Drug Info: N: Narcotic Analgesics and Acetaminophen (Systemic)

Some commonly used brand names are:

In the U.S.—

In Canada—

Other commonly used names are: APAP with codeineCo-codAPAP Co-hycodAPAP Co-oxycodAPAP Co-proxAPAP Drocode,acetaminophen, and caffeine Hydrocodone with APAP Oxycodonewith APAP Propoxyphene with APAP

• Analgesic

Combination medicines containing narcotic analgesics(nar-KOT-ik an-al-JEE-zicks) and acetaminophen (a-seat-a-MIN-oh-fen) are used to relieve pain. A narcoticanalgesic and acetaminophen used together may provide betterpain relief than either medicine used alone. In some cases,relief of pain may come at lower doses of each medicine.

Narcotic analgesics act in the central nervous system(CNS) to relieve pain. Many of their side effects are alsocaused by actions in the CNS. When narcotics are used for along time, your body may get used to them so that largeramounts are needed to relieve pain. This is called toleranceto the medicine. Also, when narcotics are used for a longtime or in large doses, they may become habit-forming(causing mental or physical dependence). Physical dependencemay lead to withdrawal symptoms when you stop taking themedicine.

Acetaminophen does not become habit-forming when taken fora long time or in large doses, but it may cause otherunwanted effects, including liver damage, if too much istaken.

In the U.S., these medicines are available only with yourmedical doctor's or dentist's prescription. In Canada, someacetaminophen, codeine, and caffeine combinations areavailable without a prescription.

These medicines are available in the following dosageforms:

• Oral
• Acetaminophen and Codeine
  • Capsules (U.S.)
  • Oral solution (U.S. and Canada)
  • Oral suspension (U.S.)
  • Tablets (U.S. and Canada)
• Acetaminophen, Codeine, and Caffeine
  • Tablets (Canada)
• Dihydrocodeine, Acetaminophen, and Caffeine
  • Capsules (U.S.)
• Hydrocodone and Acetaminophen
  • Capsules (U.S.)
  • Oral solution (U.S.)
  • Tablets (U.S.)
• Oxycodone and Acetaminophen
  • Capsules (U.S.)
  • Oral solution (U.S.)
  • Tablets (U.S. and Canada)
• Pentazocine and Acetaminophen
  • Tablets (U.S.)
• Propoxyphene and Acetaminophen
  • Tablets (U.S.)

In deciding to use a medicine, the risks of taking themedicine must be weighed against the good it will do. This isa decision you and your doctor will make. For narcoticanalgesic and acetaminophen combinations, the followingshould be considered:

Allergies—Tell your doctor if you haveever had any unusual or allergic reaction to acetaminophen orto a narcotic analgesic. Also tell your health careprofessional if you are allergic to any other substances,such as foods, preservatives, or dyes.

Pregnancy—

• For acetaminophen: Although studies on birth defectswith acetaminophen have not been done in pregnant women, ithas not been reported to cause birth defects or otherproblems.
• For narcotic analgesics: Although studies on birthdefects with narcotic analgesics have not been done inpregnant women, they have not been reported to cause birthdefects. However, hydrocodone caused birth defects inanimal studies when very large doses were used. Codeine didnot cause birth defects in animals, but it caused slowerdevelopment of bones and other toxic or harmful effects inthe fetus. Pentazocine and propoxyphene did not cause birthdefects in animals. There is no information about whetherdihydrocodeine or oxycodone causes birth defects inanimals.Too much use of a narcotic during pregnancy maycause the fetus to become dependent on the medicine. Thismay lead to withdrawal side effects in the newborn baby.Also, some of these medicines may cause breathing problemsin the newborn baby if taken just before or duringdelivery.
• For caffeine: Studies in humans have not shown thatcaffeine (contained in some of these combination medicines)causes birth defects. However, studies in animals haveshown that caffeine causes birth defects when given in verylarge doses (amounts equal to those present in 12 to 24cups of coffee a day).

Breast-feeding—Acetaminophen, codeine,and propoxyphene pass into the breast milk. It is not knownwhether other narcotic analgesics pass into the breast milk.However, these medicines have not been reported to causeproblems in nursing babies.

Children—Breathing problems may beespecially likely to occur when narcotic analgesics are givento children younger than 2 years of age. These children areusually more sensitive than adults to the effects of narcoticanalgesics. Also, unusual excitement or restlessness may bemore likely to occur in children receiving thesemedicines.

Acetaminophen has been tested in children and has not beenshown to cause different side effects or problems in childrenthan it does in adults.

Older adults—Elderly people areespecially sensitive to the effects of narcotic analgesics.This may increase the chance of side effects, especiallybreathing problems, during treatment.

