Oxycodone 10mg 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
Not available
FDA Approved
Dec 1995
DEA Schedule
Schedule II
Overview
What is this medicine?
Oxycodone extended-release is a strong prescription pain medicine that contains an opioid (narcotic) and is used to manage severe and long-lasting pain that requires around-the-clock treatment. Because it is extended-release, it slowly releases the medicine over 12 hours. It is important to take it exactly as prescribed and never crush, chew, or dissolve the tablet, as this can lead to a dangerous overdose.
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.
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 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 trouble 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 safe and secure location, out of the reach of children and pets, and inaccessible to others. Consider using a locked box or area to store it.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of medication, and consider participating in a drug take-back program 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 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.
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 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 trouble 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 safe and secure location, out of the reach of children and pets, and inaccessible to others. Consider using a locked box or area to store it.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of medication, and consider participating in a drug take-back program 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
- Do not drink alcohol while taking this medication, as it can increase the risk of serious side effects like respiratory depression.
- 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, and dispose of unused medication properly (e.g., drug take-back programs).
- Maintain a regular bowel regimen (e.g., increase fiber, fluids, use stool softeners/laxatives) to prevent opioid-induced constipation.
- Discuss the availability of naloxone (Narcan) with your healthcare provider, especially if you live with others or are at high risk for overdose.
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 opioid-tolerant patients, convert from previous opioid regimen.
Dose Range:
10 - 160 mg
Condition-Specific Dosing:
opioidNaive:
Initial 10 mg every 12 hours.
opioidTolerant:
Individualized conversion from previous opioid, typically 50% of total daily oral morphine equivalent dose given every 12 hours.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (generally not recommended for children under 11 years)
Adolescent:
Highly individualized, generally not recommended for opioid-naive patients. Use with extreme caution and only if benefits outweigh risks for severe chronic pain.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for mild impairment, monitor closely.
Moderate:
Reduce initial dose by 50% (e.g., 5 mg every 12 hours) and titrate cautiously.
Severe:
Reduce initial dose by 50% (e.g., 5 mg every 12 hours) and titrate cautiously. Monitor closely for respiratory depression and sedation.
Dialysis:
Oxycodone is not significantly removed by dialysis. Dose adjustment needed, monitor closely.
Hepatic Impairment:
Mild:
No specific adjustment for mild impairment, monitor closely.
Moderate:
Reduce initial dose by 50% (e.g., 5 mg every 12 hours) and titrate cautiously.
Severe:
Reduce initial dose by 50% (e.g., 5 mg every 12 hours) and titrate cautiously. Monitor closely for respiratory depression and sedation.
Pharmacology
Mechanism of Action
Oxycodone is a full opioid agonist with a high affinity for mu-opioid receptors in the central nervous system (CNS). Its primary therapeutic action is analgesia. It produces its effects by binding to and activating mu-opioid 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%
Tmax:
3-5 hours (for ER formulation)
FoodEffect:
A high-fat meal can increase the extent of absorption (AUC) and peak plasma concentration (Cmax) for some ER formulations. Administer consistently with or without food.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
45%
CnssPenetration:
Yes
Elimination:
HalfLife:
4.5-5.6 hours (terminal half-life for ER formulation)
Clearance:
Not available
ExcretionRoute:
Renal (primarily as metabolites, ~8-14% as unchanged oxycodone)
Unchanged:
8-14%
Pharmacodynamics
OnsetOfAction:
Approximately 1 hour (for ER formulation)
PeakEffect:
3-5 hours (for ER formulation)
DurationOfAction:
12 hours
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE: Oxycodone Extended-Release Tablets expose 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 Extended-Release Tablets, and monitor all patients regularly 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.
RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of Oxycodone Extended-Release Tablets or following a dose increase.
ACCIDENTAL INGESTION: Accidental ingestion of even one dose of Oxycodone Extended-Release Tablets, especially by children, can result in a fatal overdose of oxycodone.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of Oxycodone Extended-Release Tablets 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 Extended-Release Tablets with all CYP3A4 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 CYP3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving Oxycodone Extended-Release Tablets 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.
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.
RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of Oxycodone Extended-Release Tablets or following a dose increase.
