NARCOTICANALGESICS AND ACETAMINOPHEN (Systemic)

Some commonly used brand names are:

In the U.S.?

• Allay ⁴
• Anexsia 5/500 ⁴
• Anexsia 7.5/650 ⁴
• Anolor DH 5 ⁴
• Bancap-HC ⁴
• Capital with Codeine ¹
• Co-Gesic ⁴
• Darvocet-N 50 ⁷
• Darvocet-N 100 ⁷
• DHCplus ³
• Dolacet ⁴
• Dolagesic ⁴
• Duocet ⁴
• E-Lor ⁷
• Endocet ⁵
• EZ III ¹
• Hycomed ⁴
• Hyco-Pap ⁴
• Hydrocet ⁴
• Hydrogesic ⁴
• HY-PHEN ⁴
• Lorcet 10/650 ⁴
• Lorcet-HD ⁴
• Lorcet Plus ⁴
• Lortab ⁴
• Lortab 2.5/500 ⁴
• Lortab 5/500 ⁴
• Lortab 7.5/500 ⁴
• Lortab 10/500 ⁴
• Margesic #3 ¹
• Margesic-H ⁴
• Oncet ⁴
• Panacet 5/500 ⁴
• Panlor ⁴
• Percocet 2.5/325 ⁵
• Percocet 5/325 ⁵
• Percocet 7.5/500 ⁵
• Percocet 10/650 ⁵
• Phenaphen with Codeine No.3 ¹
• Phenaphen with Codeine No.4 ¹
• Polygesic ⁴
• Propacet 100 ⁷
• Pyregesic-C ¹
• Roxicet ⁵
• Roxicet 5/500 ⁵
• Roxilox ⁵
• Stagesic ⁴
• Talacen ⁶
• T-Gesic ⁴
• Tylenol with Codeine Elixir ¹
• Tylenol with Codeine No.2 ¹
• Tylenol with Codeine No.3 ¹
• Tylenol with Codeine No.4 ¹
• Tylox ⁵
• Ugesic ⁴
• Vanacet ⁴
• Vendone ⁴
• Vicodin ⁴
• Vicodin ES ⁴
• Wygesic ⁷
• Zydone ⁴

In Canada?

• Acet-2 ²
• Acet-3 ²
• Acet Codeine 30 ¹
• Acet Codeine 60 ¹
• Atasol-8 ²
• Atasol-15 ²
• Atasol-30 ²
• Cetaphen with Codeine ²
• Cetaphen Extra-Strength with Codeine ²
• Cotabs ²
• Empracet-30 ¹
• Empracet-60 ¹
• Emtec-30 ¹
• Endocet ⁵
• Exdol-8 ²
• Lenoltec with Codeine No.1 ²
• Lenoltec with Codeine No.2 ²
• Lenoltec with Codeine No.3 ²
• Lenoltec with Codeine No.4 ¹
• Novo-Gesic C8 ²
• Novo-Gesic C15 ²
• Novo-Gesic C30 ²
• Oxycocet ⁵
• Percocet ⁵
• Percocet-Demi ⁵
• PMS-Acetaminophen with Codeine ¹
• Roxicet ⁵
• Triatec-8 ²
• Triatec-30 ¹
• Triatec-8 Strong ²
• Tylenol with Codeine Elixir ¹
• Tylenol with Codeine No.1 ²
• Tylenol with Codeine No.2 ²
• Tylenol with Codeine No.3 ²
• Tylenol with Codeine No.4 ¹
• Tylenol with Codeine No.1 Forte ²

Other commonly used names are:

• APAP with codeine
• Co-codAPAP
• Co-hycodAPAP
• Co-oxycodAPAP
• Co-proxAPAP
• Drocode, acetaminophen, and caffeine
• Hydrocodone with APAP
• Oxycodone with APAP
• Propoxyphene with APAP

Category

• Analgesic

Description

Combination medicines containingnarcotic analgesics (nar-KOT-ikan-al-JEE-zicks) and acetaminophen (a-seat-a-MIN-oh-fen) are used to relieve pain. A narcoticanalgesic and acetaminophen used together may provide better pain relief thaneither medicine used alone. In some cases, relief of pain may come at lowerdoses of each medicine.

