CAFFEINE CITRATE solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

caffeine citrate (UNII: U26EO4675Q) (caffeine - UNII:3G6A5W338E)

Pieejams no:

Sagent Pharmaceuticals

SNN (starptautisko nepatentēto nosaukumu):

caffeine citrate

Kompozīcija:

caffeine citrate 20 mg in 1 mL

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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

Produktu pārskats:

Caffeine Citrate Injection, USP is supplied as follows: Caffeine Citrate Oral Solution, USP is supplied as follows: Both Caffeine Citrate Injection, USP and Caffeine Citrate Oral Solution, USP are available as clear, colorless, aqueous solutions. Both the injection and oral solution vials contain 3 mL solution at a concentration of 20 mg per mL caffeine citrate (60 mg per vial) equivalent to 10 mg per mL caffeine base (30 mg per vial). Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] For Single Use Only. Discard unused portion. ATTENTION PHARMACIST: Detach “Instructions for Use” from the package insert and dispense with Caffeine Citrate Oral Solution, USP prescription. Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in Canada ©2020 Sagent Pharmaceuticals, Inc. March 2020 SAGENT Pharmaceuticals®

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

CAFFEINE CITRATE- CAFFEINE CITRATE SOLUTION
SAGENT PHARMACEUTICALS
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CAFFEINE CITRATE INJECTION, USP
CAFFEINE CITRATE ORAL SOLUTION, USP
SAGENT
Rx only
DESCRIPTION
Both Caffeine Citrate Injection, USP for intravenous administration
and Caffeine Citrate Oral Solution,
USP 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 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,
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.
®
14
18
4
9
1
2
PHARMACOKINETICS
Absorption
After