Oxycodone Hcl 10mg 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. @ COMMON USES: It is used to manage pain 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 is a strong pain medicine used to treat moderate to severe pain. It belongs to a class of drugs called opioids. It works in your brain to change how your body feels and responds to pain.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. It is essential to take this medication exactly as directed.
Administration Instructions
Take this medication by mouth only. Do not inject or snort it, as this can cause severe side effects, including breathing difficulties and overdose, which can be fatal.
For Oxaydo and Roxybond tablets:
+ Swallow the tablets whole. Do not chew, break, or crush them.
+ If your dose requires more than one tablet, take one tablet at a time.
+ Do not lick or wet the tablet before placing it in your mouth. Swallow the tablet with a full glass of water immediately after putting it in your mouth.
+ If you have trouble swallowing, consult your doctor.
+ Do not administer this medication through a feeding tube.
Storage and Disposal
Store this medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep this medication in a secure location, out of sight and 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. Consult your pharmacist for guidance on the best disposal method. You may also want to explore drug take-back programs in your area.
Missed Dose Instructions
If you take this medication regularly and 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 schedule. Do not take two doses at once or extra doses.
If you take this medication as needed, do not take it more frequently than directed by your doctor.
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. It is essential to take this medication exactly as directed.
Administration Instructions
Take this medication by mouth only. Do not inject or snort it, as this can cause severe side effects, including breathing difficulties and overdose, which can be fatal.
For Oxaydo and Roxybond tablets:
+ Swallow the tablets whole. Do not chew, break, or crush them.
+ If your dose requires more than one tablet, take one tablet at a time.
+ Do not lick or wet the tablet before placing it in your mouth. Swallow the tablet with a full glass of water immediately after putting it in your mouth.
+ If you have trouble swallowing, consult your doctor.
+ Do not administer this medication through a feeding tube.
Storage and Disposal
Store this medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep this medication in a secure location, out of sight and 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. Consult your pharmacist for guidance on the best disposal method. You may also want to explore drug take-back programs in your area.
Missed Dose Instructions
If you take this medication regularly and 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 schedule. Do not take two doses at once or extra doses.
If you take this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Do not drink alcohol while taking this medication, as it can increase serious side effects like extreme 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 consider using a stool softener or laxative as recommended by your doctor.
- Store this medication securely, out of reach of children and pets, to prevent accidental ingestion, which can be fatal.
- Do not share this medication with anyone else, as it can be dangerous and is against the law.
- If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not take a double dose to make up for a missed one.
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:
10 mg every 4 to 6 hours as needed for pain
Dose Range:
5 - 30 mg
Condition-Specific Dosing:
opioid_naive:
Start with 5 mg every 4 to 6 hours
severe_pain:
May titrate cautiously based on response and tolerability
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for routine use; specific dosing for severe pain in opioid-tolerant children may be considered by specialists.
Adolescent:
Not established for routine use; specific dosing for severe pain in opioid-tolerant adolescents may be considered by specialists.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, monitor for increased effects
Moderate:
Reduce initial dose by 25-50%, titrate cautiously
Severe:
Reduce initial dose by 50% or more, titrate cautiously, extend dosing interval
Dialysis:
Supplemental dose after dialysis not typically needed for immediate-release; monitor closely
Hepatic Impairment:
Mild:
Reduce initial dose by 25-50%, titrate cautiously
Moderate:
Reduce initial dose by 50% or more, titrate cautiously, extend dosing interval
Severe:
Reduce initial dose by 50% or more, titrate cautiously, extend dosing interval
Pharmacology
Mechanism of Action
Oxycodone is a full opioid agonist with a high affinity for mu-opioid receptors in the central nervous system. Its primary therapeutic action is analgesia. Like other opioid agonists, it produces its analgesic effects by binding to mu-opioid receptors, leading to inhibition of ascending pain pathways, altering the perception of and response to pain. It also produces respiratory depression by direct action on brain stem respiratory centers, and cough suppression by direct effect on the cough center in the medulla.