Narcotic analgesics act in the central nervous system (CNS) to relievepain. Many of their side effects are also caused by actions in the CNS. Whennarcotics are used for a long time, your body may get used to them so thatlarger amounts are needed to relieve pain. This is called tolerance to themedicine. Also, when narcotics are used for a long time or in large doses,they may become habit-forming (causing mental or physical dependence). Physicaldependence may lead to withdrawal symptoms when you stop taking the medicine.

Acetaminophen does not become habit-forming when taken for a long timeor in large doses, but it may cause other unwanted effects, including liverdamage, if too much is taken.

In the U.S., these medicines are available only with your medical doctor'sor dentist's prescription. In Canada, some acetaminophen, codeine, and caffeinecombinations are available without a prescription.

These medicines are available in the following dosage forms:

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.)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For narcotic analgesicand acetaminophen combinations, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to acetaminophen or to a narcotic analgesic. Also tell yourhealth care professional if you are allergic to any other substances, suchas foods, preservatives, or dyes.

Pregnancy?

• For acetaminophen: Although studies onbirth defects with acetaminophen have not been done in pregnant women, ithas not been reported to cause birth defects or other problems.
• For narcotic analgesics: Although studieson birth defects with narcotic analgesics have not been done in pregnant women,they have not been reported to cause birth defects. However, hydrocodone causedbirth defects in animal studies when very large doses were used. Codeine didnot cause birth defects in animals, but it caused slower development of bonesand other toxic or harmful effects in the fetus. Pentazocine and propoxyphenedid not cause birth defects in animals. There is no information about whetherdihydrocodeine or oxycodone causes birth defects in animals.
  Too much use of a narcotic during pregnancy may cause the fetus to becomedependent on the medicine. This may lead to withdrawal side effects in thenewborn baby. Also, some of these medicines may cause breathing problems inthe newborn baby if taken just before or during delivery.
• For caffeine: Studies in humans have notshown that caffeine (contained in some of these combination medicines) causesbirth defects. However, studies in animals have shown that caffeine causesbirth defects when given in very large doses (amounts equal to those presentin 12 to 24 cups of coffee a day).

Breast-feeding?Acetaminophen, codeine, and propoxyphene pass intothe breast milk. It is not known whether other narcotic analgesics pass intothe breast milk. However, these medicines have not been reported to causeproblems in nursing babies.

Children?Breathing problems may be especially likely to occurwhen narcotic analgesics are given to children younger than 2 years of age.These children are usually more sensitive than adults to the effects of narcoticanalgesics. Also, unusual excitement or restlessness may be more likely tooccur in children receiving these medicines.

Acetaminophen has been tested in children and has not been shown to causedifferent side effects or problems in children than it does in adults.

Older adults?Elderly people are especially sensitive to the effectsof narcotic analgesics. This may increase the chance of side effects, especiallybreathing problems, during treatment.

Acetaminophen has been tested and has not been shown to cause differentside effects or problems in older people than it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takinga narcotic analgesic and acetaminophen combination, it is especially importantthat your health care professional know if you are taking any of the following:

• Carbamazepine (e.g., Tegretol)?Propoxyphene may increase theblood levels of carbamazepine, which increases the chance of serious sideeffects

• 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 currentlyor within the 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])?Takingthese medicines together with a narcotic analgesic may increase the chanceof serious side effects

• Naltrexone (e.g., Trexan)?Naltrexone keeps narcotic analgesicsfrom working to relieve pain; people taking naltrexone should take pain relieversthat do not contain a narcotic

• Zidovudine (e.g., AZT, Retrovir)?Acetaminophen may increasethe blood levels of zidovudine, which increases the chance of serious sideeffects

Other medical problems?The presence of other medicalproblems may affect the use of narcotic analgesic and acetaminophen combinations.Make sure you tell your doctor if you have any other medical problems, especially:

• 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 side effects maybe increased

• Enlarged prostate or problems with urination or
• Gallbladder disease or gallstones?Some of the effects of narcoticanalgesics may be especially serious in people with these medical problems

• Heart disease?Caffeine (present in some of these combinationmedicines) can make some kinds of heart disease worse

Proper Use of This Medicine

Take this medicine only as directed by your medical doctor or dentist.Do not take more of it, do not take it more often, and do not take it fora longer time than your medical doctor or dentist ordered. This is especiallyimportant for young children and elderly patients, who may be more sensitivethan other people to the effects of narcotic analgesics. If too much of anarcotic analgesic is taken, it may become habit-forming (causing mental orphysical dependence) or lead to medical problems because of an overdose. Takingtoo much acetaminophen may cause liver damage.

