Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Phenobarbital T ab l e t s , USP 15 mg: White to off-white round, biconvex tablets debossed “T35” on one side and plain on the other side. Available in bottles of 100 tablets, NDC 70752-165-10; 500 tablets, 70752-165-14; and 1000 tablets, NDC 70752-165-11. Phenobarbital T ab l e t s , USP 30 mg: White to off-white round, biconvex tablets debossed “T” above and “36” below the bisect on one side and plain on the other side. Available in bottles of 100 tablets, NDC 70752-166-10; 500 tablets, NDC 70752-166-14; and 1000 tablets, NDC 70752-166-11. Phenobarbital T ab l e t s , USP 60 mg: White to off-white round, biconvex tablets debossed “T” above and “37” below the bisect on one side and plain on the other side. Available in bottles of 100 tablets, NDC 70752-167-10; 500 tablets, NDC 70752-167-14; and 1000 tablets, NDC 70752-167-11. Phenobarbital T ab l e t s , USP 100 mg: White to off-white round, biconvex tablets debossed “T” above and “38” below the bisect on one side and plain on the other side. Available in bottles of 100 tablets, NDC 70752-168-10; 500 tablets, NDC 70752-168-14; and 1000 tablets, NDC 70752-168-11.; PRINCIPAL DISPLAY PANEL NDC 70752- 165 -10 Phenobarbital Tablets, USP CIV 15 mg Rx Only 100 Tablets NDC 70752- 165 -14 Phenobarbital Tablets, USP CIV 15 mg Rx Only 500 Tablets NDC 70752- 165 -11 Phenobarbital Tablets, USP CIV 15 mg Rx Only 1000 Tablets NDC 70752 -166- 10 Phenobarbital Tablets, USP CIV 30 mg Rx Only 100 Tablets NDC 70752- 166 -14 Phenobarbital Tablets, USP CIV 30 mg Rx Only 500 Tablets NDC 70752 -166- 11 Phenobarbital Tablets, USP CIV 30 mg Rx Only 1000 Tablets NDC 70752 -167- 10 Phenobarbital Tablets, USP CIV 60 mg Rx Only 100 Tablets NDC 70752 -167 -14 Phenobarbital Tablets, USP CIV 60 mg Rx Only 500 Tablets NDC 70752- 167 -11 Phenobarbital Tablets, USP CIV 60 mg Rx Only 1000 Tablets NDC 70752- 168 -10 Phenobarbital Tablets, USP CIV 100 mg Rx Only 100 Tablets NDC 70752- 168 -14 Phenobarbital Tablets, USP CIV 100 mg Rx Only 500 Tablets NDC 70752- 168 -11 Phenobarbital Tablets, USP CIV 100 mg Rx Only 1000 Tablets containerlabel15mg100cc containerlabel15mg500cc containerlabel15mg1000cc containerlabel30mg100cc containerlabel30mg500cc containerlabel30mg1000cc containerlabel60mg100cc containerlabel60mg500cc containerlabel60mg1000cc containerlabel100mg100cc containerlabel100mg500cc containerlabel100mg1000cc
- HOW SUPPLIED Phenobarbital T ab l e t s , USP 15 mg: White to off-white round, biconvex tablets debossed “T35” on one side and plain on the other side. Available in bottles of 100 tablets, NDC 70752-165-10; 500 tablets, 70752-165-14; and 1000 tablets, NDC 70752-165-11. Phenobarbital T ab l e t s , USP 30 mg: White to off-white round, biconvex tablets debossed “T” above and “36” below the bisect on one side and plain on the other side. Available in bottles of 100 tablets, NDC 70752-166-10; 500 tablets, NDC 70752-166-14; and 1000 tablets, NDC 70752-166-11. Phenobarbital T ab l e t s , USP 60 mg: White to off-white round, biconvex tablets debossed “T” above and “37” below the bisect on one side and plain on the other side. Available in bottles of 100 tablets, NDC 70752-167-10; 500 tablets, NDC 70752-167-14; and 1000 tablets, NDC 70752-167-11. Phenobarbital T ab l e t s , USP 100 mg: White to off-white round, biconvex tablets debossed “T” above and “38” below the bisect on one side and plain on the other side. Available in bottles of 100 tablets, NDC 70752-168-10; 500 tablets, NDC 70752-168-14; and 1000 tablets, NDC 70752-168-11.
- PRINCIPAL DISPLAY PANEL NDC 70752- 165 -10 Phenobarbital Tablets, USP CIV 15 mg Rx Only 100 Tablets NDC 70752- 165 -14 Phenobarbital Tablets, USP CIV 15 mg Rx Only 500 Tablets NDC 70752- 165 -11 Phenobarbital Tablets, USP CIV 15 mg Rx Only 1000 Tablets NDC 70752 -166- 10 Phenobarbital Tablets, USP CIV 30 mg Rx Only 100 Tablets NDC 70752- 166 -14 Phenobarbital Tablets, USP CIV 30 mg Rx Only 500 Tablets NDC 70752 -166- 11 Phenobarbital Tablets, USP CIV 30 mg Rx Only 1000 Tablets NDC 70752 -167- 10 Phenobarbital Tablets, USP CIV 60 mg Rx Only 100 Tablets NDC 70752 -167 -14 Phenobarbital Tablets, USP CIV 60 mg Rx Only 500 Tablets NDC 70752- 167 -11 Phenobarbital Tablets, USP CIV 60 mg Rx Only 1000 Tablets NDC 70752- 168 -10 Phenobarbital Tablets, USP CIV 100 mg Rx Only 100 Tablets NDC 70752- 168 -14 Phenobarbital Tablets, USP CIV 100 mg Rx Only 500 Tablets NDC 70752- 168 -11 Phenobarbital Tablets, USP CIV 100 mg Rx Only 1000 Tablets containerlabel15mg100cc containerlabel15mg500cc containerlabel15mg1000cc containerlabel30mg100cc containerlabel30mg500cc containerlabel30mg1000cc containerlabel60mg100cc containerlabel60mg500cc containerlabel60mg1000cc containerlabel100mg100cc containerlabel100mg500cc containerlabel100mg1000cc
Overview
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, 30 mg, 60 mg or 100 mg of phenobarbital, USP. Inactive ingredients include: colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, sodium starch glycolate and magnesium stearate. image description
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
WARNING: MAY BE HABIT-FORMING 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 non-analgesic 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 Rising Pharma Holdings, Inc. at 1-844-874-7464, 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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