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The following serious adverse reactions are described elsewhere in the labeling:
- 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 Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
- Hypotensive Effects [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal Effects [see WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Adult Clinical Trial 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. The safety of OXYCONTIN was evaluated in double-blind clinical trials involving 713 patients with moderate to severe pain of various etiologies. In open-label studies of cancer pain, 187 patients received OXYCONTIN in total daily doses ranging from 20 mg to 640 mg per day. The average total daily dose was approximately 105 mg per day.
OXYCONTIN may increase the risk of serious adverse reactions such as those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, or shock [see OVERDOSAGE].
The most common adverse reactions ( > 5%) reported by patients in clinical trials comparing OXYCONTIN with placebo are shown in Table 2 below:
TABLE 2: Common Adverse Reactions ( > 5%)
In clinical trials, the following adverse reactions were reported in patients treated with OXYCONTIN with an incidence between 1% and 5%:
General disorders and administration site conditions: chills, fever
Metabolism and nutrition disorders: anorexia
Musculoskeletal and connective tissue disorders: twitching
Skin and subcutaneous tissue disorders: rash
Vascular disorders: postural hypotension
The following adverse reactions occurred in less than 1% of patients involved in clinical trials:
Blood and lymphatic system disorders: lymphadenopathy
Ear and labyrinth disorders: tinnitus
Eye disorders: abnormal vision
General disorders and administration site conditions: withdrawal syndrome (with and without seizures), edema, peripheral edema, thirst, malaise, chest pain, facial edema
Injury, poisoning and procedural complications: accidental injury
Investigations: ST depression
Metabolism and nutrition disorders: dehydration
Reproductive system and breast disorders: impotence
Respiratory, thoracic and mediastinal disorders: cough increased, voice alteration
Skin and subcutaneous tissue disorders: dry skin, exfoliative dermatitis
Clinical Trial Experience in Pediatric Patients 11Years and Older
The safety of OXYCONTIN has been evaluated in one clinical trial with 140 patients 11 to 16 years of age. The median duration of treatment was approximately three weeks. The most frequently reported adverse events were vomiting, nausea, headache, pyrexia, and constipation. Table 3 includes a summary of the incidence of treatment emergent adverse events reported in ≥ 5% of patients.
Table 3: Incidence of Adverse Reactions Reported in
≥ 5.0% Patients 11 to 16 Years
|System Organ Class
|11 to 16 Years
|Any Adverse Event > = 5%||71 (51)|
|GASTROINTESTINAL DISORDERS||56 (40)|
|GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS||32 (23)|
|METABOLISM AND NUTRITION DISORDERS||9 (6)|
|Decreased appetite||7 (5)|
|NERVOUS SYSTEM DISORDERS||37 (26)|
|SKIN AND SUBCUTANEOUS TISSUE DISORDERS||23 (16)|
The following adverse reactions occurred in a clinical trial of OXYCONTIN in patients 11 to 16 years of age with an incidence between ≥ 1.0% and < 5.0%. Events are listed within each System/Organ Class.
Cardiac disorders: tachycardia
Gastrointestinal disorders: abdominal pain, gastroesophageal reflux disease
General disorders and administration site conditions: fatigue, pain, chills, asthenia
Injury, poisoning, and procedural complications: procedural pain, seroma
Investigations: oxygen saturation decreased, alanine aminotransferase increased, hemoglobin decreased, platelet count decreased, neutrophil count decreased, red blood cell count decreased, weight decreased
Metabolic and nutrition disorders: hypochloremia, hyponatraemia
Musculoskeletal and connective tissue disorders: pain in extremity, musculoskeletal pain
Psychiatric disorders: insomnia, anxiety, depression, agitation
Renal and urinary disorders: dysuria, urinary retention
Respiratory, thoracic, and mediastinal disorders: oropharyngeal pain
Skin and subcutaneous tissue disorders: hyperhidrosis, rash
The following adverse reactions have been identified during post-approval use of controlled-release oxycodone: abuse, addiction, aggression, amenorrhea, cholestasis, completed suicide, death, dental caries, increased hepatic enzymes, hyperalgesia, hypogonadism, hyponatremia, ileus, intentional overdose, mood altered, muscular hypertonia, overdose, palpitations (in the context of withdrawal), seizures, suicidal attempt, suicidal ideation, syndrome of inappropriate antidiuretic hormone secretion, and urticaria.
Anaphylaxis has been reported with ingredients contained in OXYCONTIN. Advise patients how to recognize such a reaction and when to seek medical attention.
In addition to the events listed above, the following have also been reported, potentially due to the swelling and hydrogelling property of the tablet: choking, gagging, regurgitation, tablets stuck in the throat and difficulty swallowing the tablet.
