CAFFEINE CITRATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAFFEINE CITRATE (UNII: U26EO4675Q) (CAFFEINE - UNII:3G6A5W338E)

Available from:

Fresenius Kabi USA, LLC

INN (International Name):

CAFFEINE CITRATE

Composition:

CAFFEINE CITRATE 20 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Caffeine citrate oral solution is indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age. Caffeine citrate is contraindicated in patients who have demonstrated hypersensitivity to any of its components.

Product summary:

Caffeine Citrate Oral Solution, USP is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in colorless glass vials. The vials contain 3 mL of solution at a concentration of 20 mg/mL caffeine citrate (60 mg/vial) equivalent to 10 mg/mL caffeine base (30 mg/vial). Caffeine Citrate Oral Solution, USP Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Preservative Free.  For single use only.  Discard unused portion. The container closure is not made with natural rubber latex. PHARMACIST:  Dispense the “Patient Information” leaflet with the drug product.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CAFFEINE CITRATE - CAFFEINE CITRATE SOLUTION
Fresenius Kabi USA, LLC
----------
MED GUIDE
CAFFEINE CITRATE
Oral Solution, USP
Rx only
Each bottle (vial) of Caffeine Citrate Oral Solution, USP contains a
total of 60 mg of caffeine citrate in 3
mL (20 mg/mL).
Information and Instructions for Use
This leaflet tells you about caffeine citrate oral solution and how to
give it to your baby. Read the
following information before giving this medicine to your baby.
Completely discuss caffeine citrate oral
solution with your baby’s doctor. Continue to discuss any questions
you have about this medicine at your
baby’s checkups.
After you remove your baby’s dose, throw away the open bottle (vial)
and all medicine left in it. Use each
vial of caffeine citrate oral solution for only one dose. There will
be extra medicine left in the vial after
one dose is removed. Leftover medicine should not be used because
caffeine citrate oral solution does
not contain preservatives. Once the vial is open, any medicine that is
not used right away must be
discarded.
What is Caffeine Citrate Oral Solution?
The main ingredient of caffeine citrate oral solution is caffeine
citrate. Caffeine citrate oral solution is a
clear, colorless, medicine to treat apnea of prematurity - short
periods when premature babies stop
breathing. Apnea of prematurity is due to the baby’s breathing
centers not being fully developed.
How do I give Caffeine Citrate Oral Solution to my baby?
Give caffeine citrate oral solution to your baby once a day, at about
the same time each day. Your baby’s
doctor will prescribe the right amount of caffeine citrate oral
solution based on your baby’s weight and
age. Carefully follow the doctor’s dosing instructions.
Measure the dose of caffeine citrate oral solution carefully. Your
baby’s doctor, nurse, or pharmacist will
give you a suitable syringe or supply of syringes to measure small but
accurate doses of caffeine citrate
oral solution.
Never change (increase or decrease) your baby’s dose without
speaking to yo

Summary of Product characteristics

CAFFEINE CITRATE - CAFFEINE CITRATE SOLUTION
FRESENIUS KABI USA, LLC
----------
CAFFEINE CITRATE ORAL SOLUTION, USP
Rx only
DESCRIPTION
Caffeine Citrate Oral Solution, USP is a clear, colorless, sterile,
non-pyrogenic, preservative-free,
aqueous solution adjusted to pH 4.7. Each mL contains 20 mg caffeine
citrate (equivalent to 10 mg of
caffeine base) prepared in solution by the addition of 10 mg caffeine
anhydrous to 5 mg citric acid
monohydrate, 8.3 mg sodium citrate dihydrate and Water for Injection.
Caffeine, a central nervous system stimulant, is an odorless white
crystalline powder or granule, with a
bitter taste. It is sparingly soluble in water and ethanol at room
temperature. The chemical name of
caffeine is 3,7-dihydro-1,3,7-trimethyl-1_H_-purine-2,6-dione. In the
presence of citric acid it forms
caffeine citrate salt in solution. The structural formula and
molecular weight of caffeine citrate
follows.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
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 A and
A subtypes, by caffeine, which has been demonstrated in receptor
binding assays and observed at
concentrations approximating those achieved therapeutically.
PHARMACOKINETICS
_Absorption_
After oral administration of 10 mg caffeine base/kg to preterm
neonates, the peak plasma level (C
)
1
2
max
for caffeine ranged from 6 to 10 mg/L and the mean time to reach