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caffeine citrate
Overview
What is CAFCIT?
CAFCIT® Injection (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 to 5 mg citric acid monohydrate, 8.3 mg sodium citrate dihydrate 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-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
CHNO MW 386.31
What does CAFCIT look like?
What are the available doses of CAFCIT?
Sorry No records found.
What should I talk to my health care provider before I take CAFCIT?
Sorry No records found
How should I use CAFCIT?
CAFCIT (caffeine citrate) is indicated for the short-term treatment of apnea of prematurity in infants between 28 and <33 weeks gestational age.
Prior to initiation of CAFCIT (caffeine citrate), 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 CAFCIT follow.
*using a syringe infusion pump**beginning 24 hours after the loading dose
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.
CAFCIT should be inspected visually for particulate matter and discoloration prior to administration. Vials containing discolored solution or visible particulate matter should be discarded.
What interacts with CAFCIT?
CAFCIT (caffeine citrate) is contraindicated in patients who have demonstrated hypersensitivity to any of its components.
What are the warnings of CAFCIT?
Because buspirone hydrochloride has no established antipsychotic activity, it should not be employed in lieu of appropriate antipsychotic treatment.
During the double-blind, placebo-controlled clinical trial, 6 cases of necrotizing 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 CAFCIT (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 CAFCIT should be carefully monitored for the development of necrotizing enterocolitis.
What are the precautions of CAFCIT?
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General
Apnea of prematurity is a diagnosis of exclusion. Other causes of apnea (e.g., central nervous system disorders, primary lung disease, anemia, sepsis, metabolic disturbances, cardiovascular abnormalities, or obstructive apnea) should be ruled out or properly treated prior to initiation of CAFCIT (caffeine citrate).
Caffeine is a central nervous system stimulant and in cases of caffeine overdose, seizures have been reported. CAFCIT should be used with caution in infants with seizure disorders.
The duration of treatment of apnea of prematurity in the placebo-controlled trial was limited to 10 to 12 days. The safety and efficacy of CAFCIT for longer periods of treatment have not been established. Safety and efficacy of CAFCIT for use in the prophylactic treatment of sudden infant death syndrome (SIDS) or prior to extubation in mechanically ventilated infants have also not been established.
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Cardiovascular
Although no cases of cardiac toxicity were reported in the placebo-controlled trial, caffeine has been shown to increase heart rate, left ventricular output, and stroke volume in published studies. Therefore, CAFCIT should be used with caution in infants with cardiovascular disease.
Renal and Hepatic Systems
CAFCIT should be administered with caution in infants with impaired renal or hepatic function. Serum concentrations of caffeine should be monitored and dose administration of CAFCIT should be adjusted to avoid toxicity in this population. (See , and .)
Laboratory Tests
Prior to initiation of CAFCIT (caffeine citrate), 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.
In the placebo-controlled clinical trial, caffeine levels ranged from 8 to 40 mg/L. A therapeutic plasma concentration range of caffeine could not be determined from the placebo-controlled clinical trial. Serious toxicity has been reported in the literature when serum caffeine levels exceed 50 mg/L. Serum concentrations of caffeine may need to be monitored periodically throughout treatment to avoid toxicity.
In clinical studies reported in the literature, cases of hypoglycemia and hyperglycemia have been observed. Therefore, serum glucose may need to be periodically monitored in infants receiving CAFCIT.
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Drug Interactions
Cytochrome P450 1A2 (CYP1A2) is known to be the major enzyme involved in the metabolism of caffeine. Therefore, caffeine has the potential to interact with drugs that are substrates for CYP1A2, inhibit CYP1A2, or induce CYP1A2.
Few data exist on drug interactions with caffeine in preterm neonates. Based on adult data, lower doses of caffeine may be needed following coadministration of drugs which are reported to decrease caffeine elimination (e.g., cimetidine and ketoconazole) and higher caffeine doses may be needed following coadministration of drugs that increase caffeine elimination (e.g., phenobarbital and phenytoin).
Caffeine administered concurrently with ketoprofen reduced the urine volume in four healthy volunteers. The clinical significance of this interaction in preterm neonates is not known.
Interconversion between caffeine and theophylline has been reported in preterm neonates. The concurrent use of these drugs is not recommended.
Carcinogenesis, Mutagenesis, Impairment of Fertility
In a 2-year study in Sprague-Dawley rats, caffeine (as caffeine base) administered in drinking water was not carcinogenic in male rats at doses up to 102 mg/kg or in female rats at doses up to 170 mg/kg (approximately 2 and 4 times, respectively, the maximum recommended intravenous loading dose for infants on a mg/m basis). In an 18-month study in C57BL/6 mice, no evidence of tumorigenicity was seen at dietary doses up to 55 mg/kg (less than the maximum recommended intravenous loading dose for infants on a mg/m basis).
Caffeine (as caffeine base) increased the sister chromatid exchange (SCE) SCE/cell metaphase (exposure time dependent) in an mouse metaphase analysis. Caffeine also potentiated the genotoxicity of known mutagens and enhanced the micronuclei formation (5-fold) in folate-deficient mice. However, caffeine did not increase chromosomal aberrations in Chinese hamster ovary cell (CHO) and human lymphocyte assays and was not mutagenic in an CHO/hypoxanthine guanine phosphoribosyltransferase (HGPRT) gene mutation assay, except at cytotoxic concentrations. In addition, caffeine was not clastogenic in an mouse micronucleus assay.
Caffeine (as caffeine base) administered to male rats at 50 mg/kg/day subcutaneously (approximately equal to the maximum recommended intravenous loading dose for infants on a mg/m basis) for 4 days prior to mating with untreated females, caused decreased male reproductive performance in addition to causing embryotoxicity. In addition, long-term exposure to high oral doses of caffeine (3 g over 7 weeks) was toxic to rat testes as manifested by spermatogenic cell degeneration.
Pregnancy
What are the side effects of CAFCIT?
Sorry No records found
What should I look out for while using CAFCIT?
CAFCIT (caffeine citrate) is contraindicated in patients who have demonstrated hypersensitivity to any of its components.
During the double-blind, placebo-controlled clinical trial, 6 cases of necrotizing 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 CAFCIT (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 CAFCIT should be carefully monitored for the development of necrotizing enterocolitis.
What might happen if I take too much CAFCIT?
Following overdose, serum caffeine levels have ranged from approximately 24 mg/L (a postmarketing spontaneous case report in which an infant exhibited irritability, poor feeding, and insomnia) to 350 mg/L. Serious toxicity has been associated with serum levels greater than 50 mg/L (see and ). Signs and symptoms reported in the literature after caffeine overdose in preterm infants include fever, tachypnea, jitteriness, insomnia, fine tremor of the extremities, hypertonia, opisthotonos, tonic-clonic movements, nonpurposeful jaw and lip movements, vomiting, hyperglycemia, elevated blood urea nitrogen, and elevated total leukocyte concentration. Seizures have also been reported in cases of overdose. One case of caffeine overdose complicated by development of intraventricular hemorrhage and long-term neurological sequelae has been reported. Another case of caffeine citrate overdose (from New Zealand; not CAFCIT) of an estimated 600 mg caffeine citrate (approximately 322 mg/kg) administered over 40 minutes was complicated by tachycardia, ST depression, respiratory distress, heart failure, gastric distention, acidosis, and a severe extravasation burn with tissue necrosis at the peripheral intravenous injection site. No deaths associated with caffeine overdose have been reported in preterm infants.
Treatment of caffeine overdose is primarily symptomatic and supportive. Caffeine levels have been shown to decrease after exchange transfusions. Convulsions may be treated with intravenous administration of diazepam or a barbiturate such as pentobarbital sodium.
How should I store and handle CAFCIT?
Storage:Revised: 10/2013© 2013 Allergan, Inc., Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc.Patented. See: www.allergan.com/products/patent_noticesMade in the U.S.A. Array71654PY10 Storage:Revised: 10/2013© 2013 Allergan, Inc., Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc.Patented. See: www.allergan.com/products/patent_noticesMade in the U.S.A. Array71654PY10 Storage:Revised: 10/2013© 2013 Allergan, Inc., Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc.Patented. See: www.allergan.com/products/patent_noticesMade in the U.S.A. Array71654PY10 Storage:Revised: 10/2013© 2013 Allergan, Inc., Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc.Patented. See: www.allergan.com/products/patent_noticesMade in the U.S.A. Array71654PY10 Storage:Revised: 10/2013© 2013 Allergan, Inc., Irvine, CA 92612, U.S.A.® marks owned by Allergan, Inc.Patented. See: www.allergan.com/products/patent_noticesMade in the U.S.A. Array71654PY10 CAFCIT® Injection (caffeine citrate injection, USP) is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 3 mL colorless glass vials. The vials are sealed with a teflon-faced 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).CAFCIT® Injection (caffeine citrate injection, USP) is supplied as: NDC 0641-6164-10, 3 mL Single Dose Vial packaged in a carton of 10Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Not made with natural rubber latex.Preservative free. For single dose only. Discard unused portion.To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARDPHARMACEUTICALSEatontown, NJ 07724 USARevised February 2015462-708-00CAFCIT® Injection (caffeine citrate injection, USP) is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 3 mL colorless glass vials. The vials are sealed with a teflon-faced 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).CAFCIT® Injection (caffeine citrate injection, USP) is supplied as: NDC 0641-6164-10, 3 mL Single Dose Vial packaged in a carton of 10Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Not made with natural rubber latex.Preservative free. For single dose only. Discard unused portion.To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARDPHARMACEUTICALSEatontown, NJ 07724 USARevised February 2015462-708-00CAFCIT® Injection (caffeine citrate injection, USP) is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 3 mL colorless glass vials. The vials are sealed with a teflon-faced 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).CAFCIT® Injection (caffeine citrate injection, USP) is