Hydrocodone/acetaminophen 10-325 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 by inhibiting prostaglandin synthesis in the CNS and possibly through other central mechanisms.

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. It is essential to contact your doctor or seek immediate medical attention if you experience any of the following symptoms:

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
Note: Some allergic reactions can be life-threatening.
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
Clammy skin
Excessive sweating
Confusion
Difficulty walking
Severe constipation or stomach pain, which may indicate a severe bowel problem
Hearing loss or changes in hearing
Chest pain or pressure
Abnormal heartbeat (fast or slow)
Breathing difficulties, including:
+ 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
Note: These skin reactions can be life-threatening. Seek medical help immediately if you experience:
+ Red, swollen, blistered, or peeling skin
+ Skin irritation (with or without fever)
+ Red or irritated eyes
+ Sores in your mouth, throat, nose, or eyes
Serotonin syndrome, a potentially life-threatening condition, may occur when taking this medication with certain other drugs. Seek medical help immediately if you experience:
+ 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

Most people experience no side effects or only mild side effects while taking this medication. However, if you experience any of the following side effects, contact your doctor or seek medical help if they bother you or do not go away:

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

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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
Current or recent use of specific medications, such as:
+ Buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
+ Certain antidepressants or Parkinson's disease medications taken within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline (as this may lead to severely high blood pressure)
All your medications, including prescription and over-the-counter drugs, natural products, and vitamins, to ensure safe use with this medication

Please note that this is not an exhaustive list of potential interactions. It is crucial to consult with your doctor and pharmacist to verify the safety of taking this medication with your existing health conditions and medications. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

Important Warnings and Cautions

Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position. Be cautious when climbing stairs.

Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, and higher doses may be required to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose.

Additionally, long-term or regular use of opioid medications like this one may 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 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 may 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 may cause liver damage. Follow the dosage instructions precisely, and do not take more than 4,000 mg (milligrams) of acetaminophen per day unless directed by your doctor. Certain individuals, such as those with liver problems or children, may require lower doses. If you are unsure about the safe dosage, consult your doctor or pharmacist. If you 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 may lead to decreased sex hormone levels. If you experience a decrease in libido, fertility problems, irregular menstrual periods, or ejaculation difficulties, inform your doctor.

Additionally, taking an opioid medication like this one may cause a rare but severe adrenal gland problem. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.

Seizure Risk
This medication may increase the risk of seizures in some individuals, particularly those with a history of seizures. Discuss your risk with your doctor.

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

Breastfeeding Warning
If you are breastfeeding, inform your doctor, as this medication passes into breast milk and may harm your baby. If your baby appears excessively sleepy, limp, or has breathing difficulties, seek medical attention immediately.

• Other acetaminophen-containing products (risk of overdose)
• Monoamine Oxidase Inhibitors (MAOIs) or use within 14 days of MAOI therapy (risk of serotonin syndrome, respiratory depression, coma)

• 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.
• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - decreased hydrocodone plasma concentrations, leading to decreased opioid efficacy and potential withdrawal.
• CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - decreased conversion of hydrocodone to hydromorphone, potentially reducing analgesic effect.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol, fentanyl, St. John's Wort) - risk of serotonin syndrome.
• Anticholinergic drugs (e.g., atropine, scopolamine) - increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

• Diuretics - opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
• Antihypertensives - additive hypotensive effects.
• P-glycoprotein inhibitors (e.g., amiodarone, verapamil) - may increase hydrocodone exposure.

• Not available

• Pain relief efficacy
• Sedation level
• Respiratory depression (slow, shallow breathing)
• Constipation
• Nausea/vomiting
• Dizziness/lightheadedness
• Itching
• Signs of acetaminophen hepatotoxicity (e.g., yellowing skin/eyes, dark urine, severe abdominal pain, unusual tiredness)
• Signs of opioid withdrawal (if abruptly discontinued after prolonged use)

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

Both hydrocodone and acetaminophen are excreted into breast milk. Opioids can cause sedation, respiratory depression, and death in a breastfed infant. Monitor infants for signs of sedation, difficulty feeding, and breathing problems. Acetaminophen is generally considered compatible with breastfeeding at usual doses, but caution is advised with combination products.

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended due to the risk of serious adverse events, including fatal respiratory depression, especially in children with certain risk factors (e.g., sleep apnea, obesity, severe pulmonary disease).

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 verify the strength of acetaminophen in combination products to avoid exceeding the maximum daily dose from all sources.
• Educate patients thoroughly on the risks of addiction, abuse, and misuse, and the importance of safe storage and disposal.
• Counsel patients on the signs of respiratory depression and the importance of seeking immediate medical attention.
• Emphasize the danger of combining with alcohol or other CNS depressants.
• For chronic pain management, consider non-opioid alternatives or lower-strength opioid combinations first.
• Be aware of potential drug interactions, especially with CYP3A4 inhibitors/inducers and CYP2D6 inhibitors, which can alter hydrocodone levels and effects.
• Provide a bowel regimen to prevent opioid-induced constipation.

• NSAIDs (e.g., ibuprofen, naproxen, celecoxib) for mild to moderate pain
• Acetaminophen (single agent) for mild pain/fever
• Other non-opioid analgesics (e.g., gabapentin, pregabalin for neuropathic pain)
• Topical analgesics
• Physical therapy
• Cognitive behavioral therapy
• Interventional pain procedures

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 safe use, do not share your medication with others, and never take someone else's medication.

This medication is accompanied by a Medication Guide, which provides crucial information about its safe and effective use. It is essential 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 used as an emergency treatment. 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 quantity, 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, provide as much information as possible about the medication, including the amount taken and the time of ingestion.