CAFFEINE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Caffedrine Caplets ¹
• Cafcit ²
• Dexitac Stay Alert Stimulant ¹
• Enerjets ¹
• Keep Alert ¹
• Maximum Strength SnapBack Stimulant Powders ¹
• NoDoz Maximum Strength Caplets ¹
• Pep-Back ¹
• Quick Pep ¹
• Ultra Pep-Back ¹
• Vivarin ¹

In Canada?

• Wake-Up ¹

Category

• Analgesia adjunct?Caffeine
• Respiratory stimulantadjunct?Caffeine; Caffeine, Citrated
• Stimulant, central nervoussystem?Caffeine; Caffeine and Sodium Benzoate; Caffeine,Citrated

Description

Caffeine (KAF-feen)belongs to the group of medicines called central nervous system (CNS) stimulants.It is used to help restore mental alertness when unusual tiredness or weaknessor 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 thispurpose.

Caffeine is also used in combination with ergotamine (for treatment ofmigraine and cluster headaches) or with certain pain relievers, such as aspirinor aspirin and acetaminophen. When used in this way, caffeine may increasethe effectiveness of the other medicines. Caffeine is sometimes used in combinationwith 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, andkola nuts.

Caffeine powder and tablets are available without a prescription; however,your health care professional may have special instructions on its properuse. Citrated caffeine and caffeine and sodium benzoate are to be administeredonly by or under the supervision of your doctor. Caffeine is available inthe following dosage forms:

Oral
• Caffeine
  • Powder (U.S.)
  • Tablets (U.S. and Canada)
• Citrated caffeine
  • Oral solution (U.S.)

Parenteral
• Citrated caffeine
  • Injection (U.S.)
• Caffeine and sodium benzoate
  • Injection (U.S.)

Before Using This Medicine

If you are taking this medicine without a prescription, carefully readand follow any precautions on the label. For caffeine, the following shouldbe considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reactions to aminophylline, caffeine, dyphylline, oxtriphylline,theobromine (also found in cocoa or chocolate), or theophylline. Also tellyour health care professional if you are allergic to any other substances,such as foods, preservatives, or dyes.

Pregnancy?Studies in humans have shown that caffeine may causemiscarriage or may slow the growth of a developing fetus when given in dosesgreater 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 causeproblems with the heart rhythm of the fetus. Therefore, it is recommendedthat pregnant women consume less than 300 mg of caffeine a day. Studies inanimals have shown that caffeine causes birth defects when given in very largedoses (amounts equal to 12 to 24 cups of coffee a day) and problems with bonegrowth when given in smaller doses.

Breast-feeding?Caffeine passes into breast milk in small amountsand may build up in the nursing baby. Studies have shown that babies may appearjittery and have trouble in sleeping when their mothers drink large amountsof caffeine-containing beverages.

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

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

Other medicines?Althoughcertain medicines should not be used together at all, in other cases two differentmedicines may be used together even if an interaction might occur. In thesecases, your doctor may want to change the dose, or other precautions may benecessary. When you are taking caffeine, it is especially important that yourhealth care professional know if you are taking any of the following:

• Amantadine (e.g., Symmetrel) or
• Amphetamines (e.g., Desoxyn, Dexedrine) or
• Appetite suppressants (diet pills) or
• Bupropion (e.g., Wellbutrin) or
• Chlophedianol (e.g., Ulone) or
• Cocaine or
• Fluoxetine (e.g., Prozac) or
• Medicine for asthma or other breathing problems or
• Medicine for colds, sinus problems, hay fever or other allergies(including nose drops or sprays) or
• Methylphenidate (e.g., Ritalin) or
• Nabilone (e.g., Cesamet) or
• Other medicines or beverages containing caffeine or
• Paroxetine (e.g., Paxil) or
• Pemoline (e.g., Cylert) or
• Sertraline (e.g., Zoloft)?Using these medicines with caffeinemay increase the CNS-stimulant effects, such as nervousness, irritability,or trouble in sleeping, or possibly cause convulsions (seizures) or changesin the rhythm of your heart

