Phenobarbital
Generic: PHENOBARBITAL
Basic Information
Manufacturer
Rising Pharma Holdings, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
e81ffc2f-9aa0-4b68-9d42-63d23dc30824
Indications & Usage
INDICATIONS AND USAGE Phenobarbital Tablets, USP are indicated for use as a sedative or anticonvulsant.
Warnings
WARNINGS In small doses, the barbiturates may increase the reaction to painful stimuli.
Taken by themselves, the barbiturates cannot be relied upon to relieve pain or even to produce sedation or sleep in the presence of severe pain.
Taken by themselves, the barbiturates cannot be relied upon to relieve pain or even to produce sedation or sleep in the presence of severe pain.
Adverse Reactions
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.
Like other non-analgesic 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 diffused myalgic, neuralgic, or arthritic pain, especially in psychoneurotic patients with insomnia.
The pain may appear in paroxysms, is most intense in the early morning hours, and is most frequently located in the region of the neck, shoulder girdle, and upper limbs.
Symptoms may last for days after the drug is discontinued.
Respiratory/Circulatory: Respiratory depression, apnea, circulatory collapse.
Allergic: Acquired hypersensitivity to barbiturates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angioedema, and similar conditions.
Hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematous dermatitis.
Rarely, exfoliative dermatitis (e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis) may be caused by phenobarbital and can prove fatal.
The skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs.
In a few cases, megaloblastic anemia has been associated with the chronic use of phenobarbital.
Other: Nausea and vomiting; headache.
To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc.
at 1-844-874-7464, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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.
Like other non-analgesic 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 diffused myalgic, neuralgic, or arthritic pain, especially in psychoneurotic patients with insomnia.
The pain may appear in paroxysms, is most intense in the early morning hours, and is most frequently located in the region of the neck, shoulder girdle, and upper limbs.
Symptoms may last for days after the drug is discontinued.
Respiratory/Circulatory: Respiratory depression, apnea, circulatory collapse.
Allergic: Acquired hypersensitivity to barbiturates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angioedema, and similar conditions.
Hypersensitivity reactions in this category include localized swelling, particularly of the eyelids, cheeks, or lips, and erythematous dermatitis.
Rarely, exfoliative dermatitis (e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis) may be caused by phenobarbital and can prove fatal.
The skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs.
In a few cases, megaloblastic anemia has been associated with the chronic use of phenobarbital.
Other: Nausea and vomiting; headache.
To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc.
at 1-844-874-7464, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .