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|Lenoltec with Codeine No.4

NARCOTIC ANALGESICS 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 containing narcotic analgesics (nar-KOT-ik an-al-JEE-zicks) and acetaminophen (a-seat-a-MIN-oh-fen) 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.

In the U.S., these medicines are available only with your medical doctor"s or dentist"s prescription. In Canada, some acetaminophen, codeine, and caffeine combinations 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 will do. This is a decision you and your doctor will make. For narcotic analgesic and acetaminophen combinations, the following should be considered:

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

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—Acetaminophen, codeine, and propoxyphene pass into the breast milk. It is not known whether other narcotic analgesics pass into the breast milk. However, these medicines have not been reported to cause problems in nursing babies.

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.

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 acetaminophen combination, it is especially important that your health care professional know if you are taking any of the following:

• Carbamazepine (e.g., Tegretol)—Propoxyphene may increase the blood levels of carbamazepine, which increases the 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 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])—Taking these medicines together with a narcotic analgesic may increase the chance of serious side effects

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

• Zidovudine (e.g., AZT, Retrovir)—Acetaminophen may increase the blood levels of zidovudine, which increases the chance of serious side effects

Other medical problems—The presence of other medical problems 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 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 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 or teaspoonfuls of solution or suspension that 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 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 solution or suspension dosage form:
  • For pain:
    • Adults—1 tablespoonful (3 teaspoonfuls) every four hours as needed.
    • Children younger than 3 years of age—Dose must be determined by your doctor.
    • Children 3 to 7 years of age—1 teaspoonful three or four times a day as needed.
    • Children 7 to 12 years of age—2 teaspoonfuls three 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 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, or 10 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 as needed.
    • 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 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 tablets or capsules in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid forms of this medicine from freezing.
• 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), 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.

The narcotic analgesic in 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, 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)
• 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 medical doctor or dentist. Lying down for a while may also help relieve some other side effects, such as dizziness or lightheadedness, 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.

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

Revised: 05/21/2001

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