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Phenobarbital (Phenobarbital) - Indications and Dosage

 
 



INDICATIONS AND USAGE

A. Sedative

B. Anticonvulsant

For the treatment of generalized and partial seizures.

DOSAGE AND ADMINISTRATION

The dose of Phenobarbital must be individualized with full knowledge of it particular characteristics. Factors of consideration are the patients age, weight, and condition.

Sedation

For sedation, the drug may be administered in single doses 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 pediatric patients and infants, Phenobarbital at a loading dose to 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/kg/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 Oral Solution 20 mg/5 mL is supplied in 1 Pint (473mL) bottles NDC# 16571-330-16.

Contains alcohol, 13.5%

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

Keep tightly closed. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Distributed by:
PACK PHARMACEUTICALS, LLC
Buffalo Grove, IL 60089

Manufactured by:
Bio-Pharm, Inc.
Levittown, PA 19057

REV 04/2011

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