Oxycodone 20mg 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 in your brain to change how your body feels and responds to pain. The 'ER' means Extended-Release, so it's designed to release the medicine slowly over 12 hours to provide continuous pain relief. It's used for severe, ongoing pain that needs around-the-clock treatment and cannot be managed with 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 precisely.
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.
Do not use this medication for fast pain relief or on an as-needed basis.
Do not use this medication for pain relief after surgery if you have not been taking similar medications.
If your 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 plenty of water immediately after putting it in your mouth.
If you have trouble swallowing, consult your doctor.
Do not put this medication down a feeding tube.
Storing and Disposing of Your Medication
Store this medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
Keep this medication in a safe place where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to secure it.
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.
What to Do If You Miss a Dose
Take a missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular 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 precisely.
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.
Do not use this medication for fast pain relief or on an as-needed basis.
Do not use this medication for pain relief after surgery if you have not been taking similar medications.
If your 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 plenty of water immediately after putting it in your mouth.
If you have trouble swallowing, consult your doctor.
Do not put this medication down a feeding tube.
Storing and Disposing of Your Medication
Store this medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
Keep this medication in a safe place where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to secure it.
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.
What to Do If You Miss a Dose
Take a missed dose as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses.
Lifestyle & Tips
- Take exactly as prescribed; do not crush, chew, or dissolve the tablet, as this can lead to a rapid release of a potentially fatal dose.
- Do not take more than prescribed or more often than every 12 hours.
- Avoid alcohol completely while taking this medication, as it can increase the risk of serious side effects like severe drowsiness and breathing problems.
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
- To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and use stool softeners or laxatives as recommended by your doctor.
- Store this medication securely away from children and pets, preferably in a locked cabinet, to prevent accidental ingestion.
- Dispose of unused medication properly (e.g., take-back programs or flushing down the toilet if no other option is available, as per FDA guidelines for opioids).
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:
Initial dose for opioid-naive patients: 10 mg orally every 12 hours. For patients converting from other opioids, dose should be individualized based on prior opioid exposure and calculated opioid conversion.
Dose Range:
10 - 160 mg
Condition-Specific Dosing:
chronic_pain:
Individualize dose to achieve adequate analgesia with acceptable side effects. Titrate slowly, no more frequently than every 1 to 2 days, in increments of 10-20 mg every 12 hours.
opioid_tolerant:
Calculate total daily oral morphine equivalent (OME) and convert to oxycodone ER. Typically, 10 mg oxycodone ER is equivalent to 20 mg oral morphine.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for ER formulation. Safety and efficacy not established in pediatric patients under 18 years of age.
Adolescent:
Not established for ER formulation. Safety and efficacy not established in pediatric patients under 18 years of age.
Dose Adjustments
Renal Impairment:
Mild:
Consider dose reduction and/or extended dosing interval.
Moderate:
Reduce initial dose by 50% (e.g., 5 mg every 12 hours). Titrate cautiously.
Severe:
Reduce initial dose by 50% (e.g., 5 mg every 12 hours). Titrate cautiously. Monitor closely for respiratory depression.
Dialysis:
Not well studied. Use with extreme caution, consider significant dose reduction and extended interval. Supplemental dose after dialysis not typically needed due to large volume of distribution.
Hepatic Impairment:
Mild:
Reduce initial dose by 50% (e.g., 5 mg every 12 hours). Titrate cautiously.
Moderate:
Reduce initial dose by 50% (e.g., 5 mg every 12 hours). Titrate cautiously. Monitor closely for respiratory depression.
Severe:
Reduce initial dose by 50% (e.g., 5 mg every 12 hours). Titrate cautiously. Monitor closely for respiratory depression.
Pharmacology
Mechanism of Action
Oxycodone is a full opioid agonist that acts primarily at the mu-opioid receptors in the central nervous system (CNS). It produces analgesia by binding to these receptors, mimicking the effects of endogenous opioid peptides. This binding leads to inhibition of adenylate cyclase, hyperpolarization of neurons, and reduced neurotransmitter release, ultimately decreasing the perception of pain.
Pharmacokinetics
Absorption:
Bioavailability:
60-87% (oral)
Tmax:
3-5 hours (ER formulation)
FoodEffect:
High-fat meal can increase Cmax and AUC by 25% and 16% respectively, but does not significantly alter Tmax. Can be taken with or without food.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
45% (primarily to albumin)
CnssPenetration:
Yes
Elimination:
HalfLife:
4.5 hours (oxycodone), 12-16 hours (ER formulation)
Clearance:
Not available (highly variable)
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Approximately 8-14% (oxycodone), 10% (noroxycodone), 1% (oxymorphone) excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Approximately 1 hour (for analgesia, ER formulation)
PeakEffect:
3-5 hours (ER formulation)
DurationOfAction:
12 hours (ER formulation)
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE; REMS; RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.