supplied as: NDC 0641-6164-10, 3 mL Single Dose Vial packaged in a carton of 10Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Not made with natural rubber latex.Preservative free. For single dose only. Discard unused portion.To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARDPHARMACEUTICALSEatontown, NJ 07724 USARevised February 2015462-708-00CAFCIT® Injection (caffeine citrate injection, USP) is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 3 mL colorless glass vials. The vials are sealed with a teflon-faced 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).CAFCIT® Injection (caffeine citrate injection, USP) is supplied as: NDC 0641-6164-10, 3 mL Single Dose Vial packaged in a carton of 10Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Not made with natural rubber latex.Preservative free. For single dose only. Discard unused portion.To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARDPHARMACEUTICALSEatontown, NJ 07724 USARevised February 2015462-708-00CAFCIT® Injection (caffeine citrate injection, USP) is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 3 mL colorless glass vials. The vials are sealed with a teflon-faced 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).CAFCIT® Injection (caffeine citrate injection, USP) is supplied as: NDC 0641-6164-10, 3 mL Single Dose Vial packaged in a carton of 10Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Not made with natural rubber latex.Preservative free. For single dose only. Discard unused portion.To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARDPHARMACEUTICALSEatontown, NJ 07724 USARevised February 2015462-708-00CAFCIT® Injection (caffeine citrate injection, USP) is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 3 mL colorless glass vials. The vials are sealed with a teflon-faced 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).CAFCIT® Injection (caffeine citrate injection, USP) is supplied as: NDC 0641-6164-10, 3 mL Single Dose Vial packaged in a carton of 10Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Not made with natural rubber latex.Preservative free. For single dose only. Discard unused portion.To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARDPHARMACEUTICALSEatontown, NJ 07724 USARevised February 2015462-708-00CAFCIT® Injection (caffeine citrate injection, USP) is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 3 mL colorless glass vials. The vials are sealed with a teflon-faced 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).CAFCIT® Injection (caffeine citrate injection, USP) is supplied as: NDC 0641-6164-10, 3 mL Single Dose Vial packaged in a carton of 10Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Not made with natural rubber latex.Preservative free. For single dose only. Discard unused portion.To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARDPHARMACEUTICALSEatontown, NJ 07724 USARevised February 2015462-708-00CAFCIT® Injection (caffeine citrate injection, USP) is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 3 mL colorless glass vials. The vials are sealed with a teflon-faced 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).CAFCIT® Injection (caffeine citrate injection, USP) is supplied as: NDC 0641-6164-10, 3 mL Single Dose Vial packaged in a carton of 10Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Not made with natural rubber latex.Preservative free. For single dose only. Discard unused portion.To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARDPHARMACEUTICALSEatontown, NJ 07724 USARevised February 2015462-708-00CAFCIT® Injection (caffeine citrate injection, USP) is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 3 mL colorless glass vials. The vials are sealed with a teflon-faced 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).CAFCIT® Injection (caffeine citrate injection, USP) is supplied as: NDC 0641-6164-10, 3 mL Single Dose Vial packaged in a carton of 10Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Not made with natural rubber latex.Preservative free. For single dose only. Discard unused portion.To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARDPHARMACEUTICALSEatontown, NJ 07724 USARevised February 2015462-708-00CAFCIT® Injection (caffeine citrate injection, USP) is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 3 mL colorless glass vials. The vials are sealed with a teflon-faced 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).CAFCIT® Injection (caffeine citrate injection, USP) is supplied as: NDC 0641-6164-10, 3 mL Single Dose Vial packaged in a carton of 10Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Not made with natural rubber latex.Preservative free. For single dose only. Discard unused portion.To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARDPHARMACEUTICALSEatontown, NJ 07724 USARevised February 2015462-708-00CAFCIT® Injection (caffeine citrate injection, USP) is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 3 mL colorless glass vials. The vials are sealed with a teflon-faced 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).CAFCIT® Injection (caffeine citrate injection, USP) is supplied as: NDC 0641-6164-10, 3 mL Single Dose Vial packaged in a carton of 10Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Not made with natural rubber latex.Preservative free. For single dose only. Discard unused portion.To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARDPHARMACEUTICALSEatontown, NJ 07724 USARevised February 2015462-708-00CAFCIT® Injection (caffeine citrate injection, USP) is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 3 mL colorless glass vials. The vials are sealed with a teflon-faced 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).CAFCIT® Injection (caffeine citrate injection, USP) is supplied as: