Hydrocodone/acetaminophen 7.5-300 T
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.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 (Hydrocodone), Para-aminophenol derivative (Acetaminophen)
Pregnancy Category
Category C (D if used for prolonged periods or at high doses near term)
FDA Approved
Mar 1982
DEA Schedule
Schedule II
Overview
What is this medicine?
This medication is a combination of two pain relievers: hydrocodone, which is an opioid, and acetaminophen, a non-opioid pain reliever. It's used to treat moderate to moderately severe pain. The hydrocodone works in your brain to change how your body feels and responds to pain, while acetaminophen helps reduce pain and fever.
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 respiratory problems and overdose, which can be fatal.
Adhere to the prescribed dosage and frequency. Do not take more than your doctor instructed, and do not take it more often or for a longer period than recommended. Exceeding the prescribed dosage can 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 additional doses beyond what is prescribed.
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.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding storage in a bathroom.
Keep this medication in a secure location, out of the reach of children and pets, and inaccessible to others. Consider using a locked box or area to ensure safety.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. Consult your pharmacist for guidance on the best disposal method, and explore local drug take-back programs.
Missing a Dose
If you take this medication on a regular schedule:
Take a missed dose as soon as you remember.
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 your doctor advises.
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 respiratory problems and overdose, which can be fatal.
Adhere to the prescribed dosage and frequency. Do not take more than your doctor instructed, and do not take it more often or for a longer period than recommended. Exceeding the prescribed dosage can 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 additional doses beyond what is prescribed.
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.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding storage in a bathroom.
Keep this medication in a secure location, out of the reach of children and pets, and inaccessible to others. Consider using a locked box or area to ensure safety.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. Consult your pharmacist for guidance on the best disposal method, and explore local drug take-back programs.
Missing a Dose
If you take this medication on a regular schedule:
Take a missed dose as soon as you remember.
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 your doctor advises.
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, which is a common side effect, drink plenty of fluids, eat fiber-rich foods, and consider using a stool softener or laxative as recommended by your doctor.
- Store this medication securely out of reach of children and pets, as accidental ingestion can be fatal.
- Do not share this medication with anyone else, even if they have similar symptoms, as it can be dangerous and is illegal.
Available Forms & Alternatives
Available Strengths:
- Hydrocodone/acetaminophen 5-325 Tb
- Hydrocod/acetaminophen 7.5-325/15ml
- Hydrocodone/acetaminophen 10-325 T
- Hydrocodone/acetaminophen 7.5-325 T
- Hydrocodone/acetaminophen 5-300 Tb
- Hydrocodone/acetaminophen 7.5-300 T
- Hydrocodone/acetaminophen 10-300 T
- Hydrocod/acetaminophen 7.5-325 Sol
- Hydrocodone/acetaminophen5-300 Tb
- Hydrocod/acetaminophen 10-325/15ml
- Hydroco/apap 2.5-325mg Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet (7.5 mg hydrocodone / 300 mg acetaminophen) orally every 4 to 6 hours as needed for pain.
Dose Range:
7.5 - 60 mg
Condition-Specific Dosing:
maximumDailyDose:
Maximum 6 tablets (45 mg hydrocodone / 1800 mg acetaminophen) per 24 hours. Total acetaminophen should not exceed 4000 mg (or 3000 mg for some formulations/patients) in 24 hours from all sources.
Pediatric Dosing
Neonatal:
Not established (Contraindicated due to risk of respiratory depression and death)
Infant:
Not established (Contraindicated due to risk of respiratory depression and death)
Child:
Not established (Contraindicated in children younger than 12 years of age due to risk of respiratory depression and death)
Adolescent:
Not recommended for routine use; if used, extreme caution and lowest effective dose for shortest duration. Contraindicated in adolescents 12 to 18 years of age who are obese or have conditions such as obstructive sleep apnea or severe pulmonary disease due to increased risk of respiratory depression.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; monitor for increased opioid effects.
Moderate:
Use with caution; consider dose reduction and extended dosing interval. Monitor closely for increased opioid effects and acetaminophen accumulation.
Severe:
Contraindicated or significant dose reduction and extended dosing interval required. Monitor closely for increased opioid effects and acetaminophen accumulation. Acetaminophen metabolites can accumulate.
