Hydrocod/acetaminophen 7.5-325 Sol
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.Be sure that you know how to measure your dose. Dosing errors can lead to accidental overdose and death. If you have any questions, talk with your doctor or pharmacist. @ COMMON USES: It is used to manage pain when non- opioid pain drugs do not treat your pain well enough or you cannot take them.
Drug Class
Opioid analgesic combination
Pharmacologic Class
Opioid agonist (Hydrocodone); Para-aminophenol derivative (Acetaminophen)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Schedule II
Overview
What is this medicine?
This medicine is a combination of two pain relievers: hydrocodone, 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 with your medication and follow the instructions closely.
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 trouble breathing and overdose, which can be fatal.
Measuring Your Dose
When taking the liquid form of this medication, measure your dose carefully using the measuring device provided with the medication. If one is not provided, ask your pharmacist for a suitable measuring device. Avoid using household teaspoons or tablespoons, as this can result in an incorrect dose and potentially lead to serious side effects.
Dosage and Administration
Do not take more medication than your doctor prescribed, and do not take it more frequently or for a longer period than recommended. Taking more than the prescribed dose can increase the risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use 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.
Interactions with Lab Tests
This medication may affect certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication to ensure accurate test results.
Storing and Disposing of Your Medication
Store this medication at room temperature, away from moisture and heat. Do not refrigerate or freeze. Keep it in a safe place, out of the reach of children and pets, and secure it in a locked box or area to prevent unauthorized access. Dispose of unused or expired medication according to the instructions provided by your pharmacist. Check with your pharmacist for information on drug take-back programs in your area, and do not flush medication down the toilet or pour it down the drain unless instructed to do so.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication on an as-needed basis, do not take it more frequently than your doctor recommends.
To ensure safe and effective use of this medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely.
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 trouble breathing and overdose, which can be fatal.
Measuring Your Dose
When taking the liquid form of this medication, measure your dose carefully using the measuring device provided with the medication. If one is not provided, ask your pharmacist for a suitable measuring device. Avoid using household teaspoons or tablespoons, as this can result in an incorrect dose and potentially lead to serious side effects.
Dosage and Administration
Do not take more medication than your doctor prescribed, and do not take it more frequently or for a longer period than recommended. Taking more than the prescribed dose can increase the risk of severe side effects. Additionally, do not take this medication with other strong pain medications or use 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.
Interactions with Lab Tests
This medication may affect certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication to ensure accurate test results.
Storing and Disposing of Your Medication
Store this medication at room temperature, away from moisture and heat. Do not refrigerate or freeze. Keep it in a safe place, out of the reach of children and pets, and secure it in a locked box or area to prevent unauthorized access. Dispose of unused or expired medication according to the instructions provided by your pharmacist. Check with your pharmacist for information on drug take-back programs in your area, and do not flush medication down the toilet or pour it down the drain unless instructed to do so.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication on an as-needed basis, do not take it more frequently than your doctor recommends.
Lifestyle & Tips
- Do not drink alcohol while taking this medication, as it can increase the risk of serious side effects like extreme drowsiness and breathing problems.
- Avoid driving or operating heavy machinery until you know how this medicine affects you, as it can cause dizziness and drowsiness.
- Do not take more than the prescribed dose, and do not take it more often than prescribed. Taking too much can lead to serious liver damage or overdose.
- Do not take other medicines that contain acetaminophen (Tylenol) without checking with your doctor or pharmacist, as this can lead to an overdose of acetaminophen.
- Store this medication securely away from children and pets, as accidental ingestion can be fatal.
- Discuss any other medications, supplements, or herbal products you are taking with your doctor to avoid dangerous interactions.
