Med Guide

 

CAFFEINE CITRATE

Oral Solution, USP

Rx only

Each bottle (vial) of Caffeine Citrate Oral Solution, USP 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 caffeine citrate oral solution and how to give it to your baby.  Read the following information before giving this medicine to your baby.  Completely discuss caffeine citrate oral solution with your baby’s doctor.  Continue to discuss any questions you have about this medicine at your baby’s checkups.

After you remove your baby’s dose, throw away the open bottle (vial) and all medicine left in it. Use each vial of caffeine citrate oral solution 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 caffeine citrate oral solution does not contain preservatives.  Once the vial is open, any medicine that is not used right away must be discarded.

What is Caffeine Citrate Oral Solution?

The main ingredient of caffeine citrate oral solution is caffeine citrate. Caffeine citrate oral solution is a clear, colorless, medicine to treat apnea of prematurity - short periods when premature babies stop breathing.  Apnea of prematurity is due to the baby’s breathing centers not being fully developed.

How do I give Caffeine Citrate Oral Solution to my baby?

Give caffeine citrate oral solution to your baby once a day, at about the same time each day.  Your baby’s doctor will prescribe the right amount of caffeine citrate oral solution based on your baby’s weight and age.  Carefully follow the doctor’s dosing instructions.

Measure the dose of caffeine citrate oral solution carefully.  Your baby’s doctor, nurse, or pharmacist will give you a suitable syringe or supply of syringes to measure small but accurate doses of caffeine citrate oral solution.

Never change (increase or decrease) your baby’s dose without speaking to your baby’s doctor.

If your baby continues to have periods of apnea, call your baby’s doctor right away.

Caffeine citrate oral solution can be swallowed by mouth or given through a feeding tube. Based on your baby’s own situation, your baby’s doctor or other healthcare professional should teach you how to give caffeine citrate oral solution correctly.

Caffeine citrate oral solution should be clear and colorless.  Before giving caffeine citrate oral solution, look for small particles, cloudiness, or discoloration in the medicine.  Do not use vials that contain cloudy or discolored medicine, or any visible particles.

Caffeine citrate oral solution 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 baby’s dose, throw away the vial and all medicine left in the opened vial.

Five (5) vials of caffeine citrate oral solution are packaged in a child-resistant container.  Caffeine citrate oral solution vials are NOT CHILD-RESISTANT.  Always store  vials of caffeine citrate oral solution in the child-resistant container.  Follow the instructions below to open the child-resistant carton, to open a vial of caffeine citrate oral solution, and to remove a dose of medicine from the vial.

To open the child-resistant carton for caffeine citrate oral solution:

(Instructions with pictures are also printed on the top of the container)

1.     Holding base with one hand, squeeze semicircular section with your thumb.

2.     With your other hand, push up cover until you hear two clicks.

3.     Grasp narrow sides of the top.  Using the index finger and thumb, press the two semicircular locking tabs on the sides of the cover.  Lift cover completely.

To open a vial of caffeine citrate oral solution:

1.    Hold the blue plastic top between the thumb and index finger.  Use your thumb to flip the blue plastic top completely off the vial.

2.     Carefully lift up the metal ring.

3.     Pull the metal ring away from the vial and then pull it down towards the bottom of the vial without twisting the ring.

4.     After you pull the ring down and the metal band around the top of the vial is completely broken through, carefully remove the rest of the metal band by pulling it out and away from the vial.

5.     Being careful not to spill any medicine, remove the rubber stopper from the top of the vial.

To remove the prescribed dose from the vial:

You will need a small syringe to measure the exact amount of medicine that your baby’s doctor prescribed.  Your baby’s doctor, nurse or pharmacist will give you this small syringe.  Note that a milliliter (mL) is the same as a cubic centimeter (cc).

1.      Insert the tip of the syringe in the medicine and pull up on the plunger to draw the medicine into the syringe.  Remove slightly more of the medicine than the exact amount to be given to your baby.

2.    Turn the syringe tip up so that any air in it rises to the top.  Remove the air by gently pushing up on the syringe plunger.  Continue to push the syringe plunger up to remove any extra medicine in the syringe, until only the exact number of milliliters (or cubic centimeters) that your baby’s doctor prescribed remains in the syringe.

3.     Give the caffeine citrate oral solution to your baby as your baby’s doctor instructed.

4.     Throw away the sharp metal pieces, the rubber stopper, the open vial, and any medicine that remains in it after your baby receives the dose.

What are possible side effects of Caffeine Citrate Oral Solution?

Your baby may or may not develop side effects from taking caffeine citrate oral solution.  Each baby is different.  If your baby develops one or more of the following symptoms, speak with your baby’s doctor right away:

restlessness, jitteriness or shakiness

• faster heart beat

• increased urination (increased diaper wetting)

The following symptoms may be caused by serious bowel or stomach problems.  Call your baby’s doctor right away if your baby develops:

• bloated abdomen (stomach area)

• vomiting

• bloody stools (bloody bowel movements)

• loss of energy, lethargy (acting sluggish)

This is not a complete list of side effects reported with caffeine citrate oral solution.  If you have a concern about your baby, speak with your baby’s doctor.  If you want more information about caffeine citrate oral solution, speak with your baby’s doctor or pharmacist.