2011501344 Health Library | Health and Wellness | Wellmont Health System
  • Acetaminophen and Propoxyphene

    (a set a mee' noe fen) (proe pox' i feen)

    IMPORTANT WARNING:

    Acetaminophen and Propoxyphene will no longer be available in the U.S. after November 19, 2010. If you are currently using propoxyphene, you should call your doctor to discuss switching to another treatment.
    [Posted 01/13/2011] ISSUE: FDA notified healthcare professionals that it has asked drug manufacturers to limit the strength of acetaminophen in prescription drug products, predominantly combinations of acetaminophen and opioids, to 325 mg per tablet, capsule, or other dosage unit, making these products safer for patients. This action will help to reduce the risk of severe liver injury and allergic reactions associated with acetaminophen. A Boxed Warning highlighting the potential for severe liver injury and a Warning highlighting the potential for allergic reactions (swelling of the face, mouth, and throat, difficulty breathing, itching, or rash) will be added to the label of all prescription drug products that contain acetaminophen.
    BACKGROUND: Acetaminophen, one of the most commonly used drugs in the United States, is widely and effectively used in both prescription and over-the-counter (OTC) products to reduce pain and fever. Examples of prescription products that contain acetaminophen include hydrocodone with acetaminophen (Vicodin, Lortab), and oxycodone with acetaminophen (Tylox, Percocet). OTC products containing acetaminophen (e.g., Tylenol) are not affected by this action. Information about the potential for liver injury is already required on the label for OTC products containing acetaminophen. FDA is continuing to evaluate ways to reduce the risk of acetaminophen related liver injury from OTC products. No drug shortages are expected, because the 3-year implementation period should permit adequate time for necessary reformulations.
    RECOMMENDATION: Healthcare professionals were reminded to advise patients not to exceed the acetaminophen maximum total daily dose (4 grams/day), and not to drink alcohol while taking acetaminophen-containing medications.
    Healthcare professionals were encouraged to inform patients that there is no immediate danger to patients who take these combination pain medications, and patients should continue to take them as directed by their health care provider. The Drug Safety Communication provides additional information for healthcare professionals, information for patients, a data summary and a list of all affected products. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety .
    [Posted 11/19/2010] ISSUE: FDA notified healthcare professionals that Xanodyne Pharmaceuticals has agreed to withdraw propoxyphene (Darvon), an opioid pain reliever used to treat mild to moderate pain, from the U.S. market at the request of the FDA, due to new data showing that the drug can cause serious toxicity to the heart, even when used at therapeutic doses. FDA concluded that the safety risks of propoxyphene outweigh its benefits for pain relief at recommended doses. FDA requested that the generic manufacturers of propoxyphene-containing products [e.g., propoxyphene combined with acetaminophen (Darvocet)] remove their products as well.
    BACKGROUND: FDA's recommendation is based on all available data including data from a new study that evaluated the effects that increasing doses of propoxyphene have on the heart (see Data Summary in Drug Safety Communication). The results of the new study showed that when propoxyphene was taken at therapeutic doses, there were significant changes to the electrical activity of the heart: prolonged PR interval, widened QRS complex and prolonged QT interval. These changes can increase the risk for serious abnormal heart rhythms.
    RECOMMENDATION: FDA recommends that healthcare professionals stop prescribing and dispensing propoxyphene-containing products to patients, contact patients currently taking propoxyphene-containing products and ask them to discontinue the drug, inform patients of the risks associated with propoxyphene, and discuss alternative pain management strategies. Patients were advised to dispose of unused propoxyphene in household trash by following the recommendations outlined in the Federal Drug Disposal Guidelines at: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm226353.htm . For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety .
    [Posted 7/7/2009] FDA notified healthcare professionals that it is taking several actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses. The agency will require manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products and to provide a medication guide to patients stressing the importance of using the drugs as directed.
    FDA is requiring a new safety study assessing unanswered questions about the effects of propoxyphene on the heart at higher than recommended doses. Findings from this study, as well as other data, could lead to additional regulatory action. To further evaluate the safety of propoxyphene, FDA plans to work with several groups including the Centers for Medicare & Medicaid Services and the Veterans Health Administration to study how often the elderly are prescribed propoxyphene instead of other pain relievers and the difference in the safety profiles of propoxyphene compared to other drugs. For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety .

    IMPORTANT WARNING:

    Propoxyphene in high doses, taken by itself or in combination with other drugs, has been associated with drug-related deaths. Do not take propoxyphene in combination with other drugs that cause drowsiness: alcohol, tranquilizers, sleep aids, antidepressant drugs, or antihistamines. Do not take a larger dose, take it more often, or for a longer period than your doctor tells you to.

    WHY is this medicine prescribed?

    This combination of drugs is used to relieve mild to moderate pain. The drug also will help treat fever.
    This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

    HOW should this medicine be used?

    The combination of acetaminophen and propoxyphene comes as a tablet to take by mouth. It usually is taken every 4 hours as needed. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take acetaminophen and propoxyphene exactly as directed.
    Propoxyphene can be habit-forming. Do not take a larger dose, take it more often, or for a longer period than your doctor tells you to.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking acetaminophen and propoxyphene,
    • tell your doctor and pharmacist if you are allergic to acetaminophen, propoxyphene, sulfite, or any other drugs.
    • tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially acetaminophen (Tylenol); anticoagulants ('blood thinners') such as warfarin (Coumadin); antidepressants; medications for cough, cold, or allergies; sedatives; seizure medications; sleeping pills; tranquilizers; and vitamins.
    • tell your doctor if you have or have ever had liver or kidney disease, a history of alcoholism, lung or thyroid disease, prostatic hypertrophy, or urinary retention.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking acetaminophen and propoxyphene, call your doctor.
    • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking acetaminophen and propoxyphene.
    • you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
    • remember that alcohol can add to the drowsiness caused by this drug.

    What should I do IF I FORGET to take a dose?

    This medication usually is taken as needed. If your doctor has told you to take acetaminophen and propoxyphene regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Acetaminophen and propoxyphene may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • dizziness
    • lightheadedness
    • drowsiness
    • upset stomach
    • vomiting
    • constipation
    • stomach pain
    • rash
    • difficulty urinating
    If you experience either of the following symptoms, call your doctor immediately:
    • difficulty breathing
    • mood changes
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor.
    Too much acetaminophen may cause liver damage; do not take more than 4000 mg of acetaminophen per day.
    Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Balacet® (as a combination product containing Acetaminophen, Propoxyphene)
    • Darvocet A500® (as a combination product containing Acetaminophen, Propoxyphene)
    • Darvocet-N® (as a combination product containing Acetaminophen, Propoxyphene)
    • Propacet® (as a combination product containing Acetaminophen, Propoxyphene)
    • Wygesic® (as a combination product containing Acetaminophen, Propoxyphene)
    • Also available generically

    Other Names

    • APAP and Propoxyphene (as a combination product containing Acetaminophen and Propoxyphene)

    Tramadol

    (tra' ma dole)

    WHY is this medicine prescribed?

    Tramadol is used to relieve moderate to moderately severe pain. Tramadol extended-release tablets are only used by people who are expected to need medication to relieve pain around-the-clock for a long time. Tramadol is in a class of medications called opiate agonists. It works by changing the way the body senses pain.

    HOW should this medicine be used?

    Tramadol comes as a tablet and an extended-release (long-acting) tablet to take by mouth. The regular tablet is usually taken with or without food every 4-6 hours as needed. The extended-release tablet should be taken once a day. Take the extended-release tablet at about the same time of day every day, and either always take it with food or always take it without food. Take tramadol exactly as directed. Do not take more medication as a single dose or take more doses per day than prescribed by your doctor. Taking more tramadol than prescribed by your doctor may cause serious side effects or death.
    Your doctor may start you on a low dose of tramadol and gradually increase the amount of medication you take, not more often than every 3 days if you are taking the regular tablets or every 5 days if you are taking the extended-release tablets.
    Swallow the extended-release tablets whole; do not split, chew, or crush them. Do not snort (inhale powder from crushed tablet) or inject the dissolved extended-release tablets. Taking this medication in a way that is not recommended may cause serious side effects or death.
    Tramadol can be habit-forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor. Call your doctor if you find that you want to take extra medication or if you notice any other unusual changes in your behavior or mood.
    Do not stop taking tramadol without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking tramadol you may experience withdrawal symptoms such as nervousness; panic; sweating; difficulty falling asleep or staying asleep; runny nose, sneezing, or cough; numbness, pain, burning, or tingling in your hands or feet; hair standing on end; chills; nausea; uncontrollable shaking of a part of your body; diarrhea; or rarely, hallucinations (seeing things or hearing voices that do not exist).

    Are there OTHER USES for this medicine?

