Cafcit (Oral)

Caffeine tablets are used to help you stay awake when you feel drowsy or unusually tired or weak. Do not use this medicine instead of getting sleep.

Caffeine oral solution 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 happens because the baby's breathing centers are not fully developed.

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

Your doctor will closely monitor your progress while you or your child are using this medicine. This will help your doctor determine if the medicine is effective and if you should continue to use it.

If you are using caffeine solution:

• Call your baby's doctor immediately if your baby continues to have apnea.
• Inform your baby's doctor right away if your baby shows any of these symptoms: faster heartbeat, increased diaper wetting, restlessness, jitteriness, or shaking.
• Contact your baby's doctor immediately if your baby experiences any of the following symptoms: abdominal or stomach swelling, vomiting, or bloody stools. These may indicate a serious bowel or stomach issue.
• Do not adjust your baby's dose without first consulting your baby's doctor.

If you are using caffeine tablets:

• Limit the use of medicines, foods, or beverages that contain caffeine. Consuming too much caffeine can lead to nervousness, irritability, sleeplessness, and rapid heartbeat.
• Consult your doctor if you experience drowsiness, tiredness, or weakness that keeps returning.

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

In deciding to use a medicine, it is important to consider the risks of taking it against the benefits it will provide. This is a choice you and your doctor will make together. For this medicine, the following should be taken into account:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been done on how caffeine tablets affect children younger than 12 years old. Safety and effectiveness have not been proven.

Studies conducted so far have not shown any pediatric-specific issues that would limit the usefulness of caffeine oral solution in premature infants.

Geriatric

There is no information available on how caffeine affects older patients.

Breast Feeding

Research in women suggests that this medicine poses minimal risk to the baby when used during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be combined even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. When you are taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and are not necessarily a complete list.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medication or may change your other medicines.

• Riociguat
• Viloxazine

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

• Capmatinib
• Givosiran
• Iobenguane I 131
• Peginterferon Alfa-2b
• Pixantrone
• Ritlecitinib
• Tocilizumab

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. The following interactions have been chosen based on their potential importance and are not necessarily a complete list.

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

• Tobacco

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

• Anemia or
• Central nervous system problems or
• Heart or blood vessel issues or
• Lung disease or breathing problems (e.g., obstructive apnea) or
• Sepsis (infection in the blood)—This should be treated or ruled out before using caffeine oral solution.

• Kidney disease or
• Liver disease—Use with caution. Effects may be stronger because caffeine oral solution is removed from the body more slowly.

• Necrotizing enterocolitis or
• History of seizures—Use with caution. This may worsen these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might require medical attention.

Check with your doctor right away 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
• severe stomach pain
• stomach upset
• stupor
• 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 right away if any of the following overdose symptoms occur:

Symptoms of overdose

• Irritability
• nervousness
• rapid heartbeat
• trouble sleeping

Some side effects may happen that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your healthcare professional may also be able to suggest ways to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects persist or are bothersome, or if you have any questions about them:

More common

• Rash

Less common

• Dry skin

Other side effects not listed may also occur in some patients. If you notice any other effects, consult 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.

In the U.S.

• Cafcit
• Lucidex
• No Doz Maximum Strength
• Revive
• Stay Awake
• Vivarin

Available Dosage Forms:

• Tablet
• Solution

Therapeutic Class: CNS Stimulant

Chemical Class: Methylxanthine

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read the information carefully and make sure you understand it before taking this medicine. If you have any questions, talk to your doctor.

Swallow the tablets whole. Do not break, crush, or chew it.

If you are using the oral liquid:

• Give this medicine at the same time each day.
• Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
• This medicine may be given through mouth or a feeding tube.
• You might not use all of the medicine in each vial (glass container). Use each vial only one time. Do not save an open vial. If the medicine in the vial or syringe has changed color, or if you see particles in it, do not use it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (solution):For treatment of apnea of prematurity: Premature babies—Dose is based on body weight and must be determined by your baby's doctor. The dose is usually given once a day.
• For oral dosage form (tablets):For mental alertness or wakefulness: Adults and children 12 years of age and older—200 milligrams (mg) not more often than every 3 to 4 hours per day. Children younger than 12 years of age—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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