ACCIDENTAL INGESTION: Accidental ingestion of even one dose of Oxycodone Extended-Release Tablets, especially by children, can result in a fatal overdose of oxycodone.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of Oxycodone Extended-Release Tablets 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 Extended-Release Tablets with all CYP3A4 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 CYP3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving Oxycodone Extended-Release Tablets 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 fainting
Confusion
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 difficulties
Abnormal heartbeat (fast, slow, or irregular)
Seizures
Shakiness
Changes in vision
Chest pain or pressure
Hallucinations (seeing or hearing things that are not there)
Mood changes
Memory problems or loss
Difficulty 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 of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Balance problems
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or irregular)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, stomach upset, or vomiting
Severe headache
Adrenal Gland Problems: A Rare but Serious Condition
Long-term use of opioid medications like this one may lead to a rare but severe adrenal gland problem. Seek medical help immediately if you experience:
Extreme fatigue or weakness
Fainting
Severe dizziness
Severe stomach upset
Vomiting
Decreased appetite
Hormonal Changes: A Potential Side Effect of Long-Term Use
Long-term use of opioid medications like this one may lead to lower sex hormone levels. Contact your doctor if you experience:
Decreased interest in sex
Fertility problems
Irregular menstrual periods
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:
Dizziness
Drowsiness
Fatigue
Headache
Sleep disturbances
Itching
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
If you experience any of these side effects or any other unusual symptoms, 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 fainting
Confusion
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 difficulties
Abnormal heartbeat (fast, slow, or irregular)
Seizures
Shakiness
Changes in vision
Chest pain or pressure
Hallucinations (seeing or hearing things that are not there)
Mood changes
Memory problems or loss
Difficulty 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 of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Balance problems
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or irregular)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, stomach upset, or vomiting
Severe headache
Adrenal Gland Problems: A Rare but Serious Condition
Long-term use of opioid medications like this one may lead to a rare but severe adrenal gland problem. Seek medical help immediately if you experience:
Extreme fatigue or weakness
Fainting
Severe dizziness
Severe stomach upset
Vomiting
Decreased appetite
Hormonal Changes: A Potential Side Effect of Long-Term Use
Long-term use of opioid medications like this one may lead to lower sex hormone levels. Contact your doctor if you experience:
Decreased interest in sex
Fertility problems
Irregular menstrual periods
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:
Dizziness
Drowsiness
Fatigue
Headache
Sleep disturbances
Itching
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
If you experience any of these side effects or any other unusual symptoms, 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
- Pinpoint pupils
- Cold, clammy skin
- 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 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 dose 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.
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 dose 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. Taking more than the recommended dose may increase your risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use a pain patch without first consulting your doctor.
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 you may require higher doses 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 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 Warnings
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. Consult your doctor to discuss the risks.
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 down position, and be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended dose may increase your risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use a pain patch without first consulting your doctor.
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 you may require higher doses 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 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 Warnings
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. Consult your doctor to discuss the risks.
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:
- Slowed or stopped breathing
- Extreme drowsiness or inability to wake up
- Pinpoint pupils
- Limp body
- Cold, clammy skin
- Blue or grayish lips or fingernails
- Gurgling sounds or choking
- Unresponsiveness
What to Do:
Seek immediate emergency medical attention. Administer naloxone if available and trained to do so. Call 911 or 1-800-222-1222 (Poison Control Center).
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, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, gabapentinoids): Increased risk of profound sedation, respiratory depression, coma, and death.
- CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir): Increased plasma concentrations of oxycodone, leading to increased opioid effects.
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): Decreased plasma concentrations of oxycodone, leading to decreased opioid efficacy or withdrawal.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol): Risk of serotonin syndrome.
- Mixed agonist/antagonist and partial agonist opioids (e.g., butorphanol, nalbuphine, pentazocine, buprenorphine): May reduce the analgesic effect of oxycodone or precipitate withdrawal symptoms.
Moderate Interactions
- Anticholinergics (e.g., atropine, scopolamine): Increased risk of urinary retention and/or severe constipation.
- Diuretics: Opioids may reduce the efficacy of diuretics by causing the 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 neurological status and identify risk factors for excessive sedation.
Timing: Prior to initiation of therapy
Bowel function history
Rationale: To assess for baseline constipation risk and plan for bowel regimen.
Timing: Prior to initiation of therapy
Renal and hepatic function tests (e.g., creatinine, BUN, LFTs)
Rationale: To identify impairment that may require dose adjustment.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain assessment
Frequency: Regularly, especially during dose titration and with any change in pain.
Target: Achieve acceptable pain control with minimal adverse effects.
Action Threshold: Inadequate pain control or worsening pain requires reassessment and potential dose adjustment.
Respiratory rate and depth
Frequency: Regularly, especially during initiation and dose titration (e.g., daily or more frequently if concerns).
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 titration.
Target: Alert and oriented, or easily aroused.
Action Threshold: Excessive sedation (e.g., somnolence, difficulty arousing) requires dose reduction or discontinuation.
Bowel function
Frequency: Daily
Target: Regular bowel movements (e.g., every 1-2 days).
Action Threshold: Constipation (no bowel movement for >2-3 days) requires intervention with laxatives/stool softeners.
Signs of opioid abuse/misuse
Frequency: Periodically, at each visit.
Target: Adherence to prescribed regimen, no aberrant drug-related behaviors.
Action Threshold: Signs of diversion, escalating use, or other aberrant behaviors require re-evaluation of treatment plan.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation/drowsiness
- Dizziness
- Nausea and vomiting
- Constipation
- Pruritus (itching)
- Urinary retention
- Confusion
- Hypotension
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. 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 increased risk of congenital malformations, though data are mixed and not definitively established for all opioids.
Second Trimester:
Risk of fetal growth restriction and preterm birth.
Third Trimester:
High risk of Neonatal Opioid Withdrawal Syndrome (NOWS) if used chronically. Respiratory depression in the neonate at 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, respiratory depression, and poor feeding. If opioid use is necessary, consider alternative feeding methods or use the lowest effective dose for the shortest duration possible.
Infant Risk:
L4 (Potentially Hazardous) - Risk of sedation, respiratory depression, and withdrawal symptoms in the infant.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients under 11 years of age. Use in adolescents should be highly individualized and generally reserved for severe chronic pain in opioid-tolerant patients, with careful monitoring.
Geriatric Use
Elderly patients may be more sensitive to the analgesic and adverse effects of oxycodone, particularly respiratory depression. Start with lower doses and titrate slowly. Monitor closely for sedation, respiratory depression, and constipation.
Clinical Information
Clinical Pearls
- Oxycodone ER tablets must be swallowed whole. Crushing, chewing, or dissolving the tablet can lead to rapid release and absorption of a potentially fatal dose of oxycodone.
- Always co-prescribe naloxone for patients at increased risk of overdose (e.g., history of overdose, concomitant CNS depressant use, higher doses).
- Educate patients and caregivers on the signs of opioid overdose and how to administer naloxone.
- Regularly assess for signs of addiction, abuse, and misuse. Implement risk mitigation strategies as appropriate.
- Opioid-induced constipation is a common and persistent side effect; proactive management with a bowel regimen is crucial.
- Consider the patient's total daily opioid dose when converting from other opioids or immediate-release formulations to avoid over-dosing.
Alternative Therapies
- Other extended-release opioid analgesics (e.g., Morphine ER, Hydromorphone ER, Fentanyl transdermal system)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, tricyclic antidepressants)
- Interventional pain management techniques (e.g., nerve blocks, spinal cord stimulation)
- Physical therapy, occupational therapy, psychological therapies (e.g., CBT)
Cost & Coverage
Average Cost:
Variable, typically $50-$300+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for generic), Tier 3 or Tier 4 (for brand)
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, which provides crucial information about its safe use. Read this guide carefully and review it again each time you refill your prescription. 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 its 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 seeking help, be prepared to provide detailed information about the overdose, including what was taken, the quantity, and the time of the incident.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully and review it again each time you refill your prescription. 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 its 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 seeking help, be prepared to provide detailed information about the overdose, including what was taken, the quantity, and the time of the incident.