If you think that this medicine is not working properly after you havebeen taking it for a few weeks, do not increase the dose. Instead, check with your medical doctor or dentist.

Dosing?The dose of these medicines will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of these medicines. If your dose isdifferent, do not change it unless your doctor tells you to do so.

The number of capsules or tablets or teaspoonfuls of solution or suspensionthat you take depends on the strength of the medicine.

For acetaminophen and codeine
• For oral capsule or tablet dosage form:
  • For pain:
    • Adults?1 or 2 capsules or tablets containing acetaminophenwith 15 or 30 milligrams (mg) of codeine, or 1 capsule or tablet containingacetaminophen with 60 mg of codeine, every four hours as needed.
    • Children?Dose must be determined by the doctor, depending onthe age of the child. Most young children will receive the oral solution orsuspension, rather than tablets or capsules.
• For oral solution or suspension dosageform:
  • For pain:
    • Adults?1 tablespoonful (3 teaspoonfuls) every four hours asneeded.
    • Children younger than 3 years of age?Dose must be determinedby your doctor.
    • Children 3 to 7 years of age?1 teaspoonful three or four timesa day as needed.
    • Children 7 to 12 years of age?2 teaspoonfuls three or fourtimes a day as needed.

For acetaminophen, codeine, and caffeine
• For oral tablet dosage form:
  • For pain:
    • Adults?1 or 2 tablets every four hours as needed.
    • Children?Dose must be determined by your doctor.

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

For hydrocodone and acetaminophen
• For oral capsule dosage form:
  • For pain:
    • Adults?1 capsule every four to six hours as needed.
    • Children?Dose must be determined by your doctor.
• For oral solution dosage form:
  • For pain:
    • Adults?1 to 3 teaspoonfuls every four to six hours as needed.
    • Children?Dose must be determined by your doctor.
• For oral tablet dosage form:
  • For pain:
    • Adults?1 or 2 tablets containing acetaminophen with 2.5 milligrams(mg) of hydrocodone, or 1 tablet containing acetaminophen with 5, 7.5, or10 mg of hydrocodone, every four to six hours as needed.
    • Children?Dose must be determined by your doctor.

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

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

For propoxyphene and acetaminophen
• For oral tablet dosage form:
  • For pain:
    • Adults?1 or 2 tablets, depending on the strength, every fourhours as needed.
    • Children?Dose must be determined by your doctor.

Missed dose?If your medical doctor or dentist has ordered youto take this medicine according to a regular schedule and you miss a dose,take it as soon as you remember. However, if it is almost time for your nextdose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children. Overdose is very dangerous inyoung children.
• Store away from heat and direct light.
• Do not store tablets or capsules in the bathroom, near the kitchensink, or in other damp places. Heat or moisture may cause the medicine tobreak down.
• Keep the liquid forms of this medicine from freezing.
• 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

If youwill be taking this medicine for a long time (for example, for several monthsat a time), or in high doses, your doctor should check your progress at regularvisits.

Check the labels of all nonprescription (over-the-counter[OTC]) and prescription medicines you now take. If any contain acetaminophenor a narcotic be especially careful, since taking them while taking this medicinemay lead to overdose. If you have any questions about this, check with yourmedical doctor, dentist, or pharmacist.

The narcotic analgesic in this medicine will add to the effects of alcoholand other CNS depressants (medicines that slow down the nervous system, possiblycausing drowsiness). Some examples of CNS depressants are antihistamines ormedicine for hay fever, other allergies, or colds; sedatives, tranquilizers,or sleeping medicine; other prescription pain medicine or narcotics; barbiturates;medicine for seizures; muscle relaxants; or anesthetics, including some dentalanesthetics. Also, there may be a greater risk of liver damage if you drinkthree or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your medicaldoctor or dentist before taking any of the medicines listed above, while youare using this medicine.

