Brand Names:

• APAP w/Codeine
• Capital w/Codeine
• Darvocet A500
• Darvocet-N 100
• Darvocet-N 50
• Endocet
• Lorcet
• Lortab
• Panlor-DC
• Panlor-SS
• Percocet
• Pyregesic-C
• Roxicet
• Vicodin
• Zerlor

Dosage Forms:

• Tablet
• Solution
• Elixir
• Capsule
• Liquid
• Syrup
• Suspension

Uses of This Medicine:

Combination medicines containing narcotic analgesics and acetaminophen are used to relieve pain. A narcotic analgesic and acetaminophen used together may provide better pain 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 also caused by actions in the CNS. When narcotics are used for a long time, your body may get used to them so that larger amounts are needed to relieve pain. This is called tolerance to the medicine. Also, when narcotics are used for a long time or in large doses, they may become habit-forming (causing mental or physical dependence). Physical dependence may lead to withdrawal symptoms when you stop taking the medicine.

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

These medicines are available only with your doctor's prescription. In Canada, some acetaminophen, codeine, and caffeine combinations are available without a prescription.

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

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

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

Older adults

Elderly people are especially sensitive to the effects of narcotic analgesics. This may increase the chance of side effects, especially breathing problems, during treatment.

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

Pregnancy

For acetaminophen Although studies on birth defects with acetaminophen have not been done in pregnant women, it has not been reported to cause birth defects or other problems.

For narcotic analgesics Although studies on birth defects with narcotic analgesics have not been done in pregnant women, they have not been reported to cause birth defects. However, hydrocodone caused birth defects in animal studies when very large doses were used. Codeine did not cause birth defects in animals, but it caused slower development of bones and other toxic or harmful effects in the fetus. Pentazocine and propoxyphene did not cause birth defects in animals. There is no information about whether dihydrocodeine or oxycodone causes birth defects in animals.

Too much use of a narcotic during pregnancy may cause the fetus to become dependent on the medicine. This may lead to withdrawal side effects in the newborn baby. Also, some of these medicines may cause breathing problems in the newborn baby if taken just before or during delivery.

For caffeine Studies in humans have not shown that caffeine (contained in some of these combination medicines) causes birth defects. However, studies in animals have shown that caffeine causes birth defects when given in very large doses (amounts equal to those present in 12 to 24 cups of coffee a day).

Breast-feeding

Most of these medicines have not been reported to cause problems in nursing babies.

For acetaminophen and propoxyphene These medicines do pass into the breast milk.

For codeine and other narcotic analgesics (e.g., dihydrocodeine, hydrocodone, oxycodone, and pentazocine) Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "ultra-rapid metabolizers of codeine". If a nursing mother is an ultra-rapid metabolizer of codeine, it could lead to a morphine overdose in the nursing baby and cause very serious side effects. A nursing mother should talk to her doctor if she has any questions about taking codeine or about how this medicine may affect her baby .

Other medicines

Using medicines in this class 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.

• Fospropofol

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class 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 your medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

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:

• 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 may be increased.

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

• Heart disease Caffeine (present in some of these combination medicines) 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 for a longer time than your medical doctor or dentist ordered. This is especially important for young children and elderly patients, who may be more sensitive than other people to the effects of narcotic analgesics. If too much of a narcotic analgesic is taken, it may become habit-forming (causing mental or physical dependence) or lead to medical problems because of an overdose. Taking too much acetaminophen may cause liver damage.

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

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

• For oral dosage form (tablets):
  • For pain:
    • Adults 1 or 2 tablets every four hours as needed.
    • Children Dose must be determined by your doctor.

• For oral dosage form (capsules):
  • For pain:
    • Adults 2 capsules every four hours.
    • Children Dose must be determined by your doctor.

• For oral dosage form (capsules):
  • For pain:
    • Adults 1 capsule every four to six hours as needed.
    • Children Dose must be determined by your doctor.
• For oral dosage form (oral solution):
  • For pain:
    • Adults 1 to 3 teaspoonfuls every four to six hours as needed.
    • Children Dose must be determined by your doctor.
• For oral dosage form (tablets):
  • 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, or 10 mg of hydrocodone, every four to six hours as needed.
    • Children Dose must be determined by your doctor.

• For oral dosage form (solution):
  • For pain:
    • Adults 1 teaspoonful every four to six hours as needed.
    • Children Dose must be determined by your doctor.

• For oral dosage form (tablets):
  • For pain:
    • Adults 1 tablet every four hours.
    • Children Dose must be determined by your doctor.

• For oral dosage form (tablets):
  • For pain:
    • Adults 1 or 2 tablets, depending on the strength, every four hours as needed.
    • Children Dose must be determined by your doctor.

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

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:

If you will be taking this medicine for a long time (for example, 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 any contain acetaminophen or a narcotic be especially careful, since taking them while taking this medicine may lead to overdose. If you have any questions about this, check with your medical doctor, dentist, or pharmacist.

For patients taking a codeine-containing medicine or any other narcotic analgesics (e.g., dihydrocodeine, hydrocodone, oxycodone, and pentazocine):

• Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine". Ultra-rapid metabolizers change codeine to morphine more quickly and completely than other people. As a result, there is too much morphine in the body and more side effects of morphine than usual

For nursing mothers taking a codeine-containing medicine or any other narcotic analgesic (dihydrocodeine, hydrocodone, oxycodone, or pentazocine):

• Call your doctor if you become extremely tired and have difficulty caring for your baby.
• Your baby should generally nurse every two to three hours and should not sleep more than four hours at a time.
• Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breast-feeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention .

The narcotic analgesic in this medicine will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine 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 dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above, while you are using this medicine.

Too much use of the acetaminophen in this combination medicine together with certain other medicines may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your doctor directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take this medicine together with any of the following medicines for more than a few days, unless your doctor has directed you to do 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)
• 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, light-headed, or to feel a false sense of well-being. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and clearheaded.

Dizziness, light-headedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen 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 or vomiting continues, check with your medical doctor or dentist. Lying down for a while may also help relieve some other side effects, such as dizziness or light-headedness, that may occur.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this 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 saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, 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 checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely, to lessen the chance of withdrawal side effects. This will depend on which of these medicines you have been taking, and the amount you have been taking every day.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of this medicine or taking alcohol or CNS depressants with this medicine may lead 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 after the overdose is taken.

Flush unused, unneeded, or expired oxycodone/acetaminophen (Percocet(R)) down the toilet. Otherwise, do not flush your medicine down the toilet to dispose of it unless the medicine label or patient information specifically instructs you to do so. If you are unsure about how to dispose of your prescription medication, contact your pharmacist or doctor.

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.

Get emergency help immediately if 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)

If you are a nursing mother and you notice any of the following symptoms of overdose in your baby, get emergency help immediately:

Difficulty breathing

difficulty nursing

increased sleepiness (more than usual)

limpness

Check with your doctor as soon as possible if any of the 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 to urinate

hallucinations (seeing, hearing, or feeling things 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 or flushing of face

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 uncontrolled muscle movements

unusual bleeding or bruising

unusual excitement (especially in children)

yellow eyes or skin

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

Dizziness, light-headedness, 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 codeine or meperidine)

dry mouth

false sense of well-being

general feeling of discomfort or illness

headache

loss of appetite

nervousness or restlessness

nightmares or unusual dreams

trouble in sleeping

Although not all of the side effects 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 the narcotic analgesics are very similar, any of the above side effects may occur with any of these medicines.

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on which of these medicines you were taking, 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:

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

trouble in sleeping

weakness

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.