Pronunciation:

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

Brand Names:

• APAP/Pentazocine HCl
• Talacen

Dosage Forms:

• Tablet

Warnings:

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

Classifications:

Therapeutic—

Opioid Agonist/Antagonist/Acetaminophen Combination

Pharmacologic—

Pentazocine

Uses of This Medicine:

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 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 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.

Children—

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.

Older adults—

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.

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 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
• Almotriptan
• Alphaprodine
• Amitriptyline
• Buprenorphine
• Codeine
• Desvenlafaxine
• Dihydrocodeine
• Dolasetron
• Donepezil
• Fentanyl
• Fluoxetine
• Fospropofol
• Granisetron
• Hydrocodone
• Hydromorphone
• Hydroxytryptophan
• Imatinib
• Isoniazid
• Levomilnacipran
• Levorphanol
• Lorcaserin
• Meperidine
• Methadone
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Oxycodone
• Oxymorphone
• Palonosetron
• Pixantrone
• Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
• Propoxyphene
• Selegiline
• Sibutramine
• Sufentanil
• Suvorexant
• Tapentadol
• Tramadol
• Trazodone
• Vilazodone
• Vortioxetine
• Ziprasidone

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
• Fosphenytoin
• Lixisenatide
• Phenytoin
• Warfarin
• Zidovudine

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 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
• Tobacco

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 This Medicine:

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 This Medicine:

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.

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.

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.