Phenobarbital (Page 4 of 4)
Treatment
To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians’ Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.
Protect the patient’s airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient’s vital signs, blood gases, serum electrolytes, etc. Absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient’s airway when employing gastric emptying or charcoal.
Alkalinization of urine hastens phenobarbital excretion, but dialysis and hemoperfusion are more effective and cause less troublesome alterations in electrolyte equilibrium. If the patient has chronically abused sedatives, withdrawal reactions may be manifest following acute overdose.
DOSAGE AND ADMINISTRATION
The dose of phenobarbital must be individualized with full knowledge of its particular characteristics.
Factors of consideration are the patient’s age, weight, and condition.
Sedation
For sedation, the drug may be administered in single dose of 30 to 120 mg repeated at intervals: frequency will be determined by the patient’s response. It is generally considered that no more than 400 mg of phenobarbital should be administered during a 24-hour period.
Adults
Daytime Sedation: 30 to 120 mg daily in 2 to 3 divided doses.
Oral Hypnotic: 100 to 200 mg.
Anticonvulsant Use
Clinical laboratory reference values should be used to determine the therapeutic anticonvulsant level of phenobarbital in the serum. To achieve the blood levels considered therapeutic in pediatric patients, higher per-kilogram dosages are generally necessary for phenobarbital and most other anticonvulsants. In children and infants, phenobarbital at a loading dose of 15 to 20 mg/kg produces blood levels of about 20 mcg/mL shortly after administration.
Phenobarbital has been used in the treatment and prophylaxis of febrile seizures. However, it has not been established that prevention of febrile seizures influences the subsequent development of epilepsy.
Adults: 60 to 200 mg/day.
Pediatric Patients: 3 to 6 mg/kg/day.
Special Patient Population
Dosage should be reduced in the elderly or debilitated because these patients may be more sensitive to barbiturates. Dosage should be reduced for patients with impaired renal function or hepatic disease.
HOW SUPPLIED
Phenobarbital Tablets, USP 16.2 mg (1/4 grain) are white, round, biconvex, scored tablets, debossed “625” below the score on one side and “ECI” on the reverse side, supplied in bottles of 100 and 1000.
100 Tablets NDC 69367-625-01.
1000 Tablets NDC 69367-625-10.
Phenobarbital Tablets, USP 32.4 mg (1/2 grain) are white, round, biconvex, scored tablets, debossed “626” below the score on one side and “ECI” on the reverse side, supplied in bottles of 100 and 1000.
100 Tablets NDC 69367-626-01.
1000 Tablets NDC 69367-626-10.
Phenobarbital Tablets, USP 64.8 mg (1 grain) are white, round, flat face, bevel edge, scored tablets debossed “627” below the score on one side and “ECI” on the reverse side, supplied in bottles of 100 and 1000.
100 Tablets NDC 69367-627-01.
1000 Tablets NDC 69367-627-10.
Phenobarbital Tablets, USP 97.2 mg (1 1/2 grain) are white, round, flat face, bevel edge, scored tablets debossed “628” below the score on one side and “ECI” on the reverse side, supplied in bottles of 100 and 1000.
100 Tablets NDC 69367-628-01.
1000 Tablets NDC 69367-628-10.
Manufactured for:
Westminster Pharmaceuticals, LLC.
Nashville, TN 37217
Rev. 08/2023
500432-1
PRINCIPAL DISPLAY PANEL — 16.2 mg Tablet Bottle Label
NDC 69367-625-01
Rx Only
PHENOBARBITAL*
TABLETS, USP
CIV
16.2 mg (1/4 grain)
*WARNING: May be habit forming.
100 Tablets
WestminsterPharmaceuticals
PRINCIPAL DISPLAY PANEL — 32.4 mg Tablet Bottle Label
NDC 69367-626-01
Rx Only
PHENOBARBITAL*
TABLETS, USP
CIV
32.4 mg (1/2 grain)
*WARNING: May be habit forming.
100 Tablets
WestminsterPharmaceuticals
PRINCIPAL DISPLAY PANEL — 64.8 mg Tablet Bottle Label
NDC 69367-627-01
Rx Only
PHENOBARBITAL*
TABLETS, USP
CIV
64.8 mg (1 grain)
*WARNING: May be habit forming.
100 Tablets
WestminsterPharmaceuticals
PRINCIPAL DISPLAY PANEL — 97.2 mg Tablet Bottle Label
NDC 69367-628-01
Rx Only
PHENOBARBITAL*
TABLETS, USP
CIV
97.2 mg (1 1/2 grain)
*WARNING: May be habit forming.
100 Tablets
WestminsterPharmaceuticals
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Labeler — Westminster Pharmaceuticals, LLC (079516651) |
Revised: 09/2023 Westminster Pharmaceuticals, LLC
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