Pharmacokinetics
Absorption:
Bioavailability:
60-87%
Tmax:
1-2 hours (immediate-release)
FoodEffect:
Food may delay Tmax but does not significantly affect bioavailability.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
45%
CnssPenetration:
Yes
Elimination:
HalfLife:
3.2 hours (immediate-release)
Clearance:
Not available
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
<19%
Pharmacodynamics
OnsetOfAction:
10-30 minutes
PeakEffect:
1-2 hours
DurationOfAction:
4-6 hours
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE: Oxycodone 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 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 or following a dose increase.
ACCIDENTAL INGESTION: Accidental ingestion of even one dose, especially by children, can result in a fatal overdose.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use 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 NOWS and ensure appropriate care will be available.
CYP3A4 INTERACTION: Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in increased oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. Concomitant use with CYP3A4 inducers (or discontinuation of CYP3A4 inhibitors) can result in decreased oxycodone plasma concentrations, potentially leading to decreased efficacy and opioid withdrawal. Avoid the use of CYP3A4 inhibitors or inducers in patients taking oxycodone. If co-administration is necessary, monitor patients closely and consider dose adjustments.
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS: Concomitant use with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing 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 or following a dose increase.
ACCIDENTAL INGESTION: Accidental ingestion of even one dose, especially by children, can result in a fatal overdose.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use 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 NOWS and ensure appropriate care will be available.
CYP3A4 INTERACTION: Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in increased oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. Concomitant use with CYP3A4 inducers (or discontinuation of CYP3A4 inhibitors) can result in decreased oxycodone plasma concentrations, potentially leading to decreased efficacy and opioid withdrawal. Avoid the use of CYP3A4 inhibitors or inducers in patients taking oxycodone. If co-administration is necessary, monitor patients closely and consider dose adjustments.
RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS: Concomitant use with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing 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 immediate medical attention:
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
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
Fast or abnormal heartbeat
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
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 fatigue or weakness
Passing out
Severe dizziness
Upset stomach
Vomiting
Decreased appetite
Long-Term Use and Hormonal Changes
Prolonged use of an opioid medication may lead to lower sex hormone levels. If you experience any of the following symptoms, consult your doctor:
Decreased interest in sex
Fertility problems
Irregular or absent 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 possible side effects:
Dizziness
Sleepiness
Fatigue
Weakness
Headache
Trouble sleeping
Itching
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
* Decreased appetite
If you're concerned about any side effects or have questions, consult your doctor. 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 immediate medical attention:
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
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
Fast or abnormal heartbeat
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
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 fatigue or weakness
Passing out
Severe dizziness
Upset stomach
Vomiting
Decreased appetite
Long-Term Use and Hormonal Changes
Prolonged use of an opioid medication may lead to lower sex hormone levels. If you experience any of the following symptoms, consult your doctor:
Decreased interest in sex
Fertility problems
Irregular or absent 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 possible side effects:
Dizziness
Sleepiness
Fatigue
Weakness
Headache
Trouble sleeping
Itching
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
* Decreased appetite
If you're concerned about any side effects or have questions, consult your doctor. 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
- Blue-tinged lips or fingernails
- Cold, clammy skin
- Pinpoint pupils
- Severe dizziness or lightheadedness
- Confusion
- Unresponsiveness or inability to be awakened
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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Respiratory problems, including asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of certain medications, such as buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins
Discuss your health problems and any potential interactions with this medication
* Never start, stop, or adjust 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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Respiratory problems, including asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of certain medications, such as buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins
Discuss your health problems and any potential interactions with this medication
* Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
Precautions & Cautions
Important Information About Your Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and engaging in other activities that require you to be alert. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended dose, or taking it more frequently or for a longer period than directed, can increase the risk of severe side effects.
