Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
CAFFEINE CITRATE (UNII: U26EO4675Q) (CAFFEINE - UNII:3G6A5W338E)
American Regent, Inc.
CAFFEINE CITRATE
CAFFEINE CITRATE 20 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
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.
Caffeine citrate injection, USP is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 5 mL colored glass vials. The vials contain 3 mL solution at a concentration of caffeine citrate 20 mg/mL (60 mg/vial) equivalent to caffeine base 10 mg/mL (30 mg/vial). Caffeine Citrate Injection, USP is supplied as: NDC 0517-0020-10 3 mL Single Dose Vial Packages of 10 NDC 0517-0020-25 3 mL Single Dose Vial Packages of 25 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°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 American Regent, Inc. at 1-800-734-9236 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-800-354-4855. IN0020 Rev. 9/2020 AMERICAN REGENT, INC. SHIRLEY, NY 11967
Abbreviated New Drug Application
CAFFEINE CITRATE- CAFFEINE CITRATE INJECTION, SOLUTION AMERICAN REGENT, INC. ---------- 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 4.2 to 5.2. Each mL contains caffeine citrate 20 mg (equivalent to 10 mg of caffeine base) prepared in solution by the addition of caffeine anhydrous 10 mg to citric acid monohydrate 5 mg, sodium citrate dihydrate 8.3 mg and water for injection q.s. 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: 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 1 2 _Absorption:_ After oral administration of 10 mg caffeine base/kg to preterm neonates, the peak plasma level (C ) for caffeine ranged f Læs hele dokumentet