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:
15 mL (Hydrocodone 7.5 mg / Acetaminophen 325 mg) orally every 4 to 6 hours as needed for pain
Dose Range:
7.5 - 60 mg
Condition-Specific Dosing:
Maximum daily dose of hydrocodone:
60 mg
Maximum daily dose of acetaminophen:
4000 mg (or 3000 mg for chronic use/risk factors)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 6 years due to risk of respiratory depression. For children 6-12 years, use with extreme caution and consider lower doses (e.g., 0.1-0.2 mg/kg hydrocodone component, not exceeding 10 mg/dose or 60 mg/day; acetaminophen component 10-15 mg/kg/dose, not exceeding 75 mg/kg/day or 4000 mg/day).
Adolescent:
For adolescents 12 years and older, adult dosing may be considered, but start with lowest effective dose and monitor closely.
Dose Adjustments
Renal Impairment:
Mild:
Use with caution; consider dose reduction for acetaminophen if CrCl < 50 mL/min.
Moderate:
Reduce dose and/or extend dosing interval. For acetaminophen, consider reducing dose by 50% or extending interval to every 8 hours if CrCl < 30 mL/min. For hydrocodone, monitor for increased opioid effects.
Severe:
Avoid or significantly reduce dose and extend interval. For acetaminophen, avoid or use with extreme caution. For hydrocodone, significant dose reduction and extended interval required.
Dialysis:
Acetaminophen is dialyzable; hydrocodone is minimally dialyzable. Administer dose after dialysis for acetaminophen. For hydrocodone, monitor closely and adjust as needed.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function. Consider lower doses of acetaminophen.
Moderate:
Reduce dose and/or extend dosing interval for both components. Acetaminophen dose reduction (e.g., 50%) is recommended. Hydrocodone metabolism may be impaired, increasing opioid effects.
Severe:
Contraindicated or use with extreme caution at significantly reduced doses. Acetaminophen is contraindicated in severe hepatic impairment. Hydrocodone clearance may be significantly reduced.
Confidence:
Medium
Pharmacology
Mechanism of Action
Hydrocodone is a semisynthetic opioid analgesic that acts as a full agonist at mu-opioid receptors in the central nervous system (CNS), producing analgesia, sedation, and respiratory depression. Acetaminophen is a non-opioid analgesic and antipyretic that is thought to produce analgesia by inhibiting prostaglandin synthesis primarily in the CNS and by blocking pain impulse generation peripherally. Its antipyretic action is mediated through effects on the hypothalamic heat-regulating center.
Pharmacokinetics
Absorption:
Bioavailability:
Hydrocodone: ~60-80%; Acetaminophen: ~60-90%
Tmax:
Hydrocodone: ~1.3 hours; Acetaminophen: ~0.5-2 hours
FoodEffect:
Food may slightly delay Tmax but does not significantly affect 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
Elimination:
HalfLife:
Hydrocodone: ~3.8 hours; Acetaminophen: ~1-4 hours (prolonged in liver disease)
Clearance:
Not available
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Hydrocodone: <10%; Acetaminophen: <5%
Pharmacodynamics
OnsetOfAction:
10-30 minutes
PeakEffect:
Hydrocodone: ~1 hour; Acetaminophen: ~1-2 hours
DurationOfAction:
4-6 hours
Safety & Warnings
BLACK BOX WARNING
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, 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 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.
CYP3A4 Interaction: Concomitant use with CYP3A4 inhibitors or discontinuation of CYP3A4 inducers can result in a fatal overdose of hydrocodone.
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 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.
CYP3A4 Interaction: Concomitant use with CYP3A4 inhibitors or discontinuation of CYP3A4 inducers can result in a fatal overdose of hydrocodone.