Acetaminophen has been tested and has not been shown tocause different side effects or problems in older people thanit does in younger adults.

Other medicines—Although certainmedicines should not be used together at all, in other casestwo different medicines may be used together even if aninteraction might occur. In these cases, your doctor may wantto change the dose, or other precautions may be necessary.When you are taking a narcotic analgesic and acetaminophencombination, it is especially important that your health careprofessional know if you are taking any of the following:

• Carbamazepine (e.g., Tegretol)—Propoxyphene mayincrease the blood levels of carbamazepine, which increasesthe chance of serious side effects

• Central nervous system (CNS) depressants or
• Monoamine oxidase (MAO) inhibitor activity(isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil],procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl],tranylcypromine [e.g., Parnate]) (taken currently or withinthe past 2 weeks) or
• Tricyclic antidepressants (amitriptyline [e.g.,Elavil], amoxapine [e.g., Asendin], clomipramine [e.g.,Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g.,Sinequan], imipramine [e.g., Tofranil], nortriptyline[e.g., Aventyl], protriptyline [e.g., Vivactil],trimipramine [e.g., Surmontil])—Taking thesemedicines together with a narcotic analgesic may increasethe chance of serious side effects

• Naltrexone (e.g., Trexan)—Naltrexone keepsnarcotic analgesics from working to relieve pain; peopletaking naltrexone should take pain relievers that do notcontain a narcotic

• Zidovudine (e.g., AZT, Retrovir)—Acetaminophenmay increase the blood levels of zidovudine, whichincreases the chance of serious side effects

• Alcohol and/or other drug abuse, or history of, or
• Brain disease or head injury or
• Colitis or
• Convulsions (seizures), history of, or
• Emotional problems or mental illness or
• Emphysema, asthma, or other chronic lung disease or
• Hepatitis or other liver disease or
• Kidney disease or
• Underactive thyroid—The chance of serious sideeffects may be increased

• Enlarged prostate or problems with urination or
• Gallbladder disease or gallstones—Some of theeffects of narcotic analgesics may be especially serious inpeople with these medical problems

• Heart disease—Caffeine (present in some of thesecombination medicines) can make some kinds of heart diseaseworse

Take this medicine only as directed by your medicaldoctor or dentist. Do not take more of it, do not takeit more often, and do not take it for a longer time than yourmedical doctor or dentist ordered. This is especiallyimportant for young children and elderly patients, who may bemore sensitive than other people to the effects of narcoticanalgesics. If too much of a narcotic analgesic is taken, itmay become habit-forming (causing mental or physicaldependence) or lead to medical problems because of anoverdose. Taking too much acetaminophen may cause liverdamage.

If you think that this medicine is not working properlyafter you have been taking it for a few weeks, do not increase the dose . Instead, check with yourmedical doctor or dentist.

Dosing—

The dose of these medicines will be different fordifferent patients. Follow your doctor's orders or the directions on thelabel. The following information includes only theaverage doses of these medicines. If your dose is different, do not change it unlessyour doctor tells you to do so.

The number of capsules or tablets or teaspoonfuls ofsolution or suspension that you take depends on the strengthof the medicine.

• For acetaminophen and codeine
• For oral capsule or tablet dosage form:
  • For pain:
    • Adults—1 or 2 capsules or tablets containingacetaminophen with 15 or 30 milligrams (mg) of codeine,or 1 capsule or tablet containing acetaminophen with 60mg of codeine, every four hours as needed.
    • Children—Dose must be determined by thedoctor, depending on the age of the child. Most youngchildren will receive the oral solution or suspension,rather than tablets or capsules.
• For oral solution or suspension dosage form:
  • For pain:
    • Adults—1 tablespoonful (3 teaspoonfuls) everyfour hours as needed.
    • Children younger than 3 years of age—Dosemust be determined by your doctor.
    • Children 3 to 7 years of age—1 teaspoonfulthree or four times a day as needed.
    • Children 7 to 12 years of age—2 teaspoonfulsthree or four times a day as needed.

• For acetaminophen, codeine, and caffeine
• For oral tablet dosage form:
  • For pain:
    • Adults—1 or 2 tablets every four hours asneeded.
    • Children—Dose must be determined by yourdoctor.

• For dihydrocodeine, acetaminophen, and caffeine
• For oral capsule dosage form:
  • For pain:
    • Adults—2 capsules every four hours.
    • Children—Dose must be determined by yourdoctor.

