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What is acetaminophen and oxycodone?
Oxycodone is in a group of drugs called narcotic pain relievers. Acetaminophen is a less potent pain reliever that increases the effects of oxycodone. The combination of acetaminophen and oxycodone is used to relieve moderate to severe pain. Acetaminophen and oxycodone may also be used for other purposes not listed in this medication guide.

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What are the possible side effects of acetaminophen and oxycodone?

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:

• shallow breathing, slow heartbeat;

• feeling light-headed, fainting;

• confusion, unusual thoughts or behavior;

• seizure (convulsions); or

• nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

• feeling dizzy or drowsy;

• mild nausea, vomiting, upset stomach, constipation;

• blurred vision; or

• dry mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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How should I take acetaminophen and oxycodone?
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 oxycodone tablet may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

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What is the most important information I should know about acetaminophen and oxycodone?
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. Oxycodone 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.

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What happens if I miss a dose?
Since acetaminophen and oxycodone 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.

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What other drugs will affect acetaminophen and oxycodone?
Before taking this medication, tell your doctor if you are using any of the following drugs: 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

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Acetaminophen-oxycodone has been assigned to pregnancy category C by the FDA. Acetaminophen is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Use of narcotic analgesics in late pregnancy is associated with the risk of neonatal withdrawal. There are no controlled data in human pregnancy. Acetaminophen-oxycodone containing products should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

Two cases of acetaminophen overdose in late pregnancy have been reported. In both cases neither the neonate nor the mother suffered hepatic toxicity. Investigations have revealed conflicting results with regards to the pharmacokinetic disposition of acetaminophen in pregnancy women. One study has suggested that the oral clearance of acetaminophen is 58% higher and the elimination half-life is 28% longer in pregnant women. Another study has suggested that the elimination half-life is not different in patients who are pregnant. That study also suggested that the volume of distribution of acetaminophen may be higher in pregnant women. One study has suggested that acetaminophen in typical oral doses may result in a reduced production of prostacyclin in pregnant women. That study also suggested that acetaminophen does not affect thromboxane production.

Acetaminophen is excreted into human milk in small concentrations. One case of an adverse effect (involving a rash) has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics. Oxycodone is excreted into human milk, but the clinical significance in regard to breast-fed infants is unknown.

One small study reported that following a 1000 mg dose of acetaminophen to nursing mothers, nursing infants receive less than 1.85% of the weight-adjusted maternal oral dose.

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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 oxycodone can be fatal. Overdose symptoms may include extreme drowsiness, pinpoint pupils, nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes), confusion, cold and clammy skin, muscle weakness, fainting, weak pulse, coma, blue lips, shallow breathing, or no breathing.

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What should I discuss with my healthcare provider before taking acetaminophen and oxycodone?
Do not use this medication if you are allergic to acetaminophen (Tylenol) or oxycodone. Oxycodone may be habit-forming and should be used only by the person it was prescribed for. Acetaminophen and oxycodone 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. Before using acetaminophen and oxycodone, tell your doctor if you are allergic to any drugs, or if you have:

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Can I stop taking the medication if I feel better?
If you are taking an analgesic for pain and you are no longer experiencing the pain you may stop using the medication. In general, pain medications are to be used on an as needed basis.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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