Stay Awake

In the U.S.

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

Available Dosage Forms:

• Tablet
• Capsule, Extended Release
• Tablet, Enteric Coated
• Tablet, Extended Release
• Powder for Suspension
• Packet
• Capsule
• Tablet, Chewable
• Solution

Therapeutic Class: CNS Stimulant

Chemical Class: Methylxanthine

Caffeine tablets are used as an alertness aid to help you keep awake when you experience drowsiness or unusual tiredness or weakness. Do not use this medicine as substitute for 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 is caused by the baby's breathing centers not being fully developed.

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

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of caffeine tablets in children younger than 12 years of age. Safety and efficacy have not been established.

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

Geriatric

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

Pregnancy

Breast Feeding

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

Interactions with 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 taking 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

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.

• Peginterferon Alfa-2b
• Pixantrone
• Regadenoson

Interactions with Food/Tobacco/Alcohol

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 caffeine oral solution.

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

• Necrotizing enterocolitis or
• Seizures, history of—Use with caution. May make these conditions worse.

This section provides information on the proper use of a number of products that contain caffeine. It may not be specific to Stay Awake. Please read with care.

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.

Your doctor will check your progress closely while you or your child are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

If you are using caffeine solution:

• 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 change your baby's dose without checking first with your baby's doctor.

If you are using caffeine tablets:

• Limit the use of medicines, foods, or beverages that contain caffeine. Taking too much caffeine may cause nervousness, irritability, sleeplessness, and rapid heartbeat.
• Check with your doctor if you have drowsiness, tiredness, or weakness that keeps coming back.

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.

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 immediately if any of the following side effects occur:

• Feeding intolerance

• 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:

• 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:

• Rash

• 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.

Applies to caffeine: oral capsule, oral capsule extended release, oral packet, oral powder for suspension, oral solution, oral tablet, oral tablet chewable, oral tablet enteric coated, oral tablet extended release

Other dosage forms:

• intravenous solution

Along with its needed effects, caffeine (the active ingredient contained in Stay Awake) 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 immediately if any of the following side effects occur while taking caffeine:

• Feeding intolerance

• 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 while taking caffeine:

• Irritability
• nervousness
• rapid heartbeat
• trouble sleeping

Some side effects of caffeine 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:

• Rash

• Dry skin

Applies to caffeine: compounding powder, intravenous solution, oral gum, oral liquid, oral tablet, oral tablet dispersible, oral tablet extended release

Gastrointestinal

Very common (10% or more): Constipation (up to 17.4%)
Common (1% to 10%): Necrotizing enterocolitis, gastritis, GI hemorrhage, gastroesophageal reflux, dilated bowel loops
Frequency not reported: Increased gastric aspirate, GI intolerance, vomiting, regurgitation[Ref]

General

Long-term follow-up studies have not shown caffeine (the active ingredient contained in Stay Awake) to adversely affect neurological development or growth parameters.[Ref]

Cardiovascular

Common (1% to 10%): Hemorrhage, tachycardia
Uncommon (0.1% to 1%): Arrhythmia
Frequency not reported: Increased left ventricular output, increased stroke volume, hypertension[Ref]

Dermatologic

Common (1% to 10%): Rash, dry skin, skin breakdown[Ref]

Hematologic

Common (1% to 10%): Disseminated intravascular coagulation, anemia
Frequency not reported: Decreased hemoglobin[Ref]

Hepatic

Common (1% to 10%): Kidney failure[Ref]

Metabolic

Common (1% to 10%): Acidosis, hyperglycemia
Frequency not reported: Hypoglycemia, temporary reduced weight gain, decreased thyroxine[Ref]

Nervous system

Common (1% to 10%): Cerebral hemorrhage
Uncommon (0.1% to 1%): Convulsions/seizures
Frequency not reported: Irritability, restlessness, jitteriness, tremors, brain injury[Ref]

Ocular

Common (1% to 10%): Retinopathy of prematurity[Ref]

Other

Common (1% to 10%): Perinatal disorder (trace aspirates, feeding intolerances), injection site reaction, sepsis, accidental injury, abnormal healing, infusion site phlebitis and inflammation
Frequency not reported: Failure to thrive, deafness[Ref]

Respiratory

Common (1% to 10%): Dyspnea, lung edema
Frequency not reported: Tachypnea[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity reaction[Ref]

Renal

Frequency not reported: Increased urine flow rate, increased creatinine clearance, increased sodium and calcium excretion[Ref]

Some side effects of Stay Awake may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.