Narcotic: Oxycontin

Categories: Pain

Often we have patients that call requesting pain medication.  As a physician and surgeon, we are always weighing the risk versus the benefit of prescribing pain meds.

The following is an except from the manufacturer of a commonly abused pain medication.  Although sometimes indicated, you should only take pain medications such as Oxycontin for severe, prolonged pain control.  This is the reason why we rarely, if ever prescribe this pain med.

As the old adage goes: “no pain,  no gain”.  There is no way to 100% eliminate pain, some pain is actually helpful for healing.  The pain chemical recruit vital cells in your body to aid in healing the injured site.  So the pain medication we provide will make you comfortable, but it will never eliminate pain 100%.

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WARNING: ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE

Abuse Potential
OxyContin
® contains oxycodone, an opioid agonist and Schedule II controlled substance with an abuse liability similar to other opioid agonists, legal or illicit [see Warnings and Precautions (5.1)]. Assess each patient’s risk for opioid abuse or addiction prior to prescribing OxyContin. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depressive disorder). Routinely monitor all patients receiving OxyContin for signs of misuse, abuse, and addiction during treatment [see Drug Abuse and Dependence (9)].

Life-Threatening Respiratory Depression
Respiratory depression, including fatal cases, may occur with use of OxyContin, even when the drug has been used as recommended and not misused or abused [see Warnings and Precautions (5.2)]. Proper dosing and titration are essential and OxyContin should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain. Monitor for respiratory depression, especially during initiation of OxyContin or following a dose increase. Instruct patients to swallow OxyContin tablets intact. Crushing, dissolving, or chewing the tablet can cause rapid release and absorption of a potentially fatal dose of oxycodone.

Accidental Exposure
Accidental ingestion of OxyContin, especially in children, can result in a fatal overdose of oxycodone [see Warnings and Precautions (5.3)].

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Indications and Usage
OxyContin is indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Limitations of Use

OxyContin is not for use:

  • As an as-needed (prn) analgesic
  • For pain that is mild or not expected to persist for an extended period of time
  • For acute pain
  • In the immediate postoperative period (the first 24 hours following surgery) for patients not previously taking the drug, because its safety in this setting has not been established
  • For postoperative pain unless the patient is already receiving chronic opioid therapy prior to surgery, or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time

OxyContin 60 mg and 80 mg tablets, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for patients in whom tolerance to an opioid of comparable potency is established. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.

Contraindications

OxyContin is contraindicated in patients with:

  • Significant respiratory depression
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Known or suspected paralytic ileus and gastrointestinal obstruction
  • Hypersensitivity (e.g., anaphylaxis) to oxycodone

When converting to OxyContin, 7 tablet strengths allow you to individualize the dose.

To convert from IR oxycodone to OxyContin:

  • Determine the patient’s total daily oral oxycodone dose
  • Administer one-half of the patient’s total daily oral oxycodone dose as OxyContin, q12h

Below are some reasonable starting doses:

All trademarks are property of respective owners.
Tablets shown are not actual size.

Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with OxyContin.

Important Safety Information Regarding Life-Threatening Respiratory Depression

  • Respiratory depression is the chief hazard of opioid agonists, including OxyContin, which if not immediately recognized and treated, may lead to respiratory arrest and death
  • Respiratory depression from opioids is manifested by a reduced urge to breathe and a decreased rate of respiration, often associated with a “sighing” pattern of breathing (deep breaths separated by abnormally long pauses)
  • Closely monitor elderly, cachectic, or debilitated patients, since respiratory depression is more likely to occur due to altered pharmacokinetics or clearance—particularly when initiating and titrating OxyContin and when given concomitantly with other drugs that depress respiration
  • When initiating or titrating OxyContin, monitor patients with significant chronic obstructive pulmonary disease or cor pulmonale and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression. In these patients, even usual therapeutic doses of OxyContin may decrease respiratory drive to the point of apnea. The use of alternative non-opioid analgesics should be considered in these patients
  • To reduce the risk of respiratory depression, proper dosing and titration of OxyContin are essential. Overestimating the OxyContin dose when converting patients from another opioid product can result in fatal overdose with the first dose. Respiratory depression has also been reported with use of modified-release opioids when used as recommended and not misused or abused