Read the Oxycontin (oxycodone hcl) Side Effects Center for a complete guide to possible side effects
The concomitant use of OXYCONTIN and other CNS depressants including sedatives, hypnotics, tranquilizers, general anesthetics, phenothiazines, other opioids, and alcohol can increase the risk of respiratory depression, profound sedation, coma, or death. Monitor patients receiving CNS depressants and OXYCONTIN for signs of respiratory depression, sedation, and hypotension.
Drugs Affecting Cytochrome P450 Isoenzymes
Inhibitors of CYP3A4 and 2D6
Because the CYP3A4 isoenzyme plays a major role in the metabolism of oxycodone, drugs that inhibit CYP3A4 activity may cause decreased clearance of oxycodone which could lead to an increase in oxycodone plasma concentrations and result in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of CYP2D6 and 3A4 inhibitors. If co-administration with OXYCONTIN is necessary, monitor patients for respiratory depression and sedation at frequent intervals and consider dose adjustments until stable drug effects are achieved [see CLINICAL PHARMACOLOGY].
Inducers of CYP3A4
CYP450 3A4 inducers may induce the metabolism of oxycodone and, therefore, may cause increased clearance of the drug which could lead to a decrease in oxycodone plasma concentrations, lack of efficacy or, possibly, development of an abstinence syndrome in a patient who had developed physical dependence to oxycodone. If co-administration with OXYCONTIN is necessary, monitor for signs of opioid withdrawal and consider dose adjustments until stable drug effects are achieved.
After stopping the treatment of a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration will increase which could increase or prolong both the therapeutic and adverse effects, and may cause serious respiratory depression [see CLINICAL PHARMACOLOGY].
Mixed Agonist/Antagonist And Partial Agonists Opioid Analgesics
Mixed agonist/antagonist (i.e., pentazocine, nalbuphine, and butorphanol) and partial agonist (buprenorphine) analgesics may reduce the analgesic effect of oxycodone or precipitate withdrawal symptoms. Avoid the use of mixed agonist/antagonist and partial agonist analgesics in patients receiving OXYCONTIN.
Oxycodone may enhance the neuromuscular blocking action of true skeletal muscle relaxants and produce an increased degree of respiratory depression. Monitor patients receiving muscle relaxants and OXYCONTIN for signs of respiratory depression that may be greater than otherwise expected.
Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Opioids may also lead to acute retention of urine by causing spasm of the sphincter of the bladder, particularly in men with enlarged prostates.
Anticholinergics or other medications with anticholinergic activity when used concurrently with opioid analgesics may result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Monitor patients for signs of urinary retention or reduced gastric motility when OXYCONTIN is used concurrently with anticholinergic drugs.
Drug Abuse And Dependence
OXYCONTIN contains oxycodone, a Schedule II controlled substance with a high potential for abuse similar to other opioids including fentanyl, hydromorphone, methadone, morphine, and oxymorphone. OXYCONTIN can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS AND PRECAUTIONS].
The high drug content in extended-release formulations adds to the risk of adverse outcomes from abuse and misuse.
All patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use.
Drug abuse is the intentional non-therapeutic use of an over-the-counter or prescription drug, even once, for its rewarding psychological or physiological effects. Drug abuse includes, but is not limited to, the following examples: the use of a prescription or over-the-counter drug to get “high”, or the use of steroids for performance enhancement and muscle build up.
Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and include: 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 to addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated claims of loss of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(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. Physicians 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.
OXYCONTIN, like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful recordkeeping of prescribing information, including quantity, frequency, and renewal requests as required by state 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 reduce abuse of opioid drugs.
Risks Specific to Abuse of OXYCONTIN
OXYCONTIN is for oral use only. Abuse of OXYCONTIN poses a risk of overdose and death. The risk is increased with concurrent use of OXYCONTIN with alcohol and other central nervous system depressants. Taking cut, broken, chewed, crushed, or dissolved OXYCONTIN enhances drug release and increases the risk of overdose and death.
With parenteral abuse, the inactive ingredients in OXYCONTIN can be expected to result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. Parenteral drug abuse is commonly associated with transmission of infectious diseases, such as hepatitis and HIV.
Abuse Deterrence Studies
OXYCONTIN is formulated with inactive ingredients intended to make the tablet more difficult to manipulate for misuse and abuse. For the purposes of describing the results of studies of the abuse-deterrent characteristics of OXYCONTIN resulting from a change in formulation, in this section, the original formulation of OXYCONTIN, which is no longer marketed, will be referred to as “original OxyContin” and the reformulated, currently marketed product will be referred to as “OXYCONTIN”.
In Vitro Testing
In vitro physical and chemical tablet manipulation studies were performed to evaluate the success of different extraction methods in defeating the extended-release formulation. Results support that, relative to original OxyContin, there is an increase in the ability of OXYCONTIN to resist crushing, breaking, and dissolution using a variety of tools and solvents. The results of these studies also support this finding for OXYCONTIN relative to an immediate-release oxycodone. When subjected to an aqueous environment, OXYCONTIN gradually forms a viscous hydrogel (i.e., a gelatinous mass) that resists passage through a needle.
In a randomized, double-blind, placebo-controlled 5-period crossover pharmacodynamic study, 30 recreational opioid users with a history of intranasal drug abuse received intranasally administered active and placebo drug treatments. The five treatment arms were finely crushed OXYCONTIN 30 mg tablets, coarsely crushed OXYCONTIN 30 mg tablets, finely crushed original OxyContin 30 mg tablets, powdered oxycodone HCl 30 mg, and placebo. Data for finely crushed OXYCONTIN, finely crushed original OxyContin, and powdered oxycodone HCl are described below.
Drug liking was measured on a bipolar drug liking scale of 0 to 100 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 take the study drug again was also measured on a bipolar scale of 0 to 100 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”).
Twenty-seven of the subjects completed the study. Incomplete dosing due to granules falling from the subjects' nostrils occurred in 34% (n = 10) of subjects with finely crushed OXYCONTIN, compared with 7% (n = 2) of subjects with finely crushed original OxyContin and no subjects with powdered oxycodone HCl.
The intranasal administration of finely crushed OXYCONTIN was associated with a numerically lower mean and median drug liking score and a lower mean and median score for take drug again, compared to finely crushed original OxyContin or powdered oxycodone HCl as summarized in Table 4.
Table 4: Summary of Maximum Drug Liking (Emax) Data
Following Intranasal Administration
|VAS Scale (100 mm)*||OXYCONTIN (finely crushed)||Original OxyContin (finely crushed)||Oxycodone HCl (powdered)|
|Drug Liking||Mean (SE)||80.4 (3.9)||94.0 (2.7)||89.3 (3.1)|
|Median (Range)||88 (36-100)||100 (51-100)||100 (50-100)|
|Take Drug Again||Mean (SE)||64.0 (7.1)||89.6 (3.9)||86.6 (4.4)|
|Median (Range)||78 (0-100)||100 (20-100)||100 (0-100)|
|* Bipolar scales (0 = maximum negative response, 50 = neutral response, 100 = maximum positive response)|
Figure 1 demonstrates a comparison of drug liking for finely crushed OXYCONTIN compared to powdered oxycodone HCl in subjects who received both treatments. The Y-axis represents the percent of subjects attaining a percent reduction in drug liking for OXYCONTIN vs. oxycodone HCl powder greater than or equal to the value on the X-axis. Approximately 44% (n = 12) had no reduction in liking with OXYCONTIN relative to oxycodone HCl. Approximately 56% (n = 15) of subjects had some reduction in drug liking with OXYCONTIN relative to oxycodone HCl. Thirty-three percent (n = 9) of subjects had a reduction of at least 30% in drug liking with OXYCONTIN compared to oxycodone HCl, and approximately 22% (n = 6) of subjects had a reduction of at least 50% in drug liking with OXYCONTIN compared to oxycodone HCl.
Figure 1: Percent Reduction
Profiles for Emax of Drug Liking VAS for OXYCONTIN vs. oxycodone HCl, N=27
Following Intranasal Administration
The results of a similar analysis of drug liking for finely crushed OXYCONTIN relative to finely crushed original OxyContin were comparable to the results of finely crushed OXYCONTIN relative to powdered oxycodone HCl. Approximately 43% (n = 12) of subjects had no reduction in liking with OXYCONTIN relative to original OxyContin. Approximately 57% (n = 16) of subjects had some reduction in drug liking, 36% (n = 10) of subjects had a reduction of at least 30% in drug liking, and approximately 29% (n = 8) of subjects had a reduction of at least 50% in drug liking with OXYCONTIN compared to original OxyContin.
The in vitro data demonstrate that OXYCONTIN has physicochemical properties expected to make abuse via injection difficult. The data from the clinical study, along with support from the in vitro data, also indicate that OXYCONTIN has physicochemical properties that are expected to reduce abuse via the intranasal route. However, abuse of OXYCONTIN by these routes, as well as by the oral route, is still possible.
Additional data, including epidemiological data, when available, may provide further information on the impact of the current formulation of OXYCONTIN on the abuse liability of the drug. Accordingly, this section may be updated in the future as appropriate.
OXYCONTIN contains oxycodone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit, including fentanyl, hydromorphone, methadone, morphine, and oxymorphone. OXYCONTIN can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS AND PRECAUTIONS and Drug Abuse and Dependence].
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 results in withdrawal symptoms after abrupt discontinuation or a significant dose 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 (pentazocine, butorphanol, nalbuphine), or partial agonists (buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.
OXYCONTIN should not be abruptly discontinued [see DOSAGE AND ADMINISTRATION]. If OXYCONTIN is abruptly discontinued in a physically-dependent patient, an abstinence syndrome may occur. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.
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 Oxycontin Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 8/28/2015
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