Oxycodone 20mg Immediate Rel Tabs
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
May 1976
DEA Schedule
Schedule II
Overview
What is this medicine?
Oxycodone is a strong pain medicine that belongs to a group of drugs called opioids. It works in your brain and nervous system to change how your body feels and responds to pain. It is used for moderate to severe pain that needs a strong pain reliever.
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.
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 without chewing, breaking, or crushing them.
+ If your dose requires more than one tablet, take them one 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.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep the medication in a secure location where children and pets cannot access it, and where others cannot easily find it. Consider using a locked box or area.
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, and explore potential drug take-back programs in your area.
Missing a Dose
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.
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 without chewing, breaking, or crushing them.
+ If your dose requires more than one tablet, take them one 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.
Storing and Disposing of Your Medication
Store the medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep the medication in a secure location where children and pets cannot access it, and where others cannot easily find it. Consider using a locked box or area.
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, and explore potential drug take-back programs in your area.
Missing a Dose
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.
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
- To prevent constipation, increase fiber in your diet, drink plenty of fluids, and consider using a stool softener or laxative as directed by your doctor.
- Store this medication securely away from children and pets, preferably in a locked cabinet, to prevent accidental ingestion.
- Do not share this medication with anyone else, as it can be dangerous and is illegal.
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:
5-15 mg orally every 4-6 hours as needed for pain
Dose Range:
5 - 30 mg
Condition-Specific Dosing:
acutePain:
Initial dose 5-15 mg every 4-6 hours, titrated to effect.
chronicPain:
Not typically recommended for chronic pain due to short duration; extended-release formulations are preferred. If used, titrate carefully.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (safety and efficacy not established for children under 18 years of age)
Adolescent:
Not established (safety and efficacy not established for children under 18 years of age)
Dose Adjustments
Renal Impairment:
Mild:
Consider dose reduction and/or extended dosing interval.
Moderate:
Reduce initial dose by 50% and/or extend dosing interval.
Severe:
Reduce initial dose by 50-75% and/or extend dosing interval; monitor closely.
Dialysis:
Oxycodone is not significantly removed by dialysis. Dose adjustment needed based on renal function.
Hepatic Impairment:
Mild:
Reduce initial dose by 33-50% and/or extend dosing interval.
Moderate:
Reduce initial dose by 50-67% and/or extend dosing interval.
Severe:
Reduce initial dose by 50-75% and/or extend dosing interval; monitor closely.
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. Other effects include respiratory depression, miosis, euphoria, dysphoria, constipation, and physical dependence. It acts by mimicking the effects of endogenous opioid peptides, leading to inhibition of pain transmission at the spinal cord and supraspinal levels.
Pharmacokinetics
Absorption:
Bioavailability:
60-87%
Tmax:
1-1.5 hours
FoodEffect:
Food may delay Tmax but does not significantly affect Cmax or AUC.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
45%
CnssPenetration:
Yes
Elimination:
HalfLife:
3.2-4.5 hours
Clearance:
0.8 L/min
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
8-14%
Pharmacodynamics
OnsetOfAction:
10-30 minutes
PeakEffect:
1 hour
DurationOfAction:
4-6 hours
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.
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 or 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)
Trouble passing urine
Abnormal heartbeat (fast, slow, or irregular)
Seizures
Shakiness
Changes in eyesight
Chest pain or pressure
Hallucinations (seeing or hearing things that are not there)
Mood changes
Memory problems or loss
Trouble walking or speaking
Swelling in the arms or legs
Fever
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk for serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, upset stomach, or vomiting
Severe headache
Adrenal Gland Problems: A Rare but Serious Condition
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Contact your doctor right away if you experience:
Extreme tiredness or weakness
Passing out
Severe dizziness
Upset stomach
Vomiting
Decreased appetite
Long-Term Use and Hormonal Changes
Long-term use of an opioid medication may lead to lower sex hormone levels. If you experience any of the following, contact your doctor:
Decreased interest in sex
Fertility problems
No menstrual period
Ejaculation problems
Other Side Effects
While many people may not experience side effects or may only have minor side effects, it's essential to be aware of the following:
Feeling dizzy, sleepy, tired, or weak
Headache
Trouble sleeping
Itching
Dry mouth
* Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
If you're concerned about any side effects or have questions, contact 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 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 or 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)
Trouble passing urine
Abnormal heartbeat (fast, slow, or irregular)
Seizures
Shakiness
Changes in eyesight
Chest pain or pressure
Hallucinations (seeing or hearing things that are not there)
Mood changes
Memory problems or loss
Trouble walking or speaking
Swelling in the arms or legs
Fever
Serotonin Syndrome: A Potentially Life-Threatening Condition
If you take this medication with certain other drugs, you may be at risk for serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:
Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, upset stomach, or vomiting
Severe headache
Adrenal Gland Problems: A Rare but Serious Condition
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Contact your doctor right away if you experience:
Extreme tiredness or weakness
Passing out
Severe dizziness
Upset stomach
Vomiting
Decreased appetite
Long-Term Use and Hormonal Changes
Long-term use of an opioid medication may lead to lower sex hormone levels. If you experience any of the following, contact your doctor:
Decreased interest in sex
Fertility problems
No menstrual period
Ejaculation problems
Other Side Effects
While many people may not experience side effects or may only have minor side effects, it's essential to be aware of the following:
Feeling dizzy, sleepy, tired, or weak
Headache
Trouble sleeping
Itching
Dry mouth
* Constipation, diarrhea, stomach pain, upset stomach, vomiting, or decreased appetite
If you're concerned about any side effects or have questions, contact 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 or shallow breathing
- Extreme drowsiness or difficulty waking up
- Dizziness or lightheadedness when standing up
- Confusion
- Pinpoint pupils
- Severe constipation
- Hives or rash (signs of allergic reaction)
- Swelling of the face, lips, tongue, or throat
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 you experienced, including any 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
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline
Note: Combining these medications can lead to severely high blood pressure.
