Hydrocodone/acetaminophen 7.5-325 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; Antipyretic
Pharmacologic Class
Opioid agonist; Para-aminophenol derivative (COX inhibitor)
Pregnancy Category
Category C
FDA Approved
Apr 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, which is a non-opioid pain reliever. It's used to treat moderate to 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 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 it causes stomach upset, take it with food to 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. This can increase the risk of severe side effects.
Avoid concomitant use of this medication with other strong pain medications or pain patches without consulting your doctor first.
* If your pain worsens, you experience increased sensitivity to pain, or you develop 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.
Storage and Disposal
Store this medication at room temperature in a dry place, away from bathrooms. Keep it in a secure location, inaccessible to children and pets, and out of reach of others. Consider using a locked box or area to store this 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, and explore potential drug take-back programs in your area.
Missed Dose Instructions
If you take this medication regularly and miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses. If you take this medication on an as-needed basis, 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 it causes stomach upset, take it with food to 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. This can increase the risk of severe side effects.
Avoid concomitant use of this medication with other strong pain medications or pain patches without consulting your doctor first.
* If your pain worsens, you experience increased sensitivity to pain, or you develop 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.
Storage and Disposal
Store this medication at room temperature in a dry place, away from bathrooms. Keep it in a secure location, inaccessible to children and pets, and out of reach of others. Consider using a locked box or area to store this 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, and explore potential drug take-back programs in your area.
Missed Dose Instructions
If you take this medication regularly and miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses. If you take this medication on an as-needed basis, 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 severe drowsiness, breathing problems, and liver damage.
- Avoid driving or operating heavy machinery until you know how this medication 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 overdose and liver damage.
- Be aware of all other medications you are taking, including over-the-counter drugs, as many contain acetaminophen. Do not exceed the maximum daily dose of acetaminophen (usually 3000-4000 mg from all sources).
- 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 away from children and pets, as accidental ingestion can be fatal.
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:
1 tablet (hydrocodone 7.5 mg/acetaminophen 325 mg) orally every 4 to 6 hours as needed for pain
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
maximum_daily_dose:
No more than 6 tablets (45 mg hydrocodone/1950 mg acetaminophen) per 24 hours. Total acetaminophen should not exceed 4000 mg (or 3000 mg for chronic use/hepatic risk) from all sources.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for routine use due to hydrocodone component; specific dosing for pain may be considered by specialists, but generally avoided.
Adolescent:
Not established (use in adolescents should be with extreme caution and only if benefits outweigh risks, considering adult dosing with appropriate weight-based adjustments and lower starting doses)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, monitor for increased opioid effects.
Moderate:
Consider dose reduction (e.g., 50% of usual dose) and/or increased dosing interval; monitor closely for respiratory depression and sedation.
Severe:
Avoid use or significantly reduce dose (e.g., 75% reduction) and extend dosing interval; monitor closely. Acetaminophen metabolites can accumulate.
Dialysis:
Hydrocodone and its metabolites are not significantly removed by hemodialysis. Acetaminophen is dialyzable, but its metabolites may accumulate. Use with caution, monitor for effects.
Hepatic Impairment:
Mild:
Use with caution, monitor for increased opioid effects and signs of hepatotoxicity.
Moderate:
Avoid use if possible. If necessary, significantly reduce dose (e.g., 50% reduction) and/or extend dosing interval; monitor liver function and for increased opioid effects. Acetaminophen maximum daily dose should not exceed 2000 mg.
Severe:
Contraindicated due to risk of precipitating hepatic encephalopathy and severe hepatotoxicity from acetaminophen. Avoid use.
Pharmacology
Mechanism of Action
Hydrocodone is a semisynthetic opioid agonist that primarily acts on mu-opioid receptors in the central nervous system (CNS), producing analgesia, sedation, and respiratory depression. Acetaminophen is a non-opioid analgesic and antipyretic, believed to act primarily through central inhibition of prostaglandin synthesis (COX-3 inhibition) and possibly through other mechanisms involving serotonergic pathways.
Pharmacokinetics
Absorption:
Bioavailability:
Hydrocodone: ~60-70%; 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.
Distribution:
Vd:
Hydrocodone: ~2.2-4.1 L/kg; Acetaminophen: ~0.95 L/kg
ProteinBinding:
Hydrocodone: ~20-50%; Acetaminophen: ~10-25%
CnssPenetration:
Yes
Elimination:
HalfLife:
Hydrocodone: ~3.8 hours; Acetaminophen: ~2-3 hours
Clearance:
Not available (variable)
ExcretionRoute:
Renal (primarily as metabolites)
Unchanged:
Hydrocodone: <10%; Acetaminophen: <5%
Pharmacodynamics
OnsetOfAction:
10-30 minutes
PeakEffect:
Hydrocodone: 30-60 minutes; Acetaminophen: 1-2 hours
DurationOfAction:
4-6 hours
Safety & Warnings
BLACK BOX WARNING
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY.
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.
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 develop and make available education programs for healthcare providers and patients.
