A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Cafcit Indications, Dosage, Storage, Stability - Caffeine Citrate
Cafcit Indications, Dosage, Storage, Stability - Caffeine Citrate
INDICATIONS
CAFCIT® (caffeine citrate) is indicated for the short term
treatment of apnea of
prematurity in infants
between 28 and <33 weeks gestational age.
DOSAGE AND ADMINISTRATION
Prior to initiation of CAFCIT® (caffeine citrate), baseline
serum levels of caffeine
should be measured in infants previously treated with theophylline,
since preterm infants
metabolize theophylline
to caffeine. Likewise, baseline
serum levels of caffeine
should be measured in infants born to mothers who consumed caffeine
prior to delivery, since caffeine readily crosses the placenta.
The recommended loading
dose and maintenance doses
of CAFCIT® follow. NOTE THAT
THE DOSE EXPRESSED AS CAFFEINE
B.S. IS ONE-HALF THE DOSE
WHEN EXPRESSED AS CAFFEINE
CITRATE.
|
.
|
Dose of
CAFCIT®
(Volume)
|
Dose
Expressed
as Caffeine
Citrate
|
Dose
Expressed
as Caffeine
Base
|
Route
|
Frequency
|
|
Loading Dose
|
1 mL/ kg
|
20 mg/ kg
|
10 mg/ kg
|
Intravenous*
(over 30
minutes)
|
One Time
|
|
Maintenance
Dose
|
0.25 mL/ kg
|
5 mg/ kg
|
2.5 mg/ kg
|
Intravenous*
(over 10
minutes) or
Orally
|
Every 24
hours**
|
- * using a syringe
infusion pump
- **beginning 24 hours after the loading
dose
Serum concentrations of caffeine
may need to be monitored
periodically throughout treatment
to avoid toxicity. Serious toxicity
has been associated with serum
levels greater than 50 mg/L. Like all parenteral
drug products, CAFCIT®
should be inspected visually for particulate
matter and discoloration
prior to administration, whenever solution
and container permit.
Vials containing discolored solution
or visible particulate
matter should be discarded.
Drug Compatibility
To test for drug
compatibility
with common intravenous
solutions or medications, twenty (20) mL of CAFCIT® (caffeine
citrate) were combined with 20 mL of a solution
or medication, with
the exception of an Intralipid ® admixture, which was combined
as 80 mL/80 mL. The physical
appearance of the combined solutions was evaluated for precipitation.
The admixtures were mixed
for 10 minutes and then assayed for caffeine. The admixtures were
then continually mixed
for 24 hours, with further sampling
for caffeine assays at 2, 4, 8, and 24 hours.
Based on this testing, CAFCIT® (caffeine citrate) Injection,
20 mg/mL (equivalent to 10 mg/mL caffeine
base) is chemically stable
for 24 hours at room temperature
when combined with the following test
products.
- Dextrose Injection, USP 5%
- 50% Dextrose Injection USP
- Intralipid ® 20% IV
Fat Emulsion
- Aminosyn ® 8.5% Crystalline Amino Acid Solution
- Dopamine HCl Injection, USP 40 mg/mL diluted to 0.6 mg/mL with
Dextrose Injection, USP 5%
- Calcium Gluconate Injection, USP 10% (0.465 mEq/Ca+2
/mL)
- Heparin Sodium Injection, USP 1000 units/mL diluted to 1 unit/mL
with Dextrose Injection, USP 5%
- Fentanyl Citrate Injection, USP 50 µg/mL diluted to 10
µg/mL with Dextrose Injection, USP 5%
HOW SUPPLIED
CAFCIT® (caffeine citrate) Injection is available as a clear,
colorless, sterile, non-pyrogenic, preservative-free, aqueous
solution in 3 mL colorless
glass vials. The vials are sealed with a teflon-faced gray
rubber stopper and an aluminum
over-seal with white flip-off
polypropylene disk inset.
Each vial contains 3 mL
solution at a concentration
of 20 mg/mL caffeine citrate (60 mg/vial) equivalent
to 10 mg/mL caffeine
base (30 mg/vial).
NDC 0054-8118-01: 3 mL single-dose vial,
individually packaged in a carton.
Store at 15°-30°C (59°-86°F).
Preservative Free. For single use only. Discard unused portion.
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