Hydrocodone/acetaminophen5-300 Tb

Hydrocodone is a semisynthetic opioid analgesic that acts as an 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, believed to act primarily through central inhibition of prostaglandin synthesis (COX-3 inhibition) and possibly through other mechanisms involving serotonergic pathways.

Urgent Side Effects: Seek Medical Help Right Away

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 immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of 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
Trouble 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 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 encounter mild or moderate side effects. If you experience any of the following, contact your doctor or seek medical attention if they bother you or persist:

Constipation
Upset stomach or vomiting
Stomach pain or heartburn
Dizziness
Drowsiness
Fatigue
* Headache

Reporting Side Effects

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.

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.
Certain health conditions, including:
+ Respiratory problems like asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage or narrowing
Other medications you are currently taking, particularly:
+ 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 they may cause a sudden increase in blood pressure
All your prescription and over-the-counter medications, natural products, vitamins, and health problems. This information is crucial to ensure safe use of this medication.

Remember, this is not an exhaustive list of potential interactions. Always consult your doctor and pharmacist about all your medications and health conditions to confirm it is safe to take this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

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 activities that require you to be alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down 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 lower your dose or stop taking this medication, consult your doctor first, as suddenly stopping or reducing the dose 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 acetaminophen can lead to liver problems. Always check the labels of other medications carefully.

Acetaminophen Dosage
Follow the dosage instructions exactly, and do not take more than the recommended amount of acetaminophen per day. The maximum daily dose is 4,000 mg (milligrams) for some individuals, but people with liver problems or children may require lower doses. If you are unsure about your daily acetaminophen limit, consult your doctor or pharmacist. If you have taken too much acetaminophen, contact your doctor immediately, even if you feel well.

Liver Problems
Be aware of the signs of liver problems, such as 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, inform your doctor.

Adrenal Gland Problems
Taking an opioid medication like this one can cause a rare but severe adrenal gland problem. If you feel extremely tired or weak, faint, or experience 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 breathing difficulties, seek medical help immediately.

• Monoamine Oxidase Inhibitors (MAOIs) within 14 days (risk of serotonin syndrome, CNS depression)
• Severe hepatic impairment (due to acetaminophen component)

• Other CNS depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants) - increased risk of profound sedation, respiratory depression, coma, and death
• CYP3A4 inhibitors (e.g., macrolide antibiotics, azole antifungals, protease inhibitors) - 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) - increased risk of serotonin syndrome
• Drugs that affect acetaminophen metabolism (e.g., alcohol, isoniazid, phenobarbital, phenytoin, carbamazepine) - increased risk of hepatotoxicity
• Anticholinergic drugs (e.g., atropine, scopolamine) - increased risk of urinary retention and severe constipation

• Diuretics (opioids can reduce efficacy of diuretics)
• Antihypertensives (additive hypotensive effects)
• P-glycoprotein inhibitors (may increase hydrocodone absorption)

• Not available

• Excessive sedation
• Dizziness
• Nausea/vomiting
• Constipation
• Itching
• Difficulty breathing/shallow breathing
• Confusion
• Yellowing of skin/eyes (jaundice)
• Dark urine
• Abdominal pain (especially right upper quadrant)
• Unusual tiredness/weakness

Use during pregnancy should be avoided if possible. Prolonged use during pregnancy can lead to neonatal opioid withdrawal syndrome (NOWS) in the newborn, which can be life-threatening. Acetaminophen crosses the placenta but is generally considered safe at recommended doses; however, combination products carry the opioid risk.

Hydrocodone and acetaminophen are excreted into breast milk. Opioids can cause sedation, respiratory depression, and even death in a breastfed infant. Acetaminophen is generally considered safe in breastfeeding at usual doses. Use with caution, monitor infant for sedation, poor feeding, and breathing difficulties. Avoid if possible, or use lowest effective dose for shortest duration.

Safety and efficacy have not been established in pediatric patients. Not recommended for use in children due to the fixed combination and risk of accidental overdose, especially with the opioid component.

Elderly patients may be more sensitive to the analgesic and adverse effects of opioids, including respiratory depression, sedation, and constipation. Start with lower doses and titrate slowly. Monitor renal and hepatic function closely.

• Always counsel patients on the maximum daily dose of acetaminophen (4000 mg, or 3000 mg for chronic use/risk factors) and to check other medications for acetaminophen content.
• Emphasize the risks of addiction, abuse, and misuse, and the importance of secure storage and proper disposal.
• Warn patients about the dangers of combining with alcohol or other CNS depressants.
• Be aware of CYP2D6 poor metabolizers (may have reduced analgesic effect from hydrocodone) and ultra-rapid metabolizers (may have increased opioid effects).
• Constipation is a common and often persistent side effect of opioids; advise patients on preventative measures (e.g., fiber, fluids, stool softeners).
• Consider alternative non-opioid analgesics or non-pharmacological treatments for chronic pain management to minimize opioid exposure.

• NSAIDs (e.g., ibuprofen, naproxen)
• Acetaminophen (single agent)
• Other opioid analgesics (e.g., morphine, hydromorphone, oxycodone)
• Non-pharmacological therapies (e.g., physical therapy, acupuncture, massage, cognitive behavioral therapy)
• Topical analgesics
• Adjuvant analgesics (e.g., gabapentin, pregabalin, duloxetine for neuropathic pain)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the safety of others, never share your medication with anyone, and do not take medication prescribed to someone else.

This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. 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 for clarification.

In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss the availability and use of naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken.

In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When reporting the incident, be prepared to provide details about the medication, including the dose and time it was taken, to ensure you receive appropriate treatment.