, stubbornness,depressive symptoms) or cognitive effects (e.g., deficits on neuropsychiatric tests, impaired short-term memory and
memory concentration tasks) associated with anticonvulsant use.di If such changes occur and alternative causes arenot readily evident, consider the possibility that anticonvulsant therapy may be responsible and the need for dosage
reduction or substitution of alternative anticonvulsant(s). i
Phenobarbital sodium injection contains benzyl alcohol.d Manufacturer does not recommend use in neonates;d AAPstates that the presence of small amounts of this preservative in a commercially available injection should not proscribe
its use when indicated in neonates.h
Geriatric Use
Possible increased sensitivity to barbiturates.d Geriatric patients may frequently react to barbiturates with excitement,
confusion, or depression.cf
http://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rhhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rihttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rihttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rihttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rd7/30/2019 Phenobarbital Sodium AHFS DI
8/16
/11/2012 Phenobarbi tal Sodi um - Pri nt Versi on
8ww.drugs.com/monograph/phenobarbital-sodium.html?printable=1
Hepatic Impairment
Use with caution; should not be used in patients with marked hepatic impairment.cd (See Contraindications underCautions.)
Renal Impairment
Use with extreme caution in patients with nephritis.bd Use parenterally with extreme caution in patients with uremia.d
Common Adverse Effects
Residual sedation, drowsiness, lethargy, vertigo, nausea, vomiting, headache.cdf
Interactions for Phenobarbital Sodium
Metabolized by hepatic microsomal enzymes.d Induces hepatic microsomal enzymes.cd
Specific Drugs
Drug Interaction Comments
Anticoagulants,oral (e.g.,warfarin)
Possible decreased plasma warfarin
concentrationscd
Monitor PT; adjust anticoagulant dosage asnecessary, especially with initiation or
discontinuance of phenobarbitalcf
Antidepressants,tricyclics
Antidepressant may precipitate seizures,
resulting in decreased seizure controli
Potentiation of respiratory depression following
toxic doses of tricyclic antidepressantsi
Monitor epileptic patients for decreased seizurecontrol following initiation of antidepressant
therapy; adjust phenobarbital dosage, if necessar
CNS depressants(e.g., sedatives,hynotics,antihistamines,tranquilizers,alcohol)
Possible additive depressant effectscd
Contraceptives,
oral
Possible enhanced metabolism of estrogenicand progestinic components; potential fordecreased oral contraceptive effectiveness and
increased risk of pregnancy with phenobarbital
pretreatment or concurrent therapyd
Consider alternate methods of contraceptiond
Corticosteroids Possible increased corticosteroid metabolismdDosage adjustment of corticosteriod may be
required;d closely monitor asthmatics receiving
corticosteroids when phenobarbital is initiatedi
Doxycycline
Possible decreased half-life of doxycycline;effect may persist up to 2 weeks after
discontinuance of phenobarbitald
If possible, avoid concomitant administration;f ifadministered concomitantly, monitor clinical
response to doxycyclined
http://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rihttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rihttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rihttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rc7/30/2019 Phenobarbital Sodium AHFS DI
9/16
/11/2012 Phenobarbi tal Sodi um - Pri nt Versi on
9ww.drugs.com/monograph/phenobarbital-sodium.html?printable=1
GriseofulvinPossible decreased griseofulvin absorption,
resulting in decreased blood concentrationsd
Avoid concomitant administration;d if concomitantherapy is necessary, administration of griseofulvi
in 3 divided daily doses may improve absorption.f
Monitor blood griseofulvin concentrations and
increase dosage, if necessaryf
MAO inhibitors Possible prolongation of phenobarbital effectsdDosage adjustment of phenobarbital may be
requiredf
PhenytoinIncreased, decreased, or no change in plasma
phenytoin concentrations reporteddiMonitor plasma concentrations of phentoin and
phenobarbital; adjust dosages as necessarydi
Valproic acidPossible increased plasma phenobarbital
concentrationsdMonitor plasma phenobarbital concentrations and
adjust dosage as neededd
Phenobarbital Sodium Pharmacokinetics
Absorption
Bioavailability
Slowly absorbed from GI tract following oral administration,b with peak plasma concentrations usually attained within 8
12 hours and peak brain concentrations in 1015 hours.b
Following IV administration, 15 minutes may be required to reach peak brain concentrations.d
Onset
Following oral administration, onset occurs within 30 minutes.c
Following IV administration, onset occurs within 5 minutes, with maximum CNS depression occurring 15 minutes afte
administration.bd Onset is slower following IM administration.bd
Duration
About 56 hoursc or 46 hoursd following oral or parenteral administration, respectively.
