Brand Names:

• Darvon Compound
• Empirin w/Codeine
• Endodan
• Percodan
• Synalgos-DC

Dosage Forms:

• Tablet
• Capsule

Uses of This Medicine:

Combination medicines containing narcotic analgesics and aspirin are used to relieve pain. A narcotic analgesic and aspirin 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.

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

These medicines are available only with your doctor's prescription. In Canada, some strengths of aspirin, codeine, and caffeine combination 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

Do not give a medicine containing aspirin to a child or a teenager with a fever or other symptoms of a virus infection, especially flu or chickenpox, without first discussing its use with your child's doctor. This is very important because aspirin may cause a serious illness called Reye's syndrome in children with fever caused by a virus infection, especially flu or chickenpox. Children who do not have a virus infection may also be more sensitive to the effects of aspirin, especially if they have a fever or have lost large amounts of body fluid because of vomiting, diarrhea, or sweating. This may increase the chance of side effects during treatment.

The narcotic analgesic in this combination medicine can cause breathing problems, especially in 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.

Older adults

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

Pregnancy

For aspirin Studies in humans have not shown that aspirin causes birth defects. However, studies in animals have shown that aspirin causes birth defects.

Some reports have suggested that too much use of aspirin late in pregnancy may cause a decrease in the newborn's weight and possible death of the fetus or newborn baby. However, the mothers in these reports had been taking much larger amounts of aspirin than are usually recommended. Studies of mothers taking aspirin in the doses that are usually recommended did not show these effects. However, regular use of aspirin late in pregnancy may cause unwanted effects on the heart or blood flow in the fetus or in the newborn baby. Also, use of aspirin during the last 2 weeks of pregnancy may cause bleeding problems in the fetus before or during delivery or in the newborn baby.

Too much use of aspirin during the last 3 months of pregnancy may increase the length of pregnancy, prolong labor, cause other problems during delivery, or cause severe bleeding in the mother before, during, or after delivery. Do not take aspirin during the last 3 months of pregnancy unless it has been ordered by your doctor.

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 given in very large doses. Codeine did not cause birth defects in animals, but it caused slower development of bones and other toxic or harmful effects on 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 combination medicines have not been reported to cause problems in nursing babies.

For aspirin, caffeine, 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 not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

• Ketorolac

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.

• Acenocoumarol
• Anisindione
• Beta Glucan
• Citalopram
• Desirudin
• Desvenlafaxine
• Dicumarol
• Duloxetine
• Eptifibatide
• Escitalopram
• Fluoxetine
• Fluvoxamine
• Ginkgo
• Heparin
• Ketoprofen
• Methotrexate
• Milnacipran
• Nefazodone
• Paroxetine
• Phenindione
• Phenprocoumon
• Reteplase, Recombinant
• Sertraline
• Ticlopidine
• Varicella Virus Vaccine
• Venlafaxine
• Warfarin

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.

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
• Asthma, allergies, and nasal polyps (history of) or
• Brain disease or head injury or
• Colitis or
• Convulsions (seizures), history of, or
• Emphysema or other chronic lung disease or
• Kidney disease or
• Liver disease or
• Underactive thyroid The chance of serious side effects may be increased.

• Overactive thyroid or
• Stomach ulcer or other stomach problems Aspirin may make these conditions worse.

• Enlarged prostate or problems with urination or
• Gallbladder disease or gallstones Narcotic analgesics have side effects that may be dangerous if these medical problems are present.

• Gout Aspirin can make this condition worse and can also lessen the effects of some medicines used to treat gout.

• Heart disease Large amounts of aspirin and caffeine (present in some of these combination medicines) can make some kinds of heart disease worse.

• Hemophilia or other bleeding problems or
• Vitamin K deficiency Aspirin increases the chance of serious bleeding.

Proper Use of This Medicine:

Take this medicine with food or a full glass (8 ounces) of water to lessen stomach irritation.

Do not take this medicine if it has a strong vinegar-like odor. This odor means the aspirin in it is breaking down. If you have any questions about this, check with your health care professional.

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 children and elderly patients, who are usually more sensitive to the effects of these medicines. 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. Also, taking too much aspirin may cause stomach problems or lead to medical problems because of an overdose.

