CAFFEINE CITRATE injection

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Hikma Pharmaceuticals USA Inc.

DCI (Denominação Comum Internacional):

CAFFEINE CITRATE

Composição:

CAFFEINE CITRATE 20 mg in 1 mL

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

Caffeine Citrate Injection, USP 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 overseal with a white flip-off printed with “FOR INTRAVENOUS USE ONLY” in red. The 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 is supplied as:    NDC 0641-6267-10, 3 mL Single Dose Vial packaged in a carton of 10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Not made with natural rubber latex. Preservative free. For single dose only. Discard unused portion. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised July 2022 462-708-03

Status de autorização:

New Drug Application

Características técnicas

CAFFEINE CITRATE- CAFFEINE CITRATE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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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.
Caffeine citrate
C
H
N O MW 386.31
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,
14
18
4
9
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