Interactions with Other Medications
Before taking this medication with other strong pain medications or using a pain patch, consult with your doctor. If you experience worsening pain, increased sensitivity to pain, or 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 can lead to tolerance, where the medication may not work as effectively, and you may require higher doses to achieve the same effect. If you find that this medication is no longer working well, consult with your doctor. Do not take more than the prescribed dose.
Additionally, long-term or regular use of opioid medications like this one can result in dependence. If you need to reduce the dose or stop taking this medication, consult with your doctor first, as suddenly lowering the dose or stopping the medication can increase the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
Special Warnings
Do not consume alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal effects.
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk of seizures with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Breastfeeding
If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has difficulty breathing.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and engaging in other activities that require you to be alert. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor. Taking more than the recommended dose, or taking it more frequently or for a longer period than directed, can increase the risk of severe side effects.
Interactions with Other Medications
Before taking this medication with other strong pain medications or using a pain patch, consult with your doctor. If you experience worsening pain, increased sensitivity to pain, or 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 can lead to tolerance, where the medication may not work as effectively, and you may require higher doses to achieve the same effect. If you find that this medication is no longer working well, consult with your doctor. Do not take more than the prescribed dose.
Additionally, long-term or regular use of opioid medications like this one can result in dependence. If you need to reduce the dose or stop taking this medication, consult with your doctor first, as suddenly lowering the dose or stopping the medication can increase the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
Special Warnings
Do not consume alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal effects.
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk of seizures with your doctor.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Breastfeeding
If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has difficulty breathing.
Overdose Information
Overdose Symptoms:
- Pinpoint pupils
- Extreme drowsiness or loss of consciousness
- Slowed or stopped breathing
- Blue lips or fingernails
- Cold, clammy skin
- Limp body
- Unresponsiveness
What to Do:
If you suspect an overdose, call 911 immediately. Administer naloxone (Narcan) 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
- Concomitant use with benzodiazepines or other CNS depressants (unless benefits outweigh risks, and only with careful monitoring)
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy
Major Interactions
- Other opioid analgesics (increased risk of respiratory depression, sedation)
- Sedatives, hypnotics, anxiolytics, tranquilizers (increased CNS depression)
- Alcohol (increased CNS depression, respiratory depression)
- Muscle relaxants (increased CNS depression)
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir) - increased oxycodone plasma concentrations
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - decreased oxymorphone formation, but increased oxycodone exposure
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans) - risk of serotonin syndrome
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - decreased oxycodone plasma concentrations, potential for withdrawal
- Anticholinergic drugs (e.g., atropine, scopolamine) - increased risk of urinary retention and/or severe constipation
- Diuretics - opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone
Minor Interactions
- Antihistamines (sedating) - additive CNS depression
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, as respiratory depression is a serious adverse effect.
Timing: Prior to initiation of therapy
Mental status/level of consciousness
Rationale: To assess baseline neurological function and identify risk for excessive sedation.
Timing: Prior to initiation of therapy
Bowel function history
Rationale: To anticipate and proactively manage opioid-induced constipation.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain level (using a validated scale)
Frequency: Regularly during titration, then periodically (e.g., daily or weekly) during maintenance
Target: Patient-specific goal for pain reduction and functional improvement
Action Threshold: Uncontrolled pain or worsening pain may require dose adjustment or alternative strategies
Respiratory rate and depth
Frequency: Frequently during initiation/titration (e.g., every 1-2 hours), then periodically (e.g., daily) during maintenance
Target: Typically >10-12 breaths/minute, regular rhythm
Action Threshold: Respiratory rate <10 breaths/minute, shallow breathing, or signs of hypoventilation warrant immediate intervention
Sedation level (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Frequently during initiation/titration, then periodically during maintenance
Target: Alert or mildly drowsy, easily aroused
Action Threshold: Excessive sedation (e.g., difficult to arouse, somnolent) warrants dose reduction or discontinuation
Bowel movements/constipation
Frequency: Daily
Target: Regular bowel movements (e.g., every 1-2 days)
Action Threshold: Absence of bowel movement for >2-3 days, straining, or hard stools warrants intervention for opioid-induced constipation
Signs of opioid use disorder (OUD)
Frequency: Periodically (e.g., at each follow-up visit)
Target: Absence of aberrant drug-related behaviors
Action Threshold: Signs of OUD (e.g., drug-seeking behavior, escalating doses without medical indication) warrant referral for specialized care
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation/drowsiness
- Dizziness/lightheadedness
- Nausea/vomiting
- Constipation
- Pruritus (itching)
- Urinary retention
- Confusion/disorientation
- Signs of allergic reaction (rash, swelling)
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 care will be available. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for congenital malformations, though data are mixed and less clear than for some other opioids.