• For hydrocodone and acetaminophen
• For oral capsule dosage form:
  • For pain:
    • Adults—1 capsule every four to six hours asneeded.
    • Children—Dose must be determined by yourdoctor.
• For oral solution dosage form:
  • For pain:
    • Adults—1 to 3 teaspoonfuls every four to sixhours as needed.
    • Children—Dose must be determined by yourdoctor.
• For oral tablet dosage form:
  • For pain:
    • Adults—1 or 2 tablets containingacetaminophen with 2.5 milligrams (mg) of hydrocodone,or 1 tablet containing acetaminophen with 5, 7.5, or 10mg of hydrocodone, every four to six hours asneeded.
    • Children—Dose must be determined by yourdoctor.

• For oxycodone and acetaminophen
• For oral capsule or tablet dosage form:
  • For pain:
    • Adults—1 to 2 capsules or tablets every fourto six hours as needed.
    • Children—Dose must be determined by yourdoctor.
• For oral solution dosage form:
  • For pain:
    • Adults—1 teaspoonful every four to six hoursas needed.
    • Children—Dose must be determined by yourdoctor.

• For pentazocine and acetaminophen
• For oral tablet dosage form:
  • For pain:
    • Adults—1 tablet every four hours.
    • Children—Dose must be determined by yourdoctor.

• For propoxyphene and acetaminophen
• For oral tablet dosage form:
  • For pain:
    • Adults—1 or 2 tablets, depending on thestrength, every four hours as needed.
    • Children—Dose must be determined by yourdoctor.

Missed dose—

If your medical doctor or dentist has ordered you to takethis medicine according to a regular schedule and you miss adose, take it as soon as you remember. However, if it isalmost time for your next dose, skip the missed dose and goback to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children. Overdose is verydangerous in young children.
• Store away from heat and direct light.
• Do not store tablets or capsules in the bathroom, nearthe kitchen sink, or in other damp places. Heat or moisturemay cause the medicine to break down.
• Keep the liquid forms of this medicine fromfreezing.
• Do not keep outdated medicine or medicine no longerneeded. Be sure that any discarded medicine is out of thereach of children.

If you will be taking this medicine for a long time (forexample, for several months at a time), or in high doses,your doctor should check your progress at regular visits.

Check the labels of all nonprescription (over-the-counter[OTC]) and prescription medicines you now take. If anycontain acetaminophen or a narcotic be especially careful,since taking them while taking this medicine may lead tooverdose. If you have any questions about this, check withyour medical doctor, dentist, or pharmacist.

The narcotic analgesic in this medicine will add to theeffects of alcohol and other CNS depressants (medicines thatslow down the nervous system, possibly causing drowsiness).Some examples of CNS depressants are antihistamines ormedicine for hay fever, other allergies, or colds; sedatives,tranquilizers, or sleeping medicine; other prescription painmedicine or narcotics; barbiturates; medicine for seizures;muscle relaxants; or anesthetics, including some dentalanesthetics. Also, there may be a greater risk of liverdamage if you drink three or more alcoholic beverages whileyou are taking acetaminophen. Do not drink alcoholic beverages, and check with yourmedical doctor or dentist before taking any of the medicineslisted above, while you are using this medicine.

Too much use of the acetaminophen in this combinationmedicine together with certain other medicines may increasethe chance of unwanted effects. The risk will depend on howmuch of each medicine you take every day, and on how long youtake the medicines together. If your doctor directs you totake these medicines together on a regular basis, follow hisor her directions carefully. However, do not take thismedicine together with any of the following medicines formore than a few days, unless your doctor has directed you todo so and is following your progress:

• Aspirin or other salicylates
• Diclofenac (e.g., Voltaren)
• Diflunisal (e.g., Dolobid)
• Etodolac (e.g., Lodine)
• Fenoprofen (e.g., Nalfon)
• Floctafenine (e.g., Idarac)
• Flurbiprofen, oral (e.g., Ansaid)
• Ibuprofen (e.g., Motrin)
• Indomethacin (e.g., Indocin)
• Ketoprofen (e.g., Orudis)
• Ketorolac (e.g., Toradol)
• Meclofenamate (e.g., Meclomen)
• Mefenamic acid (e.g., Ponstel)
• Nabumetone (e.g., Relafen)
• Naproxen (e.g., Naprosyn)
• Oxaprozin (e.g., Daypro)
• Phenylbutazone (e.g., Butazolidin)
• Piroxicam (e.g., Feldene)
• Sulindac (e.g., Clinoril)
• Tenoxicam (e.g., Mobiflex)
• Tiaprofenic acid (e.g., Surgam)
• Tolmetin (e.g., Tolectin)

This medicine may cause some people to become drowsy,dizzy, or lightheaded, or to feel a false sense ofwell-being. Make sure you know how you react to this medicine beforeyou drive, use machines, or do anything else that could bedangerous if you are dizzy or are not alert andclearheaded.

