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 -- 16.2 mg Tablet Bottle Label
(click image for full-size original)

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 -- 32.4 mg Tablet Bottle Label
(click image for full-size original)

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 -- 64.8 mg Tablet Bottle Label
(click image for full-size original)

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

Principal Display Panel -- 97.2 mg Tablet Bottle Label
(click image for full-size original)
PHENOBARBITAL phenobarbital tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-625
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 16.2 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code 625;ECI
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-625-01 100 TABLET in 1 BOTTLE None
2 NDC:69367-625-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/08/2023
PHENOBARBITAL phenobarbital tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-626
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 32.4 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 6mm
Flavor Imprint Code 626;ECI
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-626-01 100 TABLET in 1 BOTTLE None
2 NDC:69367-626-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/08/2023
PHENOBARBITAL phenobarbital tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-627
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 64.8 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 627;ECI
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-627-01 100 TABLET in 1 BOTTLE None
2 NDC:69367-627-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/08/2023
PHENOBARBITAL phenobarbital tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-628
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENOBARBITAL (PHENOBARBITAL) PHENOBARBITAL 97.2 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code 628;ECI
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-628-01 100 TABLET in 1 BOTTLE None
2 NDC:69367-628-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/08/2023
Labeler — Westminster Pharmaceuticals, LLC (079516651)

Revised: 09/2023 Westminster Pharmaceuticals, LLC

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