Endocet 2/5-325mg (oxycod/apap) Tab
WARNING: This drug has an opioid drug in it. Opioid drugs can put you at risk for drug use disorder. Misuse or abuse of this drug can lead to overdose and death. If you have questions, talk with your doctor.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.This drug has acetaminophen in it. Liver problems have happened with the use of acetaminophen. Sometimes, this has led to a liver transplant or death. Most of the time, liver problems happened in people taking more than 4,000 mg (milligrams) of acetaminophen in a day. People were also often taking more than 1 drug that had acetaminophen.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 and non-opioid analgesic combination
Pharmacologic Class
Opioid agonist (oxycodone); Para-aminophenol derivative (acetaminophen)
Pregnancy Category
Category C
FDA Approved
Jan 1999
DEA Schedule
Schedule II
Overview
What is this medicine?
This medication is a combination of two pain relievers: oxycodone, which is a strong opioid pain medicine, and acetaminophen, a common pain and fever reducer. It's used to treat moderate to severe pain. Because it contains an opioid, it carries risks of addiction, overdose, and serious breathing problems.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely.
Take this medication by mouth only, with or without food. If it causes stomach upset, take it with food to help minimize discomfort.
Do not inject or snort this medication, as this can lead to severe side effects, including breathing difficulties and overdose, which can be fatal.
Adhere to the prescribed dosage and frequency. Do not exceed the dose or take it more often or for a longer period than recommended by your doctor, as this may increase the risk of severe side effects.
Before taking this medication with other strong pain medications or using a pain patch, consult your doctor to ensure safe use.
If your pain worsens, you become more sensitive to pain, or you experience new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose.
Important Interactions and Precautions
This medication may affect certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
Storing and Disposing of Your Medication
Store this medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep this medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to prevent unauthorized use.
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 want to explore drug take-back programs in your area.
Missing a Dose
If you 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 extra doses. Since this medication is often taken 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 carefully. Read all the information provided to you and follow the instructions precisely.
Take this medication by mouth only, with or without food. If it causes stomach upset, take it with food to help minimize discomfort.
Do not inject or snort this medication, as this can lead to severe side effects, including breathing difficulties and overdose, which can be fatal.
Adhere to the prescribed dosage and frequency. Do not exceed the dose or take it more often or for a longer period than recommended by your doctor, as this may increase the risk of severe side effects.
Before taking this medication with other strong pain medications or using a pain patch, consult your doctor to ensure safe use.
If your pain worsens, you become more sensitive to pain, or you experience new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose.
Important Interactions and Precautions
This medication may affect certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
Storing and Disposing of Your Medication
Store this medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep this medication in a secure location where children cannot see or reach it, and where others cannot access it. Consider using a locked box or area to prevent unauthorized use.
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 want to explore drug take-back programs in your area.
Missing a Dose
If you 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 extra doses. Since this medication is often taken as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Do not drink alcohol while taking this medication, as it can increase the risk of serious side effects, including fatal overdose.
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
- Store this medication securely away from children and pets, preferably in a locked cabinet, to prevent accidental ingestion.
- Do not share this medication with anyone else, as it can be dangerous and is against the law.
- If you have been taking this medication regularly for a long time, do not stop suddenly without talking to your doctor, as this can cause withdrawal symptoms.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet (2.5 mg oxycodone / 325 mg acetaminophen) every 6 hours as needed for pain.
Dose Range:
1 - 6 mg
Condition-Specific Dosing:
maximumDailyDose:
Not to exceed 4000 mg acetaminophen per day (or 3000 mg in some guidelines/products) and 60 mg oxycodone per day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (safety and efficacy not established in pediatric patients under 18 years of age).
Adolescent:
Not established (safety and efficacy not established in pediatric patients under 18 years of age).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment for mild impairment, but monitor closely.
Moderate:
Use with caution; consider dose reduction and extended dosing intervals. Monitor for increased opioid effects and acetaminophen accumulation.
