Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
CAFFEINE CITRATE (UNII: U26EO4675Q) (CAFFEINE - UNII:3G6A5W338E)
Exela Pharma Sciences, LLC
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. This leaflet tells you about caffeine citrate oral solution and how to give it to your baby. Read the following information before giving this medicine to your baby. Completely discuss caffeine citrate with your baby’s doctor. Continue to discuss any questions you have about this medicine at your baby’s checkups. After you remove your baby’s dose, throw away the open bottle (vial) and all medicine left in it. Use each vial of caffeine citrate oral solution for only one dose. There will be extra medicine left in the vial after one dose is removed. Leftover medicine should not be used because caffeine citrate oral solution does not contain preservatives. Once the vial is open
Both caffeine citrate Injection and caffeine citrate oral solution are available as clear, colorless, sterile, nonpyrogenic, preservative-free, aqueous solutions in 3 mL colorless glass vials. The vials of caffeine citrate injection are sealed with a teflon-faced gray rubber stopper and an aluminum overseal with a white flip-off polypropylene disk inset. The vials of caffeine citrate oral solution are sealed with a teflon-faced gray rubber stopper and a peel-off aluminum overseal with a blue flip-off polypropylene disk inset. Both the injection and oral solution 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 NDC 51754-0502-1 3 mL vial, individually packaged in a carton. 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. Manufactured by: Exela Pharma Sciences Lenoir, NC 28645 USA N+ and NOVAPLUS are registered trademarks of Novation, LLC.
Abbreviated New Drug Application
CAFFEINE CITRATE- CAFFEINE CITRATE INJECTION EXELA PHARMA SCIENCES, LLC ---------- Rx Only 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. 1 2 PHARMACOKINETICS _Absorption: _After oral administration of 10 mg caffeine base/kg to preterm neonates, the peak plasma level (C ) for Διαβάστε το πλήρες έγγραφο