Oxycodone Hydrochloride and Acetaminophen 325 mg/1
Oxycodone Hydrochloride and Acetaminophen · TABLET · Elite Laboratories, Inc.
Oxycodone hydrochloride and acetaminophen is a prescription tablet that combines an opioid pain reliever with acetaminophen to treat moderate to moderately severe pain. This medication should only be used as prescribed by your doctor, as opioids carry risks of dependence and serious side effects.
Key Facts
- Brand Name
- Oxycodone Hydrochloride and Acetaminophen
- Generic Name
- Oxycodone Hydrochloride and Acetaminophen
- NDC Code (Product)
64850-623- Manufacturer
- Elite Laboratories, Inc.
- Strength
- 325 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA209385
- Marketing Start
- 12/04/2017
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 & USAGE Oxycodone and acetaminophen 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, 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 oxycodone and acetaminophen tablets, for use in patients for whom alternative treatment options and ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Dosage & Administration
DOSAGE & ADMINISTRATION Important Dosage and Administration Instructions Oxycodone and acetaminophen 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 acetaminophen 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…
Warnings
WARNINGS Addiction, Abuse, and Misuse Oxycodone and acetaminophen tablets contain oxycodone, a Schedule II controlled substance. As an opioid, oxycodone and acetaminophen 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 acetaminophen tablets. Addiction can occur at recommended doses 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 [see ADVERSE REACTIONS ]. Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing oxycodone and acetaminophen tablets, and reassess all patients receiving oxycodone and acetaminophen 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 addicti…
Contraindications
CONTRAINDICATIONS Oxycodone and acetaminophen tablets 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 and ADVERSE REACTIONS ]
Adverse Reactions
ADVERSE REACTIONS The following adverse reactions have been identified during post approval use of oxycodone and acetaminophen tablets. 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 has likewise been associated with acet…
Frequently Asked Questions
What is Oxycodone Hydrochloride and Acetaminophen used for?
Oxycodone hydrochloride and acetaminophen is a prescription tablet that combines an opioid pain reliever with acetaminophen to treat moderate to moderately severe pain. This medication should only be used as prescribed by your doctor, as opioids carry risks of dependence and serious side effects.
Is Oxycodone Hydrochloride and Acetaminophen a controlled substance?
Yes, Oxycodone Hydrochloride and Acetaminophen is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Oxycodone Hydrochloride and Acetaminophen?
The generic name for Oxycodone Hydrochloride and Acetaminophen is Oxycodone Hydrochloride and Acetaminophen. There are 7 other brand versions of Oxycodone Hydrochloride and Acetaminophen.
What is the NDC code for Oxycodone Hydrochloride and Acetaminophen 325 mg/1?
The NDC (National Drug Code) for Oxycodone Hydrochloride and Acetaminophen 325 mg/1 is 64850-623, listed by Elite Laboratories, Inc..