NDC 0641-6164-10, 3 mL Single Dose Vial packaged in a carton of 10Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Not made with natural rubber latex.Preservative free. For single dose only. Discard unused portion.To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARDPHARMACEUTICALSEatontown, NJ 07724 USARevised February 2015462-708-00CAFCIT® Injection (caffeine citrate injection, USP) is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 3 mL colorless glass vials. The vials are sealed with a teflon-faced 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).CAFCIT® Injection (caffeine citrate injection, USP) is supplied as: NDC 0641-6164-10, 3 mL Single Dose Vial packaged in a carton of 10Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Not made with natural rubber latex.Preservative free. For single dose only. Discard unused portion.To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARDPHARMACEUTICALSEatontown, NJ 07724 USARevised February 2015462-708-00CAFCIT® Injection (caffeine citrate injection, USP) is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 3 mL colorless glass vials. The vials are sealed with a teflon-faced 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).CAFCIT® Injection (caffeine citrate injection, USP) is supplied as: NDC 0641-6164-10, 3 mL Single Dose Vial packaged in a carton of 10Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Not made with natural rubber latex.Preservative free. For single dose only. Discard unused portion.To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARDPHARMACEUTICALSEatontown, NJ 07724 USARevised February 2015462-708-00CAFCIT® Injection (caffeine citrate injection, USP) is available as a clear, colorless, sterile, non-pyrogenic, preservative-free, aqueous solution in 3 mL colorless glass vials. The vials are sealed with a teflon-faced 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).CAFCIT® Injection (caffeine citrate injection, USP) is supplied as: NDC 0641-6164-10, 3 mL Single Dose Vial packaged in a carton of 10Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Not made with natural rubber latex.Preservative free. For single dose only. Discard unused portion.To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .For Product Inquiry call 1-877-845-0689.Manufactured by:WEST-WARDPHARMACEUTICALSEatontown, NJ 07724 USARevised February 2015462-708-00
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Caffeine is structurally related to other methylxanthines, theophylline, and theobromine. 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) stimulation 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 metabolic rate, and (8) increased oxygen consumption.
Most of these effects have been attributed to antagonism of adenosine receptors, both A and A subtypes, by caffeine, which has been demonstrated in receptor binding assays and observed at concentrations approximating those achieved therapeutically.
Non-Clinical Toxicology
CAFCIT (caffeine citrate) is contraindicated in patients who have demonstrated hypersensitivity to any of its components.During the double-blind, placebo-controlled clinical trial, 6 cases of necrotizing 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 CAFCIT (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 CAFCIT should be carefully monitored for the development of necrotizing enterocolitis.
Apnea of prematurity is a diagnosis of exclusion. Other causes of apnea (e.g., central nervous system disorders, primary lung disease, anemia, sepsis, metabolic disturbances, cardiovascular abnormalities, or obstructive apnea) should be ruled out or properly treated prior to initiation of CAFCIT (caffeine citrate).
Caffeine is a central nervous system stimulant and in cases of caffeine overdose, seizures have been reported. CAFCIT should be used with caution in infants with seizure disorders.
The duration of treatment of apnea of prematurity in the placebo-controlled trial was limited to 10 to 12 days. The safety and efficacy of CAFCIT for longer periods of treatment have not been established. Safety and efficacy of CAFCIT for use in the prophylactic treatment of sudden infant death syndrome (SIDS) or prior to extubation in mechanically ventilated infants have also not been established.
Overall, the reported number of adverse events in the double-blind period of the controlled trial was similar for the CAFCIT (caffeine citrate) and placebo groups. The following table shows adverse events that occurred in the double-blind period of the controlled trial and that were more frequent in CAFCIT-treated patients than placebo.
In addition to the cases above, three cases of necrotizing enterocolitis were diagnosed in patients receiving CAFCIT (caffeine citrate) during the open-label phase of the study.
Three of the infants who developed necrotizing enterocolitis during the trial died. All had been exposed to caffeine. Two were randomized to caffeine, and one placebo patient was “rescued” with open-label caffeine for uncontrolled apnea.
Adverse events described in the published literature include: central nervous system stimulation (i.e., irritability, restlessness, jitteriness), cardiovascular effects (i.e., tachycardia, increased left ventricular output, and increased stroke volume), gastrointestinal effects (i.e., increased gastric aspirate, gastrointestinal intolerance), alterations in serum glucose (i.e., hypoglycemia and hyperglycemia), and renal effects (i.e., increased urine flow rate, increased creatinine clearance, and increased sodium and calcium excretion). Published long-term follow-up studies have not shown caffeine to adversely affect neurological development or growth parameters.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
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