Phenobarbital Oral

Generic Name: phenobarbital oral

Over-the-Counter (OTC)

Brand Names:

Phenobarbital Oral Solution

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.

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.

Uses

INDICATIONS USAGE A. Sedative B. Anticonvulsant - For the treatment of generalized and partial seizures.

Dosage

DOSAGE & 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 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 laboratories 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 the localized or diffuse myalgic, neuralgic, or arthritic pain, especially in psychoneurotic patients with insomnia.

Warnings

WARNINGS 1. 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.

Storage

NDC 54288-163-47: 16 fl oz (473 mL) bottle. Contains alcohol, 14.25% Dispense in a tight, light-resistant container as defined in the USP/NF with a child resistant closure. Shake well before use. Keep tightly closed. Store at 20° - 25°C (68° - 77°F). [see USP Controlled Room Temperature]. Distributed By: BPI Labs, LLC.

Frequently Asked Questions

What is Phenobarbital Oral used for?

INDICATIONS USAGE A. Sedative B. Anticonvulsant - For the treatment of generalized and partial seizures.

What are the side effects of Phenobarbital Oral?

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 the localized or diffuse myalgic, neuralgic, or arthritic pain, especially in psychoneurotic patients with insomnia.

What are the important warnings for Phenobarbital Oral?

WARNINGS 1. 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.