Caffeine And Sodium Benzoate
FDA Drug Information • Also known as: Caffeine And Sodium Benzoate
- Brand Names
- Caffeine And Sodium Benzoate
- Drug Class
- Central Nervous System Stimulant [EPC], Methylxanthine [EPC]
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Caffeine and Sodium Benzoate Injection, USP is a clear, sterile, nonpyrogenic, solution of Caffeine Alkaloid. Each mL contains: Caffeine (anhydrous) 125 mg; Sodium Benzoate (added to increase the solubility of Caffeine) 125 mg; Water for Injection, USP q.s. pH (range 6.5 to 8.5) adjusted with Hydrochloric Acid and/or Sodium Hydroxide. For intramuscular or slow intravenous administration only.
What Is Caffeine And Sodium Benzoate Used For?
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.
Dosage 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.
Contraindications
CONTRAINDICATIONS None known.
Pregnancy and Breastfeeding
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.
Overdosage
OVERDOSAGE 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 and oral doses of 18.50 grams have been fatal. In one 5-year-old patient, death occurred following oral ingestion of approximately 3 grams of caffeine. Convulsions may be treated with IV administration of diazepam or a barbiturate such as pentobarbital sodium.
How Supplied
HOW SUPPLIED Caffeine and Sodium Benzoate Injection, USP 250 mg/mL NDC 0517-2502-10 2 mL Single Dose Vials Packed in boxes of 10. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30"C (59°-86°F) (See USP Controlled Room Temperature). AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN2502 Rev. 11/05
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.