Pronunciation:

KAF-een

Brand Names:

• Cafcit

Dosage Forms:

• Solution

Uses of This Medicine:

Caffeine belongs to the group of medicines called central nervous system (CNS) stimulants. It is used to help restore mental alertness when unusual tiredness or weakness or drowsiness occurs. Caffeine's use as an alertness aid should be only occasional. It is not intended to replace sleep and should not be used regularly for this purpose.

Caffeine is also used in combination with ergotamine (for treatment of migraine and cluster headaches) or with certain pain relievers, such as aspirin or aspirin and acetaminophen. When used in this way, caffeine may increase the effectiveness of the other medicines. Caffeine is sometimes used in combination with an antihistamine to overcome the drowsiness caused by the antihistamine.

Citrated caffeine is used to treat breathing problems in premature babies.

Caffeine may also be used for other conditions as determined by your doctor.

Caffeine is present in coffee, tea, soft drinks, cocoa, chocolate, and kola nuts.

Caffeine powder and tablets are available without a prescription; however, your health care professional may have special instructions on its proper use. Citrated caffeine and caffeine and sodium benzoate are to be administered only by or under the supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, caffeine is used in certain patients with the following medical conditions:

• Postoperative infant apnea (breathing problems after surgery in young babies)
• Psychiatric disorders requiring electroconvulsive or shock therapy (ECT)

Before Using This Medicine:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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—

With the exception of infants, there is no specific information comparing use of caffeine in children with use in other age groups. However, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of caffeine in the elderly with use in other age groups.

Pregnancy—

Studies in humans have shown that caffeine may cause miscarriage or may slow the growth of a developing fetus when given in doses greater than 300 mg (an amount equal to three cups of coffee) a day. In addition, use of large amounts of caffeine by the mother during pregnancy may cause problems with the heart rhythm of the fetus. Therefore, it is recommended that pregnant women consume less than 300 mg of caffeine a day. Studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to 12 to 24 cups of coffee a day) and problems with bone growth when given in smaller doses.

Breast-feeding—

Caffeine passes into breast milk in small amounts and may build up in the nursing baby. Studies have shown that babies may appear jittery and have trouble in sleeping when their mothers drink large amounts of caffeine-containing beverages.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

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

• Agoraphobia (fear of being in open places) or
• Anxiety or
• Convulsions (seizures) (in newborn babies) or
• Heart disease, severe or
• High blood pressure or
• Panic attacks or
• Trouble in sleeping—Caffeine may make the condition worse.

• Liver disease—Higher blood levels of caffeine may result, increasing the chance of side effects.

Proper Use of This Medicine:

Take caffeine in powder or tablet form only as directed. Do not take more of it, do not take it more often, and do not take it for a longer time than directed. Taking too much of this medicine may increase the chance of side effects. It may also become habit-forming.

For patients taking the powder form of this medicine: Each packet contains one dose of medicine. The contents of the packet may be stirred into water or other liquid and drunk. Or, the powder may be placed on the tongue and washed down with water or other liquid drink.

For patients taking the oral solution form of this medicine: Throw away any unused portion of the medicine left in the single-use vial (bottle). Follow the manufacturer's instruction for use.

If you think this medicine is not working properly after you have taken it for a long time, do not increase the dose. To do so may increase the chance of side effects.

Dosing—

The dose medicines in this class 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 these medicines. 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 unusual tiredness or weakness, or drowsiness:
  • For oral dosage form (powder):
    • Adults and children 12 years of age and older—The usual dose is 200 milligrams (mg) of caffeine (1 packet) repeated no sooner than every three or four hours. You should not take more than 1600 mg in twenty-four hours.
    • Children up to 12 years of age—Use is not recommended.
  • For oral dosage form (tablets):
    • Adults and children 12 years of age and older—The usual dose is 100 to 200 mg of caffeine repeated no sooner than every three or four hours. You should not take more than 1000 mg in twenty-four hours.
    • Children up to 12 years of age—Use is not recommended.
• For breathing problems in premature babies:
  • For oral dosage form (oral solution):
    • Newborn babies—At first, the dose is 20 mg (1 milliliter [mL]) per kilogram (kg) (9.1 mg per pound) of body weight given one time. Then, the dose is 5 mg (0.25 mL) per kg (2.3 mg per pound) of body weight given once a day.

