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The barbiturates are nonselective central nervous system (CNS) depressants which are primarily used as sedative hypnotics and also anticonvulsants in subhypnotic doses. The barbiturates and their …
- CLINICAL PHARMACOLOGY
Barbiturates are capable of producing all levels of CNS mood alteration from excitation to mild sedation, to hypnosis and deep coma. Overdosage can produce death. In high enough therapeutic doses …
- INDICATIONS AND USAGE
Parenteral – Sedative. Sedation is obtainable within an hour, and in adequate dosage, the duration of action is more than six hours. Included in the more common conditions in which the …
- CONTRAINDICATIONS
Barbiturates are contraindicated in patients with known barbiturate sensitivity. Barbiturates are also contraindicated in patients with a history of manifest or latent porphyria, marked impairment …
- WARNINGS
Phenobarbital Sodium Injection contains the preservative benzyl alcohol and is not recommended for use in neonates. There have been reports of fatal ‘gasping syndrome’ in neonates (children less …
- PRECAUTIONS
General – Untoward reactions may occur in the presence of fever, hyperthyroidism, diabetes mellitus and severe anemia. In cases of great debility, severely impaired liver function, pulmonary or …
- ADVERSE REACTIONS
The following adverse reactions and their incidence were compiled from surveillance of thousands of hospitalized patients. Because such patients may be less aware of certain of the milder adverse …
- DRUG ABUSE AND DEPENDENCE
Phenobarbital Sodium Injection is a Schedule IV controlled substance. Barbiturates may be habit forming. Tolerance and psychological dependence and physical dependence may occur especially …
- OVERDOSAGE
The toxic dose of barbiturates varies considerably. Barbiturate intoxication may be confused with alcoholism, bromide intoxication and various neurological disorders. For sedation, therapeutic …
- DOSAGE AND ADMINISTRATION
Dosages of barbiturates must be individualized with full knowledge of their particular characteristics and recommended rates of administration. Factors to consider are the patient’s age, weight …
- HOW SUPPLIED
Phenobarbital Sodium Injection, USP is available in the following: 65 mg/mL, 1 mL vials packaged in 25s (NDC 0641-0476-25) 130 mg/mL, 1 mL vials packaged in 25s (NDC …
- PRINCIPAL DISPLAY PANEL
Phenobarbital Sodium Injection, USP – 65 mg/mL – 1 mL Vial – NDC 0641-0476-21 – Phenobarbital Sodium Injection, USP – 65 mg/mL – 25 x 1 mL Vials – NDC 0641-0476-25
- PRINCIPAL DISPLAY PANEL
Phenobarbital Sodium Injection, USP – 130 mg/mL – 1 mL Vial – NDC 0641-0477-21 – Phenobarbital Sodium Injection, USP – 130 mg/mL – 25 x 1 mL Vials – NDC 0641-0477-25