If you are currently taking any of the following medications:
+ Buprenorphine
+ Butorphanol
+ Linezolid
+ Methylene blue
+ Nalbuphine
+ Pentazocine
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 (OTC) medications
Natural products
* Vitamins
Your doctor needs to be aware of all your medications and health conditions to ensure it is safe for you to take this medication. Do not start, stop, or adjust the dosage of any medication without 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. Be sure to describe the allergic reaction you experienced, including any 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
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline
Note: Combining these medications can lead to severely high blood pressure.
If you are currently taking any of the following medications:
+ Buprenorphine
+ Butorphanol
+ Linezolid
+ Methylene blue
+ Nalbuphine
+ Pentazocine
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 (OTC) medications
Natural products
* Vitamins
Your doctor needs to be aware of all your medications and health conditions to ensure it is safe for you to take this medication. Do not start, stop, or adjust the dosage of any medication without 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, get up slowly from a sitting or lying down position, and be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dose prescribed by your doctor. Taking more than the recommended dose, or taking it more frequently or for a longer period than directed, may 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 your doctor. If you experience worsening pain, increased sensitivity to pain, or new pain, 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 dose or stopping the medication, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Concomitant Use with Alcohol
Do not consume alcohol or products containing alcohol while taking this medication, as it may cause unsafe and potentially fatal effects.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk with your doctor.
Use in Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Breastfeeding
Inform your doctor if you are breastfeeding, as this medication passes into breast milk and may harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.
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, get up slowly from a sitting or lying down position, and be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dose prescribed by your doctor. Taking more than the recommended dose, or taking it more frequently or for a longer period than directed, may 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 your doctor. If you experience worsening pain, increased sensitivity to pain, or new pain, 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 dose or stopping the medication, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.
Concomitant Use with Alcohol
Do not consume alcohol or products containing alcohol while taking this medication, as it may cause unsafe and potentially fatal effects.
Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk with your doctor.
Use in Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Breastfeeding
Inform your doctor if you are breastfeeding, as this medication passes into breast milk and may harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.
Overdose Information
Overdose Symptoms:
- Slowed or stopped breathing
- Extreme drowsiness or unresponsiveness
- Cold, clammy skin
- Pinpoint pupils
- Limp muscles
- Bluish discoloration of lips and fingernails
- Loss of consciousness
What to Do:
Call 911 immediately. Administer naloxone (Narcan) if available and trained to do so. Stay with the person until emergency medical help arrives. Provide rescue breathing if necessary.
Drug Interactions
Contraindicated Interactions
- Concomitant use with benzodiazepines or other CNS depressants (unless benefits outweigh risks, and only with careful monitoring and reduced dosages)
- MAO inhibitors (within 14 days)
Major Interactions
- Other opioid analgesics (additive CNS depression, respiratory depression)
- Alcohol (additive CNS depression, respiratory depression)
- Sedative hypnotics (additive CNS depression, respiratory depression)
- Anesthetics (additive CNS depression, respiratory depression)
- Muscle relaxants (additive CNS depression, respiratory depression)
- Antihistamines (sedating) (additive CNS depression)
- CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) - increased oxycodone plasma concentrations
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - decreased oxymorphone formation, potentially reduced analgesic effect in some patients
Moderate Interactions
- Anticholinergics (increased risk of severe constipation and/or urinary retention)
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans) - increased risk of serotonin syndrome (rare but serious)
- Diuretics (opioids may reduce the efficacy of diuretics by causing ADH release)
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 for respiratory depression.
Timing: Prior to initiation of therapy
Level of consciousness/sedation
Rationale: To assess baseline mental status and identify risk for excessive sedation.
Timing: Prior to initiation of therapy
Bowel function
Rationale: To assess baseline and anticipate opioid-induced constipation.
