Endocet 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; Non-opioid analgesic
Pharmacologic Class
Opioid agonist; Para-aminophenol derivative
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Schedule II
Overview
What is this medicine?
Endocet is a prescription medicine that combines two pain relievers: oxycodone, which is a strong opioid pain medicine, and acetaminophen, a common pain and fever reducer. It is used to treat moderate to severe pain.
How to Use This Medicine
Taking Your Medication Correctly
To ensure safe and effective use of this medication, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the prescribed dosage and administration guidelines.
Take this medication orally only, with or without food. If you experience 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 respiratory distress and overdose, which can be fatal.
Adhere to the prescribed dosage and frequency. Do not exceed the recommended dose, take it more frequently, or use it for a longer period than directed. Doing so may increase the risk of severe side effects.
Avoid taking this medication with other strong pain medications or using a pain patch without consulting your doctor first.
* 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 additional doses without consulting your doctor.
Important Interactions and Precautions
This medication may affect certain laboratory test results. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
Storage and Disposal
Store this medication at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms. Store it in a secure location, out of reach of children and pets, and inaccessible to others. Consider using a locked box or area to safeguard the medication.
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. You may also want to explore local drug take-back programs.
Missed Doses
If you miss a dose, take it as soon as you remember. However, if it 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 the same time or take extra doses. Since this medication is often taken as needed, do not take it more frequently than directed by your doctor.
To ensure safe and effective use of this medication, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the prescribed dosage and administration guidelines.
Take this medication orally only, with or without food. If you experience 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 respiratory distress and overdose, which can be fatal.
Adhere to the prescribed dosage and frequency. Do not exceed the recommended dose, take it more frequently, or use it for a longer period than directed. Doing so may increase the risk of severe side effects.
Avoid taking this medication with other strong pain medications or using a pain patch without consulting your doctor first.
* 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 additional doses without consulting your doctor.
Important Interactions and Precautions
This medication may affect certain laboratory test results. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
Storage and Disposal
Store this medication at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms. Store it in a secure location, out of reach of children and pets, and inaccessible to others. Consider using a locked box or area to safeguard the medication.
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. You may also want to explore local drug take-back programs.
Missed Doses
If you miss a dose, take it as soon as you remember. However, if it 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 the same time or take 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 liver damage and severe drowsiness.
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
- To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and consider using a stool softener or laxative as directed by your doctor.
- Store this medication securely in a locked cabinet, out of reach of children and pets, to prevent accidental ingestion.
- Do not share this medication with anyone else, as it can be dangerous and is against the law.
- Dispose of unused medication properly, often by flushing down the toilet or mixing with undesirable substances (e.g., coffee grounds) and placing in a sealed bag in the trash, as per FDA guidelines.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
1 tablet (5 mg oxycodone / 325 mg acetaminophen) orally every 4 to 6 hours as needed for pain.
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
maximumDailyDose:
Do not exceed 12 tablets (60 mg oxycodone / 3900 mg acetaminophen) in 24 hours. For chronic use, limit acetaminophen to 3000 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (generally not recommended due to fixed combination and opioid risks)
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; consider dose reduction.
Moderate:
Use with caution; consider dose reduction and extended dosing interval.
Severe:
Avoid or use with extreme caution; significant dose reduction and extended interval required. Monitor closely for accumulation.
Dialysis:
Oxycodone is not significantly removed by dialysis. Acetaminophen metabolites are dialyzable. Use with caution, monitor for adverse effects.
Hepatic Impairment:
Mild:
Use with caution; consider dose reduction, especially for acetaminophen component.
Moderate:
Avoid or use with extreme caution; significant dose reduction required for acetaminophen. Monitor liver function closely.
Severe:
Contraindicated due to risk of acetaminophen hepatotoxicity.
Confidence:
Medium
Pharmacology
Mechanism of Action
Oxycodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, producing analgesia by binding to opioid receptors in the central nervous system (CNS). Acetaminophen produces analgesia by inhibiting prostaglandin synthesis, primarily in the CNS, and possibly through other central mechanisms.
Pharmacokinetics
Absorption:
Bioavailability:
Oxycodone: ~60-87%; Acetaminophen: ~60-90%
Tmax:
Oxycodone: 1-2 hours; Acetaminophen: 0.5-2 hours
FoodEffect:
Food may delay Tmax but does not significantly affect the extent of absorption for either component.