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 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, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Clammy skin
Excessive sweating
Confusion
Trouble 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:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Mood changes
Difficulty passing urine
Changes in urine output
Vision changes
Seizures
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions, which can be life-threatening
Signs of serotonin syndrome, a potentially life-threatening condition, including:
+ Agitation
+ Balance problems
+ Confusion
+ Hallucinations
+ Fever
+ Abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea
+ Upset stomach or vomiting
+ Severe headache
Other Possible Side Effects
Most people taking this medication do not experience severe side effects. However, some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
Constipation
Upset stomach or vomiting
Stomach pain or heartburn
Dizziness
Sleepiness
Fatigue
* 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, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Clammy skin
Excessive sweating
Confusion
Trouble 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:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Mood changes
Difficulty passing urine
Changes in urine output
Vision changes
Seizures
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions, which can be life-threatening
Signs of serotonin syndrome, a potentially life-threatening condition, including:
+ Agitation
+ Balance problems
+ Confusion
+ Hallucinations
+ Fever
+ Abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea
+ Upset stomach or vomiting
+ Severe headache
Other Possible Side Effects
Most people taking this medication do not experience severe side effects. However, some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
Constipation
Upset stomach or vomiting
Stomach pain or heartburn
Dizziness
Sleepiness
Fatigue
* 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 inability to wake up
- Dizziness or lightheadedness when standing up
- Bluish lips or fingernails
- Pinpoint pupils
- Yellowing of the skin or eyes (jaundice)
- Dark urine or clay-colored stools
- Severe stomach pain, nausea, or vomiting
- Rash, hives, or swelling of the face, lips, tongue, or throat
- Confusion or unusual thoughts
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:
+ Lung or breathing problems, such as asthma, difficulty breathing, or sleep apnea
+ High levels of carbon dioxide in the blood
+ Stomach or bowel blockage or narrowing
Current or recent use of specific medications, including:
+ Buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
+ Certain drugs for depression or Parkinson's disease taken in the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as they may cause very high blood pressure
All your medications, including prescription and over-the-counter drugs, natural products, and vitamins, to ensure safe use with this medication
Remember, this is not an exhaustive list of potential interactions. It is crucial to consult your doctor and pharmacist about all your medications and health conditions to confirm the safe use of this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Lung or breathing problems, such as asthma, difficulty breathing, or sleep apnea
+ High levels of carbon dioxide in the blood
+ Stomach or bowel blockage or narrowing
Current or recent use of specific medications, including:
+ Buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
+ Certain drugs for depression or Parkinson's disease taken in the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as they may cause very high blood pressure
All your medications, including prescription and over-the-counter drugs, natural products, and vitamins, to ensure safe use with this medication
Remember, this is not an exhaustive list of potential interactions. It is crucial to consult your doctor and pharmacist about all your medications and health conditions to confirm the safe use of this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, get up 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 can lead to tolerance, where the medication may not work as well, and you may need higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact 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 first, as sudden changes can lead to withdrawal or other severe problems.
Interactions and Risks
Do not consume alcohol or products containing alcohol while taking this medication, as it can cause unsafe and potentially deadly effects. Also, avoid taking other products that contain acetaminophen, as excessive intake can lead to liver problems. Always check the labels carefully and follow the directions exactly. Do not take more than 4,000 mg of acetaminophen per day, unless instructed by your doctor. Some individuals, such as those with liver problems or children, may require lower doses. If you have taken too much acetaminophen, contact your doctor immediately, even if you feel well.
Liver Problems
Monitor for signs of liver problems, including dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellow skin and eyes. If you experience any of these symptoms, contact your doctor right away.
Hormonal Effects
Long-term use of opioid medications like this one can lead to lower sex hormone levels. If you experience a decrease in libido, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.
Adrenal Gland Problems
Taking this medication can rarely cause a 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
If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. If your baby appears overly sleepy, limp, or has trouble breathing, seek medical help immediately.
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, get up 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 can lead to tolerance, where the medication may not work as well, and you may need higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact 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 first, as sudden changes can lead to withdrawal or other severe problems.
