CAFFEINE CITRATE- caffeine citrate injection

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Armas Pharmaceuticals Inc.

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

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 a clear USP Type I 5 mL glass vial with grey chlorobutyl rubber stoppers with white colored, flip off aluminum seals. 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 60 mg/3 mL is a clear, colorless aqueous solution, individually packaged in a carton and is available as follows. 3 mL fill in 5 mL glass vial                                          Mono Carton of 5 mL glass vial                                   NDC 72485-104-01 3 mL Single Dose Vial packaged in a carton of 10       NDC 72485-104-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].    Preservative free. For single use only. Discard unused portion. To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA, Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-855-839-8195. For Intravenous Use Only Manufactured by: Micro Labs Limited Bangalore-560 099, INDIA. Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728 (USA) Rev. 09/2022

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CAFFEINE CITRATE - CAFFEINE CITRATE INJECTION
ARMAS PHARMACEUTICALS INC.
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CAFFEINE CITRATE INJECTION, USP
CAFFEINE CITRATE INJECTION, USP
RX ONLY
DESCRIPTION
Caffeine citrate Injection, USP for intravenous administration is
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 trisodium citrate dihydrate and Water for Injection.
Caffeine USP, a central nervous system stimulant, is an odorless white
crystalline
substance or granule, with a bitter taste. It is freely soluble in
chloroform, sparingly
soluble in water and in alcohol, slightly soluble in ether. 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,
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
14
18
4
9
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 administ