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Phenobarbital Sodium - Print Version

Phenobarbital Sodium
Class: Barbiturates VA Class: CN301 CAS Number: 50-06-6 Brands: Luminal

Introduction
Barbiturate;a b c d anxiolytic, sedative, hypnotic, and anticonvulsant.a b f

Uses for Phenobarbital Sodium

Insomnia and Anxiety
Relief of anxiety, tension, and apprehension.c d However, barbiturates used infrequently for routine sedation, since there are few clinical situations in which oral barbiturates provide a safety or efficacy advantage over nonbarbiturate sedatives/hypnotics.f Short-term treatment of insomnia.c d However, generally not used orally as a hypnotic because several hours are required to achieve maximal effects a and barbiturates have decreased effectiveness for sleep induction and maintenance 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.a c

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 are initially terminated with other anticonvulsants (e.g., diazepam, phenytoin) or for termination of status epilepticus that does not respond to initial therapy with other anticonvulsants.b c Usefulness of parenteral phenobarbital in terminating acute seizure episodes is limited by its slow onset of action.a b d Prophylactic management of epilepsy.c d

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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.a b Following chronic administration, withdraw phenobarbital slowly to avoid the possibility of precipitating withdrawal symptoms if the patient is physically dependent on the drug.a d 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.a b c d Sub-Q injection not recommended.a d Oral Administration Frequently administered in 2 or 3 divided doses;a however, there is no advantage in dividing the daily dosage (because of the long half-life).a b 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.a b (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 Adm inistration

60 mg/minute.a b d 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.a c

Surgery
Oral

13 mg/kg preoperatively.a d
IM

16100 mg administered 6090 minutes before surgery;a alternatively, 13 mg/kg preoperatively.a d

Drug Withdraw al
Oral

Infants: 310 mg/kg daily.a After symptoms are relieved, decrease dosage gradually and withdraw drug completely over 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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Prevention of Febrile Seizures

Phenobarbital Sodium - Print Version

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
Hyperbilirubinem ia 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 <12 years of age: Dosages of 312 mg/kg daily in 2 or 3 divided doses have been used.a Adults
Insom nia and Anxiety
Anxiety

Oral 30120 mg daily.c

Insomnia

Oral 100320 mg.c IM 100320 mg.c d

Drug Withdraw al
Oral

30-mg dose for each 100- to 200-mg dose of the barbiturate or nonbarbiturate hypnotic that the patient has been taking daily, administered in 3 or 4 divided doses.a If the patient shows signs of withdrawal on the first day, a loading dose of 100200 mg of phenobarbital sodium may be administered IM in addition to the oral dose.a After stabilization on phenobarbital sodium, decrease the total daily dose of phenobarbital sodium by 30 mg per day.a
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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.a d

Seizure Disorders
Oral

100300 mg daily,b c 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.a b 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;c d e avoid use in patients with marked hepatic impairment.c d Renal Impairment Dosage reduction recommended.d e Geriatric Patients Dosage reduction recommended.d e f

Cautions for Phenobarbital Sodium

Contraindications
Known hypersensitivity to any barbiturates.c d Respiratory disease in which dyspnea or obstruction is evident.c d
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Marked impairment of hepatic function.c d History of manifest or latent porphyriac d (due to potential for exacerbation of acute intermittent porphyria or porphyria variegata).f Previous addiction to sedative and/or hypnotic drugs.c d

Warnings/Precautions
Warnings
Pain Reaction

Potential for paradoxical excitement and/or euphoria, restlessness, or delirium in patients with severe pain.f Barbiturates could mask important symptoms in patients with acute or chronic pain.d f Use with caution in such patients.d f Should not be used to relieve pain or to produce sedation or sleep in the presence of uncontrolled pain.c f
Abuse Potential

Possible tolerance, psychologic dependence, and physical dependence.c d (See Contraindications under Cautions.)
WIthdraw al Effects

Abrupt cessation after prolonged use in dependent individuals may result in withdrawal symptoms (e.g., delirium, convulsions) and potentially be fatal.c d 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.c d Concurrent use of other CNS depressants may potentiate CNS depression.c d (See Specific Drugs under Interactions.)
Respiratory and Cardiovascular Effects

Possible respiratory depression, apnea, laryngospasm, hypertension, or vasodilation and hypotension, particularly if phenobarbital is administered IV too rapidly.d f Administer slowly; personnel and equipment should be readily available for administration of artificial respiration.d f Sensitivity Reactions
Derm atologic Effects and Hypersensitivity Reactions

Exfolative dermatitis (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes fatal, reported rarely.b c d Because skin eruptions can precede potentially fatal reactions, discontinue phenobarbital whenever dermatologic reactions occur.d f 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.b d Appropriate therapy for such inadvertent injection has not been fully established; consult manufacturers labeling for current recommendations.b d
Suicide

Use with caution, if at all, in depressed patients; potential for suicidal tendencies.c d f Prescribe drug in the smallest feasible quantity.c
Concom itant Diseases

Use parenterally with extreme caution in debilitated patients or patients with severe hepatic impairment, pulmonary or cardiac disease, status asthmaticus, uremia, or shock.d f 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.f i 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.c d

Pediatric Use

May produce paradoxical excitement and hyperactivity or exacerbate existing hyperactivity; if severe, substitute another 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.d i If such changes occur and alternative causes are not 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 AAP states 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.c f
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Hepatic Im pairm ent

Use with caution; should not be used in patients with marked hepatic impairment.c d (See Contraindications under Cautions.)
Renal Im pairm ent