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 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 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 analgesic efficacy and/or cause withdrawal symptoms in patients who had developed physical dependence.
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.
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.
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 develop and make available education programs for healthcare providers and patients.
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 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 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 analgesic efficacy and/or cause withdrawal symptoms in patients who had developed physical dependence.
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 while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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
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:
+ 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 urinating
Changes in urination patterns
Vision changes
Seizures
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions, which may be life-threatening
Signs of serotonin syndrome, a potentially life-threatening condition, including:
+ Agitation
+ Balance problems
+ Confusion
+ Hallucinations
+ Fever
+ Abnormal heartbeat (fast or irregular)
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea
+ Upset stomach or vomiting
+ Severe headache
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:
Constipation
Upset stomach or vomiting
Stomach pain or heartburn
Dizziness
Drowsiness
Fatigue
* Headache
If any of these side effects or other symptoms bother you or persist, consult your doctor for guidance. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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
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:
+ 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 urinating
Changes in urination patterns
Vision changes
Seizures
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions, which may be life-threatening
Signs of serotonin syndrome, a potentially life-threatening condition, including:
+ Agitation
+ Balance problems
+ Confusion
+ Hallucinations
+ Fever
+ Abnormal heartbeat (fast or irregular)
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea
+ Upset stomach or vomiting
+ Severe headache
Other Possible Side Effects
While many people may not experience any side effects or only minor ones, it's essential to be aware of the following potential side effects:
Constipation
Upset stomach or vomiting
Stomach pain or heartburn
Dizziness
Drowsiness
Fatigue
* Headache
If any of these side effects or other symptoms bother you or persist, consult your doctor for guidance. 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 shallow breathing
- Extreme drowsiness or difficulty waking up
- Bluish lips or fingernails
- Severe dizziness or lightheadedness
- Confusion
- 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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Respiratory problems, including asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Current or recent use of specific medications, including:
+ Buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as these may increase the risk of 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 with your doctor and pharmacist about all your medications and health conditions to confirm the safe use of this medication. Never start, stop, or adjust 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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Respiratory problems, including asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
Current or recent use of specific medications, including:
+ Buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as these may increase the risk of 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 with your doctor and pharmacist about all your medications and health conditions to confirm the safe use of this medication. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
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 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 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 (milligrams) 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 for you, 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 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.
Additionally, taking an opioid medication like this one can 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. Seek medical attention immediately if your baby appears overly 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 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 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 (milligrams) 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 for you, 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 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.
Additionally, taking an opioid medication like this one can 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. Seek medical attention immediately if your baby appears overly sleepy, limp, or has breathing difficulties.
Overdose Information
Overdose Symptoms:
- Hydrocodone overdose: pinpoint pupils, extreme drowsiness, slow/shallow breathing, cold/clammy skin, limp muscles, loss of consciousness, coma, death.
- Acetaminophen overdose: nausea, vomiting, stomach pain, loss of appetite, sweating, extreme tiredness, dark urine, yellowing of skin/eyes (jaundice). Liver damage may not be apparent for 24-48 hours after overdose.
What to Do:
Seek immediate emergency medical attention. Call 911 or your local emergency number. For suspected poisoning, call a poison control center immediately at 1-800-222-1222. Naloxone may be administered for opioid overdose. N-acetylcysteine (NAC) is the antidote for acetaminophen overdose.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 14 days of MAOI discontinuation due to risk of serotonin syndrome and severe respiratory depression)
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) (may increase hydrocodone plasma concentrations, leading to increased opioid effects and respiratory depression)
Major Interactions
- Other CNS depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants) (additive CNS depression, profound sedation, respiratory depression, coma, death)
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol, fentanyl, St. John's Wort) (risk of serotonin syndrome)
- Anticholinergic drugs (e.g., atropine, scopolamine, TCAs, antihistamines) (increased risk of urinary retention and/or severe constipation, paralytic ileus)
- Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol) (may reduce analgesic effect of hydrocodone and/or precipitate withdrawal symptoms)
- Opioid antagonists (e.g., naltrexone, naloxone) (may precipitate withdrawal)
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) (may decrease hydrocodone plasma concentrations, leading to decreased efficacy and potential withdrawal symptoms)
- Hepatotoxic drugs (e.g., isoniazid, methotrexate, amiodarone) (increased risk of acetaminophen-induced hepatotoxicity)
Moderate Interactions
- CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) (may decrease conversion of hydrocodone to hydromorphone, potentially reducing analgesic effect)
- Anticoagulants (e.g., warfarin) (acetaminophen may enhance anticoagulant effect, monitor INR)
- Loop diuretics (e.g., furosemide) (acetaminophen may reduce diuretic effect)
- Cholestyramine (reduces acetaminophen absorption if given within 1 hour)
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 and identify risk for respiratory depression.
Timing: Prior to initiation of therapy
Level of consciousness/sedation
Rationale: To assess baseline mental status and identify risk for excessive sedation.
Timing: Prior to initiation of therapy
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess baseline hepatic function, especially important due to acetaminophen component and potential for hepatotoxicity.
