CAFFEINE CITRATE solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Exela Pharma Sciences, LLC

INN (Nama Antarabangsa):

CAFFEINE CITRATE

Komposisi:

CAFFEINE CITRATE 20 mg in 1 mL

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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

Ringkasan produk:

Both caffeine citrate Injection and caffeine citrate oral solution are available as clear, colorless, sterile, nonpyrogenic, preservative-free, aqueous solutions in 3 mL colorless glass vials. The vials of caffeine citrate injection are sealed with a teflon-faced gray rubber stopper and an aluminum overseal with a white flip-off polypropylene disk inset. The vials of caffeine citrate oral solution are sealed with a teflon-faced gray rubber stopper and a peel-off aluminum overseal with a blue flip-off polypropylene disk inset. Both the injection and oral solution vials contain 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). Caffeine citrate injection, USP NDC 51754-0502-1 3 mL vial, individually packaged in a carton. Caffeine citrate oral solution, USP NDC 51754-0503-3 3 mL vial (NOT CHILD-RESISTANT), 10 vials per white polypropylene child-resistant container. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Preservative free. For single use only. Discard unused portion. ATTENTION PHARMACIST: Detach "Instructions for Use" from the package insert and dispense with caffeine citrate oral solution prescription. Manufactured by: Exela Pharma Sciences Lenoir, NC 28645 USA N+ and NOVAPLUS are registered trademarks of Novation, LLC.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

CAFFEINE CITRATE- CAFFEINE CITRATE SOLUTION
EXELA PHARMA SCIENCES, LLC
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Rx Only
DESCRIPTION
Both caffeine citrate injection for intravenous administration and
caffeine citrate oral
solution are clear, colorless, sterile, non-pyrogenic,
preservative-free, aqueous solutions
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, USP to
5 mg citric acid monohydrate, USP, 8.3 mg sodium citrate dihydrate,
USP and Water for
Injection, USP.
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 theo‑bromine.
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)
stimu‑lation 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 meta‑bolic rate,
and (8) increased
oxygen consumption.
Most of these effects have been attributed to antagonism of adenosine
recep‑tors, both
A and A subtypes, by caffeine, which has been demonstrated in receptor
binding
assays and observed at concentrations approximating those achieved
therapeutically.
1
2
PHARMACOKINETICS
_Absorption: _After oral administration of 10 mg caffeine base/kg to
preterm neonates,
the peak plasma level (C
) for