Interactions and Risks
Do not consume alcohol or products containing alcohol while taking this medication, as it can cause unsafe and potentially deadly effects. Also, avoid taking other products that contain acetaminophen, as excessive intake can lead to liver problems. Always check the labels carefully and follow the directions exactly. Do not take more than 4,000 mg of acetaminophen per day, unless instructed by your doctor. Some individuals, such as those with liver problems or children, may require lower doses. If you have taken too much acetaminophen, contact your doctor immediately, even if you feel well.
Liver Problems
Monitor for signs of liver problems, including dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellow skin and eyes. If you experience any of these symptoms, contact your doctor right away.
Hormonal Effects
Long-term use of opioid medications like this one can lead to lower sex hormone levels. If you experience a decrease in libido, fertility problems, irregular menstrual periods, or ejaculation problems, contact your doctor.
Adrenal Gland Problems
Taking this medication can rarely cause a 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
If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. If your baby appears overly sleepy, limp, or has trouble breathing, seek medical help immediately.
Overdose Information
Overdose Symptoms:
- Opioid overdose: Severe drowsiness, unresponsiveness, slow or stopped breathing, pinpoint pupils, cold/clammy skin, limp body, loss of consciousness.
- Acetaminophen overdose: Nausea, vomiting, stomach pain, loss of appetite, sweating, extreme tiredness, dark urine, yellowing of the skin or eyes (jaundice).
What to Do:
Seek immediate emergency medical attention. Call 911 or your local poison control center (1-800-222-1222). Naloxone (Narcan) may be administered for opioid overdose. N-acetylcysteine (NAC) is the antidote for acetaminophen overdose.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) within 14 days (risk of serotonin syndrome, respiratory depression, coma)
- Other products containing acetaminophen (risk of overdose/hepatotoxicity)
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., ketoconazole, itraconazole, clarithromycin, ritonavir): Increased hydrocodone plasma concentrations, leading to increased opioid effects.
- CYP3A4 Inducers (e.g., rifampin, carbamazepine, phenytoin): Decreased hydrocodone plasma concentrations, leading to reduced efficacy.
- CYP2D6 Inhibitors (e.g., fluoxetine, paroxetine, quinidine, bupropion): Decreased conversion of hydrocodone to hydromorphone, potentially reducing analgesic effect.
- Serotonergic Drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol, fentanyl): Risk of serotonin syndrome.
- Drugs that affect acetaminophen metabolism (e.g., carbamazepine, phenytoin, phenobarbital, rifampin, isoniazid, alcohol): Increased risk of acetaminophen hepatotoxicity.
Moderate Interactions
- Anticholinergic Drugs (e.g., atropine, scopolamine): Increased risk of urinary retention and/or severe constipation, paralytic ileus.
- Diuretics: Opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
- P-glycoprotein (P-gp) Inhibitors/Inducers: May alter hydrocodone absorption and distribution.
- Naltrexone: Precipitates opioid withdrawal.
Minor Interactions
- Not available
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 due to risk of respiratory depression.
Timing: Prior to initiation of therapy
Level of consciousness/sedation
Rationale: To assess baseline CNS status.
Timing: Prior to initiation of therapy
Liver function tests (ALT, AST, bilirubin)
Rationale: Recommended 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, especially after dose adjustments and during chronic therapy
Target: Acceptable pain control with minimal side effects
Action Threshold: Inadequate pain control or excessive side effects warrant dose adjustment or re-evaluation.
Respiratory rate and depth
Frequency: Regularly, especially during initiation and dose titration
Target: Normal for age (e.g., >12 breaths/min for adults)
Action Threshold: Respiratory rate <10-12 breaths/min, shallow breathing, or signs of hypoventilation require immediate intervention.
Level of consciousness/sedation
Frequency: Regularly, especially during initiation and dose titration
Target: Alert and oriented, able to respond to verbal stimuli
Action Threshold: Excessive sedation (e.g., somnolence, difficulty arousing) requires dose reduction or discontinuation.
Bowel function (constipation)
Frequency: Daily during chronic therapy
Target: Regular bowel movements
Action Threshold: Constipation requires prophylactic measures (e.g., stool softeners, laxatives).