Timing: Prior to initiation, especially in patients with pre-existing liver disease or risk factors
Renal function (BUN, creatinine, eGFR)
Rationale: To assess baseline renal function, as metabolites are renally excreted and impairment may require dose adjustment.
Timing: Prior to initiation, especially in patients with pre-existing renal disease
Routine Monitoring
Pain assessment
Frequency: Regularly, as needed, or at each follow-up visit
Target: Acceptable pain control with minimal side effects
Action Threshold: Inadequate pain control or worsening pain; consider dose adjustment or alternative therapy
Respiratory rate and depth
Frequency: Periodically, especially during dose titration or initiation; more frequently if signs of respiratory depression
Target: Normal for patient (e.g., >10-12 breaths/min, unlabored)
Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, cyanosis; administer naloxone, provide ventilatory support
Level of consciousness/sedation
Frequency: Periodically, especially during dose titration or initiation
Target: Alert and oriented, or easily aroused
Action Threshold: Excessive sedation (e.g., somnolence, difficult to arouse); reduce dose, hold dose, or administer naloxone
Bowel function (constipation)
Frequency: Regularly, at each follow-up visit
Target: Regular bowel movements
Action Threshold: Severe constipation; initiate bowel regimen, consider opioid-induced constipation (OIC) specific treatment
Liver function tests (ALT, AST)
Frequency: Periodically for long-term use or if signs/symptoms of liver injury; not routinely for short-term use
Target: Within normal limits
Action Threshold: Significant elevation (e.g., >3x ULN); discontinue drug, investigate cause
Symptom Monitoring
- Respiratory depression (slow, shallow breathing, cyanosis)
- Excessive sedation/drowsiness
- Dizziness
- Nausea and vomiting
- Constipation
- Pruritus (itching)
- Signs of liver injury (yellowing of skin/eyes, dark urine, abdominal pain, unusual tiredness)
- Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, incoordination, nausea, vomiting, diarrhea)
- Signs of adrenal insufficiency (fatigue, dizziness, weakness, loss of appetite, nausea, vomiting)
Special Patient Groups
Pregnancy
Category C. Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which can be life-threatening. Use only if the potential benefit justifies the potential risk to the fetus. Advise pregnant patients of the risk of NOWS.
Trimester-Specific Risks:
First Trimester:
Potential for congenital malformations (e.g., neural tube defects, cardiac defects) with opioid exposure, though data are mixed. Acetaminophen is generally considered safe for occasional use.
Second Trimester:
Risk of NOWS increases with prolonged use. Risk of respiratory depression in the neonate if used close to delivery.
Third Trimester:
High risk of NOWS with prolonged use. Risk of respiratory depression in the neonate if used close to delivery. Risk of preterm birth and low birth weight.
Lactation
L3. Hydrocodone and acetaminophen are excreted in breast milk. Monitor infants for signs of sedation, respiratory depression, poor feeding, and withdrawal symptoms. Use with caution, lowest effective dose for shortest duration. Acetaminophen is generally considered compatible with breastfeeding at usual doses.
Infant Risk:
Risk of sedation, respiratory depression, and poor feeding in breastfed infants, especially if the mother is a CYP2D6 ultra-rapid metabolizer (leading to higher hydromorphone levels in milk). Risk of withdrawal symptoms if drug is abruptly discontinued in mother.
Pediatric Use
Not recommended for routine use in children due to the hydrocodone component and risk of respiratory depression. Safety and efficacy have not been established in pediatric patients. Accidental ingestion in children can be fatal.
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. Monitor renal and hepatic function more closely.
Clinical Information
Clinical Pearls
- Always counsel patients on the maximum daily dose of acetaminophen from all sources to prevent hepatotoxicity.
- Emphasize the risks of addiction, abuse, and misuse, and the importance of safe storage and disposal.
- Warn patients about the dangers of combining with alcohol or other CNS depressants.
- Be vigilant for signs of respiratory depression, especially during initiation or dose escalation.
- Consider a bowel regimen (e.g., stool softener, laxative) proactively to manage opioid-induced constipation.
- Educate patients on the signs of opioid overdose and the availability of naloxone.
- For long-term use, consider the risks of opioid-induced hyperalgesia, endocrine dysfunction (e.g., hypogonadism), and bone density loss.
Alternative Therapies
- NSAIDs (e.g., ibuprofen, naproxen) for mild to moderate pain
- Acetaminophen alone for mild pain or fever
- Other non-opioid analgesics (e.g., celecoxib)
- Topical analgesics (e.g., lidocaine patches, capsaicin cream)
- Adjuvant analgesics (e.g., gabapentin, pregabalin for neuropathic pain; duloxetine for chronic musculoskeletal 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 Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand), often requires prior authorization for brand or higher quantities.
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 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 it. 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 reporting the incident, be prepared to disclose what was taken, the quantity, and the time of the incident to ensure timely and effective treatment.
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 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 it. 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 reporting the incident, be prepared to disclose what was taken, the quantity, and the time of the incident to ensure timely and effective treatment.