Oxycodone and Aspirin 325 mg/1
Oxycodone and Aspirin · TABLET · Epic Pharma, LLC
Oxycodone and Aspirin is a tablet containing oxycodone and aspirin at 325 mg/1, taken oral. Manufactured by Epic Pharma, LLC.
Key Facts
- Brand Name
- Oxycodone and Aspirin
- Generic Name
- Oxycodone and Aspirin
- NDC Code (Product)
42806-061- Manufacturer
- Epic Pharma, LLC
- Strength
- 325 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA040910
- Drug Class
- Nonsteroidal Anti-inflammatory Drug [EPC]; Platelet Aggregation Inhibitor [EPC]
- Marketing Start
- 06/30/2020
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Oxycodone and aspirin tablets are 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 oxycodone and aspirin tablets 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 Oxycodone and Aspirin tablets 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 Oxycodone and aspirin tablets 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 oxycodone and aspirin tablets 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 patie…
Warnings
WARNINGS Addiction, Abuse, and Misuse Oxycodone and aspirin tablets contain Oxycodone, a Schedule II controlled substance. As an opioid, oxycodone and aspirin tablets 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 oxycodone and aspirin tablets. 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 oxycodone and aspirin tablets, and reassess all patients receiving oxycodone and aspirin tablets 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 oxycodone and aspirin tablets but use in such patients necessitates intensive counseling about the risks and proper use of oxycodo…
Contraindications
CONTRAINDICATIONS Oxycodone and aspirin tablets are 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 or aspirin, (e.g. angioedema) (see WARNINGS ) • Patients with hemophilia. • Aspirin should not be used in children or teenagers for viral infections, with or without fever, because of the risk of Reye syndrome (see WARNINGS )
Drug Interactions
Drug -Drug Interactions (see PRECAUTIONS) Inhibitors of CYP3A4 Since the CYP3A4 isoenzyme plays a major role in the metabolism of oxycodone and aspirin tablets, drugs that inhibit CYP3A4 activity, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may cause decreased clearance of oxycodone, which could lead to an increase in oxycodone plasma concentrations. A published study showed that the co-administration of the antifungal drug, voriconazole, increased oxycodone AUC and Cmax by 3.6 and 1.7 fold, respectively. The expected clinical results would be increased or prolonged opioid effects. Inducers of CYP450 CYP450 inducers, such as rifampin, carbamazepine, and phenytoin, may induce the metabolism of oxycodone, may cause increased clearance of the drug which could lead to a decrease in oxycodone plasma concentrations. A published study showed that the co-administration of rifampin, a drug metabolizing enzyme inducer, decreased oxycodone (oral) AUC and Cmax by 86% and 63% respectively. The expected clinical results would be lack of efficacy or, possibly, development of abstinence syndrome in a p…
Adverse Reactions
ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse (see WARNINGS ) • Life-Threatening Respiratory Depression (see WARNINGS ) • Neonatal Opioid Withdrawal Syndrome (see WARNINGS ) • Opioid-Induced Hyperalgesia and Allodynia [see WARNINGS ] • Interactions with Benzodiazepines and Other CNS Depressants (see WARNINGS ) • Adrenal Insufficiency (see WARNINGS ) • Severe Hypotension (see WARNINGS ) • Gastrointestinal Adverse Reactions (see WARNINGS ) • Seizures (see WARNINGS ) • Withdrawal (see WARNINGS ) Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Serious adverse reactions that may be associated with oxycodone and aspirin tablet use include, apnea, circulatory depression, hypotension, respiratory arrest, respiratory depression, and shock (see OVERDOSAGE ). The most frequently observed non-serious adverse reactions include lightheadedness, dizzi…
Frequently Asked Questions
What is Oxycodone and Aspirin used for?
Oxycodone and Aspirin contains Oxycodone and Aspirin. It is a tablet taken oral. Consult your doctor for specific uses.
Is Oxycodone and Aspirin a controlled substance?
Yes, Oxycodone and Aspirin is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Oxycodone and Aspirin?
The generic name for Oxycodone and Aspirin is Oxycodone and Aspirin. There are no other listed brand versions of Oxycodone and Aspirin.
What is the NDC code for Oxycodone and Aspirin 325 mg/1?
The NDC (National Drug Code) for Oxycodone and Aspirin 325 mg/1 is 42806-061, listed by Epic Pharma, LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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