Label: PHENOBARBITAL- phenobarbital tablet 

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: CIV
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 04/11

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  • SPL UNCLASSIFIED SECTION

    PHENOBARBITAL TABLETS, USP
        Rev. 04/04   CIV
             Rx only

    DESCRIPTION:
    Phenobarbital is a barbituric acid derivative for oral administration and occurs as a white, odorless, slightly bitter powder that is soluble in chloroform, freely soluble in alcohol or ether, and slightly soluble in water. Its saturated solution has a pH of about 5.6. Chemically, it is 5-ethyl-5-phenylbarbituric acid with the molecular formula C12H12N2O3 (232.24). The structural formula is as follows:

    Phenobarbital structural formula

    Each phenobarbital tablet contains 15 mg, 30 mg, 60 mg or 100 mg of phenobarbital. Inactive ingredients are as follows:
    15 mg, 30 and 60 mg: Calcium Stearate, Colloidal Silicon Dioxide, Corn Starch, and Microcrystalline Cellulose.
    100 mg: Anhydrous Lactose, Colloidal Silicon Dioxide, Corn Starch, Docusate Sodium, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, and Sodium Starch Glycolate.

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  • CLINICAL PHARMACOLOGY:

    Phenobarbital, a long-acting barbiturate, is a central nervous system depressant. In ordinary doses, the drug acts as a sedative and anticonvulsant. Its onset of action occurs within 30 minutes, and the duration of action ranges from 5 to 6 hours. It is detoxified in the liver.

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  • INDICATION AND USAGE:

    Phenobarbital is indicated for use as a sedative or anticonvulsant.

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  • CONTRAINDICATIONS:

    Phenobarbital is contraindicated in patients who are hypersensitive to barbiturates. In such patients, severe hepatic damage can occur from ordinary doses and is usually associated with dermatitis and involvement of parenchymatous organs. A personal or familial history of acute intermittent porphyria represents one of the few absolute contraindications to the use of barbiturates. Phenobarbital is also contraindicated in patients with marked impairment of liver function, or respiratory disease in which dyspnea or obstruction is evident. It should not be administered to persons with known previous addiction to the sedative/hypnotic group, since ordinary doses may be ineffectual and may contribute to further addiction.

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  • WARNINGS:

    In small doses, the barbiturates may increase the reaction to painful stimuli. Taken by themselves, the barbiturates cannot be relied upon to relieve pain or even to produce sedation or sleep in the presence of severe pain.

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  • PRECAUTIONS:

    General Precautions

    Barbiturates induce liver microsomal enzyme activity. This accelerates the biotransformation of various drugs and is probably part of the mechanism of the tolerance encountered with barbiturates. Phenobarbital, therefore, should be used with caution in patients with decreased liver function. This drug should also be administered cautiously to patients with a history of drug dependence or abuse (see DRUG ABUSE AND DEPENDENCE).

    Phenobarbital may decrease the potency of coumarin anticoagulants; therefore, patients receiving such concomitant therapy should have more frequent prothrombin determinations. As with other sedatives and hypnotics, elderly or debilitated patients may react to barbiturates with marked excitement, depression, or confusion.

    The systemic effects of exogenous hydrocortisone and endogenous hydrocortisone (cortisol) may be diminished by phenobarbital. Thus, this product should be administered with caution to patients with borderline hypoadrenal function, regardless of whether it is of pituitary or of primary adrenal origin.

    Information for Patients: 

    Phenobarbital may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. The patient should be cautioned accordingly.

    Drug Interactions:

    Phenobarbital in combination with alcohol, tranquilizers, and other central nervous system depressants has additive depressant effects, and the patients should be so advised. Patients taking this drug should be warned not to exceed the dosage recommended by their physician. Toxic effects and fatalities have occurred following overdoses of phenobarbital alone and in combination with other central nervous system depressants. Caution should be exercised in prescribing unnecessarily large amounts of phenobarbital for patients who have a history of emotional disturbances or suicidal ideation or who have misused alcohol and other CNS drugs (see OVERDOSAGE).

