Oxycodone 5mg 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 works in your brain 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 cannot see or access it, and where others cannot reach it. Consider using a locked box or area.
Keep all medications away from pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on the best disposal method. You may also have access to 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 take 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 cannot see or access it, and where others cannot reach it. Consider using a locked box or area.
Keep all medications away from pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on the best disposal method. You may also have access to 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 take 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 oxycodone, as it can increase dangerous 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 directed by your doctor.
- Store this medication securely away from children and pets, as accidental ingestion can be fatal.
- Do not share this medication with anyone else, as it can be dangerous and is against the law.
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 mg every 4-6 hours as needed for pain
Dose Range:
5 - 15 mg
Condition-Specific Dosing:
acutePain:
Initial dose 5-15 mg every 4-6 hours as needed. Titrate to effect.
chronicPain:
Not typically used 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 for routine use; limited data for severe pain in opioid-tolerant children (0.05-0.15 mg/kg/dose every 4-6 hours, max 5 mg/dose).
Adolescent:
For severe pain, 0.05-0.15 mg/kg/dose every 4-6 hours, max 5 mg/dose. Or, adult dosing (5 mg every 4-6 hours) if appropriate weight/age.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, but monitor closely.
Moderate:
Reduce initial dose by 25-50% (e.g., 2.5 mg every 4-6 hours) and titrate carefully. Monitor for increased adverse effects.
Severe:
Reduce initial dose by 50% or more (e.g., 2.5 mg every 6 hours or less frequently) and titrate very carefully. Avoid if possible.
Dialysis:
Oxycodone is not significantly removed by dialysis. Administer after dialysis. Reduce dose and extend dosing interval.
Hepatic Impairment:
Mild:
Reduce initial dose by 25-50% (e.g., 2.5 mg every 4-6 hours) and titrate carefully. Monitor for increased adverse effects.
Moderate:
Reduce initial dose by 50% or more (e.g., 2.5 mg every 6 hours or less frequently) and titrate very carefully.
Severe:
Avoid use if possible. If necessary, reduce initial dose by 50-75% and extend dosing interval. Monitor closely for respiratory depression.
Pharmacology
Mechanism of Action
Oxycodone is a full opioid agonist that acts primarily at the mu-opioid receptors in the central nervous system (CNS). It produces analgesia by binding to these receptors, inhibiting the release of neurotransmitters involved in pain transmission (e.g., substance P, acetylcholine, norepinephrine, dopamine) and altering the perception of pain.
Pharmacokinetics
Absorption:
Bioavailability:
60-87%
Tmax:
1-1.5 hours
FoodEffect:
High-fat meal can increase Cmax by 25% and AUC by 15% for immediate-release formulations, but generally not clinically significant for IR.
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
45%
CnssPenetration:
Yes
Elimination:
HalfLife:
3.2 hours (range 2-4 hours)
Clearance:
0.8 L/min
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 8-14%
Pharmacodynamics
OnsetOfAction:
10-30 minutes
PeakEffect:
1 hour
DurationOfAction:
4-6 hours
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
Addiction, Abuse, and Misuse; Respiratory Depression; Accidental Ingestion; Neonatal Opioid Withdrawal Syndrome; Concomitant Use with Benzodiazepines or Other CNS Depressants; Cytochrome P450 3A4 Interaction.