Timing: Prior to initiation of therapy
Renal and hepatic function tests (e.g., BUN, creatinine, LFTs)
Rationale: To identify potential need for dose adjustment in patients with organ impairment.
Timing: Prior to initiation of therapy, if clinically indicated
Routine Monitoring
Pain assessment
Frequency: Regularly during therapy (e.g., 1-2 hours after dose, then every 4-6 hours or as needed)
Target: Acceptable pain relief with tolerable side effects
Action Threshold: Inadequate pain control or intolerable side effects warrant dose adjustment or alternative therapy.
Respiratory rate and depth
Frequency: Regularly, especially during initiation and dose titration (e.g., every 1-2 hours initially, then every 4-6 hours or as clinically indicated)
Target: >10-12 breaths/minute, regular rhythm
Action Threshold: <10 breaths/minute, shallow breathing, or signs of respiratory distress require immediate intervention (e.g., naloxone, respiratory support).
Level of consciousness/sedation (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Regularly, especially during initiation and dose titration (e.g., every 1-2 hours initially, then every 4-6 hours or as clinically indicated)
Target: Alert or mildly drowsy, easily aroused
Action Threshold: Difficult to arouse, somnolent, or unresponsive requires immediate intervention (e.g., naloxone, reduce/hold dose).
Bowel function (frequency of bowel movements)
Frequency: Daily
Target: Regular bowel movements (e.g., every 1-2 days)
Action Threshold: Constipation (e.g., no bowel movement for 3 days) requires initiation or escalation of laxative regimen.
Signs of abuse, misuse, or addiction
Frequency: Periodically throughout therapy
Target: Absence of aberrant drug-related behaviors
Action Threshold: Evidence of diversion, dose escalation without medical indication, or other concerning behaviors requires re-evaluation of therapy and potential referral to addiction specialist.
Symptom Monitoring
- Drowsiness
- Dizziness
- Nausea
- Vomiting
- Constipation
- Itching
- Sweating
- Confusion
- Difficulty breathing
- Pinpoint pupils
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended due to potential for neonatal opioid withdrawal syndrome (NOWS) in the newborn, which can be life-threatening if not recognized and treated. Opioids may also increase the risk of birth defects if used early in pregnancy. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential increased risk of birth defects (e.g., cardiac defects, neural tube defects, gastroschisis) with first-trimester exposure, though data are mixed.
Second Trimester:
Risk of fetal growth restriction and other adverse outcomes.
Third Trimester:
High risk of neonatal opioid withdrawal syndrome (NOWS) if used chronically. Symptoms include irritability, hyperactivity, abnormal sleep patterns, high-pitched cry, tremor, vomiting, diarrhea, and poor feeding.
Lactation
Oxycodone is excreted into breast milk. While the amount is generally low, infants, especially neonates, premature infants, or those with respiratory compromise, are at risk for serious adverse reactions including sedation and respiratory depression. Monitor infants for increased sleepiness, difficulty breathing, or limpness. If possible, avoid or use the lowest effective dose for the shortest duration. Consider alternative analgesics.
Infant Risk:
Moderate to High (L3-L4) depending on dose, duration, and infant age/health status.
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 18 years of age. Use is generally not recommended.
Geriatric Use
Elderly patients may be more sensitive to the analgesic and adverse effects of opioids, particularly respiratory depression. Start with lower doses and titrate slowly. Monitor closely for sedation, respiratory depression, and constipation. Consider age-related decline in renal and hepatic function.
Clinical Information
Clinical Pearls
- Oxycodone IR is intended for acute pain or breakthrough pain in patients on chronic opioid therapy, not for opioid-naive patients requiring chronic pain management.
- Always start with the lowest effective dose and titrate slowly to minimize adverse effects, especially respiratory depression.
- Educate patients and caregivers on the risks of addiction, abuse, and misuse, and the importance of safe storage and disposal.
- Co-prescribe naloxone for patients at increased risk of opioid overdose (e.g., history of overdose, concomitant CNS depressant use, higher doses).
- Aggressively manage opioid-induced constipation with prophylactic laxatives (e.g., stimulant laxative plus stool softener).
Alternative Therapies
- Other opioid analgesics (e.g., hydrocodone, morphine, hydromorphone, fentanyl)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen)
- Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants for neuropathic pain)
- Regional anesthesia/nerve blocks
- Physical therapy, acupuncture, cognitive behavioral therapy for chronic pain
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (20mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
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 your safety and the safety of others, never share your medication with anyone, and do not take medication prescribed to someone else.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is vital to read this guide carefully and review it again whenever your prescription is refilled. 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 administered to help counteract the effects. Discuss the availability and use of 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 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 the necessary information, including what was taken, the quantity, 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 vital to read this guide carefully and review it again whenever your prescription is refilled. 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 administered to help counteract the effects. Discuss the availability and use of 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 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 the necessary information, including what was taken, the quantity, and the time of the incident, to ensure prompt and effective treatment.