CAFFEINE AND SODIUM BENZOATE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)

Available from:

American Regent, Inc.

INN (International Name):

CAFFEINE

Composition:

CAFFEINE 125 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. None known.

Product summary:

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

Authorization status:

unapproved drug other

Summary of Product characteristics

CAFFEINE AND SODIUM BENZOATE- CAFFEINE AND SODIUM BENZOATE INJECTION,
SOLUTION
AMERICAN REGENT, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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CAFFEINE AND SODIUM BENZOATE INJECTION, USP
RX ONLY
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.
CLINICAL PHARMACOLOGY
Caffeine is pharmacologically similar to the other xanthine drugs,
such as theobromine and
theophylline; however, these three agents differ in the intensity of
their actions on various structures.
Caffeine's CNS and skeletal muscle effects are greater than those of
the other xanthines. In all other
areas, theophylline has greater activity than caffeine, although some
studies report that caffeine has
greater diuretic effect than theobromine. The increased levels of
intracellular cyclic-AMP mediate
most of caffeine's pharmacologic actions. Caffeine competitively
inhibits phosphodiesterase, the
enzyme that degrades cyclic 3'- 5' adenosine monophosphate. Caffeine
stimulates all levels of the CNS.
Caffeine's cortical effects are milder and of shorter duration than
those of the amphetamines. In slightly
larger doses, caffeine stimulates medullary vagal, vasomotor and
respiratory centers, promoting
bradycardia, vasoconstriction, and increased respiratory rate.
Caffeine produces a positive inotropic effect of the myocardium and a
positive chronotropic effect at
the sinoatrial node, causing transient increases in heart rate, force
of contraction, cardiac output and
heart work. In doses greater than 250 mg, the centrally mediated vagal
effects of caffeine ma