Oxycodone 100mg/5ml Solution 30ml
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.Make sure you have the right drug; there is more than one strength. A lower strength may not ease pain well enough. A higher strength could lead to accidental overdose and death.Be sure that you know how to measure your dose. Dosing errors can lead to accidental overdose and death. If you have any questions, talk with your doctor or pharmacist. @ 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
Category C
FDA Approved
May 1995
DEA Schedule
Schedule II
Overview
What is this medicine?
Oxycodone is a strong pain medicine (an opioid) used to treat severe pain that is not controlled by other pain relievers. This specific solution is very concentrated, meaning a small amount contains a lot of medicine. It is usually prescribed for people who are already used to taking strong pain medicines or who have very severe, ongoing pain, often in cancer or palliative care.
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, as directed. Do not inject or snort this medication, as this can cause severe side effects, including breathing difficulties and overdose, which can be fatal.
When taking the liquid form of this medication, measure your dose carefully using the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device. Avoid using a household teaspoon or tablespoon to measure your dose, as this can lead to taking too much medication.
Storing and Disposing of Your Medication
Store this medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in a bathroom. To prevent accidental ingestion, store this medication in a secure location where children and pets cannot access it. Consider using a locked box or area to keep the medication safe. Keep all medications out of reach of pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to check if there are any drug take-back programs in your area.
Missing a Dose
If you take this medication on a regular schedule and miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
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, as directed. Do not inject or snort this medication, as this can cause severe side effects, including breathing difficulties and overdose, which can be fatal.
When taking the liquid form of this medication, measure your dose carefully using the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device. Avoid using a household teaspoon or tablespoon to measure your dose, as this can lead to taking too much medication.
Storing and Disposing of Your Medication
Store this medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in a bathroom. To prevent accidental ingestion, store this medication in a secure location where children and pets cannot access it. Consider using a locked box or area to keep the medication safe. Keep all medications out of reach of pets.
When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to check if there are any drug take-back programs in your area.
Missing a Dose
If you take this medication on a regular schedule and miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses.
If you take this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Always use the special measuring device (oral syringe) provided with this medicine to ensure you take the exact dose. Never use a household spoon.
- Do not drink alcohol while taking this medicine, as it can increase dangerous side effects like severe drowsiness and breathing problems.
- Avoid driving or operating heavy machinery until you know how this medicine affects you, as it can cause dizziness and drowsiness.
- To prevent severe constipation, drink plenty of fluids, eat fiber-rich foods, and use a stool softener or laxative as directed by your doctor.
- Store this medicine securely away from children and pets, as accidental ingestion can be fatal.
- Do not share this medicine with anyone else, as it can be dangerous for them.
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:
For opioid-tolerant patients: Initial dose typically 10-30 mg (0.5-1.5 mL of 100mg/5ml solution) every 4-6 hours as needed for pain. Titrate slowly based on patient response and previous opioid intake. This concentrated solution is NOT for opioid-naive patients.
Dose Range:
5 - 30 mg
Condition-Specific Dosing:
severe_chronic_pain:
Individualized titration based on patient's opioid tolerance and pain severity. Doses can exceed 30mg in highly tolerant patients.
palliative_care:
Often used for ease of administration and high dose requirements in terminally ill patients.
Pediatric Dosing
Neonatal:
Not established; extreme caution and specialist consultation required for opioid-tolerant neonates.
Infant:
Not established; extreme caution and specialist consultation required for opioid-tolerant infants.
Child:
Not established for routine use; extreme caution and specialist consultation required for opioid-tolerant children. Dosing must be highly individualized and carefully titrated.
Adolescent:
Not established for routine use; extreme caution and specialist consultation required for opioid-tolerant adolescents. Dosing must be highly individualized and carefully titrated.
Dose Adjustments
Renal Impairment:
Mild:
Consider 25-50% dose reduction or increased dosing interval.
Moderate:
Consider 50% dose reduction or increased dosing interval.
Severe:
Consider 50-75% dose reduction and/or increased dosing interval (e.g., every 8-12 hours). Monitor closely for respiratory depression and sedation.
Dialysis:
Oxycodone is not significantly removed by dialysis. Administer after dialysis. Dose reduction and extended interval likely needed.
Hepatic Impairment:
Mild:
Consider 25-50% dose reduction or increased dosing interval.
Moderate:
Consider 50% dose reduction and/or increased dosing interval (e.g., every 8-12 hours). Monitor closely for respiratory depression and sedation.
Severe:
Consider 50-75% dose reduction and/or increased dosing interval (e.g., every 8-12 hours). Monitor closely for respiratory depression and sedation.
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, leading to inhibition of ascending pain pathways, altering the perception of and response to pain. It also produces CNS depression, respiratory depression, euphoria, and physical dependence.
Pharmacokinetics
Absorption:
Bioavailability:
60-87%
Tmax:
1-1.5 hours (immediate-release)
FoodEffect:
Food may delay Tmax but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
2.6 L/kg
ProteinBinding:
45%
CnssPenetration:
Yes
Elimination:
HalfLife:
3-4.5 hours
Clearance:
Not readily available, but primarily hepatic metabolism and renal excretion.