Severe:
Contraindicated or significantly reduced dose and extended intervals. Acetaminophen is dialyzable, but oxycodone is not significantly dialyzed.
Dialysis:
Use with extreme caution. Acetaminophen is removed by hemodialysis; oxycodone is not. Consider reduced doses and extended intervals.
Hepatic Impairment:
Mild:
Use with caution; consider dose reduction, especially for acetaminophen component. Max acetaminophen 2000 mg/day.
Moderate:
Contraindicated or significantly reduced dose and extended intervals due to risk of acetaminophen hepatotoxicity and increased oxycodone exposure.
Severe:
Contraindicated due to risk of precipitating hepatic encephalopathy and severe acetaminophen hepatotoxicity.
Confidence:
Medium
Pharmacology
Mechanism of Action
Oxycodone: A pure opioid agonist that binds to mu-opioid receptors in the central nervous system (CNS), producing analgesia, respiratory depression, euphoria, and physical dependence. Acetaminophen: A non-opioid analgesic that produces analgesia by inhibiting prostaglandin synthesis primarily in the CNS and possibly through other mechanisms (e.g., serotonergic pathways). It has weak anti-inflammatory effects.
Pharmacokinetics
Absorption:
Bioavailability:
Oxycodone: 60-87%; Acetaminophen: 60-90%
Tmax:
Oxycodone: 1-2 hours; Acetaminophen: 0.5-2 hours
FoodEffect:
Food may delay Tmax for both components but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
Oxycodone: 2.6 L/kg; Acetaminophen: 0.95 L/kg
ProteinBinding:
Oxycodone: 45%; Acetaminophen: 10-25%
CnssPenetration:
Yes (both)
Elimination:
HalfLife:
Oxycodone: 3.2 hours; Acetaminophen: 2-3 hours
Clearance:
Oxycodone: 0.8 L/min; Acetaminophen: 5 mL/min/kg
ExcretionRoute:
Renal (primarily metabolites)
Unchanged:
Oxycodone: 8-14%; Acetaminophen: <5%
Pharmacodynamics
OnsetOfAction:
10-30 minutes
PeakEffect:
1 hour
DurationOfAction:
3-6 hours
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.
Addiction, Abuse, and Misuse: Oxycodone and Acetaminophen Tablets expose 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 Oxycodone and Acetaminophen Tablets, and monitor all patients regularly for the development of these behaviors and conditions.
Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of Oxycodone and Acetaminophen Tablets or following a dose increase.
Accidental Ingestion: Accidental ingestion of even one dose of Oxycodone and Acetaminophen Tablets, especially by children, can result in a fatal overdose of oxycodone.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of Oxycodone and Acetaminophen Tablets 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 neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
CYP3A4 Interaction: The concomitant use of Oxycodone and Acetaminophen Tablets with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving Oxycodone and Acetaminophen Tablets and any CYP3A4 inhibitor or inducer.
Hepatotoxicity: Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (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 and Acetaminophen Tablets expose 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 Oxycodone and Acetaminophen Tablets, and monitor all patients regularly for the development of these behaviors and conditions.
Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of Oxycodone and Acetaminophen Tablets or following a dose increase.
Accidental Ingestion: Accidental ingestion of even one dose of Oxycodone and Acetaminophen Tablets, especially by children, can result in a fatal overdose of oxycodone.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of Oxycodone and Acetaminophen Tablets 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 neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
CYP3A4 Interaction: The concomitant use of Oxycodone and Acetaminophen Tablets with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving Oxycodone and Acetaminophen Tablets and any CYP3A4 inhibitor or inducer.
Hepatotoxicity: Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (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 Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be life-threatening.
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Signs of low blood sugar: dizziness, headache, feeling sleepy, feeling weak, shaking, fast heartbeat, confusion, hunger, or sweating.
Urination problems: inability to pass urine or changes in urine output.
Severe dizziness or fainting.
Breathing difficulties: trouble breathing, slow breathing, shallow breathing, or noisy breathing.
Sleep apnea (breathing problems during sleep).
