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|Empirin with Codeine No.4

NARCOTIC ANALGESICS AND ASPIRIN (Systemic)

Some commonly used brand names are:

In the U.S.—

• Damason-P ⁵
• Darvon Compound-65 ⁹
• Empirin with Codeine No.3 ²
• Empirin with Codeine No.4 ²
• Endodan ⁶
• Lortab ASA ⁵
• Panasal 5/500 ⁵
• PC-Cap ⁹
• Percodan ⁶
• Percodan-Demi ⁶
• Propoxyphene Compound-65 ⁹
• Roxiprin ⁶
• Synalgos-DC ¹
• Talwin Compound ⁷

In Canada—

• Anacin with Codeine ³
• C2 Buffered with Codeine ⁴
• C2 with Codeine ³
• Darvon-N Compound ⁹
• Darvon-N with A.S.A. ⁸
• Endodan ⁶
• Novo-AC and C ³
• Oxycodan ⁶
• Percodan ⁶
• Percodan-Demi ⁶
• 692 ⁹
• 222 ³
• 282 ³
• 292 ³

Other commonly used names are:

• A.C.&C
• AC and C
• Co-codaprin
• dihydrocodeine compound
• drocode and aspirin
• propoxyphene hydrochloride compound

# In Canada, Aspirin is a brand name. Acetylsalicylic acid is the generic name in Canada. ASA, a synonym for acetylsalicylic acid, is the term that commonly appears on Canadian product labels.

Category

• Analgesic

Description

Combination medicines containing narcotic analgesics (nar-KOT-ik an-al-JEE-zicks) and aspirin (AS-pir-in) 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.

In the U.S., these medicines are available only with your medical doctor"s or dentist"s prescription. In Canada, some strengths of aspirin, codeine, and caffeine combination are available without a prescription.

These medicines are available in the following dosage forms:

• Oral
• Aspirin, Caffeine, and Dihydrocodeine
  • Capsules (U.S.)
• Aspirin and Codeine
  • Tablets (U.S.)
• Aspirin, Codeine, and Caffeine
  • Tablets (Canada)
• Aspirin, Codeine, and Caffeine, Buffered
  • Tablets (Canada)
• Hydrocodone and Aspirin
  • Tablets (U.S.)
• Oxycodone and Aspirin
  • Tablets (U.S. and Canada)
• Pentazocine and Aspirin
  • Tablets (U.S.)
• Propoxyphene and Aspirin
  • Capsules (Canada)
• Propoxyphene, Aspirin, and Caffeine
  • Capsules (U.S. and Canada)
  • Tablets (Canada)

Before Using This Medicine

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to a narcotic analgesic, aspirin or other salicylates, including methyl salicylate (oil of wintergreen), or any of the following medicines:

• 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)
• Oxyphenbutazone (e.g., Tandearil)
• Phenylbutazone (e.g., Butazolidin)
• Piroxicam (e.g., Feldene)
• Sulindac (e.g., Clinoril)
• Suprofen (e.g., Suprol)
• Tenoxicam (e.g., Mobiflex)
• Tiaprofenic acid (e.g., Surgam)
• Tolmetin (e.g., Tolectin)
• Zomepirac (e.g., Zomax)

Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

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—These combination medicines have not been reported to cause problems in nursing babies. However, aspirin, caffeine, codeine, and propoxyphene pass into the breast milk. It is not known whether dihydrocodeine, hydrocodone, oxycodone, or pentazocine passes into the breast milk.

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.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking a narcotic analgesic and aspirin combination, it is especially important that your health care professional know if you are taking any of the following:

• Anticoagulants (blood thinners) or
• Carbenicillin by injection (e.g., Geopen) or
• Cefamandole (e.g., Mandol) or
• Cefoperazone (e.g., Cefobid) or
• Cefotetan (e.g., Cefotan) or
• Dipyridamole (e.g., Persantine) or
• Divalproex (e.g., Depakote) or
• Heparin or
• Medicine for inflammation or pain, except narcotics, or
• Pentoxifylline (e.g., Trental) or
• Plicamycin (e.g., Mithracin) or
• Ticarcillin (e.g., Ticar) or
• Valproic acid (e.g., Depakene)—Taking these medicines together with aspirin may increase the chance of bleeding

• Antidiabetics, oral (diabetes medicine you take by mouth)—Aspirin may increase the effects of the antidiabetic medicine; a change in the dose of the antidiabetic medicine may be needed if aspirin is taken regularly

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

• Central nervous system (CNS) depressants or
• Diarrhea medicine or
• Methotrexate (e.g., Mexate) 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]) or
• Vancomycin (e.g., Vancocin)—The chance of side effects may be increased

• Naltrexone (e.g., Trexan)—Naltrexone keeps narcotic analgesics from working to relieve pain; people taking naltrexone should use pain relievers that do not contain a narcotic

• Probenecid (e.g., Benemid) or
• Sulfinpyrazone (e.g., Anturane)—Aspirin can keep these medicines from working as well for treating gout; also, use of sulfinpyrazone and aspirin together may increase the chance of bleeding

• Urinary alkalizers (medicine that makes the urine less acid, such as acetazolamide [e.g., Diamox], calcium- and/or magnesium-containing antacids, dichlorphenamide [e.g., Daranide], methazolamide [e.g., Neptazane], potassium or sodium citrate and/or citric acid, sodium bicarbonate [baking soda])—These medicines may make aspirin less effective by causing it to be removed from the body more quickly

• Zidovudine (e.g., AZT, Retrovir)—Higher blood levels of zidovudine and an increased chance of serious side effects may occur

Other medical problems—The presence of other medical problems may affect the use of narcotic analgesic and aspirin 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
• Asthma, allergies, and nasal polyps (history of) or
• Brain disease or head injury or
• Colitis or
• Convulsions (seizures), history of, or
• Emotional problems or mental illness 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

• Anemia or
• 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 of these medicines 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 number of capsules or tablets that you take depends on the strength of the medicine and on the amount of pain you are having.

• For aspirin, caffeine, and dihydrocodeine
• For oral dosage form (capsules):
  • For pain:
    • Adults—2 capsules every four hours as needed.
    • Children—Dose must be determined by your doctor.

• For aspirin and codeine
• 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 aspirin, codeine, and caffeine
• 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 buffered aspirin, codeine, and caffeine
• 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 hydrocodone and aspirin
• 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 oxycodone and aspirin
• 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 up to 6 years of age—Use is not recommended.
    • Children 6 to 12 years of age—One-quarter of a half-strength tablet every six hours as needed.
    • Children 12 years of age and older—One-half of a half-strength tablet every six hours as needed.

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

• For propoxyphene, aspirin, and caffeine
• For oral dosage form (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 your medical doctor or dentist has ordered you to 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 next dose, 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 in young children.
• Store away from heat and direct light.
• Do not store this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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.

This medicine will add to the effects of alcohol and other 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, lightheadedness, 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 lightheadedness.

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 (5-grain) 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.

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

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 above may also occur in some patients. If you notice any other effects, check with your medical doctor or dentist.

Revised: 07/05/1995

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