• Roxicet is a pain-relieving medication that contains a combination of acetaminophen and oxycodone.
• Acetaminophen and oxycodone are two different pain-relieving medicines with different mechanisms of action. Acetaminophen is thought to work by blocking the effects of a specific enzyme, known as cyclo-oxygenase (COX). Oxycodone binds to specific receptors known as mu opioid receptors that block pain signals on their way to the brain.
• Roxicet belongs to the group of medicines known as combination narcotic analgesics. It may also be called a combination opioid analgesic.
• The Roxicet brand has been discontinued in the United States. Other brands and the generic form of oxycodone and acetaminophen are still available.

• Roxicet is effective for the management of moderate-to-moderately severe pain unresponsive to other treatment options.
• The combination is more effective than either drug alone.
• Some people find taking fixed-dose combination tablets easier to take than taking two different medicines.
• Available in tablet and oral solution forms.
• Roxicet 5/325mg tablets are a generic form of Percocet. No generic form of Roxicet 5/500 mg caplets and 5/325 mg oral solution is currently available.

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

• Drowsiness or dizziness may impair reaction skills and affect a person's ability to drive or operate machinery (oxycodone component). Avoid alcohol.
• Stomach upset including nausea and vomiting, and constipation (oxycodone component). Laxatives may be required.
• Excessive dosages of acetaminophen can lead to liver injury or death. Care must be taken not to take additional acetaminophen from other sources.
• Unlike NSAID pain relievers like ibuprofen, acetaminophen does not have any appreciable anti-inflammatory action.
• Oxycodone is habit-forming and potentially abusable. Roxicet should only be used short-term at the lowest effective dose when other nonopioid analgesics are not effective. Legitimate supplies of Roxicet may be sought out by drug seekers.
• Abrupt discontinuation of Roxicet in a person who has become physically dependent on it may lead to a withdrawal syndrome and symptoms such as restlessness, pupil dilation, watery eyes, a runny nose, sweating, muscle aches, insomnia, irritability, and gastrointestinal complaints. Babies born to mothers who are physically dependent on Roxicet will also be physically dependent.
• Rarely, serious, life-threatening, breathing problems may occur attributable to the oxycodone component. The risk is greater with higher dosages of Roxicet, in people with pre-existing respiratory disease, in seniors or the frail, or in those taking other medications that cause respiratory depression (such as benzodiazepines).
• Interaction or overdosage may also cause serotonin syndrome. Symptoms include mental status changes such as agitation, hallucinations, coma, or delirium; a fast heart rate; dizziness; flushing; muscle tremor or rigidity; and stomach symptoms (including nausea, vomiting, and diarrhea).
• May not be suitable for people with pre-existing respiratory depression or respiratory disease, with seizure disorders or a head injury, people with gastrointestinal obstruction, or recent use of monoamine oxidase inhibitors.
• Products containing opioids such as oxycodone (in Roxicet) are required by the FDA to have a REMS (Risk Evaluation and Mitigation Strategy) associated with them and healthcare providers are encouraged to complete a REMS-compliant education program, counsel patients or their caregivers with every prescription on the safe use, storage, disposal, and serious risks associated with these products, explain to patients the importance of reading the medication guide, and improve patient, household, and community safety.
• Keep out of reach of children because accidental ingestion may result in a fatal overdose of Roxicet. Babies who have been exposed to Roxicet in the womb may experience neonatal opioid withdrawal syndrome when born. Monitor and treat accordingly.
• Not suitable for people younger than 18 years.
• Roxicet is a Schedule II controlled substance.

Note: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. View complete list of side effects

• May be taken with or without food.
• Take as directed by your doctor. Do not increase the dosage without his or her advice.
• Call emergency services if you experience any breathing difficulties, wheezing, or facial swelling.
• Tell your doctor if you think you have become addicted to this combination drug.
• Short-term use is recommended. Do not exceed the prescribed dosage.
• Tell your doctor if you have severe uncontrolled asthma, other breathing problems, or an intestinal blockage; you may not be able to use this medicine.
• Call your doctor if you experience nausea or vomiting, stomach pain, itching, yellowing of your skin or eyes (jaundice), dark (brown) urine, or light-colored stools.
• Keep Roxicet out of reach of children and pets, because even one dose can be fatal.
• Roxicet may not be interchangeable with other acetaminophen/oxycodone products because of differences in the frequency of administration.
• Avoid alcohol because the combination of alcohol and Roxicet can increase side effects such as sedation and respiratory depression.
• Keep up your fluid and fiber intake to reduce the risk of developing constipation. Tell your doctor if you experience constipation and consider taking a laxative.
• Tell your doctor if you think you have become addicted to this combination drug or if the usual dosage does not appear to be working.
• Do not double up on other medications containing either acetaminophen or oxycodone or another opioid such as codeine while taking this combination product. Check product labels thoroughly to ensure these ingredients are not "hidden" in other products.

• The peak effect of the oxycodone component of Roxicet occurs 1.8 hours after oral administration and the duration of activity lasts for 3-4 hours. The effects of the acetaminophen component of Roxicet reach a peak within 30-60 minutes of administration and the analgesic effect of acetaminophen lasts for 3 to 4 hours.

Medicines that interact with Roxicet may either decrease its effect, affect how long it works, increase side effects, or have less of an effect when taken with Roxicet. An interaction between two medications does not always mean that you must stop taking one of the medications; however, sometimes it does. Speak to your doctor about how drug interactions should be managed.

Common medications that may interact with Roxicet include:

• antibiotics, such as clarithromycin and erythromycin
• antidepressants, such as tricyclic antidepressants (eg, amitriptyline), monoamine oxidase inhibitors (eg, isocarboxazid, phenelzine, and tranylcypromine), or SSRIs (eg, fluoxetine, sertraline)
• antifungal agents, such as itraconazole and ketoconazole
• anticonvulsants, such as carbamazepine, lamotrigine, phenytoin, phenobarbital, or primidone
• antipsychotics (such as butyrophenones, phenothiazines, or thioxanthenes) and atypical antipsychotics (eg, olanzapine, quetiapine, ziprasidone)
• any medication that may cause drowsiness, such as benzodiazepines (eg, diazepam, lorazepam), first-generation antihistamines (such as doxylamine or promethazine), metoclopramide, or opioids (such as codeine, morphine)
• buprenorphine
• busulfan
• carbamazepine
• dapsone
• dasatinib
• flucloxacillin
• imatinib
• isoniazid
• migraine medications, such as almotriptan, eletriptan, or sumatriptan
• muscle relaxants, such as cyclobenzaprine
• rifampin
• any other medication that inhibits hepatic enzymes CYP3A4 or CYP2D6 or induces CYP3A4
• other medications that affect serotonin, such as amphetamines, fentanyl, lithium, tramadol, triptans (eg, almotriptan, eletriptan, or sumatriptan), or St. John's Wort.

Avoid grapefruit products and drinking alcohol or taking illegal or recreational drugs while taking Roxicet.

Note that this list is not all-inclusive and includes only common medications that may interact with Roxicet. You should refer to the prescribing information for Roxicet for a complete list of interactions.