Plasma Concentrations
Plasma concentrations of 1025 mcg/mL associated with anticonvulsant activity in most patients.d Concentrations >50
mcg/mL may produce coma; concentrations >80 mcg/mL are potentially lethal.b
Distribution
Extent
Rapidly distributed to all t issues and fluids, with high concentrations in the brain, liver, and kidneys.d
Crosses the placenta and is distributed into milk.d
http://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rbhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rihttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rihttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rd7/30/2019 Phenobarbital Sodium AHFS DI
10/16
/11/2012 Phenobarbi tal Sodi um - Pri nt Versi on
10/
Plasma Protein Binding
2045%.b
Elimination
Metabolism
Metabolized primarily by hepatic microsomal enzymes.d
Elimination Route
Excreted prinicipally in urine (2550% as unchanged drug).d
Half-life
Adults: 53118 hours.d
Children and neonates: 60180 hours.d
Stability
Storage
Oral
Tablets
Tight, light-resistant containers at 1530C.c Protect from moisture.c
Elixir
Tight containers at 2025C.e
Parenteral
Injection
1530C.d
Compatibility
For information on systemic interactions resulting from concomitant use, see Interactions.
Parenteral
Solution CompatibilityHID
Compatible
Dextran 6% in dextrose 5%
http://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rHIDhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rehttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rb7/30/2019 Phenobarbital Sodium AHFS DI
11/16
/11/2012 Phenobarbi tal Sodi um - Pri nt Versi on
ww.drugs.com/monograph/phenobarbital-sodium.html?printable=1
Dextran 6% in sodium chloride 0.9%
DextroseRingers injection combinations
DextroseRingers injection, lactated, combinations
Dextrosesaline combinations
Dextrose 2.5, 5, or 10% in water
Fructose 10% in sodium chloride 0.9%
Fructose 10% in water
Invert sugar 5 and 10% in sodium chloride 0.9%
Invert sugar 5 and 10% in water
Ionosol products
Ringers injection
Ringers injection, lactated
Sodium chloride 0.45 or 0.9%
Sodium lactate (1/6) M
Incompatible
Alcohol 5%, dextrose 5%
Drug Compatibility
Admixture CompatibilityHID
Compatible
Amikacin sulfate
Aminophylline
Calcium chloride
Calcium gluconate
Colistimethate sodium
Dimenhydrinate
7/30/2019 Phenobarbital Sodium AHFS DI
12/16
/11/2012 Phenobarbi tal Sodi um - Pri nt Versi on
12/ww.drugs.com/monograph/phenobarbital-sodium.html?printable=1
Meropenem
Polymyxin B sulfate
Thiopental sodium
Verapamil HCl
Incompatible
Chlorpromazine HCl
Ephedrine sulfate
Hydralazine HCl
Hydrocortisone sodium succinate
Hydroxyzine HCl
Meperidine HCl
Morphine sulfate
Norepinephrine bitartrate
Pentazocine lactate
Procaine HCl
Prochlorperazine mesylate
Promethazine HCl
Streptomycin sulfate
Vancomycin HCl
Y-site CompatibilityHID
Compatible
Doxapram HCl
Enalaprilat
Fentanyl citrate
Fosphenytoin sodium
7/30/2019 Phenobarbital Sodium AHFS DI
13/16
/11/2012 Phenobarbi tal Sodi um - Pri nt Versi on
13/ww.drugs.com/monograph/phenobarbital-sodium.html?printable=1
Levofloxacin
Linezolid
Meropenem
Methadone HCl
Morphine sulfate
Propofol
Sufentanil c itrate
Incompatible
Amphotericin B cholesteryl sulfate complex
Lansoprazole
Variable
Hydromorphone HCl
Actions
CNS effects appear to be related, at least partially, to the drugs ability to enhance activity of GABA, the principa
inhibitory neurotransmitter in the CNS,104105106107108 by altering inhibitory synaptic transmissions that are
mediated by GABAA receptors.105106108
Capable of producing all levels of CNS depressionfrom mild sedation to hypnosis to deep coma to death. cd
