Data from FDA - Curated by EPG Health - Last updated 12 April 2018

Indication(s)

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.

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Advisory information

contraindications
CONTRAINDICATIONS None known.
Special warnings and precautions
PRECAUTIONS 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 ß-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. Animal reproduction studies have not been conducted with Caffeine and Sodium Benzoate Injection. It is also not known whether Caffeine and Sodium Benzoate Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Caffeine and Sodium Benzoate Injection should be given to a pregnant woman only if clearly needed.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION Caffeine and Sodium Benzoate Injection may be administered by intramuscular or slow intravenous injection. Some clinicians suggest that when used as a mild CNS stimulant to overcome fatigue, oral doses of 100-200 mg of anhydrous caffeine are required. One manufacturer recommends that citrated caffeine be administered orally in dosages of 65-325 mg (about 32-162 mg of anhydrous caffeine) 3 times daily. Another manufacturer recommends an oral dosage of 250 mg of anhydrous caffeine in an extended-release formulation once daily, but warns that the drug should not be administered less than 6 hours before retiring. Analeptic use of caffeine is strongly discouraged by most clinicians. However, the manufacturer of Caffeine and Sodium Benzoate Injection recommends intramuscular, or in emergency respiratory failure, intravenous injection of 500 mg of the drug (about 250 mg of anhydrous caffeine) or a maximum single dose of 1 gram (about 500 mg of anhydrous caffeine) for the treatment of respiratory depression associated with overdosage of CNS depressants, including narcotic analgesics and alcohol, and with electric shock. The usual dose is 0.5 g (7 ½ grains) as frequently as directed by the physician. The maximum safe dose is 0.5 g and the total dose in 24 hours should rarely exceed 2.5 g. Parenteral drug products should be inspected visually for particulate matter prior to administration whenever solution and container permit.

More information

Category Value
Agency product number 3G6A5W338E
Orphan designation No
Product NDC 0517-2502
Date Last Revised 05-04-2018
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder American Regent, Inc.