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 receiving Oxycodone ER for the development of these behaviors and conditions.
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS): To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesics must make available to healthcare providers REMS-compliant education programs, and must ensure that healthcare providers have access to patient counseling documents and resources for referring patients to treatment for opioid use disorder.
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.
CYTOCHROME P450 3A4 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 reactions 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 concentrations. Monitor patients receiving Oxycodone ER and any CYP3A4 inhibitor or inducer.
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.
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 receiving Oxycodone ER for the development of these behaviors and conditions.
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS): To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesics must make available to healthcare providers REMS-compliant education programs, and must ensure that healthcare providers have access to patient counseling documents and resources for referring patients to treatment for opioid use disorder.
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.
CYTOCHROME P450 3A4 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 reactions 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 concentrations. Monitor patients receiving Oxycodone ER and any CYP3A4 inhibitor or inducer.
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
Changes 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. Seek medical help immediately 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 symptoms, contact your doctor:
Decreased interest in sex
Fertility problems
No menstrual period
Ejaculation problems
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:
Feeling dizzy, sleepy, tired, or weak
Headache
Trouble sleeping
Itching
Dry mouth
* Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
If you experience any of these side effects or have concerns, contact your doctor or seek medical attention. You can also report side effects to the FDA at 1-800-332-1088 or online at 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
Changes 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. Seek medical help immediately 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 symptoms, contact your doctor:
Decreased interest in sex
Fertility problems
No menstrual period
Ejaculation problems
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:
Feeling dizzy, sleepy, tired, or weak
Headache
Trouble sleeping
Itching
Dry mouth
* Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
If you experience any of these side effects or have concerns, contact your doctor or seek medical attention. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Slow, shallow, or difficult breathing
- Extreme drowsiness or difficulty waking up
- Dizziness or lightheadedness when standing up
- Confusion
- Bluish lips or fingernails
- Severe constipation or abdominal pain
- Signs of allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
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.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor first.
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.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor first.
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 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
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 dosage, and follow their instructions carefully. 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 of their effects. Using these strengths in people who are not tolerant may cause severe and potentially fatal respiratory 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 fatal 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 increased risk.
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 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
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 dosage, and follow their instructions carefully. 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 of their effects. Using these strengths in people who are not tolerant may cause severe and potentially fatal respiratory 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 fatal 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 increased risk.
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:
- Pinpoint pupils
- Extreme drowsiness or unresponsiveness
- Slowed or stopped breathing
- Bluish skin, especially around the lips and fingernails
- Limp body
- Cold, clammy skin
- Loss of consciousness
- Coma
What to Do:
If you suspect an overdose, call 911 immediately. Administer naloxone if available and you are 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
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy (risk of serotonin syndrome or severe respiratory depression)
Major Interactions
- Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice): Increased oxycodone plasma concentrations, leading to increased opioid effects and potential for fatal respiratory depression.
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): May decrease formation of oxymorphone, potentially reducing analgesic effect in some patients, but overall effect on oxycodone efficacy is complex.
- Anticholinergics (e.g., atropine, scopolamine, tricyclic antidepressants): Increased risk of severe constipation and/or urinary retention, paralytic ileus.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol, fentanyl, St. John's Wort): Risk of serotonin syndrome.
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): Decreased oxycodone plasma concentrations, potentially leading to reduced efficacy or withdrawal symptoms.
- Diuretics: Opioids can reduce the efficacy of diuretics by causing the release of antidiuretic hormone.
- Antihypertensives: May cause additive hypotensive effects.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Pain assessment (intensity, character, location, duration)
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 for respiratory depression.
Timing: Prior to initiation of therapy
Mental status (alertness, orientation)
Rationale: To assess baseline cognitive function and identify risk 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
Risk assessment for opioid abuse/misuse/addiction
Rationale: To identify patients at higher risk and implement appropriate monitoring strategies.
Timing: Prior to initiation of therapy and periodically thereafter
Routine Monitoring
Pain relief and functional improvement
Frequency: Regularly, especially during titration and dose changes (e.g., daily to weekly initially, then monthly to quarterly)
Target: Acceptable pain control with improved function
Action Threshold: Inadequate pain control or worsening function requires dose adjustment or re-evaluation of treatment plan.
Respiratory rate and depth, oxygen saturation
Frequency: Regularly, especially during initiation and dose escalation (e.g., daily initially, then periodically)
Target: Respiratory rate >10 breaths/min, SpO2 >90%
Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or SpO2 <90% requires immediate intervention (e.g., naloxone, respiratory support).
