Oxycodone 40mg ER Tablets
WARNING: This is an opioid drug. Opioid drugs can put you at risk for drug use disorder. These can lead to overdose and death. You will be watched closely while taking this drug.Severe breathing problems may happen with this drug. The risk is highest when you first start taking this drug or any time your dose is raised. These breathing problems can be deadly. Call your doctor right away if you have slow, shallow, or trouble breathing. Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana, other forms of cannabis, or street drugs. This includes severe drowsiness, breathing problems, and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. If you have questions, talk with the doctor.Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.If you are pregnant or plan to get pregnant, talk with your doctor right away about the benefits and risks of using this drug during pregnancy. Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. Withdrawal in the newborn can be life-threatening if not treated.Swallow whole. Do not chew, break, crush, or dissolve before swallowing. Doing these things can cause very bad side effects and death. @ COMMON USES: It is used to manage pain when daily pain treatment is needed for a long time. It is for use when non-opioid pain drugs do not treat your pain well enough or you cannot take them.
Drug Class
Opioid Analgesic
Pharmacologic Class
Opioid Agonist
Pregnancy Category
Category C
FDA Approved
Dec 1995
DEA Schedule
Schedule II
Overview
What is this medicine?
Oxycodone ER is a strong pain medicine that works by changing how your brain and nervous system respond to pain. It is an extended-release (ER) tablet, meaning it releases the medicine slowly over 12 hours to provide continuous pain relief. It is used for severe, ongoing pain that requires around-the-clock treatment and cannot be managed by other pain medicines.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.
Take this medication by mouth only. Do not inject or snort it, as this can cause severe side effects, including trouble breathing and death from overdose.
Swallow the tablet whole. Do not chew, break, crush, or dissolve it before swallowing, as this can also cause severe side effects and death.
This medication is not intended for fast pain relief or for use on an as-needed basis. Additionally, do not use it for pain relief after surgery if you have not been taking similar medications.
If your prescribed dose is more than one tablet, take one tablet at a time. Do not lick or wet the tablet before putting it in your mouth. Swallow the tablet with a full glass of water immediately after placing it in your mouth.
If you have difficulty swallowing, consult your doctor for guidance.
Do not put this medication down a feeding tube.
Storing and Disposing of Your Medication
To ensure the safety and efficacy of your medication, store it properly and dispose of it responsibly.
Store the medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
Keep the medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to store the medication.
Keep all medications away from pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on the best way to dispose of medications. You may also want to check if there are drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely.
Take this medication by mouth only. Do not inject or snort it, as this can cause severe side effects, including trouble breathing and death from overdose.
Swallow the tablet whole. Do not chew, break, crush, or dissolve it before swallowing, as this can also cause severe side effects and death.
This medication is not intended for fast pain relief or for use on an as-needed basis. Additionally, do not use it for pain relief after surgery if you have not been taking similar medications.
If your prescribed dose is more than one tablet, take one tablet at a time. Do not lick or wet the tablet before putting it in your mouth. Swallow the tablet with a full glass of water immediately after placing it in your mouth.
If you have difficulty swallowing, consult your doctor for guidance.
Do not put this medication down a feeding tube.
Storing and Disposing of Your Medication
To ensure the safety and efficacy of your medication, store it properly and dispose of it responsibly.
Store the medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
Keep the medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to store the medication.
Keep all medications away from pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on the best way to dispose of medications. You may also want to check if there are drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take exactly as prescribed; do not take more or less, or more often than prescribed.
- Swallow the tablet whole. Do not crush, chew, or dissolve the tablet, as this can lead to a rapid release of a potentially fatal dose of oxycodone.
- Do not consume alcohol while taking this medication, as it can lead to dangerous side effects, including severe breathing problems and death.
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
- Store this medication securely away from children and pets, preferably in a locked cabinet, to prevent accidental ingestion.
- Do not share this medication with anyone else, as it can be dangerous and is against the law.
- Discuss all other medications, including over-the-counter drugs, supplements, and herbal products, with your doctor or pharmacist to avoid dangerous interactions.
