Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
CAFFEINE CITRATE (UNII: U26EO4675Q) (CAFFEINE - UNII:3G6A5W338E)
Hikma Pharmaceuticals USA 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 3 mL colorless glass vials. The vials are sealed with a teflon-faced 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: NDC 0641-6267-10, 3 mL Single Dose Vial packaged in a carton of 10 Store at 20° to 25°C (68° to 77°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 Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . For Product Inquiry call 1-877-845-0689. Manufactured by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised July 2022 462-708-03
New Drug Application
CAFFEINE CITRATE- CAFFEINE CITRATE INJECTION HIKMA PHARMACEUTICALS USA 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 4.7. 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, 14 18 4 9 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 Aqra d-dokument sħiħ