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 fainting
Confusion
Severe constipation or stomach pain, which may indicate a severe bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Urination problems
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 for 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, nausea, 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
Fainting
Severe dizziness
Nausea or vomiting
Decreased appetite
Hormonal Changes: A Potential Long-Term Effect
Long-term use of an opioid medication may lead to lower sex hormone levels. If you experience any of the following symptoms, contact your doctor:
Decreased interest in sex
Fertility problems
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
Insomnia
Itching
Dry mouth
Constipation
Diarrhea
Stomach pain
Nausea or vomiting
Decreased appetite
If you experience any of these side effects or have concerns about others, 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 or 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 or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Urination problems
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 for 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, nausea, 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
Fainting
Severe dizziness
Nausea or vomiting
Decreased appetite
Hormonal Changes: A Potential Long-Term Effect
Long-term use of an opioid medication may lead to lower sex hormone levels. If you experience any of the following symptoms, contact your doctor:
Decreased interest in sex
Fertility problems
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
Insomnia
Itching
Dry mouth
Constipation
Diarrhea
Stomach pain
Nausea or vomiting
Decreased appetite
If you experience any of these side effects or have concerns about others, 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 or shallow breathing
- Extreme drowsiness or difficulty waking up
- Dizziness or lightheadedness when standing up
- Confusion
- Bluish lips or fingernails
- Severe constipation that doesn't improve
- Signs of an allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage or narrowing
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of certain medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. They will help determine whether it is safe to take this medication with your existing treatments and health conditions. Never 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, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage or narrowing
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of certain medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
This list is not exhaustive, and it is crucial to disclose all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues to your doctor and pharmacist. They will help determine whether it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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 your full attention. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.
Dosage Instructions
Adhere strictly to the dosage instructions provided by your doctor. Do not exceed the recommended dose, and do not take the medication more frequently or for a longer duration than prescribed. Deviating from these instructions may increase the risk of severe side effects.
Interactions with Other Medications
Before taking this medication with other strong pain relievers or using a pain patch, consult 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 amount.
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 are required to achieve the same effect. If you notice that the medication is no longer working as well, contact your doctor. Do not take more than the prescribed amount.
Additionally, long-term or regular use of opioid medications like this one may result in dependence. If you need to reduce the dose or stop taking this medication, consult your doctor first, as suddenly lowering the dose or stopping the medication may 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 may lead to unsafe and potentially fatal consequences.
Seizure Risk
This medication may increase the risk of seizures in certain individuals, including those with a history of seizures. Discuss your risk of seizures with your doctor.
Age-Related Precautions
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 potentially harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.
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 your full attention. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.
Dosage Instructions
Adhere strictly to the dosage instructions provided by your doctor. Do not exceed the recommended dose, and do not take the medication more frequently or for a longer duration than prescribed. Deviating from these instructions may increase the risk of severe side effects.
Interactions with Other Medications
Before taking this medication with other strong pain relievers or using a pain patch, consult 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 amount.
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 are required to achieve the same effect. If you notice that the medication is no longer working as well, contact your doctor. Do not take more than the prescribed amount.
Additionally, long-term or regular use of opioid medications like this one may result in dependence. If you need to reduce the dose or stop taking this medication, consult your doctor first, as suddenly lowering the dose or stopping the medication may 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 may lead to unsafe and potentially fatal consequences.
Seizure Risk
This medication may increase the risk of seizures in certain individuals, including those with a history of seizures. Discuss your risk of seizures with your doctor.
Age-Related Precautions
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 potentially harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.
Overdose Information
Overdose Symptoms:
- Pinpoint pupils
- Extreme drowsiness or unresponsiveness
- Slow, shallow, or stopped breathing
- Cold, clammy skin
- Limp muscles
- Low blood pressure
- Slowed heart rate
- Coma
What to Do:
If you suspect an overdose, call 911 immediately. Administer naloxone if available and trained to do so. Stay with the person until emergency medical help arrives. Call 1-800-222-1222 (Poison Control) for additional guidance.
Drug Interactions
Major Interactions
- Benzodiazepines and other CNS depressants (e.g., other opioids, alcohol, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines)
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice)
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort)
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol, MAOIs) - risk of serotonin syndrome
- Mixed agonist/antagonist and partial agonist opioids (e.g., butorphanol, nalbuphine, pentazocine, buprenorphine) - may precipitate withdrawal
Moderate Interactions
- Anticholinergic drugs (e.g., antihistamines, TCAs, antipsychotics) - increased risk of urinary retention and severe constipation
- Diuretics - reduced efficacy of diuretics due to ADH release
- Antihypertensives - additive hypotensive effects
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Pain assessment (intensity, location, quality)
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 major opioid adverse effect.
Timing: Prior to initiation of therapy
Level of consciousness/sedation
Rationale: To assess baseline mental status and risk of excessive sedation.
