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Darvocet A500 (acetaminophen-propoxyphene)

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Generic Name : acetaminophen and propoxyphene
Pronounced : a SEET a MIN oh fen and proe POX i feen

What is acetaminophen and propoxyphene?

Propoxyphene is in a group of drugs called narcotic pain relievers.

Acetaminophen is a less potent pain reliever and a fever reducer that increases the effects of propoxyphene.

The combination of acetaminophen and propoxyphene is used to relieve mild to moderate pain with or without fever.

Acetaminophen and propoxyphene may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about acetaminophen and propoxyphene?

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

Propoxyphene may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

What should I discuss with my healthcare provider before taking acetaminophen and propoxyphene?

Do not use this medication if you are allergic to acetaminophen (Tylenol) or propoxyphene. Propoxyphene may be habit-forming and should be used only by the person it was prescribed for. Acetaminophen and propoxyphene should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. FDA pregnancy category C. It is not known whether acetaminophen and propoxyphene is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Acetaminophen and propoxyphene can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take acetaminophen and propoxyphene?

Take this medication exactly as it was prescribed for you. Do not take it in larger amounts, or use it for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

An overdose of acetaminophen can cause serious harm to your liver. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. One acetaminophen and propoxyphene tablet may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking. Take this medicine with a full glass of water. Take with food or milk to ease stomach upset. Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking acetaminophen and propoxyphene. Ask your doctor about ways to increase the fiber in your diet. Do not use a stool softener (laxative) without first asking your doctor. You may have withdrawal symptoms when you stop using acetaminophen and propoxyphene after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely. This medication can cause you to have unusual results with certain urine tests. Tell any doctor who treats you that you are using acetaminophen and propoxyphene.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using acetaminophen and propoxyphene. You may need to stop using the medicine for a short time.

Store acetaminophen and propoxyphene at room temperature away from moisture and heat. Keep track of how many tablets have been used from each new bottle of this medicine. Propoxyphene is a drug of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

What happens if I miss a dose?

Since acetaminophen and propoxyphene is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of acetaminophen and propoxyphene can be fatal. Overdose symptoms may include extreme drowsiness, pinpoint pupils, nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes), confusion, fainting, weak pulse, seizure (convulsions), coma, blue lips, shallow breathing, or no breathing.

What should I avoid while taking acetaminophen and propoxyphene?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as "APAP") is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP. Avoid drinking alcohol while taking acetaminophen and propoxyphene. Alcohol may increase your risk of liver damage while taking acetaminophen. Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, antidepressants, or seizure medication can add to sleepiness caused by propoxyphene, or could slow your breathing. Tell your doctor if you need to use any of these other medicines together with acetaminophen and propoxyphene.

What are the possible side effects of acetaminophen and propoxyphene?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects: Less serious side effects include:

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect acetaminophen and propoxyphene?

Before taking this medication, tell your doctor if you are using any of the following drugs:

  • aspirin or a blood thinner such as warfarin (Coumadin);

  • carbamazepine (Carbatrol, Tegretol);

  • glycopyrrolate (Robinul);

  • mepenzolate (Cantil);

  • atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);

  • bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

  • a bronchodilator such as ipratropium (Atrovent) or tiotropium (Spiriva); or

  • irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

This list is not complete and there may be other drugs that can interact with acetaminophen and propoxyphene. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about acetaminophen and propoxyphene.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Multum version: 146.0 (Oct 22, 2009)
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