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Phenobarbital

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Phenobarbital

INDICATIONS

Oral

a. Sedatives.

b. Hypnotics, for the short-term treatment of insomnia, since they appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks. (See CLINICAL PHARMACOLOGY .)

c. Preanesthetics.

d. Long-term anticonvulsants for the treatment of generalized tonic-clonic and cortical local seizures. And, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics.

DOSAGE AND ADMINISTRATION

Suggested doses of phenobarbital for specific indications are as follows:

a. Pediatric Oral Dosage (as recommended by the American Academy of Pediatrics):

b. Adult Oral Dosage:

1. Daytime sedative: 30 to 120 mg daily in 2 to 3 divided doses.
2. Bedtime hypnotic: 100 to 320 mg.
3. Anticonvulsant: 50 to 100 mg 2 to 3 times daily.

Dosages of phenobarbital must be individualized with full knowledge of their particular characteristics and recommended rate of administration. Factors of consideration are the patient's age, weight, and condition. Parenteral routes should be used only when oral administration is impossible or impractical.

Anticonvulsant use: A therapeutic anticonvulsant level of phenobarbital in serum is 10 to 25 µg/mL. To achieve the blood levels considered therapeutic in children, higher per-kilogram dosages are generally necessary for phenobarbital and most other anticonvulsants. In children and infants, phenobarbital at loading dose of 15 to 20 mg/kg produces blood levels of about 20 µg/mL shortly after administration.

In status epilepticus, it is imperative to achieve therapeutic blood levels of phenobarbital as rapidly as possible. Because a barbiturate-induced depression may occur along with a postictal depression once the seizures are controlled, it is important, therefore, to use the minimal amount required, and to wait for the anticonvulsant effect to develop before administering a second dose.

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.

Special patient population: Dosage should be reduced in the elderly or debilitated because these patients may be more sensitive to phenobarbital. Dosage should be reduced for patients with impaired renal function or hepatic disease.

HOW SUPPLIED

Oral Tablets

15 mg - Each white round tablet imprinted Þ 026 contains 15 mg of Phenobarbital. Tablets are supplied in bottles of 1000 (NDC 0228-2026-96).

30 mg - Each white, round, scored tablet imprinted Þ 028 contains 30 mg of Phenobarbital. Tablets are supplied in bottles of 1000 (NDC 0228-2028-96).

100 mg - Each white, round, scored tablet imprinted Þ 030 contains 100 mg of Phenobarbital. Tablets are supplied in bottles of 1000 (NDC 0228-2030-96).

Dispense in well-closed containers as defined in the USP. Store at controlled room temperature 15º- 30º C (59º- 86º F).

Oral Elixir

Red, clear elixir contains 20 mg of Phenobarbital per teaspoon (5 ml). Alcohol 13% by volume. Elixir is supplied in pints (NDC 0228-2024-16).

Preserve and dispense in tight, light- resistant containers as defined in the USP. Store at controlled room temperature 15º- 30ºC (59º- 86º F).

Rx only.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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