Caffeine Citrate Solution

Caffeine Citrate Solution

Caffeine Citrate Solution Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

During the double-blind, placebo-controlled clinical trial, six cases of necrotizing enterocolitis developed among the 85 infants studied (caffeine=46, placebo=39), with three cases resulting in death.  Five of the six patients with necrotizing enterocolitis were randomized to or had been exposed to caffeine citrate.

Reports in the published literature have raised a question regarding the possible association between the use of methylxanthines and development of necrotizing enterocolitis, although a causal relationship between methylxanthine use and necrotizing enterocolitis has not been established.  Therefore, as with all preterm infants, patients being treated with caffeine citrate should be carefully monitored for the development of necrotizing enterocolitis.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Caffeine citrate oral solution is indicated for the short term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.


There is currently no drug history available for this drug.

Other Information

Caffeine Citrate Oral Solution, USP 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.

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-1H-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 Solution Manufacturers

  • App Pharmaceuticals, Llc
    Caffeine Citrate Solution [App Pharmaceuticals, Llc]
  • Remedyrepack Inc.
    Caffeine Citrate Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Caffeine Citrate Solution [Remedyrepack Inc. ]
  • Sagent Pharmaceuticals
    Caffeine Citrate Solution [Sagent Pharmaceuticals]
  • Exela Pharma Sciences, Llc
    Caffeine Citrate Solution [Exela Pharma Sciences, Llc]

Login To Your Free Account