Oxycodone HCL 20 mg/1
Oxycodone HCL · TABLET · Direct_Rx
Oxycodone HCL is a tablet containing oxycodone hcl at 20 mg/1, taken oral. Manufactured by Direct_Rx.
Key Facts
- Brand Name
- Oxycodone HCL
- Generic Name
- Oxycodone HCL
- NDC Code (Product)
72189-613- Manufacturer
- Direct_Rx
- Strength
- 20 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule II (Controlled)
- Application #
- ANDA077712
- Marketing Start
- 04/07/2025
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
Oxycodone hHydrochloride Tablets are 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 even at recommended doses [see Warnings and Precautions (5.1)], reserve oOxycodone hHydrochloride Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): • 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 hydrochloride 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
2.1 Important Dosage and Administration Instructions Oxycodone hydrochloride 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 and Precautions (5)]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of oxycodone hydrochloride 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…
Contraindications
Oxycodone hydrochloride tablets are contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2)] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment or hypercarbia [see Warnings and Precautions (5.8)] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12)] Known hypersensitivity (e.g., anaphylaxis) to oxycodone [see Adverse Reactions (6.2)]
Drug Interactions
Table 1 includes clinically significant drug interactions with oxycodone hydrochloride. Table 1: Clinically Significant Drug Interactions with Oxycodone Hydrochloride Tablets Inhibitors of CYP3A4 and CYP2D6 Clinical Impact: The concomitant use of oxycodone hydrochloride and CYP3A4 inhibitors can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of oxycodone hydrochloride and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of oxycodone hydrochloride is achieved [see Warnings and Precautions (5.3)]. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see Clinical Pharmacology (12.3)], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to oxycodone. Intervention: If concomitant use is necessary, consider dosage reduction of oxycodone hydrochloride until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation. If a CYP3A4 inhibitor is discontinu…
Adverse Reactions
The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3)] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4)] Opioid-Induce Hyperalgesia and Allodynia [see Warnings and Precautions (5.7)] Adrenal Insufficiency [see Warnings and Precautions (5.9)] Severe Hypotension [see Warnings and Precautions (5.10)] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12)] Seizures [see Warnings and Precautions (5.13)] Withdrawal [see Warnings and Precautions (5.14)] 6.1 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. Oxycodone hydrochloride have been evaluated in open label clinical trials in patients with cancer and nonmalignant pain. Oxy…
Frequently Asked Questions
What is Oxycodone HCL used for?
Oxycodone HCL contains Oxycodone HCL. It is a tablet taken oral. Consult your doctor for specific uses.
Is Oxycodone HCL a controlled substance?
Yes, Oxycodone HCL is classified as CII under the DEA Controlled Substances Act.
What is the generic name for Oxycodone HCL?
The generic name for Oxycodone HCL is Oxycodone HCL. There are no other listed brand versions of Oxycodone HCL.
What is the NDC code for Oxycodone HCL 20 mg/1?
The NDC (National Drug Code) for Oxycodone HCL 20 mg/1 is 72189-613, listed by Direct_Rx.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)