Generic Name: acetaminophen and oxycodone (a SEET a MIN oh fen and OX i KOE done)
Brand Names: Roxicet

What is Roxicet?

Roxicet contains a combination of acetaminophen and oxycodone. Oxycodone is an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of oxycodone.

Roxicet is used to relieve moderate to severe pain.

Roxicet may also be used for purposes not listed in this medication guide.

Important information

You should not use Roxicet if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Do not use Roxicet if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

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Do not take more of this medication than is recommended. An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of your skin or eyes).

In rare cases, acetaminophen may cause a severe skin reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Roxicet may be habit forming. Never share acetaminophen and oxycodone with another person, especially someone with a history of drug abuse or addiction.

Before taking this medicine

You should not use Roxicet if you are allergic to acetaminophen (Tylenol) or oxycodone, or if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Do not use this medicine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, phenelzine, rasagiline, selegiline, and tranylcypromine.

To make sure Roxicet is safe for you, tell your doctor if you have:

  • liver disease, cirrhosis, or if you drink more than 3 alcoholic beverages per day;

  • a history of alcoholism or drug addiction;

  • diarrhea, inflammatory bowel disease;

  • bowel obstruction, severe constipation;

  • a colostomy or ileostomy;

  • kidney disease;

  • low blood pressure, or if you are dehydrated;

  • a history of head injury, brain tumor, or stroke; or

  • asthma, COPD, sleep apnea, or other breathing disorders.

This medicine is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

Oxycodone may be habit forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether Roxicet is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Before you take Roxicet, tell your doctor if you are pregnant or plan to become pregnant during treatment.

See also: Pregnancy and breastfeeding warnings (in more detail)

Acetaminophen and oxycodone may pass into breast milk and could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take Roxicet?

Take Roxicet exactly as prescribed. Follow all directions on your prescription label. Never take this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Measure liquid Roxicet oral solution with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking Roxicet. Do not use a stool softener (laxative) without first asking your doctor.

This medicine can cause unusual results with certain urine tests. Tell any doctor who treats you that you are using Roxicet.

If you need surgery, tell the surgeon ahead of time that you are using this medicine. You may need to stop using the medicine for a short time.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using Roxicet.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Always check your bottle to make sure you have received the correct pills (same brand and type) of medicine prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.

After you have stopped using Roxicet, flush any unused medicine down the toilet. Disposal of medicines by flushing is recommended to reduce the danger of accidental overdose causing death. This advice applies to a very small number of medicines only. The FDA, working with the manufacturer, has determined this method to be the most appropriate route of disposal and presents the least risk to human safety.

What happens if I miss a dose?

Since Roxicet 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. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of Roxicet can be fatal.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Overdose symptoms may also include extreme drowsiness, pinpoint pupils, cold and clammy skin, muscle weakness, fainting, weak pulse, slow heart rate, coma, blue lips, shallow breathing, or no breathing

What should I avoid?

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how Roxicet will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Roxicet side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Roxicet: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling. If you have this type of reaction, you should never again take any medicine that contains acetaminophen.

Call your doctor at once if you have:

  • shallow breathing, slow heartbeat;

  • a light-headed feeling, like you might pass out;

  • confusion, unusual thoughts or behavior;

  • seizure (convulsions);

  • problems with urination; or

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

Common Roxicet side effects include:

  • drowsiness;

  • upset stomach, constipation;

  • blurred vision; or

  • dry mouth.

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.

See also: Side effects (in more detail)

What other drugs will affect Roxicet?

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking Roxicet with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with Roxicet, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about Roxicet.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Roxicet only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. 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. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2014 Cerner Multum, Inc. Version: 15.04. Revision Date: 2014-03-19, 10:23:17 AM.

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