"The US Food and Drug Administration (FDA) has expanded the indication for the short-acting beta-agonist albuterol sulfate inhalation powder (ProAir RespiClick, Teva) to children aged 4 to 11 years, the company announced today.
Cafcit Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Cafcit (caffeine citrate) is a central nervous system stimulant used to treat breathing problems in premature infants. Cafcit is available in generic form. Common side effects of Cafcit include nausea, vomiting, stomach upset, headache, trouble sleeping, restlessness, excessive crying, fussiness, poor feeding or loss of appetite, rash or dry skin.
Cafcit is administered intravenously. Dose is based on the child's weight and baseline blood levels of caffeine. Cafcit may interact with cimetidine, ketoconazole, phenobarbital, phenytoin, or theophylline. Tell your doctor all medications you use. 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 breast-feeding.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Cafcit in Detail - Patient Information: Side Effects
Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using caffeine citrate and call your doctor at once if your child has any of these serious side effects:
- stomach pain, tenderness, bloating,
- constipation or diarrhea;
- green-colored vomit;
- blood in the stools;
- unusual weakness;
- seizure (convulsions);
- twitching or uncontrolled muscle movements; or
- fever, fast or slow heart rate.
Less serious side effects may include sleep problems, loss of appetite, fussiness, or excessive crying.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Cafcit (Caffeine Citrate)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Cafcit Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: trouble breathing, vision changes, change in the amount of urine.
In rare (sometimes, fatal) cases, this medication has been associated with a serious stomach condition (necrotizing enterocolitis). Tell your doctor immediately if your infant experiences the following: lack of energy (lethargy), severe vomiting, stomach/abdominal bloating (distension), bloody stool.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Cafcit (Caffeine Citrate)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Cafcit FDA Prescribing Information: Side Effects
Overall, the reported number of adverse events in the double-blind period of the controlled trial was similar for the 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 caffeine citrate treated patients than placebo.
ADVERSE EVENTS THAT OCCURRED MORE FREQUENTLY IN
CAFFEINE CITRATE TREATED PATIENTS THAN PLACEBO DURING DOUBLE-BLIND THERAPY
|Adverse Event (AE)||Caffeine Citrate
N=39 n (%)
|BODY AS A WHOLE|
|Accidental Injury||1 (2.2)||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 Hemorrtiage||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)|
|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 caffeine citrate during the openlabel 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 in to lerance), 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.
To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals, Inc., at 1-866-625-1618 or FDA at 1-800-FD A-1088 or www.fda.gov/medwatch .
Read the entire FDA prescribing information for Cafcit (Caffeine Citrate)
Additional Cafcit Information
Report Problems to the Food and Drug Administration
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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