Dialysis:
Hydrocodone is not significantly removed by dialysis. Acetaminophen is dialyzable. Use with caution; consider dose reduction and extended dosing interval. Monitor for opioid effects.
Hepatic Impairment:
Mild:
Use with caution; monitor for increased opioid effects and signs of hepatotoxicity.
Moderate:
Significant dose reduction required for both components. Acetaminophen maximum daily dose should be reduced (e.g., to 2000 mg/day or less). Monitor closely for increased opioid effects and hepatotoxicity.
Severe:
Contraindicated due to risk of precipitating hepatic encephalopathy and severe hepatotoxicity from acetaminophen.
Pharmacology
Mechanism of Action
Hydrocodone is a semisynthetic opioid analgesic that acts as a full agonist at the mu-opioid receptors in the central nervous system (CNS), producing analgesia, sedation, and respiratory depression. Its analgesic effect is mediated by decreasing the perception of pain and the emotional response to pain. Acetaminophen is a non-opioid analgesic and antipyretic. Its exact mechanism of action is not fully understood but is believed to involve central inhibition of prostaglandin synthesis (possibly via COX-3 or other central mechanisms) and modulation of serotonergic descending pathways, leading to pain relief and fever reduction.
Pharmacokinetics
Absorption:
Bioavailability:
Hydrocodone: ~25-50% (oral); Acetaminophen: ~60-90% (oral)
Tmax:
Hydrocodone: ~1.3 hours; Acetaminophen: ~0.5-2 hours
FoodEffect:
Food may slightly delay Tmax but does not significantly affect the extent of absorption for either component.
Distribution:
Vd:
Hydrocodone: ~2.2-4.5 L/kg; Acetaminophen: ~0.95 L/kg
ProteinBinding:
Hydrocodone: ~20-50%; Acetaminophen: ~10-25%
CnssPenetration:
Yes (both components cross the blood-brain barrier)
Elimination:
HalfLife:
Hydrocodone: ~3.8 hours; Acetaminophen: ~1-4 hours
Clearance:
Not available (variable)
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Hydrocodone: <10%; Acetaminophen: <5%
Pharmacodynamics
OnsetOfAction:
Oral: ~10-30 minutes
PeakEffect:
Oral: ~30-60 minutes
DurationOfAction:
Oral: ~4-6 hours
Confidence:
High
Safety & Warnings
BLACK BOX WARNING
RISK OF ADDICTION, ABUSE, AND MISUSE: Hydrocodone/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 hydrocodone/acetaminophen, and monitor all patients regularly for the development of these behaviors and conditions.
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (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. Under the requirements of the REMS, drug companies must make available to healthcare professionals opioid analgesic REMS-compliant education programs and ensure that healthcare professionals have access to these programs.
RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of hydrocodone/acetaminophen or following a dose increase.
ACCIDENTAL INGESTION: Accidental ingestion of even one dose of hydrocodone/acetaminophen, especially by children, can result in a fatal overdose of hydrocodone.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of hydrocodone/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 (or discontinuation of CYP3A4 inducers) can result in increased hydrocodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. Concomitant use with CYP3A4 inducers (or discontinuation of CYP3A4 inhibitors) can result in decreased hydrocodone plasma concentrations, which could decrease efficacy and lead to symptoms of opioid withdrawal. 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.
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 mg per day, and often involve more than one acetaminophen-containing product.
OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (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. Under the requirements of the REMS, drug companies must make available to healthcare professionals opioid analgesic REMS-compliant education programs and ensure that healthcare professionals have access to these programs.
RESPIRATORY DEPRESSION: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation of hydrocodone/acetaminophen or following a dose increase.
ACCIDENTAL INGESTION: Accidental ingestion of even one dose of hydrocodone/acetaminophen, especially by children, can result in a fatal overdose of hydrocodone.
NEONATAL OPIOID WITHDRAWAL SYNDROME: Prolonged use of hydrocodone/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 (or discontinuation of CYP3A4 inducers) can result in increased hydrocodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. Concomitant use with CYP3A4 inducers (or discontinuation of CYP3A4 inhibitors) can result in decreased hydrocodone plasma concentrations, which could decrease efficacy and lead to symptoms of opioid withdrawal. 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.
