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Overall, the reported number of adverse events in the double-blind period of the controlled trial was similar for the CAFCIT (caffeine citrate) (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 (caffeine citrate) treated patients than placebo.
ADVERSE EVENTS THAT OCCURRED MORE FREQUENTLY IN CAFCIT (caffeine citrate) TREATED
PATIENTS THAN PLACEBO DURING DOUBLE-BLIND THERAPY
|Adverse Event (AE)|| CAFCIT (caffeine citrate)
|BODY AS A WHOLE|
|Accidental Injury||1 (2.2)||0 (0.0)|
|Feeding Intolerance||4 (8.7)||2 (5.1)|
|Sepsis||2 (4.3)||0 (0.0)|
|Hemorrhage||1 (2.2)||0 (0.0)|
|Necrotizing Enterocolitis||2 (4.3)||1 (2.6)|
|Gastritis||1 (2.2)||0 (0.0)|
|Gastrointestinal Hemorrhage||1 (2.2)||0 (0.0)|
|HEMIC AND LYMPHATIC SYSTEM|
|Disseminated Intravascular||1 (2.2)||0 (0.0)|
|METABOLIC AND NUTRITIVE DISORDERS|
|Acidosis||1 (2.2)||0 (0.0)|
|Healing Abnormal||1 (2.2)||0 (0.0)|
|Cerebral Hemorrhage||1 (2.2)||0 (0.0)|
|Dyspnea||1 (2.2)||0 (0.0)|
|Lung Edema||1 (2.2)||0 (0.0)|
|SKIN AND APPENDAGES|
|Dry Skin||1 (2.2)||0 (0.0)|
|Rash||4 (8.7)||3 (7.7)|
|Skin Breakdown||1 (2.2)||0 (0.0)|
|Retinopathy of Prematurity||1 (2.2)||0 (0.0)|
|Kidney Failure||1 (2.2)||0 (0.0)|
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 (hypoglycemia and hyperglycemia) and renal effects (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.
Read the Cafcit (caffeine citrate) Side Effects Center for a complete guide to possible side effects
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 4 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.
Read the Cafcit Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 5/4/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Cafcit Information
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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