Dizziness, lightheadedness, or fainting may occur,especially when you get up suddenly from a lying or sittingposition. Getting up slowly may help lessen this problem.

Nausea or vomiting may occur, especially after the firstcouple of doses. This effect may go away if you lie down fora while. However, if nausea or vomiting continues, check withyour medical doctor or dentist. Lying down for a while mayalso help relieve some other side effects, such as dizzinessor lightheadedness, that may occur.

Before having any kind of surgery (including dentalsurgery) or emergency treatment, tell the medical doctor ordentist in charge that you are taking this medicine.

Narcotic analgesics may cause dryness of the mouth. Fortemporary relief, use sugarless candy or gum, melt bits ofice in your mouth, or use a saliva substitute. However, ifdry mouth continues for more than 2 weeks, check with yourdentist. Continuing dryness of the mouth may increase thechance of dental disease, including tooth decay, gum disease,and fungus infections.

If you have been taking this medicine regularly forseveral weeks or more, do not suddenly stop taking it without first checkingwith your doctor. Your doctor may want you to reducegradually the amount you are taking before stoppingcompletely, to lessen the chance of withdrawal side effects.This will depend on which of these medicines you have beentaking, and the amount you have been taking every day.

If you think you or someone else may have taken anoverdose of this medicine, get emergency help at once.Taking an overdose of this medicine or taking alcohol or CNSdepressants with this medicine may lead to unconsciousness ordeath. Signs of overdose of narcotics include convulsions(seizures), confusion, severe nervousness or restlessness,severe dizziness, severe drowsiness, shortness of breath ortroubled breathing, and severe weakness. Signs of severeacetaminophen overdose may not occur until several days afterthe overdose is taken.

Along with its needed effects, a medicine may cause someunwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.

Get emergency help immediately if any of the followingsymptoms of overdose occur:

• Cold, clammy skin; confusion (severe) ; convulsions(seizures); diarrhea; dizziness (severe); drowsiness(severe); increased sweating; low blood pressure; nausea orvomiting (continuing); nervousness or restlessness (severe); pinpoint pupils of eyes; shortness of breath or unusuallyslow or troubled breathing; slow heartbeat; stomach crampsor pain ; weakness (severe)

Also, check with your doctor as soon as possible if any ofthe following side effects occur:

• Less common or rare
  • Black, tarry stools; bloody or cloudy urine;confusion; dark urine ; difficult or painful urination;fast, slow, or pounding heartbeat; frequent urge tourinate; hallucinations (seeing, hearing, or feelingthings that are not there); increased sweating;irregular breathing or wheezing; mental depression;pain in lower back and/or side (severe and/or sharp);pale stools; pinpoint red spots on skin; redness orflushing of face; ringing or buzzing in ears; skinrash, hives, or itching; sore throat and fever ; suddendecrease in amount of urine; swelling of face;trembling or uncontrolled muscle movements; unusualbleeding or bruising; unusual excitement (especially inchildren); yellow eyes or skin
  
  

Other side effects may occur that usually do not needmedical attention. These side effects may go away duringtreatment as your body adjusts to the medicine. However,check with your medical doctor or dentist if any of thefollowing side effects continue or are bothersome:

• More common
  • Dizziness, lightheadedness, or feeling faint;drowsiness; nausea or vomiting; unusual tiredness orweakness
  
  

• Less common or rare
  • Blurred or double vision or other changes invision; constipation (more common with long-term useand with codeine or meperidine); dry mouth; false senseof well-being; general feeling of discomfort orillness; headache; loss of appetite; nervousness orrestlessness; nightmares or unusual dreams; trouble insleeping
  
  

Although not all of the side effects listed above havebeen reported for all of these combination medicines, theyhave been reported for at least one of them. However, sinceall of the narcotic analgesics are very similar, any of theabove side effects may occur with any of these medicines.

After you stop using this medicine, your body may needtime to adjust. The length of time this takes depends onwhich of these medicines you were taking, the amount ofmedicine you were using, and how long you used it. Duringthis time check with your doctor if you notice any of thefollowing side effects:

• Body aches; diarrhea; fast heartbeat; fever, runnynose, or sneezing; gooseflesh; increased sweating;increased yawning; loss of appetite ; nausea or vomiting;nervousness, restlessness, or irritability; shivering ortrembling ; stomach cramps; trouble in sleeping;weakness

Other side effects not listed above may also occur in somepatients. If you notice any other effects, check with yourdoctor.