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 mg per day, and often involve more than one acetaminophen-containing product.
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 low blood sugar: dizziness, headache, feeling sleepy, feeling weak, shaking, fast heartbeat, confusion, hunger, or sweating.
Severe dizziness or fainting.
Clammy skin.
Excessive sweating.
Confusion.
Difficulty walking.
Severe constipation or stomach pain, which may indicate a severe bowel problem.
Hearing loss or changes in hearing.
Chest pain or pressure.
Abnormal heartbeat (fast or slow).
Breathing difficulties, including slow or shallow breathing, or noisy breathing.
Sleep apnea (breathing problems during sleep).
Fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak.
Mood changes.
Difficulty urinating.
Changes in urine output.
Vision changes.
Seizures.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe skin reactions, which can be life-threatening. Seek medical help immediately if you experience red, swollen, blistered, or peeling skin, skin irritation (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
Serotonin syndrome, a potentially life-threatening condition that can occur when taking this medication with certain other drugs. Call your doctor right away if you experience agitation, balance changes, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, upset stomach, or vomiting, or severe headache.
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's 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.
Upset stomach or vomiting.
Stomach pain or heartburn.
Dizziness, drowsiness, tiredness, or weakness.
Headache.
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 low blood sugar: dizziness, headache, feeling sleepy, feeling weak, shaking, fast heartbeat, confusion, hunger, or sweating.
Severe dizziness or fainting.
Clammy skin.
Excessive sweating.
Confusion.
Difficulty walking.
Severe constipation or stomach pain, which may indicate a severe bowel problem.
Hearing loss or changes in hearing.
Chest pain or pressure.
Abnormal heartbeat (fast or slow).
Breathing difficulties, including slow or shallow breathing, or noisy breathing.
Sleep apnea (breathing problems during sleep).
Fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak.
Mood changes.
Difficulty urinating.
Changes in urine output.
Vision changes.
Seizures.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other severe skin reactions, which can be life-threatening. Seek medical help immediately if you experience red, swollen, blistered, or peeling skin, skin irritation (with or without fever), red or irritated eyes, or sores in your mouth, throat, nose, or eyes.
Serotonin syndrome, a potentially life-threatening condition that can occur when taking this medication with certain other drugs. Call your doctor right away if you experience agitation, balance changes, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, upset stomach, or vomiting, or severe headache.
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's 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.
Upset stomach or vomiting.
Stomach pain or heartburn.
Dizziness, drowsiness, tiredness, or weakness.
Headache.
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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, shallow, or difficult breathing
- Extreme drowsiness or difficulty waking up
- Dizziness or lightheadedness when standing up
- Confusion or disorientation
- Yellowing of the skin or eyes (jaundice)
- Dark urine
- Severe stomach pain
- Unusual tiredness or weakness
- Signs of an allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Current or recent use of specific medications, such as:
+ Buprenorphine
+ Butorphanol
+ Linezolid
+ Methylene blue
+ Nalbuphine
+ Pentazocine
Use of certain depression or Parkinson's disease medications within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs can lead to very high blood pressure)
* All your prescription and over-the-counter medications, natural products, and vitamins, as this is not an exhaustive list of potential interactions.
To ensure your safety, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Current or recent use of specific medications, such as:
+ Buprenorphine
+ Butorphanol
+ Linezolid
+ Methylene blue
+ Nalbuphine
+ Pentazocine
Use of certain depression or Parkinson's disease medications within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline (note: taking this medication with these drugs can lead to very high blood pressure)
* All your prescription and over-the-counter medications, natural products, and vitamins, as this is not an exhaustive list of potential interactions.
To ensure your safety, it is crucial to discuss all your medications and health conditions with your doctor and pharmacist. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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, contact 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 first, as sudden changes may increase the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully and report any adverse effects, such as increased pain, mood changes, suicidal thoughts, or other concerns.
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 interactions.
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 dosage instructions exactly, and do not take more than 4,000 mg (milligrams) of acetaminophen per day unless directed by your doctor. Certain individuals, such as those with liver problems or children, may require lower doses. If you are unsure about the safe dosage, consult your doctor or pharmacist. If you suspect you have taken too much acetaminophen, contact your doctor immediately, even if you feel well.
