Phenobarbital Sodium AHFS DI

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/11/2012 Phenobarbi tal Sodi um - Pri nt Versi on

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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
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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.)
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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
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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


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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
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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
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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
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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
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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
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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%
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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


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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


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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
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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
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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.


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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.

Documents

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