If you think that this medicine is not working as well 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 form (capsules):
  • For pain:
    • Adults 2 capsules every four hours as needed.
    • Children 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 (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 (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 (tablets):
  • For pain:
    • Adults 1 or 2 tablets 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 half-strength tablets, or 1 full-strength tablet, every four to six hours as needed.
    • Children 12 years of age and older One-half of a half-strength tablet every six hours as needed.
    • Children 6 to 12 years of age One-quarter of a half-strength tablet every six hours as needed.
    • Children up to 6 years of age Use is not recommended.

• For oral dosage form (tablets):
  • For pain:
    • Adults 2 tablets three or four times a day as needed.
    • Children Dose must be determined by your doctor.

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

• For oral dosage forms (capsules or tablets):
  • For pain:
    • Adults 1 capsule or tablet 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.

Destroy any medicine that you do not need by flushing it down the toilet.

Precautions While Using This Medicine:

If you will be taking this medicine for a long time (for example, for several months at a time), 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 a narcotic, aspirin, or other salicylates, check with your health care professional. Taking them together with this medicine may cause an overdose.

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.

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, stomach problems may be more likely to occur if you drink alcoholic beverages while you are taking aspirin. 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.

Taking acetaminophen or certain other medicines together with the aspirin in this combination medicine 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 medical doctor or dentist directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take acetaminophen or any of the following medicines together with this combination medicine for more than a few days, unless your medical doctor or dentist has directed you to do so and is following your progress:

• 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 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 doctor. Lying down for a while may also help some other side effects, such as dizziness or light-headedness.

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.

Do not take this medicine for 5 days before any surgery, including dental surgery, unless otherwise directed by your medical doctor or dentist. Taking aspirin during this time may cause bleeding problems

For patients taking the buffered aspirin, codeine, and caffeine combination (C2 Buffered with Codeine):

• This product contains antacids that can keep many other medicines, especially some medicines used to treat infections, from working properly. This problem can be prevented by not taking the 2 medicines too close together. Ask your pharmacist how long you should wait between taking any other medicine and the buffered aspirin, codeine, and caffeine combination.

For diabetic patients:

• False urine sugar test results may occur if you are regularly taking 8 or more 325-mg or 5 or more 500-mg doses of aspirin a day. Smaller amounts or occasional use of aspirin usually will not affect urine sugar tests. If you have any questions about this, check with your health care professional, especially if your diabetes is not well controlled.

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 using it without first checking with your doctor. Depending on which of these medicines you have been taking, and the amount you have been taking every day, your doctor may want you to reduce gradually the amount you are taking before stopping completely, to lessen the chance of withdrawal side effects.

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 this medicine include convulsions (seizures); hearing loss; confusion; ringing or buzzing in the ears; severe excitement, nervousness, or restlessness; severe dizziness, severe drowsiness, shortness of breath or troubled breathing, and severe weakness.

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:

Any loss of hearing

bloody urine

cold, clammy skin

confusion (severe)

convulsions (seizures)

diarrhea (severe or continuing)

dizziness or light-headedness (severe)

drowsiness (severe)

excitement, nervousness, or restlessness (severe)

fever

hallucinations (seeing, hearing, or feeling things that are not there)

headache (severe or continuing)

increased sweating

increased thirst

low blood pressure

nausea or vomiting (severe or continuing)

pinpoint pupils of eyes

ringing or buzzing in the ears

shortness of breath or unusually slow or troubled breathing

stomach pain (severe or continuing)

uncontrollable flapping movements of the hands (especially in elderly patients)

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

Bloody or black, tarry stools

confusion

dark urine

fast, slow, or pounding heartbeat

increased sweating (more common with hydrocodone)

irregular breathing

mental depression

pale stools

redness or flushing of face (more common with hydrocodone)

skin rash, hives, or itching

stomach pain (severe)

swelling of face

tightness in chest or wheezing

trembling or uncontrolled muscle movements

unusual excitement (especially in children)

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

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

heartburn or indigestion

nausea or vomiting

stomach pain (mild)

Less common or rare

Blurred or double vision or other changes in vision

constipation (more common with long-term use and with codeine)

difficult, painful, or decreased urination

dryness of mouth

false sense of well-being

frequent urge to urinate

general feeling of discomfort or illness

headache

loss of appetite

nervousness or restlessness

nightmares or unusual dreams

trouble in sleeping

unusual tiredness

unusual weakness

Although not all of the side effects listed above have been reported for all of these 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 period of time check with your doctor if you notice any of the following side effects:

Body aches

diarrhea

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.