    Usage in Pregnancy:

    Pregnancy Category B – Reproduction studies have been performed in animals and have revealed no evidence of impaired fertility or harm to the fetus due to phenobarbital. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

    Nursing Mothers:

    Caution should be exercised when phenobarbital is administered to a nursing woman.

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  • ADVERSE REACTIONS:

    The following adverse reactions have been reported:

    CNS Depression:

    Residual sedation or “hangover”, drowsiness, lethargy, and vertigo. Emotional disturbances and phobias may be accentuated. In some persons, barbiturates such as phenobarbital repeatedly produce excitement rather than depression, and the patient may appear to be inebriated. Like other nonanalgesic hypnotic drugs, barbiturates, such as phenobarbital, when given in the presence of pain, may cause restlessness, excitement, and even delirium. Rarely, the use of barbiturates results in localized or diffused myalgic, neuralgic, or arthritic pain, especially in psychoneurotic patients with insomnia. The pain may appear in paroxysms, is most intense in the early morning hours, and is mot frequently located in the region of the neck, should girdle, and upper limbs. Symptoms may last for days after the drug is discontinued.

    Respiratory/Circulatory:

    Respiratory depression, apnea, circulatory collapse.

    Allergic:

    Acquired hypersensitivity to barbiturates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angioedema, and similar conditions. Hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematous dermatitis. Rarely, exfoliative dermatitis (e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis) may be caused by phenobarbital and can prove fatal. The skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs. In a few cases, megaloblastic anemia has been associated with the chronic use of phenobarbital.

    Other:

    Nausea and vomiting; headache.

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  • DRUG ABUSE AND DEPENDENCE:

    Controlled Substance – Phenobarbital is a Schedule IV drug.

    Dependence:

    Prolonged, uninterrupted use of barbiturates (particularly the short-acting drugs), even in therapeutic doses, may result in psychic and physical dependence. Withdrawal symptoms due to physical dependence following chronic use of large doses of barbiturates may include delirium, convulsions, and death.

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  • OVERDOSAGE:

    The signs and symptoms of barbiturate poisoning are referable especially to the central nervous system and the cardiovascular system. Moderate intoxication resembles alcoholic inebriation. In severe intoxication, the patient is comatose, the level of reflex activity conforming in a general way to the intensity of the central depression. The deep reflexes may persist for some time despite coexistent coma. The Babinski sign is often positive. The EEG may be of the “burst-suppression” type, with brief periods of electrical silence. The pupils may be constricted and react to light, but late in the courage of barbiturate poisoning they may show hypoxic paralytic dilatation. Respiration is affected early. Breathing may be either slow or rapid and shallow; Cheyne-Stokes rhythm may be present. Respiratory minute volume is diminished, and hypoxia and respiratory acidosis may develop. The blood pressure falls, owing partly to depression of medullary vasomotor centers; partly to a direct action of the drug on the myocardium, sympathetic ganglia, and vascular smooth muscle; partly to hypoxia.

    The patient thus develops a typical shock syndrome, with a weak and rapid pulse, cold and clammy skin, and a rise in the hematocrit. Respiratory complications (atelectasis, pulmonary edema, and bronchopneumonia) and renal failure are much dreaded and not infrequent concomitant of severe barbiturate poisoning. There is usually hypothermia, sometimes with temperatures as low as 32°C.

    Treatment:

    General management should consist of symptomatic and supportive therapy, including gastric lavage, administration of intravenous fluids, and maintenance of blood pressure, body temperature and adequate respiratory exchange. Dialysis will increase the rate of removal of barbiturates from the body fluids. Antibiotics may be required to control pulmonary complications.

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  • DOSAGE AND ADMINISTRATION:

    Oral Sedative Dose, Adults – 30 to 120 mg daily in 2 or 3 divided doses. Children – 6 mg/kg of body weight daily in 3 divided doses.

    Oral Hypnotic Dose, Adults – 100 to 320 mg.

