Drugplain

PERCOCET 325 mg/1

oxycodone hydrochloride and acetaminophen · TABLET · Endo USA, Inc.

No Recall HistoryCurrently in Shortage
Plain English

PERCOCET is a tablet containing oxycodone hydrochloride and acetaminophen at 325 mg/1, taken oral. Manufactured by Endo USA, Inc..

Key Facts

Brand Name
PERCOCET
Generic Name
oxycodone hydrochloride and acetaminophen
NDC Code (Product)
63481-629
Manufacturer
Endo USA, Inc.
Strength
325 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
DEA Schedule
Schedule II (Controlled)
Application #
ANDA040330
Marketing Start
11/30/2001

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dependence18,724 reports
death15,817 reports
overdose13,953 reports
toxicity to various agents9,418 reports
ill-defined disorder5,950 reports
pain4,656 reports
drug dependence3,929 reports
nausea3,768 reports
fatigue3,221 reports
drug ineffective3,136 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE PERCOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see WARNINGS], reserve opioid analgesics, including PERCOCET, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Dosage & Administration

DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions PERCOCET should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see WARNINGS ] . Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of PERCOCET for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors. Initiate the dosing regimen for each patient individually, taking into account the patient's underlying cause and severity of pai…

Warnings

WARNINGS Addiction, Abuse, and Misuse PERCOCET contains oxycodone, a Schedule II controlled substance. As an opioid, PERCOCET exposes users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE ] . Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed PERCOCET. Addiction can occur at recommended dosages and if the drug is misused or abused. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. In postmarketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use [ ADVERSE REACTIONS ] . Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing PERCOCET, and reassess all patients receiving PERCOCET for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of p…

Contraindications

CONTRAINDICATIONS PERCOCET is contraindicated in patients with: Significant respiratory depression [see WARNINGS ] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS ] Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS ] Hypersensitivity to oxycodone, acetaminophen, or any other component of the product (e.g., anaphylaxis) [see WARNINGS , ADVERSE REACTIONS ]

Drug Interactions

Drug Interactions Inhibitors of CYP3A4 and CYP2D6 The concomitant use of PERCOCET and CYP3A4 inhibitors, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), and protease inhibitors (e.g., ritonavir), can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of PERCOCET and CYP3A4 and CYP2D6 inhibitors, particularly when an inhibitor is added after a stable dose of PERCOCET is achieved [see WARNINGS ] . After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see CLINICAL PHARMACOLOGY ] , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to PERCOCET. If concomitant use is necessary, consider dosage reduction of PERCOCET until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation. If a CYP3A4 inhibitor is discontinued, consider increasing the PERCOCET dosage until stable drug effects are achieved. Evaluate for signs of opioid withdrawal. Inducers…

Adverse Reactions

ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of PERCOCET. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Serious adverse reactions that may be associated with oxycodone and acetaminophen use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock [see OVERDOSAGE ] . The most frequently observed non-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting. These effects seem to be more prominent in ambulatory than in nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include euphoria, dysphoria, constipation, and pruritus. Hypersensitivity reactions may include: Skin eruptions, urticarial, erythematous skin reactions. Hematologic reactions may include: thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia. Rare cases of agranulocytosis have likewise been associated with acetaminophen use. In high do…

Frequently Asked Questions

What is PERCOCET used for?

PERCOCET contains oxycodone hydrochloride and acetaminophen. It is a tablet taken oral. Consult your doctor for specific uses.

Is PERCOCET a controlled substance?

Yes, PERCOCET is classified as CII under the DEA Controlled Substances Act.

What is the generic name for PERCOCET?

The generic name for PERCOCET is oxycodone hydrochloride and acetaminophen. There are 9 other brand versions of oxycodone hydrochloride and acetaminophen.

What is the NDC code for PERCOCET 325 mg/1?

The NDC (National Drug Code) for PERCOCET 325 mg/1 is 63481-629, listed by Endo USA, Inc..

Product NDC

63481-629

Package NDC

63481-629-70

Other Oxycodone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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