Anticonvulsant effects of barbiturates are multiple and rather nonselective.i Principal mechanism of action appeato be reduction of monosynaptic and polysynaptic transmission resulting in decreased excitability of the entire
nerve cell; barbiturates also increase the threshold for electrical stimulation of the motor cortex. i
Barbiturates lower serum bilirubin concentrations in neonates and patients with congenital nonhemolyticunconjugated hyperbilirubinemia, presumably by induction of glucuronyl transferase, the enzyme that conjugate
bilirubin.f
Advice to Patients
Potential for phenobarbital to impair mental alertness or physical coordination; do not drive or operate machinery
until effects on individual are known.cd
Importance of taking exactly as prescribed; do not exceed the recommended dosage.cd
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and
OTC drugs and alcohol consumption.cd Importance of avoiding alcohol while taking the drug.cd
http://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rfhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rihttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rihttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#r108http://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#r106http://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#r105http://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#r108http://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#r107http://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#r106http://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#r105http://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#r1047/30/2019 Phenobarbital Sodium AHFS DI
14/16
/11/2012 Phenobarbi tal Sodi um - Pri nt Versi on
14/ww.drugs.com/monograph/phenobarbital-sodium.html?printable=1
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.cd
Importance of advising patients of other important precautionary information.cd (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consu
specific product labeling for details.
Subject to control under the Federal Controlled Substances Act of 1970 as schedule IV (C-IV) drugs.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Phenobarbital
Routes Dosage Forms Strengths Brand Names Manufacturer
Oral Elixir 20 mg/5 mL C-IV*
Tablets 15 mg*
16 mg C-IV*
30 mg C-IV*
32 mg C-IV*
60 mg C-IV*
65 mg C-IV*
100 mg C-IV*
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Phenobarbital Sodium
RoutesDosage
FormsStrengths Brand Names Manufacture
Parenteral Injection30mg/mL*
Phenobarbital Sodium Injection (C-IV; with alcohol 10% and propyleneglycol 75%)
Wyeth
60mg/mL*
Phenobarbital Sodium Injection (C-IV; with alcohol 10% and propyleneglycol 75%)
Wyeth
65mg/mL*
Phenobarbital Sodium Injection (C-IV; with alcohol 10% benzylalcohol 1.5% and propylene glycol 67.8%)
Baxter
130mg/mL*
Luminal Sodium (C-IV; with alcohol 10% and propylene glycol 67.8%) Sanofi-Avent
Phenobarbital Sodium Injection (C-IV; with alcohol 10% and propyleneWyeth
http://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rchttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rdhttp://www.drugs.com/monograph/phenobarbital-sodium.html?printable=1#rc7/30/2019 Phenobarbital Sodium AHFS DI
15/16
/11/2012 Phenobarbi tal Sodi um - Pri nt Versi on
15/ww.drugs.com/monograph/phenobarbital-sodium.html?printable=1
glycol 75%)
Phenobarbital Sodium Injection (C-IV; with alcohol 10% benzylalcohol 1.5% and propylene glycol 67.8%)
Baxter
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was
updated 02/2012. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and
health insurance copays.
