Pronunciation:

a-seet-a-MIN-oh-fen, proe-POX-i-feen NAP-si-late

Brand Names:

• Balacet 325
• Darvocet A500
• Darvocet-N 100
• Darvocet-N 50
• Pronap-100
• Propoxacet-N
• Propoxacet-N 100

Dosage Forms:

• Tablet

Warnings:

Do not prescribe propoxyphene for patients who are suicidal or addiction-prone. Prescribe propoxyphene with caution for patients taking tranquilizers or antidepressant drugs, and patients who use alcohol in excess. Patients should not exceed the recommended dose and alcohol intake should be limited. Propoxyphene products in excessive doses, either alone or in combination with other CNS depressants, including alcohol, are a major cause of drug-related deaths .

Classifications:

Therapeutic

Opioid/Acetaminophen Combination

Chemical

Propoxyphene

Uses of This Medicine:

Propoxyphene and acetaminophen combination is used to relieve mild to moderate pain. Propoxyphene belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

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.

When propoxyphene 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 propoxyphene and acetaminophen combination in the pediatric population. 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 propoxyphene 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 propoxyphene and acetaminophen combination.

Breast-feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Naltrexone
• Rasagiline
• Selegiline

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.

• Adinazolam
• Alfentanil
• Alprazolam
• Amobarbital
• Anileridine
• Aprobarbital
• Bromazepam
• Brotizolam
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Carbamazepine
• Carisoprodol
• Chloral Hydrate
• Chlordiazepoxide
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Dantrolene
• Dezocine
• Diazepam
• Estazolam
• Ethchlorvynol
• Fentanyl
• Flunitrazepam
• Flurazepam
• Fospropofol
• Halazepam
• Hydrocodone
• Hydromorphone
• Ketazolam
• Levorphanol
• Lorazepam
• Lormetazepam
• Medazepam
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methocarbamol
• Methohexital
• Midazolam
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nitrazepam
• Nordazepam
• Opium
• Oxazepam
• Oxycodone
• Oxymorphone
• Pentazocine
• Pentobarbital
• Phenobarbital
• Prazepam
• Propoxyphene
• Quazepam
• Remifentanil
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Temazepam
• Thiopental
• Triazolam

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
• Doxepin
• Isoniazid
• Metoprolol
• Phenytoin
• Propranolol
• 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

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

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:

• Alcohol abuse, or history of or
• Brain tumor, history of or
• Chronic obstructive pulmonary disease (COPD) or
• Cor pulmonale (serious heart condition) or
• Drug dependence, especially with narcotics, or history of or
• Gallbladder disease or gallstones or
• Head injuries, history of or
• Hypovolemia (low blood volume) Use with caution. May increase risk for more serious side effects.

• Asthma, severe or
• Breathing problems, severe (e.g., hypoxia) or
• Paralytic ileus (intestine stops working and may be blocked) or
• Respiratory depression (very slow breathing) or
• Suicidal ideation (thoughts of hurting or killing oneself), history of Should not be used in patients with these conditions.

• Hypotension (low blood pressure) or
• Pancreatitis (inflammation of the pancreas) 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.

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). 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).

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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 One or two tablets every 4 hours as needed. Your doctor may adjust your dose if needed. However, the dose is usually not more than 6 to 12 tablets per day.
    • Children 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.

Precautions While Using This Medicine:

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

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 taking any of the medicines listed above while you are using this medicine.

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

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

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 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 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 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.

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.

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

Abdominal or stomach pain

chills

clay-colored stools

dark urine

dizziness

fever

headache

itching

loss of appetite

nausea

rash

unpleasant breath odor

unusual tiredness or weakness

vomiting of blood

yellow eyes or skin

Incidence not known

Bloating

bloody or black, tarry stools

bloody or cloudy urine

change in consciousness

chest pain or discomfort

confusion

cough

decreased urine output

difficult or troubled breathing

dilated neck veins

drowsiness

extreme fatigue

fainting

fast, slow, pounding, or irregular heartbeat or pulse

fever with or without chills

general feeling of discomfort or illness

hives

hoarseness

irregular, fast, slow, or shallow breathing

itching

joint pain, stiffness, or swelling

light-colored stools

loss of consciousness

low blood pressure or pulse

muscle aches and pains

muscle tremors

pain or discomfort in the arms, jaw, back, or neck

pains in the stomach, side, or abdomen, possibly radiating to the back

pale or blue lips, fingernails, or skin

rapid, deep breathing

redness of the skin

restlessness

right upper stomach pain and fullness

runny nose

severe stomach pain

shakiness and unsteady walk

shivering

shortness of breath

sore throat

stomach cramps

sudden decrease in the amount of urine

sweating

swelling of the eyelids, face, fingers, lips, hands, lower legs, or feet

thoughts of suicide

tightness in the chest

trouble sleeping

troubled breathing or swallowing

unconsciousness

unsteadiness, trembling, or other problems with muscle control or coordination

very slow breathing

very slow heartbeat

vomiting of blood or material that looks like coffee grounds

weight gain

wheezing

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

Symptoms of overdose

Agitation

bluish color of the fingernails, lips, skin, palms, or nail beds

convulsion

coughing that sometimes produces a pink frothy sputum

decreased awareness or responsiveness

depression

difficult, fast, or noisy breathing, sometimes with wheezing

dilated pupils

hostility

increased sweating

irritability

lethargy

muscle tremors

muscle twitching

pale skin

pounding or rapid pulse

rapid weight gain

rapid, deep breathing

severe sleepiness

sleepiness or unusual drowsiness

slow to respond

slurred speech

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:

More common

Relaxed and calm feeling

Incidence not known

Abnormal behavior

blurred or loss of vision

constipation

diarrhea

disturbed color perception

double vision

false or unusual sense of well-being

halos around lights

indigestion

muscular pain, tenderness, wasting, or weakness

night blindness

nightmares or unusually vivid dreams

overbright appearance of lights

seeing, hearing, or feeling things that are not there

swelling of the eye

tunnel vision

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.