Storage—

Keep out of the reach of children.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

Caffeine powder and tablets are for occasional use only. They are not intended to replace sleep and should not be used regularly for this purpose. If unusual tiredness or weakness or drowsiness continues or returns often, check with your doctor.

Before you have any medical tests, tell the doctor in charge that you are taking this medicine. The results of some tests on the heart may be affected by this medicine.

The recommended dose of this medicine contains about the same amount of caffeine as a cup of coffee. Do not drink large amounts of caffeine-containing coffee, tea, or soft drinks while you are taking this medicine. Also, do not take large amounts of other medicines that contain caffeine. To do so may cause unwanted effects.

The amount of caffeine in some common foods and beverages is as follows:

• Coffee, brewed—40 to 180 milligrams (mg) per cup.
• Coffee, instant—30 to 120 mg per cup.
• Coffee, decaffeinated—3 to 5 mg per cup.
• Tea, brewed American—20 to 90 mg per cup.
• Tea, brewed imported—25 to 110 mg per cup.
• Tea, instant—28 mg per cup.
• Tea, canned iced—22 to 36 mg per 12 ounces.
• Cola and other soft drinks, caffeine-containing—36 to 90 mg per 12 ounces.
• Cola and other soft drinks, decaffeinated—0 mg per 12 ounces.
• Cocoa—4 mg per cup.
• Chocolate, milk—3 to 6 mg per ounce.
• Chocolate, bittersweet—25 mg per ounce.

Caffeine may cause nervousness or irritability, trouble in sleeping, dizziness, or a fast or pounding heartbeat. If these effects occur, discontinue the use of caffeine-containing beverages and medicines, and do not eat large amounts of chocolate-containing products.

To prevent trouble in sleeping, do not take caffeine-containing beverages or medicines too close to bedtime.

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 as soon as possible if any of the following side effects occur:

More common

Diarrhea

dizziness

fast heartbeat

hyperglycemia, including blurred vision, drowsiness, dry mouth, flushed dry skin, fruit-like breath odor, increased urination, ketones in urine, loss of appetite, nausea, stomachache, tiredness, troubled breathing, unusual thirst, or vomiting (in newborn babies)

hypoglycemia, including anxious feeling, blurred vision, cold sweats, confusion, cool pale skin, drowsiness, excessive hunger, fast heartbeat, nausea, nervousness, restless sleep, shakiness, or unusual tiredness or weakness (in newborn babies)

irritability, nervousness, or severe jitters (in newborn babies)

nausea (severe)

tremors

trouble in sleeping

vomiting

Rare

Abdominal or stomach bloating

dehydration

diarrhea (bloody)

unusual tiredness or weakness

Symptoms of overdose

Abdominal or stomach pain

agitation, anxiety, excitement, or restlessness

confusion or delirium

convulsions (seizures)—in acute overdose

dehydration

faster breathing rate

fast or irregular heartbeat

fever

frequent urination

headache

increased sensitivity to touch or pain

irritability

muscle trembling or twitching

nausea and vomiting, sometimes with blood

overextending the body with head and heels bent backward and body bowed forward

painful, swollen abdomen or vomiting (in newborn babies)

ringing or other sounds in ears

seeing flashes of "zig-zag" lights

whole-body tremors (in newborn babies)

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:

More common

Nausea (mild)

nervousness or jitters (mild)

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this time, check with your doctor if you notice any of the following side effects:

More common

Anxiety

dizziness

headache

irritability

muscle tension

nausea

nervousness

stuffy nose

unusual tiredness

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.