Pronunciation:

KAF-een SIT-rate

Brand Names:

• Cafcit

Dosage Forms:

• Solution

Classifications:

Therapeutic—

CNS Stimulant

Chemical—

Caffeine

Uses of This Medicine:

Caffeine citrate injection is used to treat short-term apnea of prematurity when premature babies (infants between 28 and 32 weeks gestational age) stop breathing. Apnea of prematurity is caused by the baby's breathing centers not being fully developed.

This medicine is available with or without your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not pediatric-specific problems that would limit the usefulness of caffeine citrate injection in premature babies.

Older adults—

No information is available on the relationship of age to the effects of caffeine citrate injection in geriatric patients.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Riociguat
• Viloxazine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Capmatinib
• Carbamazepine
• Givosiran
• Iobenguane I 131
• Pixantrone
• Ritlecitinib

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Tobacco

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Central nervous system problems or
• Heart or blood vessel problems or
• Lung disease or breathing problems (eg, obstructive apnea) or
• Sepsis (infection in the blood)—Should be ruled out or treated first before using this medicine.

• Hyperglycemia (high blood sugar) or
• Hypoglycemia (high blood sugar) or
• Necrotizing enterocolitis or
• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of caffeine oral solution from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give your baby this medicine in a hospital. This medicine is given through a needle placed in one of your baby's veins. The medicine must be injected slowly, so your baby's IV tube will need to stay in place for 10 to 30 minutes.

Precautions While Using This Medicine:

Your baby's doctor will check your baby's progress closely while your baby is receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if your baby should continue to receive it.

Call your baby's doctor right away if your baby continues to have apnea.

Tell your baby's doctor right away if your baby has one of the following symptoms: faster heartbeat, increased diaper wetting, restlessness, jitteriness, or shaking.

Call your baby's doctor right away if your baby has the following symptoms: abdominal or stomach distension, vomiting, or bloody stools. These may be symptoms of a serious bowel or stomach problem.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Feeding intolerance

Less common

Agitation

black, tarry stools

blood in the stools or urine

bruising

burning feeling or tenderness in the stomach

chills

coma

confusion

coughing or vomiting blood

decreased urine output

depression

dizziness

fainting

fast heartbeat

fever

headache

hostility

indigestion

irritability

lethargy

lightheadedness

muscle twitching

nausea

persistent bleeding

rapid, shallow breathing

rapid weight gain

rash

seizures

stomach upset

swelling of the face, ankles, or hands

trouble breathing

unusual tiredness or weakness

vomiting

vomiting of blood or material that looks like coffee grounds

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Irritability

nervousness

rapid heartbeat

trouble sleeping

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Dry skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.