Caffeine and Sodium Benzoate Injection, USP
For intramuscular or slow intravenous injection
IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE:
Caffeine and Sodium Benzoate Injection has been used in conjunction with supportive measure to treat respiratory depression associated with overdosage with CNS depressant drugs (e.g., narcotic analgesics, alcohol). However, because of questionable benefit and transient action, most authorities believe caffeine and other analeptics should not be used in these conditions and recommend other supportive therapy.
Large doses of caffeine may produce headache, excitement, agitation, a condition resembling anxiety neurosis, scintillating scotoma, hyperesthesia, tinnitus, muscle tremors or twitches, diuresis, tachycardia, extrasystoles, and other cardiac arrhythmias. Further CNS depression may occur when already depressed patients are too vigorously treated with Caffeine and Sodium Benzoate Injection.
Caffeine and other xanthines may enhance the cardiac inotropic effects of β-adrenergic stimulating agents. Caffeine has also been reported to increase its own metabolism and that of other drugs, including phenobarbital and aspirin. Caffeine produces false-positive elevations of serum urate as measured by the Bittner method. The drug also produces slight increases in urine levels of vanilamandelic acid (VMA), catecholamines, and 5-hydrocyindoleacetic acid.
Because high urine levels of VMA or catecholamines may result in false-positive diagnosis of pheochromocytoma or neuroblastoma, caffeine intake should be avoided during tests for these disorders.
Pregnancy: Teratogenic effects. Pregnancy Category C. Caffeine and Sodium Benzoate Injection should be given to a pregnant woman only if clearly needed.
Acute toxicity involving caffeine has been reported rarely. Mild delirium, insomnia, diuresis, dehydration, and fever commonly occur with overdosage. More serious symptoms of overdosage include cardiac arrhythmias and clonic-tonic convulsions.
In adults, IV doses of 57 mg/kg of body weight have been fatal. In one 5-year-old patient, death occurred following oral ingestion of approximately 3 grams of caffeine.
This product is not FDA approved
For additional safety information, please see Full Prescribing Information.
You are encouraged to report Adverse Drug Events to American Regent Inc. at
1-800-734-9236 or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.