CAFFEINE CITRATE injection, solution

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

AuroMedics Pharma LLC

INN (Jina la Kimataifa):

CAFFEINE CITRATE

Tungo:

CAFFEINE CITRATE 20 mg in 1 mL

Njia ya uendeshaji:

INTRAVENOUS

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Caffeine citrate injection, USP 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.

Bidhaa muhtasari:

Caffeine citrate injection, USP is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 5 mL colorless glass vial. The vials are sealed with a 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:  3 mL Single-Dose Vial,  individually packaged in a carton.                                                     NDC 55150-187-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The vial stopper is not made with natural rubber latex. Preservative free. For single-dose only. Discard unused portion . Intralipid® is a registered trademark of Fresenius Kabi AB. Aminosyn® is a registered trademark of Hospira, Inc. To report SUSPECTED ADVERSE REACTIONS, contact AuroMedics Pharma LLC at 1-866-850-2876 or www.auromedics.com or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-866-850-2876. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: November 2021

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

CAFFEINE CITRATE - CAFFEINE CITRATE INJECTION, SOLUTION
AUROMEDICS PHARMA 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) USP to 5 mg
citric acid
monohydrate, 8.3 mg sodium citrate dihydrate and Water for Injection,
USP.
Caffeine (anhydrous) USP, a central nervous system stimulant, is an
odorless white
crystalline powder or granules, 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
) for caffe