Too much use of the acetaminophen in this combination medicine togetherwith certain other medicines may increase the chance of unwanted effects.The risk will depend on how much of each medicine you take every day, andon how long you take the medicines together. If your doctor directs you totake these medicines together on a regular basis, follow his or her directionscarefully. However, do not take this medicine together with any of the followingmedicines for more 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 of well-being. Make sure youknow how you react to this medicine before you drive, use machines, or doanything else that could be dangerous if you are dizzy or are not alert andclearheaded.

Dizziness, lightheadedness, or fainting may occur, especially when youget up suddenly from a lying or sitting position. Getting up slowly may helplessen this problem.

Nausea or vomiting may occur, especially after the first couple of doses.This effect may go away if you lie down for a while. However, if nausea orvomiting continues, check with your medical doctor or dentist. Lying downfor a while may also help relieve some other side effects, such as dizzinessor lightheadedness, that may occur.

Before having any kind of surgery (including dental surgery) or emergencytreatment, tell the medical doctor or dentist in charge that you are takingthis medicine.

Narcotic analgesics may cause dryness of the mouth. For temporary relief,use sugarless candy or gum, melt bits of ice in your mouth, or use a salivasubstitute. However, if dry mouth continues for more than 2 weeks, check withyour dentist. Continuing dryness of the mouth may increase the chance of dentaldisease, including tooth decay, gum disease, and fungus infections.

If you have been taking this medicine regularly for several weeks or more, do not suddenly stop taking it without first checkingwith your doctor. Your doctor may want you to reduce gradually theamount you are taking before stopping completely, to lessen the chance ofwithdrawal side effects. This will depend on which of these medicines youhave been taking, 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 overdoseof this medicine or taking alcohol or CNS depressants with this medicine maylead to unconsciousness or death. Signs of overdose of narcotics include convulsions(seizures), confusion, severe nervousness or restlessness, severe dizziness,severe drowsiness, shortness of breath or troubled breathing, and severe weakness.Signs of severe acetaminophen overdose may not occur until several days afterthe overdose is taken.

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 mayneed medical attention.

Get emergency help immediatelyif any of the following symptoms of overdose occur:

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

Also, check with your doctor as soon as possibleif any of the following side effects occur:

Less common or rare

Black, tarry stools; bloody or cloudyurine; confusion; dark urine; difficult or painful urination; fast, slow, or pounding heartbeat; frequent urgeto urinate; hallucinations (seeing, hearing, or feelingthings that are not there); increased sweating; irregular breathing or wheezing; mentaldepression; pain in lower back and/or side (severeand/or sharp); pale stools; pinpoint red spots on skin; redness or flushing offace; ringing or buzzing in ears; skin rash, hives, or itching; sore throat and fever; sudden decrease in amount of urine; swelling of face; trembling or uncontrolledmuscle movements; unusual bleeding or bruising; unusual excitement (especially in children); yellow eyes or skin

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 medical doctoror dentist if any of the following side effects continue or are bothersome:

More common

Dizziness, lightheadedness, or feeling faint; drowsiness; nausea or vomiting; unusual tiredness or weakness

Less common or rare

Blurred or double vision or other changes in vision; constipation (more common with long-term use and with codeineor meperidine); dry mouth; false sense of well-being; general feeling of discomfortor illness; headache; lossof appetite; nervousness or restlessness; nightmares or unusual dreams; troublein sleeping

Although not all of the sideeffects listed above have been reported for all of these combination medicines,they have been reported for at least one of them. However, since all of thenarcotic analgesics are very similar, any of the above side effects may occurwith any of these medicines.

After you stop using thismedicine, your body may need time to adjust. The length of time this takesdepends on which of these medicines you were taking, the amount of medicineyou were using, and how long you used it. During this time check with yourdoctor if you notice any of the following side effects:

Body aches; diarrhea; fast heartbeat; fever, runny nose, or sneezing; gooseflesh; increased sweating; increased yawning; loss of appetite; nausea or vomiting; nervousness,restlessness, or irritability; shivering or trembling; stomach cramps; troublein sleeping; weakness

Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.