Distribution:
Vd:
Oxycodone: ~2.6 L/kg; Acetaminophen: ~0.95 L/kg
ProteinBinding:
Oxycodone: ~45%; Acetaminophen: ~10-25%
CnssPenetration:
Yes
Elimination:
HalfLife:
Oxycodone: ~3-4 hours; Acetaminophen: ~2-3 hours
Clearance:
Oxycodone: ~0.8 L/min; Acetaminophen: ~5 mL/min/kg
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Oxycodone: ~8-14%; Acetaminophen: <5%
Pharmacodynamics
OnsetOfAction:
10-30 minutes
PeakEffect:
Oxycodone: 1-2 hours; Acetaminophen: 0.5-2 hours
DurationOfAction:
4-6 hours
Safety & Warnings
BLACK BOX WARNING
Addiction, Abuse, and Misuse: Oxycodone/acetaminophen 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 receiving oxycodone/acetaminophen for development of these behaviors and conditions.
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 oxycodone/acetaminophen, especially by children, can result in a fatal overdose of oxycodone.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of oxycodone/acetaminophen 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.
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. In addition, discontinuation of a concomitantly used CYP3A4 inducer may result in increased oxycodone plasma concentrations. Monitor patients receiving oxycodone/acetaminophen and any CYP3A4 inhibitor or inducer.
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.
Hepatotoxicity: Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant or death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg per day, and often involve more than one acetaminophen-containing product.
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 oxycodone/acetaminophen, especially by children, can result in a fatal overdose of oxycodone.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of oxycodone/acetaminophen 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.
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. In addition, discontinuation of a concomitantly used CYP3A4 inducer may result in increased oxycodone plasma concentrations. Monitor patients receiving oxycodone/acetaminophen and any CYP3A4 inhibitor or inducer.
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.
Hepatotoxicity: Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant or death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg per day, and often involve more than one acetaminophen-containing product.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects when 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 liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of low blood sugar, such as:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Urination problems, such as:
+ Inability to pass urine
+ Changes in urine output
Severe dizziness or fainting
Breathing difficulties, including:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Confusion
Hallucinations (seeing or hearing things that are not there)
Mood changes
Severe constipation or stomach pain, which may be signs of a severe bowel problem
Abnormal heartbeat, including:
+ Fast heartbeat
+ Slow heartbeat
+ Irregular heartbeat
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Seizures
Chest pain
Difficulty walking
Severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Adrenal gland problems, which may cause:
+ Extreme tiredness or weakness
+ Fainting
+ Severe dizziness
+ Upset stomach
+ Vomiting
+ Decreased appetite
Other Possible Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Constipation
Stomach pain
Dizziness
Drowsiness
Tiredness
Weakness
Headache
Upset stomach
Vomiting
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects when 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 liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of low blood sugar, such as:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Urination problems, such as:
+ Inability to pass urine
+ Changes in urine output
Severe dizziness or fainting
Breathing difficulties, including:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Confusion
Hallucinations (seeing or hearing things that are not there)
Mood changes
Severe constipation or stomach pain, which may be signs of a severe bowel problem
Abnormal heartbeat, including:
+ Fast heartbeat
+ Slow heartbeat
+ Irregular heartbeat
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Seizures
Chest pain
Difficulty walking
Severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), which can cause:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Adrenal gland problems, which may cause:
+ Extreme tiredness or weakness
+ Fainting
+ Severe dizziness
+ Upset stomach
+ Vomiting
+ Decreased appetite
Other Possible Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
Constipation
Stomach pain
Dizziness
Drowsiness
Tiredness
Weakness
Headache
Upset stomach
Vomiting
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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:
- Difficulty breathing or very slow/shallow breathing
- Extreme drowsiness, dizziness, or feeling like you might pass out
- Confusion or unusual thoughts/behavior
- Pinpoint pupils
- Yellowing of your skin or eyes (jaundice)
- Dark urine or clay-colored stools
- Severe stomach pain, nausea, or vomiting
- Signs of an allergic reaction (hives, difficulty breathing, swelling of your face/lips/tongue/throat)
- Seizures
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
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
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
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, as well as any existing health problems. Before starting, stopping, or changing the dosage of any medication, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
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
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
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, as well as any existing health problems. Before starting, stopping, or changing the dosage of any medication, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
Precautions & Cautions
Important Warnings and Cautions
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position. 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 required to achieve the same effect. If you experience a decrease in the medication's effectiveness, consult your doctor. Do not exceed 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. Follow your doctor's instructions carefully and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
Interactions with Other Substances
Do not consume alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal effects.
