Lucidex (Oral)

Caffeine tablets are used to help you stay awake when you feel drowsy or unusually tired or weak. Do not use this medicine as a substitute for sleep.

Caffeine oral solution is used to treat short-term apnea of prematurity in premature babies (infants between 28 and 32 weeks gestational age) who stop breathing. Apnea of prematurity happens because the baby's breathing centers are not fully developed.

This medicine is available with or without a prescription from your doctor.

Your doctor will closely monitor your progress while you or your child are taking this medicine. This will help your doctor determine if the medicine is effective and decide whether to continue treatment.

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 distension, vomiting, or bloody stools. These may indicate a serious bowel or stomach issue.
• Do not change your baby's dose without first consulting your baby's doctor.

If you are using caffeine tablets:

• Limit the use of medicines, foods, or drinks that contain caffeine. Taking too much caffeine can lead to nervousness, irritability, sleeplessness, and a rapid heartbeat.
• Check with your doctor if you experience ongoing drowsiness, tiredness, or weakness.

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

In deciding to use a medicine, you need 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, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare provider know about any other allergies you may have, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been enough studies to determine how caffeine tablets affect children younger than 12 years old. Safety and effectiveness have not been established.

Current studies have not shown any specific problems in children that would limit the use of caffeine oral solution in premature infants.

Geriatric

There is no information available about how caffeine affects older adults.

Breast Feeding

Research suggests that this medicine poses minimal risk to the baby when used by breastfeeding mothers.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there is a possible interaction. In these situations, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare provider to know if you are taking any of the following medicines while using this medicine. The following interactions are based on their potential significance and are not necessarily all-inclusive.

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

• 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 adjust the dose or frequency of 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 meal times or with certain types of food because interactions may occur. Using alcohol or tobacco with some medicines can also cause interactions. The following interactions are based on 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 frequency of this medicine, or provide special instructions regarding food, alcohol, or tobacco use.

• Tobacco

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to 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 (e.g., obstructive apnea) or
• Sepsis (infection in the blood)—Should be addressed or treated before using caffeine oral solution.

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

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

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

Check with your doctor 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
• 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 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. 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, 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, 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.

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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