Signs of liver injury (e.g., jaundice, dark urine, abdominal pain)
Frequency: Periodically, especially with long-term use or high doses of acetaminophen
Target: Absence of signs/symptoms
Action Threshold: Presence of signs/symptoms requires immediate evaluation and discontinuation.
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation or somnolence
- Dizziness or lightheadedness
- Nausea and vomiting
- Constipation
- Pruritus (itching)
- Signs of liver injury (yellowing of skin/eyes, dark urine, clay-colored stools, severe abdominal pain, easy bruising/bleeding)
- Signs of allergic reaction (rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended due to the risk of neonatal opioid withdrawal syndrome (NOWS) and potential for respiratory depression in the neonate. If opioid use is required for a prolonged period, advise the patient of the risk of NOWS and ensure appropriate treatment will be available.
Trimester-Specific Risks:
First Trimester:
Limited data on major birth defects. Potential for increased risk of neural tube defects and cardiac defects with opioid exposure, though evidence is mixed. Acetaminophen is generally considered safe for occasional use.
Second Trimester:
Risk of NOWS increases with prolonged exposure. Monitor for fetal growth restriction.
Third Trimester:
High risk of NOWS if used chronically. Risk of respiratory depression in the neonate if used close to delivery. Risk of preterm birth.
Lactation
Not recommended. Hydrocodone and its active metabolite (hydromorphone) are excreted into breast milk and can cause serious adverse reactions in breastfed infants, including sedation, respiratory depression, and death. Acetaminophen is generally considered safe for use during breastfeeding, but the combination product should be avoided.
Infant Risk:
High (for hydrocodone component). Risk of sedation, respiratory depression, poor feeding, and failure to thrive in the infant.
Pediatric Use
Use with extreme caution, especially in children under 6 years of age, due to the risk of fatal respiratory depression. Opioids should only be used in pediatric patients when the benefits outweigh the risks, and alternative pain management strategies are inadequate. Dosing must be precise and based on weight, with close monitoring.
Geriatric Use
Start with lower doses and titrate slowly due to increased sensitivity to opioid effects (e.g., respiratory depression, sedation, constipation) and potential for age-related decline in renal and hepatic function. Increased risk of falls and cognitive impairment.
Clinical Information
Clinical Pearls
- This combination product carries significant risks due to both hydrocodone (opioid) and acetaminophen (hepatotoxicity). Careful patient selection, dosing, and monitoring are crucial.
- Educate patients thoroughly on the maximum daily dose of acetaminophen (3000-4000 mg) and the importance of avoiding other acetaminophen-containing products.
- Counsel patients on the risks of addiction, abuse, and misuse, and the importance of safe storage and disposal of unused medication.
- Always assess for respiratory depression, especially during initiation and dose escalation. Have naloxone readily available if appropriate.
- Be aware of drug interactions, particularly with other CNS depressants and medications affecting CYP3A4 and CYP2D6.
- Constipation is a common and often debilitating side effect of opioid use; proactive management with stool softeners and laxatives is recommended.
Alternative Therapies
- Non-opioid analgesics (e.g., NSAIDs like ibuprofen, naproxen; celecoxib)
- Other single-agent opioids (e.g., morphine, hydromorphone, oxycodone)
- Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants for neuropathic pain)
- Non-pharmacological pain management (e.g., physical therapy, acupuncture, massage, cognitive behavioral therapy)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 473 mL bottle (7.5-325 mg/15 mL)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever 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 an overdose is suspected, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek medical care immediately. When seeking help, be prepared to provide detailed information about the overdose, including what was taken, the quantity, and the time of the incident.
This medication is accompanied by a Medication Guide, which is a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever 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 an overdose is suspected, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek medical care immediately. When seeking help, be prepared to provide detailed information about the overdose, including what was taken, the quantity, and the time of the incident.