Phenobarbital
Generic Name: phenobarbital
Brand Names:
Phenobarbital
DESCRIPTION The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline hydroxides and carbonates; sparingly soluble in chloroform.
Overview
DESCRIPTION The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative-hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act. Phenobarbital is a barbituric acid derivative and occurs as white, odorless, small crystals or crystalline hydroxides and carbonates; sparingly soluble in chloroform.
Uses
INDICATIONS AND USAGE Sedative Anticonvulsant – For the treatment of generalized and partial seizures.
Dosage
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.
Side Effects
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. Irritability and hyperactivity can occur in children. Like other nonanalgesic 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 diffuse myalgic, neuralgic, or arthritic pain, especially in psychoneurotic patients with insomnia.
Interactions
Drug Interactions Most reports of clinically significant drug interactions occurring with the barbiturates have involved phenobarbital. However, the application of these data to other barbiturates appears valid and warrants serial blood level determinations of the relevant drugs when there are multiple therapies. Anticoagulants . Phenobarbital lowers the plasma levels of dicumarol and causes a decrease in anticoagulant activity as measured by the prothrombin time. Barbiturates can induce hepatic microsomal enzymes resulting in increased metabolism and decreased anticoagulant response of oral anticoagulants (e.g., acenocoumarol, warfarin, dicumarol, and phenprocoumon).
Warnings
WARNINGS Habit Forming. Phenobarbital may be habit forming. Tolerance and psychological and physical dependence may occur with continued use (see DRUG ABUSE AND DEPENDENCE and Pharmacokinetics under CLINICAL PHARMACOLOGY ). Patients who have psychologic dependence on barbiturates may increase the dosage or decrease the dosage interval without consulting a physician and may subsequently develop a physical dependence on barbiturates. In order to minimize the possibility of overdosage or the development of dependence, the prescribing and dispensing of sedative-hypnotic barbiturates should be limited to the amount required for the interval until the next appointment. CONTRAINDICATIONS Phenobarbital is contraindicated in patients who are hypersensitive to barbiturates, in patients with a history of manifest or latent porphyria, and in patients with marked impairment of liver function or respiratory disease in which dyspnea or obstruction is evident.
Pregnancy
Usage in Pregnancy Teratogenic Effects. Pregnancy Category D – See Usage in Pregnancy under WARNINGS . Nonteratogenic Effects . Reports of infants suffering from long-term barbiturate exposure in utero included the acute withdrawal syndrome of seizures and hyperirritability from birth to a delayed onset of up to 14 days (see DRUG ABUSE AND DEPENDENCE ).
Storage
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light resistant container as defined in the USP using a child-resistant closure.
Frequently Asked Questions
What is Phenobarbital used for?▼
INDICATIONS AND USAGE Sedative Anticonvulsant – For the treatment of generalized and partial seizures.
What are the side effects of Phenobarbital?▼
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. Irritability and hyperactivity can occur in children. Like other nonanalgesic 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 diffuse myalgic, neuralgic, or arthritic pain, especially in psychoneurotic patients with insomnia.
Can I take Phenobarbital during pregnancy?▼
Usage in Pregnancy Teratogenic Effects. Pregnancy Category D – See Usage in Pregnancy under WARNINGS . Nonteratogenic Effects . Reports of infants suffering from long-term barbiturate exposure in utero included the acute withdrawal syndrome of seizures and hyperirritability from birth to a delayed onset of up to 14 days (see DRUG ABUSE AND DEPENDENCE ).
What are the important warnings for Phenobarbital?▼
WARNINGS Habit Forming. Phenobarbital may be habit forming. Tolerance and psychological and physical dependence may occur with continued use (see DRUG ABUSE AND DEPENDENCE and Pharmacokinetics under CLINICAL PHARMACOLOGY ). Patients who have psychologic dependence on barbiturates may increase the dosage or decrease the dosage interval without consulting a physician and may subsequently develop a physical dependence on barbiturates. In order to minimize the possibility of overdosage or the development of dependence, the prescribing and dispensing of sedative-hypnotic barbiturates should be limited to the amount required for the interval until the next appointment. CONTRAINDICATIONS Phenobarbital is contraindicated in patients who are hypersensitive to barbiturates, in patients with a history of manifest or latent porphyria, and in patients with marked impairment of liver function or respiratory disease in which dyspnea or obstruction is evident.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.