Parents/caregivers of patients receiving CAFCIT® (caffeine citrate) should receive the following instructions:
1. CAFCIT® does not contain any preservatives and each vial is for single use only. Any unused portion of the medication should be discarded.
2. It is important that the dose of CAFCIT® be measured accurately, i.e., with a 1 cc or other appropriate syringe.
3. Consult your physician if the baby continues to have apnea events; do not increase the dose of CAFCIT® without medical consultation.
4. Consult your physician if the baby begins to demonstrate signs of gastrointestinal intolerance, such as abdominal distention, vomiting, or bloody stools, or seems lethargic.
5. CAFCIT® should be inspected visually for particulate matter and discoloration prior to its administration. Vials containing discolored solution or visible particulate matter should be discarded.
(caffeine citrate) Oral Solution
Each bottle (vial) of CAFCIT contains a total of 60 mg of caffeine citrate in 3 mL (20 mg/mL).
Information and Instructions for Use
This leaflet tells you about CAFClT (KAF-sit) and how to give it to your baby. Read the following information before giving this medicine to your baby. Completely discuss CAFCIT with your babys doctor. Continue to discuss any questions you have about this medicine at your babys checkups.
After you remove your babys dose, throw away the open bottle (vial) and all medicine left in it. Use each vial of CAFCIT for only one dose. There will be extra medicine left in the vial after one dose is removed. Leftover medicine should not be used because CAFCIT does not contain preservatives. Once the vial is open, any medicine that is not used right away must be discarded.
What is CAFCIT?
The main ingredient of CAFCIT is caffeine citrate. CAFCIT is a clear, colorless, medicine to treat apnea of prematurity - short periods when premature babies stop breathing. Apnea of prematurity is due to the babys breathing centers not being fully developed.
How do I give CAFCIT to my baby?
Give CAFCIT to your baby once a day, at about the same time each day. Your babys doctor will prescribe the right amount of CAFCIT based on your babys weight and age. Carefully follow the doctors dosing instructions.
Measure the dose of CAFCIT carefully. Your babys doctor, nurse, or pharmacist will give you a suitable syringe or supply of syringes to measure small but accurate doses of CAFCIT.
Never change (increase or decrease) your babys dose without speaking to your babys doctor.
If your baby continues to have periods of apnea, call your babys doctor right away.
CAFCIT can be swallowed by mouth or given through a feeding tube. Based on your babys own situation, your babys doctor or other healthcare professional should teach you how to give CAFCIT correctly.
CAFCIT should be clear and colorless. Before giving CAFCIT, look for small particles, cloudiness, or discoloration in the medicine. Do not use vials that contain cloudy or discolored medicine, or any visible particles.
CAFCIT does NOT contain any preservatives. Do not open the vial until it is time for your baby to receive the dose of medicine. Use each vial only once. After you remove your babys dose, throw away the vial and all medicine left in the opened vial.
Ten (10) vials of CAFCIT are packaged in a child-resistant container. CAFClT vials are NOT CHILD-RESISTANT. Always store vials of CAFCIT in the child-resistant container. Follow the instructions below to open the child-resistant container, to open a vial of CAFCIT, and to remove a dose of medicine from the vial.
To open the child-resistant container that holds the vials of CAFCIT:
(Instructions with pictures are also printed on the top of the container)
To open a vial of CAFCIT (caffeine citrate):
To remove the prescribed dose from the vial:
You will need a small syringe to measure the exact amount of medicine that your babys doctor prescribed. Your babys doctor, nurse or pharmacist will give you this small syringe. Note that a milliliter (mL) is the same as a cubic centimeter (cc).
What are possible side effects of CAFCIT (caffeine citrate)?
Your baby may or may not develop side effects from taking CAFCIT. Each baby is different. If your baby develops one or more of the following symptoms, speak with your babys doctor right away:
The following symptoms may be caused by serious bowel or stomach problems. Call your babys doctor right away if your baby develops:
This is not a complete list of side effects reported with CAFCIT. If you have a concern about your baby, speak with your babys doctor. If you want more information about CAFCIT, speak with your babys doctor or pharmacist.
Ben Venue Laboratories, Inc., Bedford, Ohio 44146.
Mead Johnson & Company, Evansville, IN 47721 U.S.A.
Mead JohnsonTM Nutritionals
©2003 Mead Johnson & Company Revised (2) May 2003
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.
CAFCIT® (caffeine citrate) is contraindicated in patients who have demonstrated hypersensitivity to any of its components.