国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
caffeine citrate (UNII: U26EO4675Q) (caffeine - UNII:3G6A5W338E)
Sagent Pharmaceuticals
caffeine citrate
caffeine citrate 20 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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.
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®
Abbreviated New Drug Application
CAFFEINE CITRATE- CAFFEINE CITRATE SOLUTION SAGENT PHARMACEUTICALS ---------- 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 阅读完整的文件