ENDOCET 325 mg/1
Oxycodone and Acetaminophen · TABLET · Redpharm Drug
ENDOCET is a tablet containing oxycodone and acetaminophen at 325 mg/1, taken oral. Manufactured by Redpharm Drug.
Key Facts
- Brand Name
- ENDOCET
- Generic Name
- Oxycodone and Acetaminophen
- NDC Code (Product)
67296-0836- Manufacturer
- Redpharm Drug
- Strength
- 325 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA040330
- Marketing Start
- 05/26/2000
Recall History
Endo Pharmaceuticals, Inc.
Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE ENDOCET 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, and misuse with opioids, which can occur at any dosage or duration [see WARNINGS ] , reserve ENDOCET for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia ENDOCET should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
Dosage & Administration
DOSAGE AND ADMINISTRATION Important Dosage and Administration Instructions ENDOCET 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 ENDOCET 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 pain,…
Warnings
WARNINGS Addiction, Abuse, and Misuse ENDOCET contains oxycodone, a Schedule II controlled substance. As an opioid, ENDOCET 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 ENDOCET. Addiction can occur at recommended dosages and if the drug is misused or abused. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing ENDOCET, and reassess all patients receiving ENDOCET 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 pain in any given patient. Patients at increased risk may be prescribed opioids such as ENDOCET, but use in such patients necessitates intensive counseling about the risks and proper use of ENDOCET along with frequent reevaluation for signs of addiction, abuse, and misuse. Consider prescribing naloxone for the emergency trea…
Contraindications
CONTRAINDICATIONS ENDOCET 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 ENDOCET 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 ENDOCET and CYP3A4 and CYP2D6 inhibitors, particularly when an inhibitor is added after a stable dose of ENDOCET 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 ENDOCET. If concomitant use is necessary, consider dosage reduction of ENDOCET 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 ENDOCET dosage until stable drug effects are achieved. Evaluate for signs of opioid withdrawal. Inducers of CY…
Adverse Reactions
ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of ENDOCET. 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 dos…
Frequently Asked Questions
What is ENDOCET used for?
ENDOCET contains Oxycodone and Acetaminophen. It is a tablet taken oral. Consult your doctor for specific uses.
Is ENDOCET a controlled substance?
Yes, ENDOCET is classified as CII under the DEA Controlled Substances Act.
What is the generic name for ENDOCET?
The generic name for ENDOCET is Oxycodone and Acetaminophen. There are 11 other brand versions of Oxycodone and Acetaminophen.
What is the NDC code for ENDOCET 325 mg/1?
The NDC (National Drug Code) for ENDOCET 325 mg/1 is 67296-0836, listed by Redpharm Drug.
Other ENDOCET Dosages
Other Oxycodone Brands
See all →- OXYCODONE AND ACETAMINOPHEN325 mg/172189-255
- oxycodone and acetaminophen300 mg/172887-683
- Oxycodone and Acetaminophen325 mg/113107-045
- Oxycodone and Acetaminophen325 mg/163629-9501
- Oxycodone and Acetaminophen325 mg/168084-699
- Oxycodone and Acetaminophen325 mg/168084-710
- Oxycodone and Acetaminophen325 mg/171205-486
- Oxycodone and Acetaminophen325 mg/171335-0316
- OXYCODONE AND ACETAMINOPHEN325 mg/10904-7095
- OXYCODONE AND ACETAMINOPHEN325 mg/131722-950
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)