• Monoamine oxidase (MAO) inhibitors (furazolidone [e.g., Furoxone],isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g.,Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])?Takinglarge amounts of caffeine while you are taking or within 2 weeks of takingMAO inhibitors may cause extremely high blood pressure or dangerous changesin the rhythm of your heart; taking small amounts of caffeine may cause mildhigh blood pressure and fast heartbeat

Other medical problems?The presence of other medical problems may affect the use of caffeine.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, increasingthe chance of side effects

Proper Use of This Medicine

Take caffeine in powder or tabletform only as directed. Do not take more of it, do not take it moreoften, and do not take it for a longer time than directed. Taking too muchof this medicine may increase the chance of side effects. It may also becomehabit-forming.

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

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

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

Dosing?The dose ofcaffeine will be different for different patients. Followthe directions on the label.

• For unusual tiredness or weakness, or drowsiness:
  • For oral dosage form (powder):
    • Adults and children 12 years of age and older?The usual doseis 200 milligrams (mg) of caffeine (1 packet) repeated no sooner than everythree or four hours. You should not take more than 1600 mg in twenty-fourhours.
    • 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 doseis 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 givenonce a day.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

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

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

The recommended dose of this medicine contains about the same amount ofcaffeine as a cup of coffee. Do not drink large amounts of caffeine-containingcoffee, tea, or soft drinks while you are taking this medicine. Also, do nottake large amounts of other medicines that contain caffeine. To do so maycause 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 mgper 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, troublein sleeping, dizziness, or a fast or pounding heartbeat. If these effectsoccur, 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 beveragesor medicines too close to bedtime.

Side Effects of This Medicine

Along with its needed effects, a medicine maycause some unwanted effects. Although not all of these side effects may occur,they may be more likely to occur if caffeine is taken in large doses or moreoften than recommended. If they do occur, they may need medical attention.

Check with your doctor as soon as possible if any of the following sideeffects occur:

More common

Diarrhea; dizziness; fast heartbeat; hyperglycemia, including blurredvision, drowsiness, dry mouth, flushed dry skin, fruit-like breath odor, increasedurination, ketones in urine, loss of appetite, nausea, stomachache, tiredness,troubled breathing, unusual thirst, or vomiting (in newborn babies); hypoglycemia, including anxious feeling, blurred vision, coldsweats, confusion, cool pale skin, drowsiness, excessive hunger, fast heartbeat,nausea, nervousness, restless sleep, shakiness, or unusual tiredness or weakness(in newborn babies); irritability, nervousness, orsevere jitters (in newborn babies); nausea (severe); tremors; trouble in sleeping; vomiting

Rare

Abdominal or stomach bloating; dehydration; diarrhea (bloody); unusualtiredness or weakness

Symptoms of overdose

Abdominal or stomach pain; agitation,anxiety, excitement, or restlessness; confusion ordelirium; convulsions (seizures)?in acute overdose; dehydration; faster breathingrate; fast or irregular heartbeat; fever; frequent urination; headache; increased sensitivity to touch or pain; irritability; muscle tremblingor twitching; nausea and vomiting, sometimes withblood; overextending the body with head and heelsbent backward and body bowed forward; painful, swollenabdomen or vomiting (in newborn babies); ringingor other sounds in ears; seeing flashes of ?zig-zag?lights; trouble in sleeping; whole-body tremors (in newborn babies)

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

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 usingand how long you used it. During this time, check with your doctor if younotice any of the following side effects:

More common

Anxiety; dizziness; headache; irritability; muscle tension; nausea; nervousness; stuffy nose; unusual tiredness

Otherside effects not listed above may also occur in some patients. If you noticeany other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experiencemay show that it is also useful for other medical problems. Although theseuses are not included in product labeling, caffeine is used in certain patientswith the following medical conditions:

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

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for these uses.