Use with extreme caution in patients with nephritis.b d Use parenterally with extreme caution in patients with uremia.d f

Common Adverse Effects

Residual sedation, drowsiness, lethargy, vertigo, nausea, vomiting, headache.c d f

Interactions for Phenobarbital Sodium

Metabolized by hepatic microsomal enzymes.d Induces hepatic microsomal enzymes.c d

Specific Drugs
Drug Anticoagulants, oral (e.g., warfarin) Interaction Possible decreased plasma warfarin concentrations c d Antidepressant may precipitate seizures, resulting in decreased seizure controli Potentiation of respiratory depression following toxic doses of tricyclic antidepressants i Comments Monitor PT; adjust anticoagulant dosage as necessary, especially with initiation or discontinuance of phenobarbitalc f

Antidepressants, tricyclics

Monitor epileptic patients for decreased seizure control following initiation of antidepressant therapy; adjust phenobarbital dosage, if necessary i

CNS depressants (e.g., sedatives, hynotics, Possible additive depressant effects c d antihistamines, tranquilizers, alcohol) Possible enhanced metabolism of estrogenic and progestinic components; potential for decreased oral contraceptive effectiveness and increased risk of pregnancy with phenobarbital pretreatment or concurrent therapy d

Contraceptives, oral

Consider alternate methods of contraceptiond

Corticosteroids

Possible increased corticosteroid metabolismd

Dosage adjustment of corticosteriod may be required;d closely monitor asthmatics receiving corticosteroids when phenobarbital is initiatedi If possible, avoid concomitant administration;f if administered concomitantly, monitor clinical response to doxycyclined
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Doxycycline

Possible decreased half-life of doxycycline; effect may persist up to 2 weeks after discontinuance of phenobarbitald

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Griseofulvin

Possible decreased griseofulvin absorption, resulting in decreased blood concentrations d

Avoid concomitant administration;d if concomitant therapy is necessary, administration of griseofulvin in 3 divided daily doses may improve absorption.f Monitor blood griseofulvin concentrations and increase dosage, if necessary f Dosage adjustment of phenobarbital may be requiredf Monitor plasma concentrations of phentoin and phenobarbital; adjust dosages as necessary d i Monitor plasma phenobarbital concentrations and adjust dosage as neededd

MAO inhibitors

Possible prolongation of phenobarbital effects d Increased, decreased, or no change in plasma phenytoin concentrations reportedd i Possible increased plasma phenobarbital concentrations d

Phenytoin

Valproic acid

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 after administration.b d Onset is slower following IM administration.b d Duration About 56 hours c or 46 hours d 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 tissues 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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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 Com patibilityHID

Compatible Dextran 6% in dextrose 5%

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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 Com patibility

Admixture CompatibilityHID Compatible Amikacin sulfate Aminophylline Calcium chloride Calcium gluconate Colistimethate sodium Dimenhydrinate
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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 citrate 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 principal inhibitory neurotransmitter in the CNS,104 105 106 107 108 by altering inhibitory synaptic transmissions that are mediated by GABAA receptors.105 106 108 Capable of producing all levels of CNS depressionfrom mild sedation to hypnosis to deep coma to death.c d Anticonvulsant effects of barbiturates are multiple and rather nonselective.i Principal mechanism of action appears to 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 nonhemolytic unconjugated hyperbilirubinemia, presumably by induction of glucuronyl transferase, the enzyme that conjugates 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.c d Importance of taking exactly as prescribed; do not exceed the recommended dosage.c d Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and alcohol consumption.c d Importance of avoiding alcohol while taking the drug.c d
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Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.c d Importance of advising patients of other important precautionary information.c d (See Cautions.)

Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult 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 Tablets 20 mg/5 mL C-IV* 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 Routes Dosage Forms Strengths Brand Names 30 mg/mL* 60 mg/mL* 65 mg/mL* 130 mg/mL* Manufacturer

Parenteral Injection

Phenobarbital Sodium Injection (C-IV; with alcohol 10% and propylene Wyeth glycol 75%) Phenobarbital Sodium Injection (C-IV; with alcohol 10% and propylene Wyeth glycol 75%) Phenobarbital Sodium Injection (C-IV; with alcohol 10% benzyl alcohol 1.5% and propylene glycol 67.8%) Baxter

Luminal Sodium (C-IV; with alcohol 10% and propylene glycol 67.8%) Sanofi-Aventis Phenobarbital Sodium Injection (C-IV; with alcohol 10% and propylene Wyeth

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glycol 75%) Phenobarbital Sodium Injection (C-IV; with alcohol 10% benzyl alcohol 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 medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use. The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was 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 implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side 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-System Pharmacists, 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). In: Physicians 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 Medical Pharmacology. 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 and Gilmans 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 clinical use 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 ED, eds. 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-System Pharmacists; 2004:2370-1. b. AHFS Drug Information 2004. McEvoy GK, ed. Phenobarbital. Bethesda, MD: American Society of Health-System Pharmacists; 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 of Health-System Pharmacists; 2004:2363-6. HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:1331-5. h. American Academy of Pediatrics Committee on Fetus and Newborn and Committee on Drugs. Benzyl alcohol: toxic agent in neonatal units. Pediatrics. 1983; 72:356 8. i. AHFS Drug Information 2004. McEvoy GK, ed. Anticonvulsants general statement . Bethesda, MD: American Society of Health-System Pharmacists; 2004:2102-7.

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