PHENobarbital 100MG Tablets (WEST-WARD): 30/$15.99 or 90/$23.97
PHENobarbital 16.2MG Tablets (QUALITEST): 100/$14.99 or 300/$23.97
PHENobarbital 20MG/5ML Elixir (QUALITEST): 473/$26.96 or 1419/$79.29
PHENobarbital 32.4MG Tablets (QUALITEST): 100/$16.99 or 200/$23.98
PHENobarbital 60MG Tablets (WEST-WARD): 100/$19.99 or 200/$28.98
Disclaimer
This report on m edications is for your information only, and is not considered individual patient advice. Because of the changin
nature of drug information, please consult your physician or pharmacis t about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunderwas formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American
Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or impl ied,including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to suchinformation and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are
complex medical decis ions requiring the independent, informed decis ion of an appropriate health care professional, and theinformation is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thoroughunderstanding of the drug's actions, uses and s ide effects. The American Society of Health-System Pharmacists, Inc. and
Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. Copyright, 1959-2012, Selected Revisions April 01, 2010. American Society of Health-SystemPharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
Only references cited for selected revisions after 1984 are available electronically.
100. Jones-Pharma. Brevital sodium (methohexital sodium) for injection prescribing information (dated 2001 Mar 28). InPhysicians desk reference. 56th ed. Montvale, NJ: Medical Economics Company Inc; 2002:1815-17.
103. Abbott. Pentothal thiopental sodium for injection prescribing information. North Chicago, IL; 1993 Nov.
104. Carmichael FJ, Haas DA. General Anesthetics. In: Kalant H and Roschlau WHE, eds. Principles of MedicalPharmacology. 6th edition. New York: Oxford University Press; 1998:278-92.
7/30/2019 Phenobarbital Sodium AHFS DI
16/16
/11/2012 Phenobarbi tal Sodi um - Pri nt Versi on
105. Evers AS, Crowder CM. General Anesthetics. In: Hardman JG, Gilman AG, Limbird LE, eds Goodman andGilmans The pharmacological basis of therapeutics. 10th ed. McGraw-Hill; 2001: 337-44.
106. Donnelly AJ, Shafer AL. Perioperative care. In: Young LL, Koda-Kimble MA, eds. Applied Therapeutics: The clinicuse of drugs. 6th ed. Vancouver WA: Applied Therapeutics, Inc.; 1995:8-1-8-24.
107. Tanelian DL, Kosek P, Mody I et al. The role of the GABAA receptor/chloride channel complex in anesthesia.
Anesthesiology. 1993; 78:757-76. [IDIS 316350] [PubMed 8385426]
108. Hales TG, Olsen RW. Basic pharmacology of intravenous induction agents. In: Bowdle TA, Horita A, Kharasch EDeds. The pharmacologic basis of anesthesiology. New York: Churchill Livingstone; 1994:295-306.
a. AHFS Drug Information 2004. McEvoy GK, ed. Phenobarbital . Bethesda, MD: American Society of Health-SystemPharmacists; 2004:2370-1.
b. AHFS Drug Information 2004. McEvoy GK, ed. Phenobarbital. Bethesda, MD: American Society of Health-SystemPharmacists; 2004:2108-9.
c. West-ward Pharmaceutical Corp. Phenobarbital tablets prescribing information. Eatontown, NJ; 2001 Jan.
d. Elkins-Sinn, Inc. Phenobarbital Sodium injection prescribing information. Cherry Hill, NJ; 2002 Apr.
e. Pharmaceutical Associates, Inc. Phenobarb elixir prescribing information. Greenville, NC; 2000 Apr.
f. AHFS Drug Information 2004. McEvoy GK, ed. Barbiturate general statement . Bethesda, MD: American Society ofHealth-System Pharmacists; 2004:2363-6.
HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-SystemPharmacists; 2007:1331-5.
h. American Academy of Pediatrics Committee on Fetus and Newborn and Committee on Drugs. Benzyl alcohol: toxicagent in neonatal units. Pediatrics. 1983; 72:356 8.
i. AHFS Drug Information 2004. McEvoy GK, ed. Anticonvulsants general statement . Bethesda, MD: American Societof Health-System Pharmacists; 2004:2102-7.