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 8-14% of the dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
10-30 minutes (oral solution)
PeakEffect:
1-2 hours
DurationOfAction:
3-6 hours
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.
Addiction, Abuse, and Misuse: Oxycodone exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing and monitor all patients regularly for the development of these behaviors and conditions.
REMS: To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a REMS for these products.
Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase.
Accidental Ingestion: Accidental ingestion of even one dose, especially by children, can result in a fatal overdose of oxycodone.
Neonatal Opioid Withdrawal Syndrome: Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of NOWS and ensure that appropriate treatment will be available.
Cytochrome P450 3A4 Interaction: Concomitant use with CYP3A4 inhibitors can result in increased oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Concomitant use with CYP3A4 inducers may decrease oxycodone plasma concentrations, potentially decreasing efficacy or precipitating withdrawal symptoms. Avoid the use of CYP3A4 inhibitors or inducers in patients taking oxycodone. If concomitant use is necessary, monitor patients closely and consider dose adjustments.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Addiction, Abuse, and Misuse: Oxycodone exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing and monitor all patients regularly for the development of these behaviors and conditions.
REMS: To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the FDA has required a REMS for these products.
Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase.
Accidental Ingestion: Accidental ingestion of even one dose, especially by children, can result in a fatal overdose of oxycodone.
Neonatal Opioid Withdrawal Syndrome: Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of NOWS and ensure that appropriate treatment will be available.
Cytochrome P450 3A4 Interaction: Concomitant use with CYP3A4 inhibitors can result in increased oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Concomitant use with CYP3A4 inducers may decrease oxycodone plasma concentrations, potentially decreasing efficacy or precipitating withdrawal symptoms. Avoid the use of CYP3A4 inhibitors or inducers in patients taking oxycodone. If concomitant use is necessary, monitor patients closely and consider dose adjustments.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or 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
+ Breathing problems during sleep (sleep apnea)
Trouble passing urine
Abnormal heartbeat, including fast, slow, or irregular rhythms
Seizures
Shakiness
Changes in eyesight
Chest pain or pressure
Hallucinations (seeing or hearing things that are not there)
Mood changes
Memory problems or loss
Trouble walking
Trouble 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
Throwing up
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:
Feeling very tired or weak
Passing out
Severe dizziness
Very upset stomach
Throwing up
Decreased appetite
Long-Term Use and Hormone Levels
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
Throwing up
* Decreased appetite
If any of these side effects or any other side effects bother you or do not go away, contact your doctor or seek medical help. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or 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
+ Breathing problems during sleep (sleep apnea)
Trouble passing urine
Abnormal heartbeat, including fast, slow, or irregular rhythms
Seizures
Shakiness
Changes in eyesight
Chest pain or pressure
Hallucinations (seeing or hearing things that are not there)
Mood changes
Memory problems or loss
Trouble walking
Trouble 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
Throwing up
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:
Feeling very tired or weak
Passing out
Severe dizziness
Very upset stomach
Throwing up
Decreased appetite
Long-Term Use and Hormone Levels
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
Throwing up
* Decreased appetite
If any of these side effects or any other side effects bother you or do not go away, contact your doctor or seek medical help. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Slow, shallow, or difficult breathing (signs of respiratory depression)
- Extreme drowsiness or difficulty waking up
- Severe dizziness or lightheadedness
- Bluish lips or fingernails
- Confusion or disorientation
- Severe constipation or abdominal pain
- Signs of allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems, such as 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, or rasagiline, as this may increase the risk of severely high blood pressure
If you are currently taking any of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions. Do not initiate, discontinue, or modify 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems, such as 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, or rasagiline, as this may increase the risk of severely high blood pressure
If you are currently taking any of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions. Do not initiate, discontinue, or modify 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 other tasks that require your full attention. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be cautious 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 it 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, contact your doctor immediately. Do not take more medication than ordered.
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 not working as well, contact your doctor. Do not take more than the prescribed dose.
Additionally, regular use of opioid medications like this one can result in dependence. If you need to reduce the dose or stop taking the medication, consult your doctor first, as sudden changes 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 can lead to unsafe and potentially fatal consequences.
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
If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has 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 other tasks that require your full attention. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be cautious 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 it 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, contact your doctor immediately. Do not take more medication than ordered.
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 not working as well, contact your doctor. Do not take more than the prescribed dose.
Additionally, regular use of opioid medications like this one can result in dependence. If you need to reduce the dose or stop taking the medication, consult your doctor first, as sudden changes 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 can lead to unsafe and potentially fatal consequences.
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
If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. Seek medical attention immediately if your baby appears excessively sleepy, limp, or has breathing difficulties.
