If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Cafcit (Caffeine Citrate) Approved in U.S. for Pre-Term Infants with Respiratory Problems COLUMBUS, OH -- May 10, 2000 -- Roxane Laboratories, Inc. and Boehringer Ingelheim Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Cafcit® (caffeine citrate) Oral Solution for the short-term treatment of apnea of prematurity (AOP) in infants between 28 and <33 weeks gestational age. This announcement follows the FDA approval in September 1999 of Cafcit (caffeine citrate) Injection, which is a ready-to-use formulation that is administered once daily in the hospital. The approval of the oral solution will allow caregivers to continue providing the once-a-day treatment to their infants after leaving the hospital. AOP is a condition in which cessation of breathing in pre-term infants can cause dangerously low levels of blood oxygen. The American Academy of Pediatrics and the U.S. Birth Cohorts estimate that there are more than 150,000 infants born each year who will be diagnosed and treated for AOP. "Given once daily, Cafcit has been shown to reduce the frequency of apnea spells in pre-term babies," said Adam A. Rosenberg, MD, Director of Newborn Services at University of Colorado Hospital, Denver, CO, and Professor of Pediatrics, University of Colorado School of Medicine. "The oral solution will allow continued and convenient Cafcit treatment." Cafcit Oral Solution is a clear, colorless, sterile, nonpyrogenic, preservative-free, aqueous solution offered in 3 mL single-dose clear glass vials. Each 3 mL single-dose vial contains a concentration of 20 mg/mL caffeine citrate (60 mg/vial). Ten vials of Cafcit Oral Solution will be securely packaged in a child- resistant Medi-Lock(R) container. Each vial is sterile and sealed, but can be easily opened by flipping up the blue tab on top, tearing off the seal and removing the rubber stopper from the vial. Distribution to pharmacies throughout the United States is planned to begin by the end of May. Physicians will prescribe the proper maintenance dosage based on each infant's weight. Recommended maintenance dosage is 0.25 mL of Cafcit Oral Solution per kilogram of weight (5 mg/kg caffeine citrate). Physicians or pharmacists will supply caregivers with syringes for administration. Cafcit, only one of three drugs approved by the FDA for neonatal use, is the first commercially available formulation of caffeine citrate. The long half-life (~ three to four days in neonates) of Cafcit allows for once daily dosing. "The infant will be started on Cafcit in the hospital, so by the time the baby is sent home, the physician will provide detailed instructions to each caregiver to make the at-home maintenance administration as easy as possible," said Dr. Rosenberg. Although the exact mechanism of action of caffeine in AOP is not known, several mechanisms have been hypothesized, including the stimulation of the respiratory center, increased minute ventilation and increased oxygen consumption. Results from a 10- to 12-day multicenter, randomized, double-blind placebo-controlled trial of 85 preterm infants (gestational age 28 to <33 weeks with apnea of prematurity demonstrated that Cafcit treatment significantly eliminated apnea events on day two of treatment [percent of patients with zero apnea events: 26.7 percent (Cafcit) vs. 8.1 percent (placebo), p=0.03]. The mean number of days with zero apnea events was 3.0 in the Cafcit group and 1.2 in the placebo group. The mean number of days with a 50 percent reduction from baseline in apnea events was 6.8 in the Cafcit group and 4.6 in the placebo group. Overall, adverse events were similar between Cafcit and placebo in the double-blind trial. However, events described in published literature include CNS stimulation, cardiovascular effects, gastrointestinal effects, alterations in serum glucose and renal effects. Six cases of necrotizing enterocolitis (NEC) developed among the 85 infants studied during the double-blind, placebo-controlled trial. Five of the six patients with NEC were randomized to or had been exposed to Cafcit. Although a causal relationship between methylxanthine (theophylline and caffeine citrate) use and necrotizing enterocolitis (NEC) has not been established, infants should be carefully monitored for the development of NEC during treatment with Cafcit. Boehringer Ingelheim Pharmaceuticals, Inc., a leader in respiratory care, will market Cafcit in the hospital environment. Roxane Laboratories, Inc. (Columbus, OH) is a leading manufacturer of ethical human pharmaceutical products with a strong commitment to palliative care and HIV. The company is a wholly owned subsidiary of Boehringer Ingelheim Corporation, located in Ridgefield, CT, and part of the Boehringer Ingelheim worldwide group of companies. The Boehringer Ingelheim group of companies, with headquarters in Ingelheim (Germany) is one of the 20 leading pharmaceutical corporations in the world. It reported revenues exceeding U.S. $5.4 billion in 1999. The corporation has more than 140 affiliated companies and it conducts business on every continent. Its product range is focused on human pharmaceuticals -- hospital, prescription and self-medication -- as well as animal health. The company has substantial research and development, production, and distribution facilities around the globe. In 1999, Boehringer Ingelheim spent U.S. $882.8 million on R&D, equivalent to 16 percent of total sales. Related Links: Boehringer Ingelheim Pharmaceuticals, Inc. and Roxane Laboratories, Inc.
|
