Oxycodone Hcl
Generic Name: oxycodone hcl
Brand Names:
Oxycodone Hcl
Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7).
Overview
Oxycodone Hydrochloride Tablets, USP contain oxycodone, an opioid agonist. Each tablet for oral administration contains 5 mg, 10 mg, 15 mg, 20 mg, or 30 mg of oxycodone hydrochloride USP. Oxycodone hydrochloride is a white, odorless crystalline powder derived from the opium alkaloid, thebaine. Oxycodone hydrochloride dissolves in water (1 g in 6 to 7 mL) and is considered slightly soluble in alcohol (octanol water partition coefficient is 0.7).
Uses
Oxycodone hydrochloride 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 and Precautions (5.1)], reserve oxycodone hydrochloride 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.
Dosage
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.
Side Effects
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...
Interactions
Table 1 includes clinically significant drug interactions with oxycodone hydrochloride. Table 1: Clinically Significant Drug Interactions with Oxycodone Hydrochloride 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)] .
Warnings
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE HYDROCHLORIDE Addiction, Abuse, and Misuse Because the use of oxycodone hydrochloride exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)]. 5.1 Addiction, Abuse, and Misuse Oxycodone hydrochloride contain oxycodone, a Schedule II controlled substance. As an opioid, oxycodone hydrochloride exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9)]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed oxycodone hydrochloride. 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 hydrochloride, and reassess all patients receiving oxycodone hydrochloride for the development of these behaviors and conditions. Oxycodone hydrochloride 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)].
Storage
Store at 20° to 25°C (68° to 77°F); excursions are permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store Oxycodone hydrochloride securely and dispose of properly [see Patient Counseling Information (17)]
Frequently Asked Questions
What is Oxycodone Hcl used for?▼
Oxycodone hydrochloride 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 and Precautions (5.1)], reserve oxycodone hydrochloride 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.
What are the side effects of Oxycodone Hcl?▼
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...
What are the important warnings for Oxycodone Hcl?▼
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE HYDROCHLORIDE Addiction, Abuse, and Misuse Because the use of oxycodone hydrochloride exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)]. 5.1 Addiction, Abuse, and Misuse Oxycodone hydrochloride contain oxycodone, a Schedule II controlled substance. As an opioid, oxycodone hydrochloride exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9)]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed oxycodone hydrochloride. 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 hydrochloride, and reassess all patients receiving oxycodone hydrochloride for the development of these behaviors and conditions. Oxycodone hydrochloride 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)].
Related Medications
Apis Mellifica, Arnica Montana, Hepar Suis, Ichthyolum, Lachesis Mutus, Mercurius Solubilis, Rhus Tox, Urtica Urens
apis mellifica, arnica montana, hepar suis, ichthyolum, lachesis mutus, mercurius solubilis, rhus tox, urtica urens
Standardized Insect Venom Allergenic Extract [EPC]
INDICATIONS: Relieves symptoms associated with Hives.
Paspalum Notatum
paspalum notatum
Dosage form: SOLUTION. Route: INTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS. Active ingredients: PASPALUM NOTATUM POLLEN (.05 g/mL). Category: BLA.
Paspalum Notatum Pollen
paspalum notatum pollen
Dosage form: INJECTION, SUSPENSION. Route: SUBCUTANEOUS. Active ingredients: PASPALUM NOTATUM POLLEN (10000 [PNU]/mL). Category: BLA.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.