Confusion, hallucinations (seeing or hearing things that are not there), or mood changes.
Severe constipation or stomach pain, which may indicate a severe bowel problem.
Abnormal heartbeat: fast, slow, or irregular heartbeat.
Fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak.
Seizures.
Chest pain.
Difficulty walking.
Severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis): red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in the mouth, throat, nose, or eyes. This condition can cause severe health problems and may be life-threatening.
Adrenal gland problems: if you experience extreme tiredness or weakness, fainting, severe dizziness, upset stomach, vomiting, or decreased appetite, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Constipation.
Stomach pain.
Dizziness, sleepiness, tiredness, or weakness.
Headache.
* Upset stomach or vomiting.
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be life-threatening.
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Signs of low blood sugar: dizziness, headache, feeling sleepy, feeling weak, shaking, fast heartbeat, confusion, hunger, or sweating.
Urination problems: inability to pass urine or changes in urine output.
Severe dizziness or fainting.
Breathing difficulties: trouble breathing, slow breathing, shallow breathing, or noisy breathing.
Sleep apnea (breathing problems during sleep).
Confusion, hallucinations (seeing or hearing things that are not there), or mood changes.
Severe constipation or stomach pain, which may indicate a severe bowel problem.
Abnormal heartbeat: fast, slow, or irregular heartbeat.
Fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak.
Seizures.
Chest pain.
Difficulty walking.
Severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis): red, swollen, blistered, or peeling skin (with or without fever), red or irritated eyes, or sores in the mouth, throat, nose, or eyes. This condition can cause severe health problems and may be life-threatening.
Adrenal gland problems: if you experience extreme tiredness or weakness, fainting, severe dizziness, upset stomach, vomiting, or decreased appetite, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Constipation.
Stomach pain.
Dizziness, sleepiness, tiredness, or weakness.
Headache.
* Upset stomach or vomiting.
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Slow or shallow breathing
- Extreme drowsiness or difficulty waking up
- Bluish lips or fingernails
- Severe dizziness or confusion
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Severe stomach pain
- Unusual tiredness or weakness
- Signs of an allergic reaction (rash, hives, swelling of face/lips/tongue/throat, difficulty 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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Respiratory problems, including asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage or narrowing
Recent use of specific medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of certain medications, such as buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins
Discuss your health problems and any potential interactions with this medication
* Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Respiratory problems, including asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage or narrowing
Recent use of specific medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of certain medications, such as buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins
Discuss your health problems and any potential interactions with this medication
* Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
Precautions & Cautions
Important 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.
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 needed 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. Additionally, regular use of opioid medications like this one can cause dependence. If you need to reduce the dose or stop taking this medication, consult your doctor to avoid withdrawal or other severe problems.
Interactions and Contraindications
Do not consume alcohol or products containing alcohol while taking this medication, as it may cause unsafe and potentially deadly effects. Also, avoid taking other products that contain acetaminophen, as excessive acetaminophen intake can lead to liver problems. Always check the labels of other medications carefully.
Acetaminophen Dosage
Follow the dosage instructions exactly, and do not take more than the recommended amount of acetaminophen per day. The maximum daily dose is 4,000 mg (milligrams) for some individuals, but people with liver problems or children may require lower doses. If you are unsure about the safe dosage for you, consult your doctor or pharmacist. If you have taken too much acetaminophen, contact your doctor immediately, even if you feel well.
Serotonin Syndrome
A severe and potentially life-threatening condition called serotonin syndrome can occur if you take this medication with certain other medications. Seek medical attention immediately if you experience symptoms such as agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
Hormonal Effects
Long-term use of opioid medications like this one may lead to lower sex hormone levels. If you experience a decrease in libido, fertility problems, irregular menstrual periods, or ejaculation problems, consult your doctor.
Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
Special Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. Seek medical help immediately if your baby appears overly 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.
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 needed 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. Additionally, regular use of opioid medications like this one can cause dependence. If you need to reduce the dose or stop taking this medication, consult your doctor to avoid withdrawal or other severe problems.
