Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
CAFFEINE CITRATE (UNII: U26EO4675Q) (CAFFEINE - UNII:3G6A5W338E)
Sun Pharmaceutical Industries, Inc.
CAFFEINE CITRATE
CAFFEINE CITRATE 20 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Caffeine citrate injection and caffeine citrate oral solution are indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age. Caffeine citrate injection and caffeine citrate oral solution are contraindicated in patients who have demonstrated hypersensitivity to any of its components.
Both caffeine citrate injection and caffeine citrate oral solution are available as clear, color‑less, sterile, non-pyrogenic, preservative-free, aqueous solutions in 5 mL colorless glass vials. The vials of caffeine citrate injection are sealed with gray rubber stopper and white flip off aluminum seal printed with “FOR INTRAVENOUS USE ONLY” in red. The vials of caffeine citrate oral solution are sealed with gray rubber stopper and a dark blue matte finish, flip off tear off aluminum seal printed with “FOR ORAL USE ONLY – FLIP UP & TEAR” in white. Both the injection and oral solution vials contain 3 mL solution at a concentra‑tion of 20 mg/mL caffeine citrate (60 mg/vial) equivalent to 10 mg/mL caffeine base (30 mg/vial). Caffeine citrate injection, USP NDC 47335-289-27: 3 mL vial, individually packaged in a carton. Caffeine citrate oral solution, USP NDC 47335-290-27: 3 mL vial (NOT CHILD-RESISTANT), 10 vials per white polypropylene child-resistant container. 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]. Preservative free. For single use only. Discard unused portion. ATTENTION PHARMACIST: Detach “Instructions for Use” from the package insert and dispense with caffeine citrate oral solution prescription. Distributed by: Caraco Pharmaceutical Laboratories, Ltd. 1150 Elijah McCoy Drive, Detroit, MI 48202 Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India. NOVAPLUS® NOVAPLUS is a registered trademark of Novation, LLC. ISS. 12/2013 PJPI0464
Abbreviated New Drug Application
CAFFEINE CITRATE - CAFFEINE CITRATE INJECTION CAFFEINE CITRATE - CAFFEINE CITRATE SOLUTION SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- CAFFEINE CITRATE INJECTION, USP CAFFEINE CITRATE ORAL SOLUTION, USP DESCRIPTION Both caffeine citrate injection for intravenous administration and caffeine citrate oral solution 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, USP to 5 mg citric acid monohydrate, USP, 8.3 mg sodium citrate dihydrate, USP 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. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Caffeine is structurally related to other methylxanthines, theophylline, and theo bromine. 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) stimu lation 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 meta bolic rate, and (8) increased oxygen consumption. Most of these effects have been attributed to antagonism of adenosine recep tors, 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 Belgenin tamamını okuyun