Second Trimester:
Risk of NOWS increases with prolonged exposure.
Third Trimester:
High risk of neonatal opioid withdrawal syndrome (NOWS) if used chronically. Risk of respiratory depression in the neonate if used close to delivery.
Lactation
Oxycodone is excreted into breast milk. Monitor infants for signs of sedation, respiratory depression, poor feeding, and withdrawal symptoms. A single dose may be acceptable, but chronic use is generally not recommended. Consider alternative analgesics or pump and dump strategies.
Infant Risk:
Risk of sedation, respiratory depression, constipation, and withdrawal symptoms in the breastfed infant. 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.
Pediatric Use
Safety and effectiveness in pediatric patients under 18 years of age have not been established for routine use. Use in children should be limited to severe pain and managed by specialists, with careful dose titration and monitoring due to increased sensitivity to respiratory depression.
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 CNS depression, respiratory depression, and constipation.
Clinical Information
Clinical Pearls
- Oxycodone is a potent opioid with a high potential for addiction, abuse, and misuse. Prescribe with caution and monitor patients closely.
- Always assess a patient's risk factors for opioid use disorder before initiating therapy.
- Educate patients and caregivers on the risks of respiratory depression, accidental ingestion, and safe storage/disposal.
- Proactive management of opioid-induced constipation is crucial; recommend stool softeners and/or laxatives from the start of therapy.
- Naloxone should be co-prescribed or made readily available to patients at high risk of overdose (e.g., those on higher doses, concomitant CNS depressants, or with a history of substance use disorder).
- Be aware of drug interactions, especially with CYP3A4 inhibitors/inducers and other CNS depressants, which can significantly alter oxycodone levels and increase adverse effects.
- Immediate-release oxycodone is for acute pain or breakthrough pain in opioid-tolerant patients; it is not suitable for chronic pain management without careful consideration and often in conjunction with extended-release formulations.
Alternative Therapies
- Other opioid analgesics (e.g., morphine, hydromorphone, fentanyl)
- NSAIDs (e.g., ibuprofen, naproxen, celecoxib)
- Acetaminophen
- Adjuvant analgesics (e.g., gabapentin, pregabalin for neuropathic pain; duloxetine for chronic musculoskeletal pain)
- Regional anesthesia/nerve blocks
- Non-pharmacological therapies (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (generic 10mg IR)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is essential to read this guide carefully and review it again each time you refill your prescription. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of an overdose, a medication called naloxone can be used as an emergency treatment. Discuss the availability and use of naloxone with your doctor or pharmacist to understand how to obtain and administer it if needed. If you suspect an overdose has occurred, 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 emergency medical care right away. When reporting the incident, be prepared to provide critical information, including the substance involved, the quantity taken, and the time of the incident, to ensure prompt and effective treatment.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is essential to read this guide carefully and review it again each time you refill your prescription. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of an overdose, a medication called naloxone can be used as an emergency treatment. Discuss the availability and use of naloxone with your doctor or pharmacist to understand how to obtain and administer it if needed. If you suspect an overdose has occurred, 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 emergency medical care right away. When reporting the incident, be prepared to provide critical information, including the substance involved, the quantity taken, and the time of the incident, to ensure prompt and effective treatment.