Hydrocodone/acetaminophen 10-300 T

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, believed to act primarily through central inhibition of prostaglandin synthesis (COX-3 inhibition) and possibly through modulation of serotonergic descending pathways.

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 or seek immediate 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 urine output
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
+ 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 you experience any of these side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice.

Reporting Side Effects

If you have questions or concerns about side effects, you can:

Call your doctor for medical advice
Report side effects to the FDA at 1-800-332-1088
Submit a report online at https://www.fda.gov/medwatch

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
If you have any of the following health conditions:
+ Respiratory problems, such as asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel obstruction or narrowing
If you are currently taking or have recently taken any of the following medications:
+ Buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
+ Certain antidepressants or Parkinson's disease medications within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
It is crucial to note that this is not an exhaustive list of all potential interactions. Therefore, you must inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.

Long-term or high-dose use of this medication can lead to tolerance, where the drug becomes less effective, and higher doses may be needed to achieve the same effect. If you suspect this is happening, contact your doctor. Do not exceed the prescribed dose.

Prolonged or 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 increase the risk of withdrawal or other severe problems. Follow your doctor's instructions carefully, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.

Do not consume alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal interactions. Also, avoid taking other products that contain acetaminophen, as excessive intake can cause liver damage. Always check the labels of other medications carefully.

Adhere strictly to the prescribed dosage instructions, and do not take more than the recommended daily amount of acetaminophen (up to 4,000 mg per day, or as 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 daily limit or have taken too much acetaminophen, consult your doctor or pharmacist immediately, even if you feel well.

Monitor for signs of liver problems, including 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 right away.

Long-term use of opioid medications can lead to decreased sex hormone levels. If you notice a reduced interest in sex, fertility issues, irregular menstrual periods, or ejaculation problems, inform your doctor.

Taking an opioid medication like this one can, in rare cases, cause a severe adrenal gland problem. Seek medical attention immediately if you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite.

This medication may increase the risk of seizures, particularly in individuals with a history of seizure disorders. Discuss your risk with your doctor.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and potentially harm your baby. Seek medical help immediately if your baby appears overly sleepy, limp, or has breathing difficulties.

• Benzodiazepines and other CNS depressants (concurrent use significantly increases risk of respiratory depression, sedation, coma, and death)
• Alcohol (concurrent use significantly increases risk of respiratory depression, sedation, coma, and death, and hepatotoxicity)
• MAO inhibitors (within 14 days of use, risk of serotonin syndrome, respiratory depression, coma)
• Other acetaminophen-containing products (risk of exceeding maximum daily dose and hepatotoxicity)

• CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir): Increased hydrocodone plasma concentrations, leading to increased opioid effects.
• CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine): Decreased conversion of hydrocodone to hydromorphone, potentially reducing analgesic effect.
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): Decreased hydrocodone plasma concentrations, potentially reducing analgesic effect and increasing withdrawal risk.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans): Risk of serotonin syndrome.
• Anticholinergic drugs (e.g., atropine, scopolamine): Increased risk of urinary retention and severe constipation.
• Muscle relaxants (e.g., carisoprodol, cyclobenzaprine): Increased risk of respiratory depression and sedation.
• Diuretics: Opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.

• Anticoagulants (e.g., warfarin): Acetaminophen may enhance the anticoagulant effect, increasing bleeding risk.
• Cholestyramine: May reduce acetaminophen absorption if given concurrently.
• Lamotrigine: Acetaminophen may reduce lamotrigine levels.
• Zidovudine: Concurrent use with acetaminophen may increase zidovudine toxicity.

• Metoclopramide: May increase acetaminophen absorption rate.

• Excessive sedation
• Dizziness
• Nausea and vomiting
• Constipation
• Itching
• Respiratory depression (slow, shallow breathing)
• Signs of liver injury (yellowing of skin/eyes, dark urine, severe abdominal pain, unusual tiredness)
• Signs of allergic reaction (rash, swelling, difficulty breathing)

Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated. Opioids cross the placenta. Use only if the potential benefit justifies the potential risk to the fetus.

Hydrocodone and its active metabolite, hydromorphone, are present in breast milk. Acetaminophen is also excreted in breast milk. Monitor infants for signs of sedation, respiratory depression, poor feeding, and poor weight gain. Use with caution, if at all, and at the lowest effective dose for the shortest duration.

Contraindicated in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Not recommended for children younger than 12 years of age due to risk of respiratory depression and death. Opioid analgesics carry significant risks in pediatric patients, especially those who are ultra-rapid metabolizers of hydrocodone.

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

• Always counsel patients on the maximum daily dose of acetaminophen (4000 mg from all sources) to prevent liver toxicity.
• Emphasize the risks of addiction, abuse, and misuse, and the importance of safe storage and disposal.
• Warn patients about the dangers of concomitant use with alcohol, benzodiazepines, or other CNS depressants.
• Educate patients on the signs of respiratory depression and how to respond (e.g., call 911, administer naloxone if available).
• Consider opioid-sparing strategies and non-opioid alternatives for pain management whenever possible.
• For chronic pain, consider the risks vs. benefits carefully and implement a comprehensive pain management plan, including regular reassessment and monitoring for aberrant drug-taking behaviors.

• NSAIDs (e.g., ibuprofen, naproxen)
• Acetaminophen (single agent)
• Other opioid analgesics (e.g., morphine, hydromorphone, oxycodone)
• Non-pharmacological therapies (e.g., physical therapy, acupuncture, cognitive behavioral therapy)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, do not share your medication with others, and never take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again each time your prescription is refilled. If you have any questions or concerns about your medication, consult your doctor, pharmacist, or other healthcare provider.

In the event of an overdose, a medication called naloxone can be administered to help treat the condition. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.

In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When seeking help, be prepared to disclose what was taken, the quantity, and the time of the incident to ensure you receive appropriate treatment.