Oxycodone 15mg* 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
Dec 1995
DEA Schedule
Schedule II
Overview
What is this medicine?
Oxycodone is a strong pain medicine (an opioid) used to treat moderate to severe pain. It works in your brain to change how your body feels and responds to pain. It is important to take it exactly as prescribed because it can be habit-forming and cause serious side effects like slow breathing.
How to Use This Medicine
Taking Your Medication Correctly
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully.
Take this medication by mouth only. Do not inject or snort it, as this can lead to 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 prescribed dose is 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 experience difficulty 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, out of sight and reach of children and pets, and inaccessible to others. 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 local drug take-back programs.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember.
If the missed dose is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at once or extra doses.
* If you take this medication as needed, do not exceed the frequency recommended by your doctor.
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully.
Take this medication by mouth only. Do not inject or snort it, as this can lead to 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 prescribed dose is 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 experience difficulty 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, out of sight and reach of children and pets, and inaccessible to others. 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 local drug take-back programs.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember.
If the missed dose is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule.
Do not take two doses at once or extra doses.
* If you take this medication as needed, do not exceed the frequency recommended 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 dizziness and drowsiness.
- To prevent constipation, increase fluid intake, eat fiber-rich foods, and consider over-the-counter laxatives as advised by your doctor.
- Store this medication securely away from children and pets, and dispose of unused medication properly (e.g., drug take-back programs).
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:
opioid_naive:
Initial dose typically 5 mg every 4-6 hours.
severe_pain:
Higher initial doses or more frequent dosing may be required, titrated to effect and tolerability.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
0.05-0.15 mg/kg/dose orally every 4-6 hours as needed for pain, not to exceed 10 mg/dose. Use with extreme caution.
Adolescent:
Typically adult dosing, starting with 5 mg orally every 4-6 hours as needed.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, but monitor closely for increased effects.
Moderate:
Reduce initial dose by 30-50% (e.g., 2.5 mg every 4-6 hours), titrate carefully.
Severe:
Reduce initial dose by 50-75% (e.g., 2.5 mg every 6 hours or less frequently), titrate carefully. Avoid if possible.
Dialysis:
Not significantly removed by dialysis. Administer after dialysis. Monitor closely.
Hepatic Impairment:
Mild:
Reduce initial dose by 30-50% (e.g., 2.5 mg every 4-6 hours), titrate carefully.
Moderate:
Reduce initial dose by 50-75% (e.g., 2.5 mg every 6 hours or less frequently), titrate carefully.
Severe:
Reduce initial dose by 50-75% (e.g., 2.5 mg every 6 hours or less frequently), titrate carefully. Avoid if possible.
Confidence:
Medium
Pharmacology
Mechanism of Action
Oxycodone is a full opioid agonist that binds to mu-opioid receptors in the central nervous system (CNS) and other tissues. Binding to these receptors inhibits ascending pain pathways, altering the perception of and response to pain. It also produces generalized CNS depression, including respiratory depression, sedation, and euphoria.
Pharmacokinetics
Absorption:
Bioavailability:
60-87%
Tmax:
0.6-1.5 hours
FoodEffect:
Food can delay Tmax but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
45%
CnssPenetration:
Yes
Elimination:
HalfLife:
3.2-4.5 hours
Clearance:
Not readily available (highly variable)
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
<19% (as unchanged drug in urine)
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; and RISKS FROM CONCOMITANT USE WITH ALCOHOL.
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 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
Fast or abnormal heartbeat
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 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 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 your medication, contact your doctor or seek medical help. You can also report side effects to the FDA at 1-800-332-1088 or visit 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 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
Fast or abnormal heartbeat
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 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 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 your medication, contact your doctor or seek medical help. You can also report side effects to the FDA at 1-800-332-1088 or visit https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe drowsiness or difficulty waking up
- Slow, shallow, or difficult breathing
- Bluish lips or fingernails
- Extreme dizziness or lightheadedness
- Confusion
- Pinpoint pupils
- Severe constipation or abdominal pain
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your other medications 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 obstruction 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your other medications and health conditions. Never 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 tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor. 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 dosage, 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.
Special Precautions
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 tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing stairs.
Dosage and Administration
Do not exceed the dosage prescribed by your doctor. 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 dosage, 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.
Special Precautions
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
- Pinpoint pupils
- Cold, clammy skin
- Limp body
- Bluish discoloration of lips or fingernails
- Loss of consciousness
What to Do:
Seek immediate emergency medical attention. Call 911 or your local emergency number. If naloxone (Narcan) is available and you are trained to use it, administer it immediately. Stay with the person until emergency help arrives. Call 1-800-222-1222 (Poison Control) for additional guidance.
Drug Interactions
Contraindicated Interactions
- Benzodiazepines and other CNS depressants (e.g., other opioids, alcohol, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines): Concomitant use significantly increases risk of profound sedation, respiratory depression, coma, and death.
- Monoamine Oxidase Inhibitors (MAOIs): Risk of serotonin syndrome, respiratory depression, coma, and death. Avoid use within 14 days of MAOI discontinuation.