Interactions and Contraindications
Do not consume alcohol or products containing alcohol while taking this medication, as it may cause unsafe and potentially deadly effects. Also, avoid taking other products that contain acetaminophen, as excessive acetaminophen intake can lead to liver problems. Always check the labels of other medications carefully.
Acetaminophen Dosage
Follow the dosage instructions exactly, and do not take more than the recommended amount of acetaminophen per day. The maximum daily dose is 4,000 mg (milligrams) for some individuals, but people with liver problems or children may require lower doses. If you are unsure about the safe dosage for you, consult your doctor or pharmacist. If you have taken too much acetaminophen, contact your doctor immediately, even if you feel well.
Serotonin Syndrome
A severe and potentially life-threatening condition called serotonin syndrome can occur if you take this medication with certain other medications. Seek medical attention immediately if you experience symptoms such as agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.
Hormonal Effects
Long-term use of opioid medications like this one may lead to lower sex hormone levels. If you experience a decrease in libido, fertility problems, irregular menstrual periods, or ejaculation problems, consult your doctor.
Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.
Special Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. Seek medical help immediately if your baby appears overly sleepy, limp, or has breathing difficulties.
Overdose Information
Overdose Symptoms:
- Pinpoint pupils
- Extreme drowsiness or loss of consciousness
- Slow, shallow, or stopped breathing
- Cold, clammy skin
- Limp muscles
- Bluish discoloration of lips and fingernails
- Nausea and vomiting (acetaminophen overdose)
- Abdominal pain (acetaminophen overdose)
What to Do:
Seek immediate emergency medical attention. Call 911 or your local emergency number. For suspected overdose, call Poison Control at 1-800-222-1222. Naloxone may be administered for opioid overdose. Acetylcysteine (NAC) may be administered for acetaminophen overdose.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (within 14 days of oxycodone)
- Severe respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected paralytic ileus
- Severe hepatic impairment (due to acetaminophen)
Major Interactions
- CNS depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants): Increased risk of respiratory depression, profound sedation, coma, and death.
- CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole, ritonavir): Increased oxycodone plasma concentrations, leading to increased opioid effects.
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): Decreased oxycodone plasma concentrations, leading to reduced efficacy.
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): May decrease formation of oxymorphone, potentially reducing analgesic effect.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans): Increased risk of serotonin syndrome.
- Mixed agonist/antagonist and partial agonist opioids (e.g., buprenorphine, nalbuphine, pentazocine): May precipitate opioid withdrawal.
- Anticholinergics: Increased risk of urinary retention and/or severe constipation.
Moderate Interactions
- Other hepatotoxic drugs: Increased risk of acetaminophen-induced liver injury.
- Warfarin: Acetaminophen may increase INR; monitor coagulation parameters.
- Loop diuretics: Opioids may reduce the diuretic effect.
Minor Interactions
- Not specifically listed as minor, but general caution with any drug affecting CNS or liver.
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 risk of respiratory depression.
Timing: Prior to initiation of therapy
Level of consciousness/sedation
Rationale: To assess baseline neurological status and risk of excessive sedation.
Timing: Prior to initiation of therapy
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess baseline hepatic function due to acetaminophen component, especially in patients with pre-existing liver disease or risk factors.
Timing: Prior to initiation of therapy (if risk factors present)
Renal function (BUN, creatinine)
Rationale: To assess baseline renal function, as both drugs are renally eliminated.