    Oral Anticonvulsant Dose, Adults – 50 to 100 mg 2 or 3 times daily.

    Children – 15 to 50 mg 2 or 3 times daily.

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  • HOW SUPPLIED:

    Phenobarbital Tablets USP 15 mg: White, round, unscored, compressed tablet imprinted “West-ward 445”.

          Bottles of 1000 tablets.

    Phenobarbital Tablets USP 30 mg: White, round, scored, compressed tablet imprinted “West-ward 450”.

          Bottles of 1000 tablets.
          Bottles of 5000 tablets.

    Phenobarbital Tablets USP 60 mg: White, round, unscored, compressed tablet imprinted “WW-455”.

          Bottles of 100 tablets.
          Bottles of 1000 tablets.

    Phenobarbital Tablets USP 100 mg: White, round, scored, compressed tablet imprinted “WW-458”.

          Bottles of 100 tablets.
          Bottles of 1000 tablets.

    Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.

    Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

    West-ward Pharmaceutical Corp.
    Eatontown, NJ 07724

    Revised April 2004

    OR

    Hikma Pharmaceuticals

    P.O. Box 182400

    Amman 11118 - Jordan

    Revised April 2004

    Phenobarbital Tablets USP 15 mg, 30 mg and 60 mg are available from

    Cardinal Health in cards of 30 tablets.

    Cardinal Health

    Zanesville, OH 43701

    OIC8544H0409

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  • Principal Display Panel 1

    NDC 0143-1445-10 (West-ward)

    Phenobarbital

    Tablets USP

    15 mg

    QTY 30

    Phenobarbital 15 mg label front
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  • (Back label 15 mg)
  • Principal Display Panel 2

    NDC 0143-1455-10 (West-ward)

    Phenobarbital

    Tablets, USP

    60 mg

    QTY 30

    Phenobarbital 60 mg front label Hikma
    Close
  • back label 60 mg
  • Principal Display Panel 3

    NDC 0143-1455-10

    Phenobarbital

    Tablets, USP

    60 mg

    QTY 30

    Phenobarbital 60 mg front label Westward
    Close
  • (Back label 60 mg WW)
  • Principal Display Panel 4

    NDC 0143-1450-10 (West-ward)

    Phenobarbital

    Tablets, USP

    30 mg

    QTY 30

    Phenobarbital 30 mg front label Hikma
    Close
  • back label 30 mg
  • Phenobarbital 30 mg Westward

    NDC 0143-1450-10 (West-ward)

    Phenobarbital

    Tablets, USP

    30 mg

    QTY 30

    Phenobarbital 30 mg front label westward

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  • back label 30 mg WW
  • INGREDIENTS AND APPEARANCE
    PHENOBARBITAL 
    phenobarbital tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55154-7467(NDC:0143-1445)
    Route of Administration ORAL DEA Schedule CIV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM STEARATE  
    COLLOIDAL SILICON DIOXIDE  
    STARCH, CORN  
    CELLULOSE, MICROCRYSTALLINE  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55154-7467-3 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 01/01/2000
    PHENOBARBITAL 
    phenobarbital tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55154-7458(NDC:0143-1450)
    Route of Administration ORAL DEA Schedule CIV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 30 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM STEARATE  
    COLLOIDAL SILICON DIOXIDE  
    STARCH, CORN  
    CELLULOSE, MICROCRYSTALLINE  
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND Size 9mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55154-7458-3 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 01/01/2000
    PHENOBARBITAL 
    phenobarbital tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55154-7457(NDC:0143-1455)
    Route of Administration ORAL DEA Schedule CIV    
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 60 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM STEARATE  
    COLLOIDAL SILICON DIOXIDE  
    STARCH, CORN  
    CELLULOSE, MICROCRYSTALLINE  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 9mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55154-7457-3 30 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 01/01/2000
    Labeler - Cardinal Health (188557102)
    Establishment
    Name Address ID/FEI Business Operations
    Cardinal Health 188557102 REPACK
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