CAFFEINE CITRATE injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Fresenius Kabi USA, LLC

INN (International Name):

CAFFEINE CITRATE

구성:

CAFFEINE CITRATE 20 mg in 1 mL

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Caffeine citrate injection is indicated for the treatment of apnea of prematurity. Caffeine citrate is contraindicated in patients who have demonstrated hypersensitivity to any of its components.

제품 요약:

Caffeine citrate injection, 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 Injection, USP STORE AT:  20 ° to 25 °C (68 ° to 77 °F) [See USP Controlled Room Temperature]. Preservative free.  For single dose only.  Discard unused portion. The container closure is not made with natural rubber latex. The brand names mentioned in this document are the trademarks of their respective owners. PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license.

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

CAFFEINE CITRATE - CAFFEINE CITRATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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CAFFEINE CITRATE INJECTION, USP
Rx only
DESCRIPTION
Caffeine citrate injection, USP for intravenous administration 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, 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 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
1
2
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
) for caffeine ranged from 6