Medical Editor: John P. Cunha, DO, FACOEP
What Is Cafcit?
What Are Side Effects of Cafcit?
Common side effects of Cafcit include:
- stomach upset,
- trouble sleeping,
- excessive crying,
- poor feeding or loss of appetite,
- rash or
- dry skin.
Tell your doctor if you child has unlikely but serious side effects of Cafcit including:
- trouble breathing,
- vision changes, or
- a change in the amount of urine.
Dosage for Cafcit
Cafcit is administered intravenously. Dose is based on the child's weight and baseline blood levels of caffeine.
What Drugs, Substances, or Supplements Interact with Cafcit?
Cafcit may interact with:
- phenytoin, or
Tell your doctor all medications you use.
Cafcit During Pregnancy and Breastfeeding
Cafcit should be used only when prescribed during pregnancy. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.
Our Cafcit (caffeine citrate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Get emergency medical help if your child has signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.
Call your child's doctor at once if your child has:
- restlessness, jitteriness, or shakiness;
- fast heartbeats;
- more wet diapers than usual;
- vomiting, stomach bloating;
- blood in the stools;
- weakness, drowsiness; or
- fever, chills, rapid breathing.
Common side effects may include:
- feeding problems; or
- skin rash.
This is not a complete list of side effects and others may occur. Call your child's doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Cafcit (Caffeine Citrate)
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.
ADVERSE EVENTS THAT OCCURRED MORE FREQUENTLY IN CAFCIT-TREATED PATIENTS THAN PLACEBO DURING DOUBLE-BLIND THERAPY
|Adverse Event (AE)||CAFCIT|
|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 Coagulation||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 (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.
A published randomized, placebo-controlled, clinical trial in premature infants with birthweights of 5001250 grams studied the safety of caffeine citrate in apnea of prematurity (NCT00182312). This trial randomized approximately 2000 premature infants with a mean gestational age of 27 weeks at birth. The median duration of caffeine therapy was 37 days. Prior to discharge home, death, ultrasonographic signs of brain injury, and necrotizing enterocolitis were not more common in the caffeine citrate group compared to the placebo. At follow up at both 18 months and 5 years corrected age, death was not more common in the caffeine citrate treated group compared to placebo, nor did caffeine citrate use adversely affect neurodevelopmental outcomes.
Read the entire FDA prescribing information for Cafcit (Caffeine Citrate)
© Cafcit Patient Information is supplied by Cerner Multum, Inc. and Cafcit Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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