Overdose Information
Overdose Symptoms:
- Pinpoint pupils
- Slowed or stopped breathing
- Extreme drowsiness or unresponsiveness
- Limp muscles
- Cold, clammy skin
- Bluish discoloration of lips and fingernails
- Loss of consciousness
- Coma
What to Do:
If you suspect an overdose, call 911 immediately. Administer naloxone if available and you are trained to do so. Stay with the person until emergency medical help arrives. Call 1-800-222-1222 (Poison Control Center) for additional guidance.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy (risk of serotonin syndrome or severe CNS depression)
Major Interactions
- Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
- CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole, itraconazole, ritonavir, grapefruit juice): Increased plasma concentrations of oxycodone, leading to increased opioid effects.
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): May decrease formation of oxymorphone, potentially reducing analgesic effect in some patients, but may increase oxycodone levels.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol, fentanyl, St. John's Wort): Risk of serotonin syndrome.
Moderate Interactions
- Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants): Increased risk of urinary retention and severe constipation.
- Diuretics: Opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
- Antihypertensives: May cause additive hypotensive effects.
Minor Interactions
- Not readily available for minor interactions with significant clinical impact.
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 of respiratory depression.
Timing: Prior to initiation of therapy.
Level of consciousness/sedation
Rationale: To assess baseline neurological status.
Timing: Prior to initiation of therapy.
Renal and hepatic function tests (e.g., BUN, creatinine, LFTs)
Rationale: To identify potential need for dose adjustment due to impaired drug clearance.
Timing: Prior to initiation, especially in patients with known or suspected impairment.
Routine Monitoring
Pain assessment
Frequency: Regularly, typically every 4-6 hours or as needed, especially after dose adjustments.
Target: Acceptable pain control with minimal side effects.
Action Threshold: Uncontrolled pain or excessive side effects warrant dose adjustment or re-evaluation.
Respiratory rate and depth
Frequency: Regularly, especially during initiation and dose titration (e.g., every 1-2 hours initially, then every 4-6 hours).
Target: >10-12 breaths/minute, regular rhythm.
Action Threshold: <10 breaths/minute, shallow breathing, or signs of hypoventilation (e.g., cyanosis, somnolence) 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.
Target: Alert or mildly drowsy, easily aroused.
Action Threshold: Moderately to excessively sedated, difficult to arouse, or unarousable requires immediate intervention.
Bowel function (frequency of bowel movements, consistency)
Frequency: Daily
Target: Regular bowel movements (e.g., every 1-2 days).
Action Threshold: Constipation (e.g., no bowel movement for >3 days, straining, hard stools) requires initiation or adjustment of bowel regimen.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation or somnolence
- Dizziness or lightheadedness
- Nausea and vomiting
- Constipation
- Pruritus (itching)
- Urinary retention
- Signs of opioid withdrawal (if abruptly discontinued)
Special Patient Groups
Pregnancy
Prolonged use of oxycodone during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated. Use only if the potential benefit justifies the potential risk to the fetus. Advise pregnant patients of the risk of NOWS.
Trimester-Specific Risks:
First Trimester:
Potential for congenital malformations (limited data, but generally avoided if possible).
Second Trimester:
Risk of NOWS increases with prolonged use.
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. Monitor infants for signs of sedation, respiratory depression, poor feeding, and poor weight gain. If opioid use is necessary, use the lowest effective dose for the shortest duration. Consider alternative analgesics if possible.
Infant Risk:
Moderate risk (L3). Potential for infant sedation, respiratory depression, and withdrawal symptoms if drug is discontinued in mother.
Pediatric Use
This concentrated solution is generally not recommended for opioid-naive pediatric patients due to the high risk of overdose. Use in opioid-tolerant children should only be under the direct supervision of a pain specialist with extreme caution and precise dose calculation.
Geriatric Use
Elderly patients may be more sensitive to the effects of oxycodone, particularly respiratory depression and sedation. Start with lower doses and titrate slowly. Monitor closely for adverse effects, especially respiratory and CNS depression, and constipation.
Clinical Information
Clinical Pearls
- This 100mg/5ml (20mg/ml) oxycodone solution is highly concentrated and carries a significant risk of overdose if not measured precisely. Always use an oral syringe calibrated in milliliters.
- It is primarily intended for opioid-tolerant patients with severe, chronic pain, often in palliative care settings, where high doses or small volumes are required.
- Never use this concentration for opioid-naive patients.
- Educate patients and caregivers thoroughly on proper measurement, storage, and the signs of overdose.
- Concomitant use with benzodiazepines or other CNS depressants significantly increases the risk of respiratory depression, coma, and death. Avoid if possible, or use with extreme caution and reduced dosages.
- Opioid-induced constipation is a common and persistent side effect; proactive bowel regimens are essential.
- Monitor for signs of addiction, abuse, and misuse throughout therapy.
Alternative Therapies
- Other strong opioid analgesics (e.g., morphine, hydromorphone, fentanyl)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain or as adjuncts
- Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants) for neuropathic pain
- Regional anesthesia or nerve blocks
- Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500+ per 30ml bottle (100mg/5ml)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization)
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. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken.
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 details about the medication, including the dose and timing of administration, to ensure you receive appropriate 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. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken.
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 details about the medication, including the dose and timing of administration, to ensure you receive appropriate treatment.