Oxycodone Hydrochloride - Oxycodone Hydrochloride tablet prescribing information
A
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.
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.
Oxycodone Hydrochloride Tablets, USP:
5 mg: white, round, biconvex tablets, debossed "K" on left and "18" on right of the bisect on one side and plain on the other side.
10 mg: pink, round, biconvex tablets, debossed "K" on left and "56"on right of the bisect on one side and plain on the other side.
15 mg: green, round, biconvex tablets, debossed "K" on left and "8" on right of the bisect on one side and plain on the other side.
20 mg: gray, round, biconvex tablets, debossed "K" on left and "57" on right of the bisect on one side and plain on the other side.
30 mg: blue, round, biconvex tablets, debossed "K" on left and "9" on right of the bisect on one side and plain on the other side.
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)]
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)]
Table 1 includes 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)] .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 discontinued, consider increasing the oxycodone hydrochloride dosage until stable drug effects are achieved. Evaluate for signs of opioid withdrawal. |
Examples: | Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir). |
CYP3A4 Inducers | |
Clinical Impact: | The concomitant use of oxycodone hydrochloride and CYP3A4inducers can decrease the plasma concentration of oxycodone [see Clinical Pharmacology (12.3)] , resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to oxycodone[see Warnings and Precautions (5.6)] .After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration will increase [see Clinical Pharmacology (12.3)] , which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression. |
Intervention: | If concomitant use is necessary, consider increasing the oxycodone hydrochloride dosage until stable drug effects are achieved. Evaluate patients for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider oxycodone hydrochloride dosage reduction and evaluate patients at frequent intervals for signs of respiratory depression and sedation. |
Examples: | Rifampin, carbamazepine, phenytoin |
Benzodiazepines and Other Central Nervous System (CNS) Depressants | |
Clinical Impact: | Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increases the risk of hypotension, respiratory depression, profound sedation, coma, and death [see Warnings and Precautions (5.3)]. |
Intervention: | Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Inform patients and caregivers of this potential interaction and educate them on the signs and symptoms of respiratory depression (including sedation). If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration (2.2), Warnings and Precautions (5.1, 5.2, 5.3)]. |
Examples: | Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol. |
Serotonergic Drugs | |
Clinical Impact: | The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome [see Adverse Reaction (6.2)]. |
Intervention: | If concomitant use is warranted, frequently evaluate the patient, particularly during treatment initiation and dose adjustment. Discontinue oxycodone hydrochloride if serotonin syndrome is suspected. |
Examples: | Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol),certain muscle relaxants (i.e., cyclobenzaprine, metaxalone),monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
Monoamine Oxidase Inhibitors (MAOIs) | |
Clinical Impact: | MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see Warnings and Precautions (5.2)]. |
Intervention: | The use of oxycodone hydrochloride is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression. |
Examples: | phenelzine, tranylcypromine, linezolid |
Mixed Agonist/Antagonist Opioid Analgesics | |
Clinical Impact: | May reduce the analgesic effect of oxycodone hydrochloride and/or may precipitate withdrawal symptoms. |
Intervention: | Avoid concomitant use |
Examples | Butorphanol, nalbuphine, pentazocine, buprenorphine |
Muscle Relaxants | |
Clinical Impact: | Oxycodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. |
Intervention: | Because respiratory depression may be greater than otherwise expected, decrease the dosage of oxycodone hydrochloride and/or the muscle relaxant as necessary. Due to the risk of respiratory depression with concomitant use of skeletal muscle relaxants and opioids, consider prescribing naloxone for the emergency treatment of opioid overdose [see Dosage and Administration (2.2), Warnings and Precautions (5.2, 5.3)]. |
Diuretics | |
Clinical Impact: | Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. |
Intervention: | Evaluate patients for signs of dismissed diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed. |
Anticholinergic Drugs | |
Clinical Impact: | The concomitant risk of anticholinergic drugs may result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. |
Intervention: | Evaluate patients for signs of urinary retention or reduced gastric motility when oxycodone hydrochloride are used concurrently with anticholinergic drugs. |