Sedation level (e.g., using Pasero Opioid-Induced Sedation Scale - POSS)
Frequency: Regularly, especially during initiation and dose escalation (e.g., daily initially, then periodically)
Target: Alert or mildly drowsy, easily aroused
Action Threshold: Moderately to excessively sedated (difficult to arouse, somnolent) requires dose reduction or discontinuation.
Bowel function (frequency, consistency)
Frequency: Daily
Target: Regular bowel movements (e.g., every 1-3 days)
Action Threshold: Constipation (e.g., no bowel movement for >3 days, straining, hard stools) requires laxative intervention.
Signs of opioid abuse, misuse, or diversion
Frequency: At every visit
Target: No signs of aberrant drug-related behaviors
Action Threshold: Evidence of abuse/misuse/diversion requires re-evaluation of treatment plan, potential discontinuation, or referral to addiction specialist.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing, blue lips/fingernails)
- Excessive sedation/drowsiness
- Dizziness
- Nausea
- Vomiting
- Constipation
- Pruritus (itching)
- Urinary retention
- Confusion
- Hypotension
- Adrenal insufficiency (fatigue, weakness, dizziness, nausea, vomiting, anorexia)
- Androgen deficiency (decreased libido, impotence, amenorrhea, infertility)
Special Patient Groups
Pregnancy
Prolonged use of oxycodone during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated. Advise pregnant patients of the risk of NOWS and ensure appropriate treatment will be available. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally avoided due to potential for congenital malformations (e.g., neural tube defects, cardiac defects) with opioid exposure, though evidence is mixed.
Second Trimester:
Risk of NOWS increases with prolonged use. Fetal growth restriction and preterm birth have been associated with opioid use.
Third Trimester:
High risk of NOWS if used chronically. Respiratory depression in the neonate at delivery is also a concern if used close to term.
Lactation
Oxycodone is excreted into breast milk. Monitor infants for signs of sedation, respiratory depression, poor feeding, and withdrawal symptoms. The American Academy of Pediatrics considers oxycodone to be a drug for which the effect on the nursing infant is unknown but may be of concern. Use with caution, or consider alternative analgesics.
Infant Risk:
Moderate risk (L3). Potential for infant sedation, respiratory depression, and withdrawal symptoms if maternal dose is high or prolonged. Monitor infant closely.
Pediatric Use
Safety and effectiveness of Oxycodone ER have not been established in pediatric patients under 18 years of age. Use is generally not recommended due to the risks of overdose and respiratory depression.
Geriatric Use
Elderly patients may be more sensitive to the analgesic and adverse effects of opioids, including respiratory depression. Start with lower doses (e.g., 5 mg every 12 hours) and titrate slowly. Monitor closely for sedation, respiratory depression, and constipation.
Clinical Information
Clinical Pearls
- Oxycodone ER is for chronic, severe pain requiring continuous, around-the-clock opioid analgesia, not for as-needed pain relief.
- Never crush, chew, or dissolve Oxycodone ER tablets due to the risk of rapid release of a potentially fatal dose.
- Educate patients and caregivers on the risks of addiction, abuse, misuse, and accidental ingestion, especially by children.
- Always co-prescribe naloxone for patients at increased risk of opioid overdose (e.g., concomitant CNS depressant use, history of substance use disorder, higher doses).
- Monitor for signs of opioid-induced constipation and proactively manage with a bowel regimen.
- Be aware of drug interactions, particularly with CYP3A4 inhibitors/inducers and other CNS depressants.
- Regularly assess the 4 A's of opioid therapy: Analgesia, Activities of daily living, Adverse effects, and Aberrant drug-related behaviors.
Alternative Therapies
- Other opioid analgesics (e.g., fentanyl transdermal, hydromorphone ER)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, duloxetine)
- Interventional pain procedures (e.g., nerve blocks, spinal cord stimulation)
- Physical therapy
- Cognitive behavioral therapy
- Acupuncture
Cost & Coverage
Average Cost:
$100 - $500+ per 30 tablets (20mg ER)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (generic), Tier 3 or 4 (brand), often requires prior authorization and/or step therapy due to opioid class.
General Drug Facts
If your symptoms or health problems do not improve or worsen, contact your doctor immediately. It is essential to use your medication responsibly: do not share it with others, and never take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Read it carefully and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide 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 emergency medical care right away. When reporting the incident, be prepared to disclose what was taken, the quantity, and the time of the overdose.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Read it carefully and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide 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 emergency medical care right away. When reporting the incident, be prepared to disclose what was taken, the quantity, and the time of the overdose.