Available Forms & Alternatives
Available Strengths:
- Oxycodone 5mg Immediate Rel Tabs
- Oxycodone 30mg Immediate Rel Tabs
- Oxycodone 15mg* Immediate Rel Tabs
- Oxycodone 20mg Immediate Rel Tabs
- Oxycodone 10mg Immediate Rel Tabs
- Oxycodone 30mg Immediate Rel Tabs
- Oxycodone 5mg/5ml Solution
- Oxycodone 5mg Immediate Rel Caps
- Oxycodone 100mg/5ml Solution 30ml
- Oxycodone Hcl 10mg Tablets
- Oxycodone 20mg ER Tablets
- Oxycodone 40mg ER Tablets
- Oxycodone 80mg ER Tablets
- Oxycodone 10mg ER Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
For opioid-tolerant patients, 40 mg orally every 12 hours. Dosage must be individualized based on patient response and tolerance.
Dose Range:
10 - 160 mg
Condition-Specific Dosing:
opioid_naive:
Not for opioid-naive patients. Initial dose for opioid-naive patients is typically 10-20 mg every 12 hours of an immediate-release opioid, then converted to ER if appropriate.
conversion_from_other_opioids:
Conversion from other opioids requires careful calculation of total daily opioid dose and conversion factor, typically 50% of the calculated daily oral morphine equivalent for initial Oxycodone ER dose, given every 12 hours.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in pediatric patients under 18 years of age. Use in adolescents should be under strict specialist guidance for severe pain in opioid-tolerant patients, with careful titration.)
Dose Adjustments
Renal Impairment:
Mild:
Consider dose reduction and/or extended dosing interval.
Moderate:
Reduce initial dose by 50% and titrate carefully. Monitor for increased adverse effects.
Severe:
Reduce initial dose by 50-75% and titrate carefully. Monitor for increased adverse effects.
Dialysis:
Oxycodone is not significantly removed by hemodialysis. Dose adjustment is necessary; monitor closely for prolonged effects.
Hepatic Impairment:
Mild:
Reduce initial dose by 50% and titrate carefully. Monitor for increased adverse effects.
Moderate:
Reduce initial dose by 50-75% and titrate carefully. Monitor for increased adverse effects.
Severe:
Reduce initial dose by 50-75% and titrate carefully. Monitor for increased adverse effects.
Pharmacology
Mechanism of Action
Oxycodone is a full opioid agonist that acts primarily at the mu-opioid receptors in the central nervous system (CNS) and other tissues. Its analgesic effect is produced by binding to these receptors, leading to inhibition of ascending pain pathways, altering the perception of and response to pain. It also produces generalized CNS depression.
Pharmacokinetics
Absorption:
Bioavailability:
60-87% (oral)
Tmax:
3-5 hours (for ER formulation)
FoodEffect:
High-fat meal can increase Cmax and AUC by 25% and 15% respectively, but is not considered clinically significant for ER formulations. However, alcohol can cause dose dumping.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
45%
CnssPenetration:
Yes
Elimination:
HalfLife:
4.5 hours (for ER formulation, range 3.2-5.5 hours)
Clearance:
Not available
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Approximately 8-14% (parent drug)
Pharmacodynamics
OnsetOfAction:
Approximately 1 hour (for ER formulation, though full effect may take longer)
PeakEffect:
3-5 hours (for ER formulation)
DurationOfAction:
12 hours
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE: Oxycodone ER 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 Oxycodone ER, and monitor all patients regularly for the development of these behaviors and conditions.
RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur with use of Oxycodone ER. Monitor for respiratory depression, especially during initiation of Oxycodone ER or following a dose increase.
ACCIDENTAL INGESTION: Accidental ingestion of even one dose of Oxycodone ER, especially by children, can result in a fatal overdose of oxycodone.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of Oxycodone ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
CYP3A4 INTERACTION: The concomitant use of Oxycodone ER with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving Oxycodone ER and any CYP3A4 inhibitor or inducer.
RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. 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 for signs and symptoms of respiratory depression and sedation.
RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur with use of Oxycodone ER. Monitor for respiratory depression, especially during initiation of Oxycodone ER or following a dose increase.
ACCIDENTAL INGESTION: Accidental ingestion of even one dose of Oxycodone ER, especially by children, can result in a fatal overdose of oxycodone.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of Oxycodone ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
CYP3A4 INTERACTION: The concomitant use of Oxycodone ER with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving Oxycodone ER and any CYP3A4 inhibitor or inducer.
RISK FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. 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 for signs and symptoms of respiratory depression and sedation.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Feeling confused
Severe constipation or stomach pain, which may indicate a severe bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Urination problems
Abnormal heartbeat, including fast, slow, or irregular rhythms
Seizures
Shakiness
Changes in eyesight
Chest pain or pressure
Hallucinations (seeing or hearing things that are not there)
Mood changes
Memory problems or loss
Trouble walking or speaking
Swelling in the arms or legs
Fever
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk for serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, upset stomach, or vomiting
Severe headache
Adrenal Gland Problems: A Rare but Serious Condition
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Contact your doctor right away if you experience:
Extreme tiredness or weakness
Passing out
Severe dizziness
Upset stomach
Vomiting
Decreased appetite
Long-Term Use and Hormonal Changes
Long-term use of an opioid medication may lead to lower sex hormone levels. If you experience any of the following, contact your doctor:
Decreased interest in sex
Fertility problems
No menstrual period
Ejaculation problems
Other Side Effects
While many people may not experience side effects or may only have minor ones, it's essential to be aware of the following:
Feeling dizzy, sleepy, tired, or weak
Headache
Trouble sleeping
Itching
Dry mouth
* Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
If any of these side effects or other concerns bother you or do not go away, contact your doctor or seek medical help. You can also report side effects to the FDA at 1-800-332-1088 or visit https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Feeling confused
Severe constipation or stomach pain, which may indicate a severe bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Urination problems
Abnormal heartbeat, including fast, slow, or irregular rhythms
Seizures
Shakiness
Changes in eyesight
Chest pain or pressure
Hallucinations (seeing or hearing things that are not there)
Mood changes
Memory problems or loss
Trouble walking or speaking
Swelling in the arms or legs
Fever
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk for serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, upset stomach, or vomiting
Severe headache
Adrenal Gland Problems: A Rare but Serious Condition
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Contact your doctor right away if you experience:
Extreme tiredness or weakness
Passing out
Severe dizziness
Upset stomach
Vomiting
Decreased appetite
Long-Term Use and Hormonal Changes
Long-term use of an opioid medication may lead to lower sex hormone levels. If you experience any of the following, contact your doctor:
Decreased interest in sex
Fertility problems
No menstrual period
Ejaculation problems
Other Side Effects
While many people may not experience side effects or may only have minor ones, it's essential to be aware of the following:
Feeling dizzy, sleepy, tired, or weak
Headache
Trouble sleeping
Itching
Dry mouth
* Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
If any of these side effects or other concerns bother you or do not go away, contact your doctor or seek medical help. You can also report side effects to the FDA at 1-800-332-1088 or visit https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Slow, shallow, or difficult breathing (signs of respiratory depression)
- Extreme drowsiness or difficulty waking up
- Dizziness or lightheadedness when standing up
- Confusion or disorientation
- Pinpoint pupils
- Severe constipation that does not respond to laxatives
- Signs of serotonin syndrome: agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea
- Signs of adrenal insufficiency: nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, low blood pressure
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
If you are currently taking any of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
* If you are breastfeeding, as you should not breastfeed while taking this medication
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Never start, stop, or change the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
If you are currently taking any of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
* If you are breastfeeding, as you should not breastfeed while taking this medication
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. This will help ensure your safety while taking this medication. Never start, stop, or change the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position, and be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor, as taking more than recommended may increase the risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use a pain patch without consulting your doctor first.
Monitoring Your Condition
If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you experience a decrease in the medication's effectiveness, consult your doctor. Do not take more than the prescribed dose.