Acetaminophen Precautions
Avoid taking other products that contain acetaminophen, and carefully check the labels of all medications. Exceeding the recommended daily dose of acetaminophen can cause liver damage. Follow the instructions exactly, and do not take more than 4,000 mg of acetaminophen per day unless directed by your doctor. Some individuals, such as those with liver problems or children, may require lower doses. If you are unsure about the safe dose or have taken too much acetaminophen, consult your doctor or pharmacist immediately, even if you feel well.
Serotonin Syndrome Warning
A severe and potentially life-threatening condition called serotonin syndrome can occur if you take this medication with certain other drugs. Seek medical attention immediately if you experience agitation, balance changes, 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 can lead to decreased sex hormone levels. If you experience a decrease in libido, fertility problems, irregular menstrual periods, or ejaculation difficulties, consult your doctor.
Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor.
Special Considerations
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.
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position. 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 required to achieve the same effect. If you experience a decrease in the medication's effectiveness, consult your doctor. Do not exceed 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. Follow your doctor's instructions carefully and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.
Interactions with Other Substances
Do not consume alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal effects.
Acetaminophen Precautions
Avoid taking other products that contain acetaminophen, and carefully check the labels of all medications. Exceeding the recommended daily dose of acetaminophen can cause liver damage. Follow the instructions exactly, and do not take more than 4,000 mg of acetaminophen per day unless directed by your doctor. Some individuals, such as those with liver problems or children, may require lower doses. If you are unsure about the safe dose or have taken too much acetaminophen, consult your doctor or pharmacist immediately, even if you feel well.
Serotonin Syndrome Warning
A severe and potentially life-threatening condition called serotonin syndrome can occur if you take this medication with certain other drugs. Seek medical attention immediately if you experience agitation, balance changes, 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 can lead to decreased sex hormone levels. If you experience a decrease in libido, fertility problems, irregular menstrual periods, or ejaculation difficulties, consult your doctor.
Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor.
Special Considerations
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:
- Extreme drowsiness or inability to wake up
- Slow, shallow, or stopped breathing
- Pinpoint pupils
- Cold, clammy skin
- Limp muscles
- Bluish lips or fingernails
- Unresponsiveness or coma
- Signs of liver failure (jaundice, severe abdominal pain, confusion, dark urine)
What to Do:
If you suspect an overdose, seek immediate emergency medical attention. Call 911 or your local emergency number. If naloxone (Narcan) is available, administer it if the person is unresponsive or has severe respiratory depression. Call 1-800-222-1222 for Poison Control Center assistance.
Drug Interactions
Contraindicated Interactions
- Significant respiratory depression
- Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Known or suspected paralytic ileus
- Known hypersensitivity to oxycodone, acetaminophen, or any component of the product
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., macrolide antibiotics, azole-antifungals, protease inhibitors): Increased oxycodone plasma concentrations, leading to increased opioid effects.
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine): May decrease formation of oxymorphone, potentially reducing analgesic effect of oxycodone.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans): Risk of serotonin syndrome.
- Anticholinergic drugs: Increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
- Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol): May reduce the analgesic effect of oxycodone and/or precipitate withdrawal symptoms.
Moderate Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): Decreased oxycodone plasma concentrations, potentially reducing efficacy.
- CYP2D6 inducers (e.g., rifampin, dexamethasone): May increase formation of oxymorphone, potentially increasing opioid effects.
- Drugs affecting gastric emptying (e.g., metoclopramide, anticholinergics): May alter absorption of oxycodone.
- Warfarin: Acetaminophen may increase the anticoagulant effect of warfarin, requiring INR monitoring.
Minor Interactions
- Not many specific minor interactions beyond general drug interactions.
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, oxygen saturation
Rationale: To assess baseline respiratory function due to risk of opioid-induced respiratory depression.
Timing: Prior to initiation of therapy.
Bowel function
Rationale: To assess baseline and anticipate opioid-induced constipation.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess baseline hepatic function, especially if patient has pre-existing liver disease or risk factors for hepatotoxicity.
Timing: Prior to initiation of therapy, if indicated.
Routine Monitoring
Pain assessment
Frequency: Regularly, as clinically indicated (e.g., daily, weekly, or at each visit)
Target: Acceptable pain control with minimal adverse effects.
