Caffeine Citrate Oral Solution, USP
Each bottle (vial) of caffeine citrate 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 and how to give
it to your baby. Read the following information before giving this medicine to
your baby. Completely discuss caffeine citrate 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 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
does not contain preservatives. Once the vial is open, any medicine that is not
used right away must be discarded.
What is caffeine citrate?
The main ingredient of caffeine citrate is caffeine citrate.
Caffeine citrate 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 to my baby?
Give caffeine citrate 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 based on your baby's weight and age. Carefully follow the doctor's
Measure the dose of caffeine citrate 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.
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 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
Caffeine citrate should be clear and colorless. Before giving
caffeine citrate, look for small particles, cloudiness, or discoloration in the
Do not use vials that contain cloudy or discolored medicine,
or any visible particles.
Caffeine citrate 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.
Ten (10) vials of caffeine citrate are packaged in a
childresistant container. Caffeine citrate vials are NOT CHILDRESISTANT.
Always store vials of caffeine citrate in the child-resistant container.
Follow the instructions below to open the child-resistant
container, to open a vial of caffeine citrate, and to remove a dose of medicine
from the vial.
To open the child-resistant container that holds the vials
of caffeine citrate: (Instructions with pictures are also printed on the
top of the container)
Hold the bottom-half of the child-resistant container
with one hand and push the lower semicircular section on the front of the
container with your thumb.
With your other hand, pull the cover up until you hear it
While holding the ends of the bottom-half of the
container with both hands, place both index fingers on the two semicircular
locking tabs on the sides of the container.
Press the two tabs and raise the cover up.
To open a vial of caffeine citrate:
Hold the plastic top between the thumb and index finger. Use
your thumb to flip the plastic top completely off the vial.
Carefully lift up the metal ring.
Pull the metal ring away from the vial and then pull it down
towards the bottom of the vial without twisting the ring.
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.
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).
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 amounttobe given to your baby.
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.
Give the caffeine citrate to your baby as your baby's doctor
Throw away the sharp metal pieces, the rubber stopper,
the open vial, and any medicine that remains in it after your baby receives the
What are possible side effects of caffeine citrate?
Your baby may or may not develop side effects from taking
caffeine citrate. 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)
- bloody stools (bloody bowel movements)
- loss of energy, lethargy (acting sluggish)
This is not a complete list of side effects reported with
caffeine citrate. If you have a concern about your baby, speak with your baby's
doctor. If you want more information about caffeine citrate, speak with your
baby's doctor or pharmacist.
To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals,
Inc. at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch