Medical Editor: John P. Cunha, DO, FACOEP
What Is RoxyBond?
Roxybond (oxycodone hydrochloride) tablets are an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Roxybond is available in generic form.
What Are Side Effects of RoxyBond?
Common side effects of Roxybond include:
- weakness or lack of energy, and
Dosage for RoxyBond
The initial dose of Roxybond is a range of 5 to 15 mg every 4 to 6 hours as needed for pain. The dose of Roxybond is individualized based on severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse.
What Drugs, Substances, or Supplements Interact with RoxyBond?
Roxybond may interact with macrolide antibiotics, azole antifungals, protease inhibitors, rifampin, carbamazepine, phenytoin, benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol, 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), monoamine oxidase (MAO) inhibitors, muscle relaxants, diuretics, and antiocholinergics. Tell your doctor all medications and supplements you use.
RoxyBond During Pregnancy or Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Roxybond; prolonged use of opioid analgesics such as Roxybond during pregnancy may cause neonatal opioid withdrawal syndrome. Roxybond passes into breast milk. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking Roxybond.
Our Roxybond (oxycodone hydrochloride) Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once if you have:
- noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
- a slow heart rate or weak pulse;
- a light-headed feeling, like you might pass out;
- confusion, unusual thoughts or behavior;
- seizure (convulsions);
- low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness; or
- high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.
Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.
Common side effects may include:
- drowsiness, headache, dizziness, tiredness; or
- constipation, stomach pain, nausea, vomiting.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for RoxyBond (Oxycodone Hydrochloride Tablets)
The following serious adverse reactions are described or are described in greater detail, in other sections:
- Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
- Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
- Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
- Interactions with Benzodiazepines or Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
- Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
- Severe Hypotension [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
- Withdrawal [see WARNINGS AND PRECAUTIONS]
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 tablets have been evaluated in open label clinical trials in patients with cancer and nonmalignant pain. Oxycodone hydrochloride tablets are associated with adverse experiences similar to those seen with other opioids.
Serious adverse reactions that may be associated with ROXYBOND therapy include: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock.
The common adverse reactions seen on initiation of therapy with oxycodone hydrochloride tablets are dose related and are opioid-related adverse reactions. The most frequent of these included nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence. The frequency of these reactions depended on several factors, including clinical setting, the patient’s level of opioid tolerance, and host factors specific to the individual.
In all patients for whom dosing information was available (n=191) from the open-label and double-blind studies involving oxycodone hydrochloride tablets, the following adverse events were recorded in oxycodone hydrochloride treated patients with an incidence ≥ 3%. In descending order of frequency, they were nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
Other less frequently observed adverse reactions from opioid analgesics, including oxycodone hydrochloride tablets included:
Blood and lymphatic system disorders: anemia, leukopenia
Cardiac disorders: cardiac failure, palpitation, tachycardia
Gastrointestinal disorders: abdominal pain, dry mouth, diarrhea, dyspepsia, dysphagia, glossitis, nausea, vomiting
General disorders and administration site conditions: chills, edema, edema peripheral, pain, pyrexia
Immune system disorders: hypersensitivity
Infections and infestations: bronchitis, gingivitis, infection, pharyngitis, rhinitis, sepsis, sinusitis, urinary tract infection
Injury, poisoning, and procedural complications: injury
Metabolism and nutritional disorders: decreased appetite, gout, hyperglycemia Musculoskeletal and connective tissue disorders: arthralgia, arthritis, back pain, bone pain, myalgia, neck pain, pathological fracture
Nervous system disorders: hypertonia, hypoesthesia, migraine, neuralgia, tremor, vasodilation
Psychiatric disorders: agitation, anxiety, confusional state, nervousness, personality disorder
Respiratory, thoracic, and mediastinal disorders: cough, dyspnea, epistaxis, laryngospasm, lung disorder
Skin and subcutaneous tissue disorders: photosensitivity reaction, rash, hyperhidrosis, urticaria
Vascular disorders: thrombophlebitis, hemorrhage, hypotension, vasodilation
The following adverse reactions have been identified during post approval use of oxycodone. 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.
General disorders and administrative site disorders: drug withdrawal syndrome neonatal [see WARNINGS AND PRECAUTIONS]
Respiratory, thoracic, and mediastinal disorders: pharyngeal edema
Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs [see DRUG INTERACTIONS].
Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use [see WARNINGS AND PRECAUTIONS].
Anaphylaxis: Anaphylactic reaction has been reported with ingredients contained in ROXYBOND [see CONTRAINDICATIONS].
Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].
Table 1 includes clinically significant drug interactions with ROXYBOND.
Table 1. Clinically Significant Drug Interactions with ROXYBOND
|Inhibitors of CYP3A4 and CYP2D6|
|Clinical Impact:||The concomitant use of ROXYBOND 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 ROXYBOND and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of ROXYBOND is achieved [see WARNINGS AND PRECAUTIONS]. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see CLINICAL PHARMACOLOGY], 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 ROXYBOND until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the ROXYBOND dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.|
|Examples:||Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir).|
|Clinical Impact:||The concomitant use of ROXYBOND and CYP3A4 inducers can decrease the plasma concentration of oxycodone [see CLINICAL PHARMACOLOGY], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to oxycodone [see WARNINGS AND PRECAUTIONS].
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration will increase [see CLINICAL PHARMACOLOGY], 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 ROXYBOND dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider ROXYBOND dosage reduction and monitor for signs of respiratory depression.|
|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 increase the risk of hypotension, respiratory depression, profound sedation, coma, and death.|
|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. Follow patients closely for signs of respiratory depression and sedation. If concomitant use is warranted, consider prescribing naloxone for the emergency treatment of opioid overdose [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].|
|Examples:||Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol.|
|Clinical Impact:||The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome [see ADVERSE REACTIONS].|
|Intervention:||If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue ROXYBOND 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].|
|Intervention:||The use of ROXYBOND 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 ROXYBOND and/or may precipitate withdrawal symptoms.|
|Intervention:||Avoid concomitant use|
|Examples:||Butorphanol, nalbuphine, pentazocine, buprenorphine|
|Clinical Impact:||Oxycodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.|
|Intervention:||Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of ROXYBOND 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, WARNINGS AND PRECAUTIONS].|
|Clinical Impact:||Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.|
|Intervention:||Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.|
|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:||Monitor patients for signs of urinary retention or reduced gastric motility when ROXYBOND is used concurrently with anticholinergic drugs.|
Drug Abuse And Dependence
ROXYBOND contains oxycodone, a Schedule II controlled substance.
ROXYBOND contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol. ROXYBOND can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS AND PRECAUTIONS].
All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.
Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects.
Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes: a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal.
“Drug-seeking” behavior is very common in persons with substance use disorders. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing, or referral, repeated “loss” of prescriptions, tampering with prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare provider(s). “Doctor shopping” (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.
Abuse and addiction are separate and distinct from physical dependence and tolerance. Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction.
ROXYBOND, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests, as required by state and federal law, is strongly advised.
Proper assessment of the patient, proper prescribing practices, periodic reevaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.
Risks Specific to Abuse of ROXYBOND
ROXYBOND is for oral use only. Abuse of ROXYBOND poses a risk of overdose and death. This risk is increased with concurrent abuse of ROXYBOND with alcohol and other central nervous system depressants.
Parenteral abuse of ROXYBOND can be expected to result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. Injection of excipients included in the ROXYBOND formulation, intended to provide abuse-deterrent properties, may be associated with additional unknown serious risks. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.
Abuse Deterrence Studies
ROXYBOND is formulated with inactive ingredients that make the tablet more difficult to manipulate for misuse and abuse even if the tablet is subjected to physical manipulation and/or chemical extraction. To evaluate the ability of the abuse-deterrent technology to reduce the potential for abuse of ROXYBOND, a series of in vitro laboratory manipulation, extraction, and syringe ability studies were conducted. An in vivo intranasal clinical abuse potential study was also conducted.
In Vitro Testing
ROXYBOND has been tested in vitro using methods of manipulation that drug abusers commonly used for preparation of opioids for administration by various routes, including oral consumption, intranasal insufflation, and injection.
Abusers may manipulate prescription opioids in order to prepare the tablets for oral, intranasal, or intravenous administration. The laboratory test data demonstrated that, relative to oxycodone immediate-release tablets, ROXYBOND has increased resistance to cutting, crushing, grinding, or breaking using selected tools. In addition, the intact and manipulated tablets resisted extraction in selected household and laboratory solvents under various conditions, including selected pre-treatments. Relative to oxycodone immediate-release tablets, the formulation forms a viscous material that resists passage through a needle; it was also more difficult to prepare solutions suitable for intravenous injection.
Clinical Abuse Potential Studies
A randomized, double-blind, double-dummy, placebo-controlled, single-dose four-way crossover study in 29 non-dependent recreational opioid users with a history of intranasal drug abuse was performed to determine the relative bioavailability and abuse potential of crushed intranasal ROXYBOND 30 mg tablets compared with crushed intranasal 30 mg oxycodone immediate-release tablets and intact orally administered ROXYBOND 30 mg tablets. Intact oral ROXYBOND tablets were included as a reference for evaluating abuse potential after manipulation and administration via an unintended route.
Drug liking was measured on a 100-mm bipolar visual analog scale (VAS) where 50 represents a neutral response of neither liking nor disliking, 0 represents maximum disliking, and 100 represents maximum liking. Response to whether the subject would be willing to take the study drug again was also measured on a bipolar 0 to 100 VAS where 50 represents a neutral response, 0 represents the strongest negative response (“definitely would not take drug again”) and 100 represents the strongest positive response (“definitely would take drug again”).
The pharmacokinetic profiles of oxycodone were also determined in this study (Table 2). When crushed and insufflated, ROXYBOND showed a lower peak oxycodone plasma concentration (Cmax ~28% reduction) and a 35% longer time to peak plasma concentration (Tmax) relative to crushed and insufflated oxycodone immediate-release tablets. Similar results were demonstrated when crushed and insufflated ROXYBOND was compared to intact oral ROXYBOND with a reduction in Cmax and a longer time to Tmax. Intact oral ROXYBOND resulted in a Cmax of oxycodone similar to that of crushed and insufflated oxycodone immediate-release tablets, with a similar Tmax.
Table 2 Summary of Plasma Oxycodone Pharmacokinetic Parameters from the Intranasal Abuse Potential Study (n=31)
|Treatment or Comparison||Cmax (ng/mL)
|Crushed, Insufflated oxycodone immediate-release tablets 30 mg||55.56||330.77||1.7|
|Crushed, Insufflated ROXYBOND 30 mg||40.04||309.21||2.3|
|Intact, oral ROXYBOND||56.97||265.38||1.3|
|AUC0-t = Area under the plasma concentration vs time curve from 0 to last measurable concentration.|
Compared to crushed intranasal oxycodone immediate-release tablets, intranasal administration of crushed ROXYBOND was associated with statistically significantly lower drug liking (Emax) and take drug again (Emax) scores, as summarized in Table 3. Similar reductions in drug liking and willingness to take the drug again were reported for crushed intranasal ROXYBOND relative to intact oral ROXYBOND. These data are consistent with the slowing of the intended immediate-release properties of ROXYBOND when manipulated then insufflated compared to taking ROXYBOND orally intact. No statistically significant differences in Emax of Drug Liking or Take Drug Again were observed between crushed intranasal oxycodone immediate-release tablets and intact oral ROXYBOND.
Table 3. Summary of Maximum Drug Liking (Emax), and Take Drug Again (Emax), Following Administration of ROXYBOND, Oxycodone Immediate-release Tablets, and Placebo in Recreational Opioid Users (N=29)
|VAS||Crushed Intranasal ROXYBOND
|Crushed Intranasal Oxycodone immediate-release tablets
|Intact Oral ROXYBOND
|Drug Liking (Emax)||Mean
(50 to 100)
(50 to 100)
(56 to 100)
(50 to 77)
|Take Drug Again (Emax)||Mean
(3 to 99)
(37 to 100)
(13 to 100)
(0.0 to 78)
Figure 1. Mean Drug Liking VAS Scores Over Time (N=29)
The majority of subjects (86%; n=25) experienced some reduction in Emax of Drug Liking VAS with crushed intranasal ROXYBOND compared with crushed intranasal oxycodone immediate-release tablets, whereas 59% (n=17) experienced at least a 30% reduction in Emax of drug liking and 21% (n=6) experienced at least a 50% reduction in Emax of drug liking.
The in vitro data demonstrate that ROXYBOND has physicochemical properties expected to make abuse via injection difficult. The data from the clinical study, along with support from in vitro data, also indicate that ROXYBOND has physicochemical properties that are expected to reduce abuse by the intranasal route of administration. However, abuse by the intranasal, oral, and intravenous route is still possible.
Additional data, including epidemiological data, when available, may provide further information on the impact of the current formulation of ROXYBOND on the abuse liability of the drug. Accordingly, this section may be updated in the future as appropriate.
Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects.
Physical dependence is a physiological state in which the body adapts to the drug after a period of regular exposure, resulting in withdrawal symptoms after abrupt discontinuation or a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.
Do not abruptly discontinue ROXYBOND in a patient physically dependent on opioids. Rapid tapering of ROXYBOND in a patient physically dependent on opioids may lead to serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse.
When discontinuing ROXYBOND, gradually taper the dosage using a patient specific plan that considers the following: the dose of ROXYBOND the patient has been taking, the duration of treatment, and the physical and psychological attributes of the patient. To improve the likelihood of a successful taper and minimize withdrawal symptoms, it is important that the opioid tapering schedule is agreed upon by the patient. In patients taking opioids for a long duration at high doses, ensure that a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].
Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see Use In Specific Populations].
Read the entire FDA prescribing information for RoxyBond (Oxycodone Hydrochloride Tablets)
© RoxyBond Patient Information is supplied by Cerner Multum, Inc. and RoxyBond Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.