    This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking tramadol,
    • tell your doctor and pharmacist if you are allergic to tramadol or other opiate pain or cough medications such as meperidine (Demerol), morphine (Avinza, Kadian, MS Contin), codeine (in some pain medications and cough syrups), hydrocodone (in Vicodin), hydromorphone (Dilaudid), oxycodone (OxyContin, in Percocet), propoxyphene (Darvon, Darvon N, in Darvocet), any other medications, or any of the ingredients in tramadol tablets or extended-release tablets. Ask your pharmacist for a list of ingredients in tramadol tablets or extended release tablets.
    • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: antifungal medications such as ketoconazole (Nizoral); digoxin (Lanoxin); erythromycin (E.E.S., E-Mycin, Erythrocin); monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate); medications for anxiety, mental illness, nausea, and pain; medications for seizures, such as carbamazepine (Tegretol); muscle relaxants such as cyclobenzaprine (Flexeril); promethazine (Phenergan); quinidine; rifampin (Rifadin, Rifamate, Rimactane, others); sedatives; sleeping pills; selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); tranquilizers; tricyclic antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil);and warfarin (Coumadin). Many other medications may also interact with tramadol, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
    • tell your doctor what herbal products you are taking, especially St. John's wort.
    • tell your doctor if you have or have ever had seizures; an infection in your brain or spine; a head injury, a brain tumor, a stroke, or any other condition that caused high pressure inside your skull; depression or thoughts about harming or killing yourself or planning or trying to do so; diabetes; breathing problems or lung disease; or kidney or liver disease. Also tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tramadol, call your doctor.
    • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tramadol.
    • you should know that this medication may make you drowsy and may affect your coordination. Do not drive a car or operate machinery until you know how this medication affects you.
    • talk to your doctor about the safe use of alcohol while you are taking this medication. Alcohol can make the side effects from tramadol worse.
    • you should know that tramadol may cause dizziness, lightheadedness, and fainting when you get up from a lying position. To avoid this, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

    What SPECIAL DIETARY instructions should I follow?

    Talk to your doctor about drinking grapefruit juice while you are taking this medication.

    What should I do IF I FORGET to take a dose?

    If your doctor has told you to take tramadol regularly, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Tramadol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • dizziness
    • weakness
    • sleepiness
    • difficulty falling asleep or staying asleep
    • headache
    • nervousness
    • agitation
    • uncontrollable shaking of a part of the body
    • muscle tightness
    • changes in mood
    • drowsiness
    • heartburn or indigestion
    • nausea
    • vomiting
    • diarrhea
    • constipation
    • itching
    • sweating
    • chills
    • dry mouth
    Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section , call your doctor immediately:
    • seizures
    • sores on the inside of your mouth, nose, eyes, or throat
    • flu-like symptoms
    • hives
    • rash
    • difficulty swallowing or breathing
    • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
    • hoarseness
    • hallucinations (seeing things or hearing voices that do not exist)
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].
    Tramadol may cause other side effects. Tell your doctor if you have any unusual problems while you are taking this medication.

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
    Symptoms of overdose may include:
    • decreased size of the pupil (the black circle in the center of the eye)
    • difficulty breathing
    • extreme drowsiness
    • unconsciousness
    • coma
    • seizure
    • heart attack

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor.
    Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Conzip®
    • Ryzolt®
    • Ultram®
    • Ultram® ER
    • Ultracet® (as a combination product containing Acetaminophen, Tramadol)
    • Also available generically
  • Join WellZones today.

    Make a Change For LifeLearn more

    Wellmont LiveWell is creating a new tradition of wellness in the mountains by providing individuals with tools and encouragement to live healthier lifestyles.

  • HeartSHAPE Spotlight

    At risk for a heart attack? Learn more

    Fight heart disease early and prevent heart attacks with HeartSHAPE® - a painless, non-invasive test that takes pictures of your heart to scan for early-stage coronary disease.

  • Calories and Energy Needs

    Calorie NeedsLearn more

    How many calories do you need to eat each day to maintain your weight and fuel your physical activity? Enter a few of your stats into this calculator to find out.

  • Ideal Body Weight

    Ideal Body WeightLearn more

    Using body mass index as a reference, this calculator determines your ideal body weight range. All you need to do is enter your height.

  • Body Mass Index

    Body Mass IndexLearn more

    This tool considers your height and weight to assess your weight status.


  • Can we help answer your questions?

    Wellmont Nurse Connection is your resource for valuable health information any time, 24 hours a day, seven days a week. Speak to a Nurse any time, day or night, at (423) 723-6877 or toll-free at 1-877-230-NURSE.