Drug Facts
Composition & Profile
Identifiers & Packaging
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; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label NDC 0517-2502-01 Rx Only Caffeine and Sodium Benzoate Injection, USP 250 mg/mL (125 mg/mL Caffeine) For IM or Slow IV Use 2 mL Single-Dose Vial Discard Unused Portion Carton Labeling NDC 0517-2502-10 Rx Only Caffeine and Sodium Benzoate Injection, USP 250 mg/mL (125 mg/mL Caffeine) For Intramuscular or Slow Intravenous Use 10 X 2 mL Single-Dose Vials Discard Unused Portion Container Label Carton Labeling; Serialization Label Serialization Label
- 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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Container Label NDC 0517-2502-01 Rx Only Caffeine and Sodium Benzoate Injection, USP 250 mg/mL (125 mg/mL Caffeine) For IM or Slow IV Use 2 mL Single-Dose Vial Discard Unused Portion Carton Labeling NDC 0517-2502-10 Rx Only Caffeine and Sodium Benzoate Injection, USP 250 mg/mL (125 mg/mL Caffeine) For Intramuscular or Slow Intravenous Use 10 X 2 mL Single-Dose Vials Discard Unused Portion Container Label Carton Labeling
- Serialization Label Serialization Label
Overview
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.
Indications & 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 & 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.
Warnings & Precautions
No warnings available yet.
Contraindications
None known.
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