Timing: Prior to initiation of therapy (if risk factors present)
Routine Monitoring
Pain assessment
Frequency: Regularly, as needed, or at each clinical encounter
Target: Acceptable pain level as defined by patient and clinician
Action Threshold: Uncontrolled pain, requiring dose adjustment or alternative therapy
Respiratory rate and depth
Frequency: Periodically, especially during initiation or dose escalation
Target: Normal for patient (e.g., 12-20 breaths/min)
Action Threshold: <10 breaths/min or shallow breathing
Level of consciousness/sedation (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Periodically, especially during initiation or dose escalation
Target: Alert or mildly drowsy, easily aroused
Action Threshold: Difficult to arouse, somnolent, or unarousable
Bowel function (constipation)
Frequency: Regularly
Target: Regular bowel movements
Action Threshold: No bowel movement for >3 days, severe straining, abdominal discomfort
Signs/symptoms of liver injury (e.g., jaundice, dark urine, abdominal pain)
Frequency: Periodically, especially with chronic use or high doses of acetaminophen
Target: Absence of symptoms
Action Threshold: Presence of symptoms, requiring immediate investigation
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation/drowsiness
- Dizziness
- Nausea and vomiting
- Constipation
- Pruritus (itching)
- Signs of liver injury (yellowing skin/eyes, dark urine, severe abdominal pain, unusual tiredness)
- Signs of allergic reaction (rash, swelling, difficulty breathing)
- Signs of opioid withdrawal (if abruptly discontinued after prolonged use)
Special Patient Groups
Pregnancy
Category C. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for congenital malformations (cardiac defects, neural tube defects, gastroschisis) with opioid exposure, though data are mixed. Acetaminophen is generally considered safe.
Second Trimester:
Risk of NOWS increases with prolonged use. No specific major risks identified for acetaminophen.
Third Trimester:
High risk of NOWS with prolonged use. Risk of respiratory depression in the neonate if administered close to delivery. Acetaminophen generally considered safe.
Lactation
L3 (Moderate risk). Both oxycodone and acetaminophen are excreted into breast milk. Monitor infants for signs of sedation, respiratory depression, poor feeding, and withdrawal symptoms. Acetaminophen is generally considered safe for breastfeeding infants at usual doses. Oxycodone should be used with caution, and the lowest effective dose for the shortest duration should be considered.
Infant Risk:
Risk of sedation, respiratory depression, and withdrawal in breastfed infants exposed to oxycodone. Acetaminophen generally low risk.
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 18 years of age. Not recommended for use in this population due to the risks of opioid analgesics and the potential for accidental overdose.
Geriatric Use
Use with caution. Elderly patients may be more sensitive to the analgesic and adverse effects of opioids, including respiratory depression, sedation, and constipation. Start with lower doses and titrate slowly. Monitor renal and hepatic function closely.
Clinical Information
Clinical Pearls
- Due to the acetaminophen component, ensure patients are not taking other acetaminophen-containing products to avoid exceeding the maximum daily dose (4000 mg, or 3000 mg in some clinical settings/products).
- Educate patients on the serious risks of addiction, abuse, and misuse, and the importance of safe storage and disposal.
- Monitor for signs of respiratory depression, especially during initiation or dose escalation, and advise patients on when to seek emergency care.
- Counsel patients on the risks of concomitant use with alcohol, benzodiazepines, or other CNS depressants.
- For chronic pain management, consider non-opioid alternatives or lower-dose opioid regimens. If long-term opioid therapy is necessary, implement a comprehensive pain management plan including risk mitigation strategies.
- Taper dose gradually when discontinuing after prolonged use to prevent opioid withdrawal symptoms.
Alternative Therapies
- NSAIDs (e.g., ibuprofen, naproxen)
- Other non-opioid analgesics (e.g., celecoxib)
- Other opioid analgesics (e.g., morphine, hydromorphone, fentanyl) for severe pain, used alone
- Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants) for neuropathic pain
- Non-pharmacological therapies (e.g., physical therapy, acupuncture, massage, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
$15 - $50 per 30 tablets (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic); Tier 3 or higher (brand)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. 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 with 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 the availability and use of naloxone with your doctor or pharmacist. If an overdose is suspected, 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, have the following information readily available: the name of the medication, the dose taken, and the time of ingestion.
This medication is accompanied by a Medication Guide, which provides crucial information about its use. 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 with 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 the availability and use of naloxone with your doctor or pharmacist. If an overdose is suspected, 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, have the following information readily available: the name of the medication, the dose taken, and the time of ingestion.