Dependence and Withdrawal
Prolonged or regular use of opioid medications like this one may cause dependence. Suddenly stopping or reducing the dose may increase the risk of withdrawal or other severe problems. Consult your doctor before changing your dose or stopping the medication, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Special Precautions
Certain strengths of this medication are only suitable for individuals who have previously taken similar medications and are tolerant to their effects. Using these strengths in people who are not tolerant may cause severe and potentially life-threatening breathing problems. Discuss this with your doctor.
Interactions with Other Substances
Do not consume alcohol or products containing alcohol while taking this medication, as this may lead to unsafe and potentially life-threatening effects.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
Use in Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position, and be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor, as taking more than recommended may increase the risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use a pain patch without consulting your doctor first.
Monitoring Your Condition
If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose.
Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you experience a decrease in the medication's effectiveness, consult your doctor. Do not take more than the prescribed dose.
Dependence and Withdrawal
Prolonged or regular use of opioid medications like this one may cause dependence. Suddenly stopping or reducing the dose may increase the risk of withdrawal or other severe problems. Consult your doctor before changing your dose or stopping the medication, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Special Precautions
Certain strengths of this medication are only suitable for individuals who have previously taken similar medications and are tolerant to their effects. Using these strengths in people who are not tolerant may cause severe and potentially life-threatening breathing problems. Discuss this with your doctor.
Interactions with Other Substances
Do not consume alcohol or products containing alcohol while taking this medication, as this may lead to unsafe and potentially life-threatening effects.
Seizure Risk
This medication may increase the risk of seizures in some individuals, including those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
Use in Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Overdose Information
Overdose Symptoms:
- Slowed or stopped breathing
- Extreme drowsiness or unresponsiveness
- Cold, clammy skin
- Pinpoint pupils
- Limp muscles
- Bluish discoloration of lips and fingernails
- Loss of consciousness
- Coma
What to Do:
If you suspect an overdose, call 911 immediately. Administer naloxone if available and trained to do so. Stay with the person until emergency medical help arrives. Call 1-800-222-1222 (Poison Control) for additional guidance.
Drug Interactions
Contraindicated Interactions
- Concomitant use with benzodiazepines or other CNS depressants (unless benefits outweigh risks, with careful monitoring and dose reduction)
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected paralytic ileus
- Hypersensitivity to oxycodone
Major Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir): Increased oxycodone plasma concentrations, potentially leading to increased opioid effects and respiratory depression.
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): May decrease formation of oxymorphone, potentially reducing analgesic effect in some patients.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans): Risk of serotonin syndrome.
- Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol): May reduce analgesic effect and/or precipitate withdrawal symptoms.
- Opioid antagonists (e.g., naltrexone, naloxone): May precipitate withdrawal.
Moderate Interactions
- Anticholinergics (e.g., atropine, scopolamine): Increased risk of urinary retention and/or severe constipation.
- Muscle relaxants: Enhanced neuromuscular blocking effects and increased risk of respiratory depression.
- Diuretics: Opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Pain assessment (intensity, character, location)
Rationale: To establish baseline pain level and guide initial dosing.
Timing: Prior to initiation of therapy
Respiratory rate and depth
Rationale: To assess baseline respiratory function and identify risk factors for respiratory depression.
Timing: Prior to initiation of therapy
Level of consciousness/sedation
Rationale: To assess baseline mental status and identify risk factors for excessive sedation.
Timing: Prior to initiation of therapy
Bowel function
Rationale: To assess baseline bowel habits and anticipate opioid-induced constipation.
Timing: Prior to initiation of therapy
Renal and hepatic function tests (e.g., creatinine, LFTs)
Rationale: To identify impairment that may require dose adjustment.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain control and adverse effects (e.g., sedation, nausea, constipation)
Frequency: Regularly, especially during dose titration and with any change in patient status
Target: Acceptable pain relief with tolerable side effects
Action Threshold: Inadequate pain control or intolerable side effects warrant dose adjustment or symptomatic management.
