Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
CAFFEINE CITRATE (UNII: U26EO4675Q) (CAFFEINE - UNII:3G6A5W338E)
Micro Labs Limited
CAFFEINE CITRATE
CAFFEINE CITRATE 60 mg in 3 mL
INTRAVENOUS
PRESCRIPTION DRUG
Caffeine citrate injection USP is indicated for the treatment of apnea of prematurity. Caffeine citrate injection USP 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 a clear USP Type I 5 mL glass vial with grey chlorobutyl rubber stoppers with white colored, flip off aluminum seals. The injection 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 60 mg/3 mL is a clear, colorless aqueous solution, individually packaged in a carton and is available as follows. 3 mL fill in 5 mL glass vial NDC 42571-244-69 Mono Carton of 5 mL glass vial NDC 42571-244-69 3 mL Single Dose Vial packaged in a carton of 10 NDC 42571-244-98 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Preservative free. For single use only. Discard unused portion. To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA, Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-855-839-8195. Manufactured by: Micro Labs Limited Bangalore-560 099, INDIA. Manufactured for: Micro Labs USA Inc. Basking Ridge, NJ 07920 Revised: March 2020
Abbreviated New Drug Application
CAFFEINE CITRATE - CAFFEINE CITRATE INJECTION, SOLUTION MICRO LABS LIMITED ---------- 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 trisodium citrate dihydrate and Water for Injection. Caffeine USP, a central nervous system stimulant, is an odorless white crystalline substance or granule, with a bitter taste. It is freely soluble in chloroform, sparingly soluble in water and in alcohol, slightly soluble in ether. 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 pla Belgenin tamamını okuyun