Phenobarbital Sodium
Generic: PHENOBARBITAL SODIUM
Basic Information
Manufacturer
Cameron Pharmaceuticals
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
9091250d-694a-4593-84dc-6fe54aef495f
Indications & Usage
INDICATIONS AND USAGE Parenteral a.
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 sedative action of this class of drugs is desired are anxiety-tension states, hyperthyroidism, essential hypertension, nausea and vomiting of functional origin, motion sickness, acute labyrinthitis, pylorospasm in infants, chorea and cardiac failure.
Phenobarbital is also a useful adjunct in treatment of hemorrhage from the respiratory or gastrointestinal tract.
Phenobarbital controls anxiety, decreases muscular activity and lessens nervous excitability in hyperthyroid patients.
However, thyrotoxic individuals occasionally react poorly to barbiturates.
b.
Hypnotic, for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks (see CLINICAL PHARMACOLOGY ).
c.
Preanesthetic.
d.
Long-term anticonvulsant, (phenobarbital, mephobarbital and metharbital) for the treatment of generalized tonic-clonic and cortical focal seizures.
And, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, cerebral hemorrhage, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics.
Phenobarbital sodium may be administered intramuscularly or intravenously as an anticonvulsant for emergency use.
When administered intravenously, it may require 15 or more minutes before reaching peak concentrations in the brain.
Therefore, injecting phenobarbital sodium until the convulsions stop may cause the brain level to exceed that required to control the convulsions and lead to severe barbiturate-induced depression.
e.
Phenobarbital is indicated in pediatric patients as an anticonvulsant and as a sedative, including its preoperative and postoperative use.
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 sedative action of this class of drugs is desired are anxiety-tension states, hyperthyroidism, essential hypertension, nausea and vomiting of functional origin, motion sickness, acute labyrinthitis, pylorospasm in infants, chorea and cardiac failure.
Phenobarbital is also a useful adjunct in treatment of hemorrhage from the respiratory or gastrointestinal tract.
Phenobarbital controls anxiety, decreases muscular activity and lessens nervous excitability in hyperthyroid patients.
However, thyrotoxic individuals occasionally react poorly to barbiturates.
b.
Hypnotic, for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks (see CLINICAL PHARMACOLOGY ).
c.
Preanesthetic.
d.
Long-term anticonvulsant, (phenobarbital, mephobarbital and metharbital) for the treatment of generalized tonic-clonic and cortical focal seizures.
And, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, cerebral hemorrhage, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics.
Phenobarbital sodium may be administered intramuscularly or intravenously as an anticonvulsant for emergency use.
When administered intravenously, it may require 15 or more minutes before reaching peak concentrations in the brain.
Therefore, injecting phenobarbital sodium until the convulsions stop may cause the brain level to exceed that required to control the convulsions and lead to severe barbiturate-induced depression.
e.
Phenobarbital is indicated in pediatric patients as an anticonvulsant and as a sedative, including its preoperative and postoperative use.
Adverse Reactions
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 effects of barbiturates, the incidence of these reactions may be somewhat higher in fully ambulatory patients.
Nervous System Somnolence, agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality Respiratory System Hypoventilation, apnea Cardiovascular System Bradycardia, hypotension, syncope Digestive System Nausea, vomiting, constipation Dermatologic Reactions Exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermic necrolysis.
Other Reported Reactions Headache; injection site reactions; hypersensitivity reactions, including but not limited to angioedema and skin rashes; fever; liver damage and megaloblastic anemia following chronic phenobarbital use.
Because such patients may be less aware of certain of the milder adverse effects of barbiturates, the incidence of these reactions may be somewhat higher in fully ambulatory patients.
Nervous System Somnolence, agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality Respiratory System Hypoventilation, apnea Cardiovascular System Bradycardia, hypotension, syncope Digestive System Nausea, vomiting, constipation Dermatologic Reactions Exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermic necrolysis.
Other Reported Reactions Headache; injection site reactions; hypersensitivity reactions, including but not limited to angioedema and skin rashes; fever; liver damage and megaloblastic anemia following chronic phenobarbital use.