caffeine citrate
caffeine citrate is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand names including caffeine citrate, Caffeine Citrate. Available dosage forms: solution, injection.
Drug Details
- Generic Name
- caffeine citrate
- Brand Names
- caffeine citrate, Caffeine Citrate
- Application Number
- ANDA091102
- Sponsor
- Sagent Pharmaceuticals
- NDC Codes
- 4
- Dosage Forms
- SOLUTION, INJECTION
- Routes
- ORAL, INTRAVENOUS
- Active Ingredients
- CAFFEINE CITRATE
Indications and Usage
INDICATIONS AND USAGE 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.
Warnings
WARNINGS During the double-blind, placebo-controlled clinical trial, 6 cases of necro‑tizing enterocolitis developed among the 85 infants studied (caffeine=46, placebo=39), with 3 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 possi‑ble association between the use of methylxanthines and development of necro‑tizing 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 moni‑tored for the development of necrotizing enterocolitis.