Drug Catalog - Product Detail
CAFFEINE CITRATE INJECTION INJECT. 60MG/3ML 1X3ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 55150-0187-03 | AUROMEDICS PHARMA | 3 | 60MG/3ML | SOLUTION |
PACKAGE FILES
Generic Name
CAFFEINE CITRATE
Substance Name
CAFFEINE CITRATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
INTRAVENOUS
Application Number
ANDA205013
Description
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) USP to 5 mg citric acid monohydrate, 8.3 mg sodium citrate dihydrate and Water for Injection, USP. Caffeine (anhydrous) USP, a central nervous system stimulant, is an odorless white crystalline powder or granules, 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 Chemical Structure
How Supplied
HOW SUPPLIED Caffeine citrate injection, USP is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 5 mL colorless glass vial. The vials are sealed with a 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: 3 mL Single-Dose Vial, individually packaged in a carton. NDC 55150-187-03 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The vial stopper is not made with natural rubber latex. Preservative free. For single-dose only. Discard unused portion . Intralipid ® is a registered trademark of Fresenius Kabi AB. Aminosyn ® is a registered trademark of Hospira, Inc. To report SUSPECTED ADVERSE REACTIONS, contact AuroMedics Pharma LLC at 1-866-850-2876 or www.auromedics.com or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-866-850-2876. Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: November 2021
Indications & Usage
INDICATIONS AND USAGE Caffeine citrate injection, USP is indicated for the treatment of apnea of prematurity.
Dosage and Administration
DOSAGE AND ADMINISTRATION Prior to initiation of caffeine citrate injection USP, baseline serum levels of caffeine should be measured in infants previously treated with theophylline, since preterm infants metabolize theophylline to caffeine. Likewise, baseline serum levels of caffeine should be measured in infants born to mothers who consumed caffeine prior to delivery, since caffeine readily crosses the placenta. The recommended loading dose and maintenance doses of caffeine citrate injection, USP follow. * Using a syringe infusion pump ** Beginning 24 hours after the loading dose Dose of Caffeine Citrate Injection, USP Volumme Dose of Caffeine Citrate Injection, USP mg/kg Route Frequency Loading Dose 1 mL/kg 20mg/kg Intravenous * (over 30 minutes) One time Maintenance Dose 0.25 mL/kg 5 mg/kg Intravenous* (Over 10 minutes) of Orally Every 24 hours ** NOTE THAT THE DOSE OF CAFFEINE BASE IS ONE-HALF THE DOSE WHEN EXPRESSED AS CAFFEINE CITRATE (e.g., 20 mg of caffeine citrate is equivalent to 10 mg of caffeine base). Serum concentrations of caffeine may need to be monitored periodically throughout treatment to avoid toxicity. Serious toxicity has been associated with serum levels greater than 50 mg/L. Caffeine citrate injection, USP should be inspected visually for particulate matter and discoloration prior to administration. Vials containing discolored solution or visible particulate matter should be discarded. Drug Compatibility To test for drug compatibility with common intravenous solutions or medications, 20 mL of caffeine citrate injection, USP were combined with 20 mL of a solution or medication, with the exception of an Intralipid ® admixture, which was combined as 80 mL/80 mL. The physical appearance of the combined solutions was evaluated for precipitation. The admixtures were mixed for 10 minutes and then assayed for caffeine. The admixtures were then continually mixed for 24 hours, with further sampling for caffeine assays at 2, 4, 8, and 24 hours. Based on this testing, caffeine citrate injection USP, 60 mg/3 mL is chemically stable for 24 hours at room temperature when combined with the following test products. • Dextrose Injection, USP 5% • 50% Dextrose Injection USP • Intralipid ® 20% IV Fat Emulsion • Aminosyn ® 8.5% Crystalline Amino Acid Solution • Dopamine HCI Injection, USP 40 mg/mL diluted to 0.6 mg/mL with Dextrose Injection, USP 5% • Calcium Gluconate Injection, USP 10% (0.465 mEq/Ca +2 /mL) • Heparin Sodium Injection, USP 1000 units/mL diluted to 1 unit/mL with Dextrose Injection, USP 5% • Fentanyl Citrate Injection, USP 50 mcg/mL diluted to 10 mcg/mL with Dextrose Injection, USP 5%