Liver Problem Warning Signs
Monitor for signs of liver problems, such as dark urine, fatigue, decreased appetite, nausea, stomach pain, pale stools, vomiting, or yellowing of the skin and eyes. If you experience any of these symptoms, contact your doctor promptly.
Hormonal and Adrenal Gland 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, inform your doctor.
Additionally, this medication may cause a rare but severe adrenal gland problem. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.
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.
Age-Related Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Breastfeeding Warning
If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. If your baby appears excessively sleepy, limp, or has breathing difficulties, seek medical attention immediately.
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, contact 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 first, as sudden changes may increase the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully and report any adverse effects, such as increased pain, mood changes, suicidal thoughts, or other concerns.
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 interactions.
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 dosage instructions exactly, and do not take more than 4,000 mg (milligrams) of acetaminophen per day unless directed by your doctor. Certain individuals, such as those with liver problems or children, may require lower doses. If you are unsure about the safe dosage, consult your doctor or pharmacist. If you suspect you have taken too much acetaminophen, contact your doctor immediately, even if you feel well.
Liver Problem Warning Signs
Monitor for signs of liver problems, such as dark urine, fatigue, decreased appetite, nausea, stomach pain, pale stools, vomiting, or yellowing of the skin and eyes. If you experience any of these symptoms, contact your doctor promptly.
Hormonal and Adrenal Gland 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, inform your doctor.
Additionally, this medication may cause a rare but severe adrenal gland problem. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.
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.
Age-Related Precautions
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
Breastfeeding Warning
If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. If your baby appears excessively sleepy, limp, or has breathing difficulties, seek medical attention immediately.
Overdose Information
Overdose Symptoms:
- Pinpoint pupils
- Slowed or stopped breathing
- Extreme drowsiness or unresponsiveness
- Cold, clammy skin
- Bluish discoloration of lips or fingernails
- Loss of consciousness
- Nausea, vomiting, abdominal pain (acetaminophen overdose)
- Signs of liver failure (jaundice, dark urine, confusion) (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 (Narcan) may be administered by emergency personnel for opioid overdose. Treatment for acetaminophen overdose may include N-acetylcysteine (NAC).
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or use within 14 days of MAOI discontinuation (risk of serotonin syndrome, severe respiratory depression)
- Other opioid analgesics (risk of additive CNS and respiratory depression)
- Alcohol (risk of additive CNS and respiratory depression, increased hepatotoxicity with acetaminophen)
- Benzodiazepines and other CNS depressants (risk of profound sedation, respiratory depression, coma, and death)
Major Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir) - increased hydrocodone plasma concentrations, leading to increased opioid effects
- CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) - decreased conversion of hydrocodone to hydromorphone, potentially reducing analgesic effect
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - decreased hydrocodone plasma concentrations, leading to reduced efficacy and potential withdrawal
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans) - risk of serotonin syndrome
- Anticholinergic drugs (e.g., atropine, scopolamine) - increased risk of urinary retention and severe constipation/paralytic ileus
- Muscle relaxants (e.g., cyclobenzaprine, carisoprodol) - additive CNS depression
- Diuretics - opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone
Moderate Interactions
- Antihypertensives - additive hypotensive effects
- P-glycoprotein inhibitors (e.g., amiodarone, verapamil) - may increase hydrocodone exposure
- Warfarin - acetaminophen may enhance the anticoagulant effect of warfarin with chronic high doses, increasing bleeding risk
Minor Interactions
- Cholestyramine - reduces acetaminophen absorption if given within 1 hour
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, especially important due to 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
Bowel function
Rationale: To assess baseline bowel habits due to common opioid-induced constipation.
Timing: Prior to initiation of therapy
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess baseline hepatic function, especially if risk factors for liver disease or chronic use is anticipated.