Timing: Prior to initiation of therapy
Medical history (including substance use disorder, mental health, sleep apnea, renal/hepatic impairment)
Rationale: To identify contraindications, precautions, and risk factors for adverse effects or misuse.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain assessment
Frequency: Regularly, as clinically indicated (e.g., before each dose, daily for chronic use)
Target: Acceptable pain relief with minimal side effects
Action Threshold: Inadequate pain control or excessive side effects warrant dose adjustment or re-evaluation.
Respiratory rate and depth
Frequency: Regularly, especially during initiation or dose titration; PRN for signs of respiratory depression.
Target: >10-12 breaths/min, unlabored
Action Threshold: <10 breaths/min, shallow breathing, or signs of hypoventilation require immediate intervention.
Level of consciousness/sedation (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Regularly, especially during initiation or dose titration; PRN for signs of over-sedation.
Target: Awake and alert or mildly drowsy, easily aroused.
Action Threshold: Difficult to arouse, somnolent, or unarousable requires immediate intervention.
Bowel function
Frequency: Daily
Target: Regular bowel movements
Action Threshold: Constipation (no bowel movement for >3 days) requires intervention (e.g., laxatives).
Signs of misuse, abuse, or addiction
Frequency: Periodically, at each visit for chronic use
Target: Not applicable
Action Threshold: Red flags (e.g., early refills, lost prescriptions, multiple prescribers) require further assessment and intervention.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing, cyanosis)
- Excessive sedation/drowsiness
- Dizziness, lightheadedness
- Nausea, vomiting
- Constipation
- Pruritus (itching)
- Confusion, disorientation
- Hypotension
- Urinary retention
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended due to risks of neonatal opioid withdrawal syndrome (NOWS) and potential for fetal harm. Should only be used if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data on major birth defects. Potential for neural tube defects and cardiac malformations, though evidence is mixed.
Second Trimester:
Risk of NOWS increases with prolonged use. Fetal growth restriction possible.
Third Trimester:
High risk of NOWS if used chronically. Risk of respiratory depression in the neonate if used close to delivery.
Lactation
Oxycodone is excreted into breast milk. While generally considered compatible with caution for short-term use, monitor the infant closely for signs of sedation, respiratory depression, and poor feeding. Avoid if possible, especially with chronic use or in mothers who are poor CYP2D6 metabolizers.
Infant Risk:
Risk of sedation, respiratory depression, poor feeding, and developmental delay. L3 (Moderately Safe) but requires close infant monitoring.
Pediatric Use
Not routinely recommended for children due to limited safety and efficacy data, especially in younger age groups. If used, extreme caution and individualized dosing based on weight and pain severity are necessary. Risk of respiratory depression is higher in children.
Geriatric Use
Start with lower doses (e.g., 2.5 mg) and titrate slowly due to increased sensitivity to opioid effects, decreased renal/hepatic function, and increased risk of falls, respiratory depression, and constipation. Monitor closely.
Clinical Information
Clinical Pearls
- Oxycodone IR is best suited for acute, severe pain or breakthrough pain in patients on long-acting opioids.
- Always start with the lowest effective dose and titrate slowly, especially in opioid-naive patients.
- Educate patients and caregivers about the risks of respiratory depression, sedation, and accidental ingestion, and the importance of safe storage.
- Co-prescribe naloxone for patients at high risk of overdose (e.g., history of overdose, concomitant CNS depressants, higher doses).
- Manage opioid-induced constipation proactively with a bowel regimen (e.g., stimulant laxative plus stool softener).
- Be aware of the significant drug interactions, particularly with CYP3A4 inhibitors/inducers and other CNS depressants.
Alternative Therapies
- Morphine (IR)
- Hydromorphone (IR)
- Hydrocodone/Acetaminophen (Norco, Vicodin)
- Tramadol
- Non-opioid analgesics (NSAIDs, Acetaminophen) for less severe pain
- Regional anesthesia, nerve blocks
- Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others, and never take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If an overdose is suspected, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care without delay. When seeking help, be prepared to provide information about what was taken, the quantity, and the timing of the incident.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If an overdose is suspected, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care without delay. When seeking help, be prepared to provide information about what was taken, the quantity, and the timing of the incident.