Action Threshold: Inadequate pain control or worsening pain requires re-evaluation of dose or therapy.
Sedation level (e.g., Pasero Opioid-Induced Sedation Scale)
Frequency: Regularly, especially during dose titration or initiation.
Target: Alert or mildly drowsy, easily aroused.
Action Threshold: Excessive sedation (e.g., difficult to arouse, somnolent) requires immediate intervention (e.g., dose reduction, naloxone).
Respiratory rate and depth, oxygen saturation
Frequency: Regularly, especially during dose titration or initiation.
Target: Normal for patient, no signs of respiratory distress.
Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or decreasing oxygen saturation requires immediate intervention.
Bowel function (frequency, consistency)
Frequency: Daily
Target: Regular bowel movements (e.g., every 1-2 days).
Action Threshold: Constipation (e.g., no bowel movement for >3 days) requires intervention (e.g., laxatives, stool softeners).
Signs of opioid abuse, misuse, or addiction
Frequency: Regularly, at each visit
Target: No signs of aberrant drug-taking behavior.
Action Threshold: Suspicion of abuse/misuse requires further assessment and intervention (e.g., urine drug screen, referral to addiction specialist).
Liver function tests (ALT, AST, bilirubin)
Frequency: Periodically, for long-term or high-dose acetaminophen use, or if liver impairment is suspected.
Target: Within normal limits.
Action Threshold: Significant elevation requires dose reduction or discontinuation.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation or drowsiness
- Confusion or disorientation
- Pinpoint pupils
- Nausea and vomiting
- Constipation
- Urinary retention
- Signs of liver injury (yellowing of skin/eyes, dark urine, severe abdominal pain, fatigue)
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended due to risks to the fetus. Prolonged use of oxycodone during pregnancy can lead to neonatal opioid withdrawal syndrome (NOWS), which can be life-threatening. Acetaminophen is generally considered safe at recommended doses during pregnancy, but high doses or overdose can cause fetal liver damage.
Trimester-Specific Risks:
First Trimester:
Limited data on specific risks of oxycodone in the first trimester; potential for congenital malformations with opioid exposure.
Second Trimester:
Risk of NOWS increases with prolonged opioid exposure.
Third Trimester:
High risk of neonatal opioid withdrawal syndrome (NOWS) if used chronically. Risk of respiratory depression in the neonate if used close to delivery.
Lactation
Both oxycodone and acetaminophen are excreted into breast milk. While acetaminophen is generally considered compatible with breastfeeding at usual doses, oxycodone can cause sedation, respiratory depression, and poor feeding in the infant. Use with caution, monitor the infant closely for adverse effects, and consider alternative analgesics if possible.
Infant Risk:
Risk of sedation, respiratory depression, poor feeding, and developmental delay in breastfed infants exposed to oxycodone. Acetaminophen risk is low at therapeutic doses.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Due to the fixed combination and the risks associated with opioid use, this product is generally not recommended for use in children.
Geriatric Use
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. Increased risk of falls.
Clinical Information
Clinical Pearls
- This combination product carries significant risks due to both the opioid (oxycodone) and acetaminophen components. Be mindful of the total daily dose of acetaminophen from all sources to avoid hepatotoxicity.
- Counsel patients extensively on the risks of addiction, abuse, and misuse, and on safe storage and disposal of the medication.
- Monitor for signs of respiratory depression, especially during initiation or dose escalation. Have naloxone readily available if appropriate.
- Opioid-induced constipation is common; proactively manage with bowel regimens.
- Avoid concomitant use with alcohol, benzodiazepines, or other CNS depressants due to additive respiratory depression and sedation.
- Patients who are ultra-rapid metabolizers of CYP2D6 may experience increased opioid effects due to increased conversion of oxycodone to oxymorphone.
Alternative Therapies
- Other opioid analgesics (e.g., morphine, hydromorphone, fentanyl) for severe pain.
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen alone) for mild to moderate pain.
- Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants) for neuropathic pain.
- Regional anesthesia or nerve blocks.
- 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 2 or Tier 3 (often requires prior authorization for brand or higher quantities)
General Drug Facts
If your symptoms or health problems do not improve or worsen, contact your doctor immediately. It is essential to use your prescribed medication responsibly: do not share it with others, and never take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract its effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When seeking help, be prepared to provide information about what was taken, the quantity, and the time of the incident.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help counteract its effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When seeking help, be prepared to provide information about what was taken, the quantity, and the time of the incident.