Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Phenobarbital Tablets, USP 15 mg: White, Round Tablet; Debossed WL on one side and 136 on the other side. Bottles of 90 tablets NDC 75826-136-90 Bottles of 100 tablets NDC 75826-136-10 Bottles of 500 tablets NDC 75826-136-50 Bottles of 1000 tablets NDC 75826-136-00 Phenobarbital Tablets, USP 16.2 mg (¼ grain): White, Round, Scored Tablet; Debossed WL on one side and 137 on the other side. Bottles of 90 tablets NDC 75826-137-90 Bottles of 100 tablets NDC 75826-137-10 Bottles of 500 tablets NDC 75826-137-50 Bottles of 1000 tablets NDC 75826-137-00 Phenobarbital Tablets, USP 30 mg: White, Round, Scored Tablet; Debossed WL on one side and 138 on the other side. Bottles of 90 tablets NDC 75826-138-90 Bottles of 100 tablets NDC 75826-138-10 Bottles of 500 tablets NDC 75826-138-50 Bottles of 1000 tablets NDC 75826-138-00 Phenobarbital Tablets, USP 32.4 mg (½ grain): White, Round, Scored Tablet; Debossed WL on one side and 139 on the other side. Bottles of 90 tablets NDC 75826-139-90 Bottles of 100 tablets NDC 75826-139-10 Bottles of 500 tablets NDC 75826-139-50 Bottles of 1000 tablets NDC 75826-139-00 Phenobarbital Tablets, USP 60 mg: White, Round Tablet; Debossed WL on one side and 140 on the other side. Bottles of 90 tablets NDC 75826-140-90 Bottles of 100 tablets NDC 75826-140-10 Bottles of 500 tablets NDC 75826-140-50 Bottles of 1000 tablets NDC 75826-140-00 Phenobarbital Tablets, USP 64.8 mg (1 grain): White, Round, Scored Tablet; Debossed WL on one side and 141 on the other side. Bottles of 90 tablets NDC 75826-141-90 Bottles of 100 tablets NDC 75826-141-10 Bottles of 500 tablets NDC 75826-141-50 Bottles of 1000 tablets NDC 75826-141-00 Phenobarbital Tablets, USP 97.2 mg (1½ grain): White, Round, Scored Tablet; Debossed WL on one side and 142 on the other side. Bottles of 90 tablets NDC 75826-142-90 Bottles of 100 tablets NDC 75826-142-10 Bottles of 500 tablets NDC 75826-142-50 Bottles of 1000 tablets NDC 75826-142-00 Phenobarbital Tablets, USP 100 mg: White, Round, Scored Tablet; Debossed WL on one side and 143 on the other side. Bottles of 90 tablets NDC 75826-143-90 Bottles of 100 tablets NDC 75826-143-10 Bottles of 500 tablets NDC 75826-143-50 Bottles of 1000 tablets NDC 75826-143-00 Store at 20° to 25°C (68° to 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.; label
- HOW SUPPLIED Phenobarbital Tablets, USP 15 mg: White, Round Tablet; Debossed WL on one side and 136 on the other side. Bottles of 90 tablets NDC 75826-136-90 Bottles of 100 tablets NDC 75826-136-10 Bottles of 500 tablets NDC 75826-136-50 Bottles of 1000 tablets NDC 75826-136-00 Phenobarbital Tablets, USP 16.2 mg (¼ grain): White, Round, Scored Tablet; Debossed WL on one side and 137 on the other side. Bottles of 90 tablets NDC 75826-137-90 Bottles of 100 tablets NDC 75826-137-10 Bottles of 500 tablets NDC 75826-137-50 Bottles of 1000 tablets NDC 75826-137-00 Phenobarbital Tablets, USP 30 mg: White, Round, Scored Tablet; Debossed WL on one side and 138 on the other side. Bottles of 90 tablets NDC 75826-138-90 Bottles of 100 tablets NDC 75826-138-10 Bottles of 500 tablets NDC 75826-138-50 Bottles of 1000 tablets NDC 75826-138-00 Phenobarbital Tablets, USP 32.4 mg (½ grain): White, Round, Scored Tablet; Debossed WL on one side and 139 on the other side. Bottles of 90 tablets NDC 75826-139-90 Bottles of 100 tablets NDC 75826-139-10 Bottles of 500 tablets NDC 75826-139-50 Bottles of 1000 tablets NDC 75826-139-00 Phenobarbital Tablets, USP 60 mg: White, Round Tablet; Debossed WL on one side and 140 on the other side. Bottles of 90 tablets NDC 75826-140-90 Bottles of 100 tablets NDC 75826-140-10 Bottles of 500 tablets NDC 75826-140-50 Bottles of 1000 tablets NDC 75826-140-00 Phenobarbital Tablets, USP 64.8 mg (1 grain): White, Round, Scored Tablet; Debossed WL on one side and 141 on the other side. Bottles of 90 tablets NDC 75826-141-90 Bottles of 100 tablets NDC 75826-141-10 Bottles of 500 tablets NDC 75826-141-50 Bottles of 1000 tablets NDC 75826-141-00 Phenobarbital Tablets, USP 97.2 mg (1½ grain): White, Round, Scored Tablet; Debossed WL on one side and 142 on the other side. Bottles of 90 tablets NDC 75826-142-90 Bottles of 100 tablets NDC 75826-142-10 Bottles of 500 tablets NDC 75826-142-50 Bottles of 1000 tablets NDC 75826-142-00 Phenobarbital Tablets, USP 100 mg: White, Round, Scored Tablet; Debossed WL on one side and 143 on the other side. Bottles of 90 tablets NDC 75826-143-90 Bottles of 100 tablets NDC 75826-143-10 Bottles of 500 tablets NDC 75826-143-50 Bottles of 1000 tablets NDC 75826-143-00 Store at 20° to 25°C (68° to 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.
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Overview
The barbiturates are nonselective central nervous system (CNS) depressants primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. 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 C 12 H 12 N 2 O 3 (232.24). The structural formula is as follows: Each Phenobarbital Tablet, USP contains 15 mg, 16.2 mg, 30 mg, 32.4 mg, 60 mg, 64.8 mg, 97.2 mg, or 100 mg of phenobarbital, USP. Inactive ingredients are as follows: Microcrystalline Cellulose; Lactose Monohydrate; Sodium Starch Glycolate, Type-A; Colloidal Silicon Dioxide; Magnesium Stearate
Indications & Usage
Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.
Dosage & 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.
Warnings & Precautions
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.
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.
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 most frequently located in the region of the neck, shoulder 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. To report SUSPECTED ADVERSE REACTIONS, contact Winder Laboratories, LLC at 1-770-307-0703, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
Phenobarbital in combination with alcohol, tranquilizers, and other central nervous system depressants has additive depressant effects, and the patient 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 ).
Storage & Handling
Store at 20° to 25°C (68° to 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.
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