Timing: Prior to initiation of therapy (if indicated)
Routine Monitoring
Pain assessment
Frequency: Regularly, as clinically indicated (e.g., before each dose, 1 hour after dose, or daily for chronic use)
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: Regularly, especially during initiation and dose titration (e.g., every 1-4 hours initially, then daily for stable chronic use)
Target: Normal for patient (e.g., 12-20 breaths/min)
Action Threshold: <10 breaths/min, shallow breathing, or signs of hypoventilation
Level of consciousness/sedation
Frequency: Regularly, especially during initiation and dose titration
Target: Alert and oriented, easily arousable
Action Threshold: Excessive sedation (e.g., somnolence, difficulty arousing), confusion, disorientation
Bowel function
Frequency: Daily for chronic use
Target: Regular bowel movements (e.g., every 1-3 days)
Action Threshold: Constipation (no bowel movement for >3 days), abdominal distension, severe cramping
Signs of liver injury (jaundice, dark urine, fatigue)
Frequency: Periodically for chronic high-dose acetaminophen use or if risk factors present
Target: Absence of signs/symptoms
Action Threshold: Presence of signs/symptoms, elevated LFTs
Symptom Monitoring
- Excessive sedation
- Dizziness
- Confusion
- Nausea
- Vomiting
- Constipation
- Difficulty breathing or shallow breathing
- Pinpoint pupils
- Cold, clammy skin
- Extreme drowsiness or inability to wake up
- Signs of liver damage (yellowing of skin/eyes, dark urine, severe abdominal pain, unusual tiredness)
Special Patient Groups
Pregnancy
Generally not recommended for prolonged use during pregnancy due to risks of neonatal opioid withdrawal syndrome (NOWS) and potential fetal harm. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data on teratogenicity, but some studies suggest a possible increased risk of birth defects (e.g., neural tube defects, cardiac defects) with first-trimester opioid exposure. Risk is generally considered low.
Second Trimester:
Risk of NOWS increases with prolonged use. Fetal growth restriction and premature birth have been reported.
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. Avoid use during labor and delivery if possible.
Lactation
Hydrocodone and its active metabolite (hydromorphone) are present in breast milk and can cause serious adverse reactions in breastfed infants, including sedation, respiratory depression, and death. Acetaminophen is generally considered safe. Due to the hydrocodone component, use is generally not recommended. If used, monitor infants closely for signs of sedation, difficulty feeding, and breathing problems.
Infant Risk:
High (due to hydrocodone component, especially in infants of mothers who are ultra-rapid CYP2D6 metabolizers or if infant has underlying respiratory issues).
Pediatric Use
Contraindicated in children younger than 12 years of age. Not recommended for routine use in adolescents 12 to 18 years of age, especially those with risk factors for respiratory depression (e.g., obesity, obstructive sleep apnea, severe pulmonary disease). Opioid analgesics carry a significant risk of respiratory depression and death in this population.
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. Monitor closely for CNS and respiratory depression.
Clinical Information
Clinical Pearls
- Always prescribe the lowest effective dose for the shortest possible duration to minimize risks of addiction, abuse, and adverse effects.
- Educate patients thoroughly on the risks of respiratory depression, accidental ingestion, and concomitant use with alcohol or other CNS depressants.
- Counsel patients on the maximum daily dose of acetaminophen from all sources to prevent hepatotoxicity.
- Implement a bowel regimen (e.g., stool softener, laxative) proactively for patients on chronic opioid therapy to manage opioid-induced constipation.
- Consider naloxone co-prescription for patients at high risk of overdose (e.g., history of overdose, concomitant benzodiazepine use, higher opioid doses).
- Be aware of drug-drug interactions, especially with CYP3A4 inhibitors/inducers and other CNS depressants.
- Monitor for signs of opioid use disorder and intervene appropriately.
Alternative Therapies
- NSAIDs (e.g., ibuprofen, naproxen)
- Other non-opioid analgesics (e.g., celecoxib)
- Topical analgesics (e.g., lidocaine patches, capsaicin cream)
- Adjuvant analgesics (e.g., gabapentin, pregabalin, duloxetine for neuropathic pain)
- Non-pharmacological therapies (e.g., physical therapy, acupuncture, massage, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand if available and preferred)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others, and never take someone else's medication.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help treat the condition. 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 immediately. When seeking help, be prepared to provide information about the substance involved, the quantity taken, and the time of the incident.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider.
In the event of an overdose, a medication called naloxone can be administered to help treat the condition. 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 immediately. When seeking help, be prepared to provide information about the substance involved, the quantity taken, and the time of the incident.