Cafcit Injection
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
For the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.
General Information
This solution of caffeine citrate aids in preventing apnea in
premature infants. Apnea of prematurity was defined as having at
least 6 apnea episodes of greater than 20 seconds duration in a
24-hour period with no other identifiable cause of apnea. Caffeine
is structurally related to other methylxanthines, theophylline and
theobromine. It is a bronchial smooth muscle relaxant, a CNS
stimulant, a cardiac muscle stimulant and a diuretic. Although the
mechanism of action of caffeine in apnea of prematurity is not
known, several mechanisms have been hypothesized. These include:
(1) stimulation of the respiratory center, (2) increased minute
ventilation, (3) decreased threshold to hypercapnia, (4) increased
response to hypercapnia, (5) increased skeletal muscle tone, (6)
decreased diaphragmatic fatigue, (7) increased metabolic rate, and
(8) increased oxygen consumption. Most of these effects have been
attributed to antagonism of adenosine receptors, both A1 and A2
subtypes, by caffeine, which has been demonstrated in receptor
binding assays and observed at concentrations approximating those
achieved therapeutically.
Clinical Results
In the placebo-controlled clinical trial, caffeine levels ranged
from 8 to 40 mg/L. A therapeutic plasma concentration range of
caffeine could not be determined from the placebo-controlled
clinical trial. Serious toxicity has been reported in the
literature when serum caffeine levels exceed 50 mg/L. In clinical
studies reported in the literature, cases of hypoglycemia and
hyperglycemia have been observed. Therefore, serum glucose may need
to be periodically monitored in infants receiving CAFCIT®.
Mechanism of Action
CAFCIT® (caffeine citrate) Injection for intravenous
administration is a clear, colorless, sterile, non-pyrogenic,
preservative-free, aqueous solution adjusted to pH 4.7. Each mL of
CAFCIT® Injection contains 20 mg caffeine citrate (equivalent to 10
mg of caffeine base). It is prepared in solution by the addition of
10 mg caffeine anhydrous to 5.0 mg citric acid monohydrate, 8.3 mg
sodium citrate dihydrate and Water for Injection.