Respiratory rate and depth
Frequency: Regularly, especially during initiation and dose escalation; more frequently if signs of respiratory depression are present.
Target: Typically >10-12 breaths/min, regular rhythm
Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or signs of hypoventilation require immediate intervention.
Level of consciousness/sedation
Frequency: Regularly, especially during initiation and dose escalation.
Target: Alert and oriented, or easily aroused
Action Threshold: Excessive sedation (e.g., difficult to arouse, somnolence) requires dose reduction or discontinuation.
Bowel function
Frequency: Daily
Target: Regular bowel movements (e.g., every 1-2 days)
Action Threshold: Constipation (e.g., no bowel movement for >3 days) requires laxative intervention.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing, cyanosis)
- Excessive sedation/somnolence
- Dizziness, lightheadedness
- Nausea, vomiting
- Constipation
- Pruritus (itching)
- Hypotension (dizziness upon standing)
- Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, loss of coordination, nausea, vomiting, diarrhea)
- Signs of adrenal insufficiency (nausea, vomiting, anorexia, fatigue, weakness, dizziness, low blood pressure)
Special Patient Groups
Pregnancy
Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated. Use only if the potential benefit justifies the potential risk to the fetus. Advise pregnant patients of the risk of NOWS.
Trimester-Specific Risks:
First Trimester:
Potential for congenital malformations, though data are mixed and not definitively established for all opioids.
Second Trimester:
Risk of NOWS increases with prolonged exposure.
Third Trimester:
High risk of NOWS with prolonged exposure. Respiratory depression in the neonate if administered shortly before delivery.
Lactation
Oxycodone is excreted into breast milk. Infants exposed to oxycodone through breast milk are at risk for serious adverse reactions, including excess sedation and respiratory depression. Monitor infants for signs of sedation and respiratory depression. If an opioid analgesic is required in a nursing mother, consider discontinuing nursing or using an alternative analgesic.
Infant Risk:
L3 (Moderate risk)
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 18 years of age. Use is generally not recommended. If used in adolescents for severe pain in opioid-tolerant patients, it should be under strict specialist guidance with careful titration and monitoring.
Geriatric Use
Elderly patients may be more sensitive to the analgesic and adverse effects of opioids, including respiratory depression. Start with lower doses and titrate slowly. Monitor closely for sedation, respiratory depression, and constipation.
Clinical Information
Clinical Pearls
- Oxycodone ER is for opioid-tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period. It is NOT for as-needed (PRN) pain relief.
- Patients must be instructed to swallow the tablet whole. Crushing, chewing, or dissolving the tablet can lead to rapid release of a potentially fatal dose.
- Due to the risk of addiction, abuse, and misuse, careful patient selection, risk assessment, and ongoing monitoring are crucial.
- Concomitant use with benzodiazepines or other CNS depressants significantly increases the risk of respiratory depression, profound sedation, coma, and death. Avoid concurrent use if possible; if necessary, use the lowest effective doses and shortest durations, and monitor closely.
- Patients should be educated on the signs of respiratory depression and overdose, and naloxone should be considered for at-risk patients.
- Opioid-induced constipation is a common and persistent side effect; proactive management with laxatives is often necessary.
Alternative Therapies
- Morphine Extended-Release (e.g., MS Contin, Kadian)
- Hydromorphone Extended-Release (e.g., Exalgo)
- Fentanyl Transdermal System (e.g., Duragesic)
- Tapentadol Extended-Release (e.g., Nucynta ER)
- Methadone (for chronic pain, requires specialized management)
Cost & Coverage
Average Cost:
$100 - $500+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help treat the condition. Discuss obtaining and using naloxone with your doctor or pharmacist. If an overdose is suspected, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek medical care immediately. When reporting the incident, be prepared to provide the necessary information, including what was taken, the quantity, and the time of the incident.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help treat the condition. Discuss obtaining and using naloxone with your doctor or pharmacist. If an overdose is suspected, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek medical care immediately. When reporting the incident, be prepared to provide the necessary information, including what was taken, the quantity, and the time of the incident.