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, nelfinavir, indinavir): Can increase oxycodone plasma concentrations, leading to increased opioid effects and potentially fatal respiratory depression.
- Strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): Can increase oxycodone plasma concentrations, leading to increased opioid effects.
Major Interactions
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol, linezolid, methylene blue): Risk of serotonin syndrome.
- Anticholinergics (e.g., atropine, scopolamine, ipratropium): Increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
- Diuretics: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): Can decrease oxycodone plasma concentrations, leading to decreased efficacy and potential withdrawal symptoms.
- CYP2D6 inducers: Can decrease oxycodone plasma concentrations.
- Naloxone, Naltrexone: Can precipitate opioid withdrawal in physically dependent patients.
Minor Interactions
- Not specifically categorized as minor for oxycodone; most interactions are significant due to the nature of the drug.
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 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 history
Rationale: To assess baseline bowel habits and anticipate opioid-induced constipation.
Timing: Prior to initiation of therapy
Routine Monitoring
Pain assessment
Frequency: Regularly, typically before each dose or at least every 4-6 hours during initial titration, then daily or as needed.
Target: Acceptable pain level as defined by patient.
Action Threshold: Uncontrolled pain or excessive pain relief (sedation).
Respiratory rate and depth
Frequency: Every 1-2 hours during initial titration, then every 4-6 hours or as clinically indicated.
Target: >10-12 breaths/min (adults), regular rhythm.
Action Threshold: <10 breaths/min, shallow breathing, or signs of respiratory distress.
Level of consciousness/sedation (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Every 1-2 hours during initial titration, then every 4-6 hours or as clinically indicated.
Target: Alert or mildly drowsy, easily aroused.
Action Threshold: Difficult to arouse, somnolent, or unarousable.
Bowel function
Frequency: Daily
Target: Regular bowel movements (e.g., every 1-2 days).
Action Threshold: No bowel movement for 2-3 days, severe constipation, or signs of ileus.
Symptom Monitoring
- Excessive sedation
- Dizziness
- Nausea/vomiting
- Constipation
- Pruritus
- Confusion
- Difficulty breathing (shallow, slow, or labored breathing)
- Pinpoint pupils
- Cold, clammy skin
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended due to the risk of neonatal opioid withdrawal syndrome (NOWS) in the newborn, which can be life-threatening if not recognized and treated. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for congenital malformations (though data is mixed and not definitively linked to oxycodone alone).
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. Monitor breastfed infants for signs of sedation, respiratory depression, poor feeding, and poor weight gain. Use the lowest effective dose for the shortest duration. Consider alternative pain management if possible. If used, administer immediately after breastfeeding and observe the infant closely.
Infant Risk:
Risk of sedation, respiratory depression, and withdrawal symptoms upon discontinuation of maternal oxycodone.
Pediatric Use
Use in pediatric patients requires extreme caution due to increased sensitivity to respiratory depression. Dosing must be carefully titrated based on weight and clinical response. Not recommended for routine use in very young children or for mild pain.
Geriatric Use
Elderly patients may be more sensitive to the analgesic and adverse effects of oxycodone, particularly respiratory depression and constipation. Start with lower doses and titrate slowly. Monitor closely for CNS and respiratory depression.
Clinical Information
Clinical Pearls
- Oxycodone IR is intended for acute pain or breakthrough pain in patients on chronic opioid therapy. It is NOT for opioid-naive patients requiring chronic pain management.
- Always assess the patient's opioid tolerance before initiating or adjusting the dose.
- Educate patients and caregivers thoroughly about the risks of addiction, abuse, misuse, and life-threatening respiratory depression.
- Co-prescribe naloxone for patients at increased risk of overdose (e.g., history of overdose, concomitant CNS depressant use, higher doses).
- Implement a bowel regimen from the start to prevent opioid-induced constipation.
- Be aware of potential drug interactions, especially with CYP3A4/2D6 inhibitors/inducers and other CNS depressants.
Alternative Therapies
- Other short-acting opioid analgesics (e.g., morphine IR, hydromorphone IR, hydrocodone IR)
- Non-opioid analgesics (e.g., NSAIDs like ibuprofen, naproxen; acetaminophen)
- Adjuvant analgesics (e.g., gabapentin, pregabalin for neuropathic pain)
- Regional anesthesia (e.g., nerve blocks)
- Non-pharmacological pain management (e.g., physical therapy, acupuncture, massage, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (15mg IR)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 (brand if available)
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, which is 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 this medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help treat it. Discuss with your doctor or pharmacist how to obtain or use naloxone. 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 medical care immediately. When seeking help, be prepared to disclose what was taken, the quantity, and the time of the incident to ensure you receive appropriate treatment.
This medication is accompanied by a Medication Guide, which is 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 this medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help treat it. Discuss with your doctor or pharmacist how to obtain or use naloxone. 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 medical care immediately. When seeking help, be prepared to disclose what was taken, the quantity, and the time of the incident to ensure you receive appropriate treatment.