APAP/Pentazocine HCl

Generic Name: pentazocine and acetaminophen (Oral route)

a-seet-a-MIN-oh-fen, pen-TAZ-oh-seen hye-droe-KLOR-ide

Oral route(Tablet)

Talacen(R) contains pentazocine hydrochloride and acetaminophen. Acetaminophen has been associated with acute liver failure, with some cases resulting in liver transplant and death. Most cases of liver injury were associated with acetaminophen use at doses exceeding 4000 mg/day, and often involved more than 1 acetaminophen-containing product

Commonly used brand name(s)

In the U.S.

• APAP/Pentazocine HCl


• Talacen

Available Dosage Forms:

• Tablet

Therapeutic Class: Opioid Agonist/Antagonist/Acetaminophen Combination

Pharmacologic Class: Pentazocine

Uses For APAP/Pentazocine HCl

Pentazocine and acetaminophen combination is used to relieve mild to moderate pain. When used together, the combination provides better pain relief than either medicine used alone. In some cases, you may get relief with lower doses of each medicine.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not become habit-forming when taken for a long time. But acetaminophen may cause other unwanted effects when taken in large doses, including liver damage.

Pentazocine belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain. When pentazocine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only with your doctor's prescription.

Before Using APAP/Pentazocine HCl

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of pentazocine and acetaminophen combination in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pentazocine and acetaminophen combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving pentazocine and acetaminophen combination.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine 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.

• Alfentanil


• Alphaprodine


• Codeine


• Dihydrocodeine


• Fentanyl


• Fospropofol


• Hydrocodone


• Hydromorphone


• Levorphanol


• Meperidine


• Methadone


• Morphine


• Morphine Sulfate Liposome


• Oxycodone


• Oxymorphone


• Propoxyphene


• Selegiline


• Sibutramine


• Sufentanil


• Tapentadol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol


• Carbamazepine


• Fluoxetine


• Isoniazid


• Phenytoin


• Warfarin


• Zidovudine

Interactions with Food/Tobacco/Alcohol

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 this medicine 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cabbage


• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Addison's disease (adrenal gland problem) or


• Alcohol abuse, or history of or


• Asthma, severe or


• Brain tumor, history of or


• Breathing problems (e.g., hypercapnia, hypoxia), severe or


• Cholecystitis (inflammation of the gallbladder) or


• Chronic obstructive pulmonary disease (COPD) or


• Cor pulmonale (serious heart condition) or


• Drug dependence, especially with narcotics, or history of or


• Enlarged prostate (BPH, prostatic hypertrophy) or


• Head injuries, history of or


• Hypothyroidism (an underactive thyroid) or


• Increased pressure in the head or


• Intestinal or bowel blockage or


• Kyphoscoliosis (curvature of spine that can cause breathing problems), severe or


• Mental illness, history of or


• Pancreatitis (inflammation of the pancreas) or


• Respiratory depression (very slow breathing) or


• Stomach problems, severe—Use with caution. May increase risk for more serious side effects.

• Heart attack, recent or


• Heart or blood vessel disease or


• Hypertension (high blood pressure) or


• Porphyria (an enzyme problem) or


• Seizures, history of—Use with caution. May make these conditions worse.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Sulfite allergy—Should not be used in patients with this condition.

Proper Use of pentazocine and acetaminophen

This section provides information on the proper use of a number of products that contain pentazocine and acetaminophen. It may not be specific to APAP/Pentazocine HCl. Please read with care.

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdosage. Liver damage can occur if large amounts of acetaminophen are taken for a long time.

This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours).

You may take this medicine with or without food.

Dosing

The dose of this medicine 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 this medicine. 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 (tablets):
  
  • For mild to moderate pain:
    
    • Adults, teenagers, and children 12 years of age and older—One tablet every 4 hours as needed. Your doctor may adjust your dose if needed. However, the dose is usually not more than 6 tablets per day.
    
    
    • Children younger than 12 years of age—Use and 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Make sure you store the medicine in a safe and secure place to prevent others from getting it.

Precautions While Using APAP/Pentazocine HCl

It is very important that your doctor check the progress of you or your child while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; 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 doctor before you or your child take any of the medicines listed above while you are using this medicine.

Make sure your doctor knows if you or your child have received narcotic medicines (e.g., methadone) in the past. Some patients who have had received narcotic pain medicines, have experienced withdrawal symptoms after receiving pentazocine.

Check with your doctor if you or your child have confusion about identity, place, and time; mood or mental changes; or seeing things that are not there while taking this medicine.

This medicine may be habit-forming. If you or your child feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

This medicine may make you dizzy, drowsy, or lightheaded. 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 not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you or your child to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

If you or your child have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You or your child may need to stop using this medicine several days before having surgery.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Tell your doctor if you smoke tobacco. Smoking may change how well this medicine works.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

APAP/Pentazocine HCl Side Effects

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.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Back, leg, or stomach pains


• black, tarry stools


• bleeding gums


• blistering, peeling, or loosening of the skin


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chest pain


• chills


• cough or hoarseness


• dark urine


• decrease in the frequency of urination


• decrease in urine volume


• diarrhea


• difficult or troubled breathing


• difficulty in passing urine (dribbling)


• difficulty with swallowing


• dizziness


• fast heartbeat


• fever


• fever with or without chills


• general body swelling


• general feeling of tiredness or weakness


• headache


• hives


• irregular, fast or slow, or shallow breathing


• itching


• joint or muscle pain


• loss of appetite


• lower back or side pain


• nausea or vomiting


• nosebleeds


• painful or difficult urination


• pale or blue lips, fingernails, or skin


• pale skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• red skin lesions, often with a purple center


• red, irritated eyes


• shakiness in the legs, arms, hands, or feet


• shortness of breath


• skin rash


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• swelling or puffiness of the face


• swollen glands


• tightness in the chest


• trembling or shaking of the hands or feet


• unusual bleeding or bruising


• unusual tiredness or weakness


• wheezing


• yellowing of the eyes or skin

Incidence not known

• Blood in the urine


• bloody nose


• fainting


• fast, pounding, or irregular heartbeat or pulse


• feeling of warmth


• heavier menstrual periods


• pinpoint red spots on the skin


• redness of the face, neck, arms, and occasionally, upper chest


• sweating

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Abdominal or stomach pain or tenderness


• bleeding gums


• bloody or cloudy urine


• blurred vision


• clay-colored stools


• cold sweats


• confusion


• cool, pale skin


• decreased appetite


• depression


• drowsiness


• fear or nervousness


• increased hunger


• muscle tremors


• nightmares


• rapid, deep breathing


• restlessness


• seeing, hearing, or feeling things that are not there


• seizures


• slurred speech


• stomach cramps


• strange thoughts


• sudden decrease in the amount of urine


• sugar in the urine


• swelling of the feet or lower legs


• unpleasant breath odor


• unusual bleeding or bruising


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness


• vomiting of blood


• weight loss

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:

Rare

• Continuing ringing or buzzing or other unexplained noise in the ears


• excitement


• hearing loss


• hives or welts


• irritability


• redness of the skin

Incidence not known

• Confusion about identity, place, and time


• constipation


• difficulty in focusing the eyes


• disturbed dreams


• drowsiness


• false or unusual sense of well-being


• relaxed and calm feeling


• sleepiness


• sleeplessness


• trouble sleeping


• unable to sleep


• 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.

See also: APAP/Pentazocine HCl side effects (in more detail)

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