Caffeine citrate (injection/oral liquid)

This medication guide provides information about Cafcit injection and oral liquid forms of caffeine citrate. Other forms of caffeine citrate used for wakefulness are NOT covered in this medication guide.

Caffeine citrate injection or oral liquid (Cafcit) is used to treat breathing problems in premature infants.

Caffeine citrate injection or oral liquid may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may sometimes change your child's dose. Use the medicine exactly as directed.

Cafcit is for short-term use only. Do not use caffeine citrate for longer than 12 days without your child's doctor's advice.

Cafcit oral liquid is taken by mouth.

Caffeine citrate injection is given as an infusion into a vein. A healthcare provider will give your child this injection.

Measure liquid medicine carefully. Use only the dosing syringe provided. Give the medicine only in the amount prescribed by your child's doctor (mL and cc are equal measurements). Cafcit oral liquid may also be given through a feeding tube.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Give the oral liquid at the same time each day.

Do not use the liquid if it looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medication.

Cafcit oral liquid doses are based on weight. Your child's dose needs may change if the child gains or loses weight. Do not change your baby's dose without first asking your doctor.

Your child will need frequent medical tests.

Call your doctor right away if your baby's apnea symptoms do not improve.

Cafcit contains no preservative. Do not open a bottle of this medicine until you are ready to give the dose.

Each bottle of Cafcit oral liquid is for one use only. Throw it away after one use, even if there is still medicine left inside.

Store at room temperature away from moisture and heat.

Follow all instructions on your medicine label and package. Inform your child's healthcare providers about all of your child's medical conditions, allergies, and all medicines given to the child.

Cafcit should not be given to a child who is allergic to it.

Tell your doctor if your child has ever had:

• seizures;
• heart problems; or
• liver or kidney disease.

Tell your child's doctor if you used caffeine during late pregnancy.

Infants being treated with Cafcit may develop necrotizing enterocolitis (a condition where a part of the bowel dies). Ask your child's doctor about this risk.

Get emergency medical help if your child shows signs of an allergic reaction: hives; trouble breathing; swelling of the face, lips, tongue, or throat.

Call your child's doctor right away 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 of caffeine citrate may include:

• feeding problems; or
• skin rash.

This is not a complete list of side effects and others may happen. Call your child's doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

Usual Pediatric Dose for Apnea of Prematurity:

Caffeine Citrate:28 Weeks to Less Than 33 Weeks Gestational Age:-Loading Dose: 20 mg/kg IV over 30 minutes one time.-Maintenance Dose: 5 mg/kg orally or IV over 10 minutes every 24 hours.-Treatment Duration: Safety and efficacy of this drug for treatment of apnea of prematurity have not been established beyond 12 days.Use: Short-term treatment of apnea of prematurity in infants.

Call your doctor for instructions if you forget to give your child's dose of caffeine citrate (oral liquid).

Because caffeine citrate (injection) is given in a clinical setting, your child is not likely to miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include fever, rapid breathing, nervousness, sleep problems, vomiting, abnormal blood tests, and seizures.

• Avoid giving the child food or drinks that contain caffeine, such as cola or chocolate milk.

Tell your doctor about all other medicines your child is taking, especially theophylline.

Other drugs may affect caffeine citrate, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all of your child's current medicines and any medicine your child starts or stops using.