Initiate the dosing regimen for each patient individually

  • Assess each patient’s risk for opioid abuse or addiction prior to prescribing OxyContin. The risk for opioid abuse is increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). All patients receiving opioids should be routinely monitored for signs of misuse, abuse, and addiction, because these drugs carry a risk for addiction even under appropriate medical use
  • Take into account the patient’s prior analgesic treatment experience
  • Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with OxyContin. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of OxyContin, the risk is greatest during the initiation of therapy or following a dose increase
  • When selecting an initial dose of OxyContin, consider the following factors: total daily dose, potency, and any prior opioid use; reliability of the relative potency estimate used to calculate the equivalent dose of oxycodone needed; patient’s degree of opioid experience and tolerance; general condition and medical status of the patient; concurrent medication; and type and severity of the patient’s pain
  • Reduce the starting dose to 1/3 to 1/2 the usual dosage in:
    • Debilitated, non–opioid-tolerant patients
    • Patients with hepatic impairment
    • Patients who are concurrently receiving other CNS depressants. In these patients, also consider using a lower dose of the concomitant CNS depressant
  • In patients with renal impairment, follow a conservative approach to dose initiation and adjust according to the clinical situation

Discontinuation of Therapy

When the patient no longer requires therapy with OxyContin tablets, use a gradual downward titration of the dose to prevent signs and symptoms of withdrawal in the physically dependent patient. Do not abruptly discontinue OxyContin.

Additional Important Safety Information

  • OxyContin contains oxycodone, an opioid agonist and Schedule II controlled substance. Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. Assess each patient’s risk for opioid abuse or addiction prior to prescribing OxyContin and routinely monitor all patients during therapy because of a risk for addiction, even under appropriate medical use
  • Instruct patients to swallow the OxyContin tablets intact. Crushing, chewing, snorting, or injecting the dissolved product could result in overdose and death
  • OxyContin 60 mg and 80 mg tablets are for use in opioid-tolerant patients only. Ingestion of these strengths may cause fatal respiratory depression when administered to patients not already tolerant to high doses of opioids
  • Accidental ingestion, especially in children, can result in a fatal overdose of oxycodone
  • Hypotension, profound sedation, coma, or respiratory depression may result if OxyContin is used concomitantly with other CNS depressants, including alcohol and/or illicit drugs that can cause CNS depression. Start with a lower OxyContin dose and consider dose reduction of the concomitant CNS depressant because of additive effects. Monitor patients for signs of sedation and respiratory depression
  • OxyContin may cause severe hypotension. Monitor patients at increased risk of hypotension during dose initiation and titration. Avoid use of OxyContin in patients with circulatory shock
  • In patients with head injury or increased intracranial pressure, monitor for signs of sedation and respiratory depression. Avoid use of OxyContin in patients with impaired consciousness or coma susceptible to intracranial effects of CO2 retention
  • Use caution when prescribing OxyContin for patients who have difficulty swallowing, or have underlying GI disorders that may predispose them to obstruction. Consider use of an alternative analgesic in these patients
  • OxyContin may cause spasm of the sphincter of Oddi. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms
  • OxyContin may aggravate convulsions in patients with convulsive disorders and may induce or aggravate seizures in some clinical settings. Monitor patients with a history of seizure disorders for worsened seizure control
  • Avoid the use of mixed agonist/antagonist analgesics, as they may reduce the analgesic effect and/or precipitate withdrawal. Do not abruptly discontinue OxyContin
  • OxyContin may impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery
  • Concomitant use of CYP3A4 inhibitors may prolong opioid effects. Use with CYP3A4 inducers may cause lack of efficacy or development of withdrawal symptoms. If co-administration is necessary, evaluate patients frequently and consider dose adjustments until stable drug effects are achieved

Adverse Reaction Information

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.

The most common adverse reactions (>5%) reported by patients in clinical trials comparing OxyContin with placebo are constipation, nausea, somnolence, dizziness, pruritus, vomiting, headache, dry mouth, asthenia, and sweating.

To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1-888-726-7535 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.

Please click here to read the Full Prescribing Information, including Boxed Warning.

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The above message was sponsored by Purdue Pharma L.P., who is solely responsible for its content.