Hydrocodone/acetaminophen 5-300 Tb

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 other mechanisms involving serotonergic pathways.

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 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

Most people taking this medication will not experience severe side effects. However, some may encounter mild or moderate side effects. If you experience any of the following, contact your doctor if they bother you or do not go away:

Constipation
Upset stomach or vomiting
Stomach pain or heartburn
Dizziness
Feeling sleepy, tired, or weak
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.

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:
+ Respiratory problems like 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, 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 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 list is not exhaustive, and it is your responsibility to verify the safety of taking this medication with all your drugs and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.

Important Warnings and Cautions

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

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When getting up from a sitting or lying down position, rise slowly to minimize the risk of dizziness or fainting. Be cautious when using stairs.

Long-term or high-dose use of this medication can lead to tolerance, where the medication may not work as effectively, and you may require higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact your doctor. Do not exceed the prescribed dose.

Prolonged or regular use of opioid medications like this one can result in dependence. Suddenly stopping or reducing the dose may increase the risk of withdrawal or other severe problems. Consult your doctor before making any changes to your dosage. Follow your doctor's instructions carefully and report any adverse effects, such as increased pain, mood changes, suicidal thoughts, or other concerns.

Do not consume alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal interactions.

Avoid taking other products that contain acetaminophen, as excessive acetaminophen consumption can cause liver damage. Carefully review labels and follow the directions provided. Do not take more than the recommended daily dose of acetaminophen (up to 4,000 mg per day, as directed by your doctor). Certain individuals, such as those 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 suspect you have taken too much acetaminophen, contact your doctor immediately, even if you feel well.

Monitor for signs of liver problems, such as dark urine, fatigue, decreased appetite, nausea, stomach pain, pale stools, vomiting, or yellow skin and eyes. If you experience any of these symptoms, contact your doctor promptly.

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 issues, inform your doctor.

Taking an opioid medication like this one can increase the risk of 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.

This medication may increase the risk of seizures in certain individuals, including those with a history of seizures. Discuss your risk of seizures 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 attention immediately if your baby appears overly sleepy, limp, or has difficulty breathing.

• Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy (risk of serotonin syndrome, respiratory depression, coma)
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) in patients who are CYP2D6 ultra-rapid metabolizers (risk of increased hydrocodone levels and respiratory depression)
• Other opioid analgesics (additive CNS depression, respiratory depression)
• Alcohol (additive CNS depression, increased risk of hepatotoxicity)

• Benzodiazepines and other CNS depressants (e.g., sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines): Increased risk of profound sedation, respiratory depression, coma, and death.
• CYP3A4 inhibitors (moderate to strong): Increased hydrocodone plasma concentrations, leading to increased or prolonged 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 leading to withdrawal symptoms.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol): 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.

• Warfarin: Acetaminophen may enhance the anticoagulant effect of warfarin, increasing INR.
• Lamotrigine: Acetaminophen may reduce lamotrigine concentrations, potentially leading to loss of seizure control.
• Cholestyramine: May reduce acetaminophen absorption if given within 1 hour.
• Zidovudine: Acetaminophen may increase zidovudine plasma concentrations.

• Not available

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

Use generally not recommended, especially prolonged use, due to risk of neonatal opioid withdrawal syndrome (NOWS) and potential for fetal harm. Benefits must outweigh risks.

Hydrocodone and acetaminophen are excreted into breast milk. Use generally not recommended due to risk of serious adverse reactions in breastfed infants (e.g., sedation, respiratory depression, poor feeding). If use is necessary, monitor infant closely for signs of sedation, difficulty breathing, or poor feeding. Avoid in mothers who are CYP2D6 ultra-rapid metabolizers.

Safety and efficacy not established in pediatric patients under 6 years of age. Use in children 6 years and older is generally not recommended due to the risk of respiratory depression and acetaminophen hepatotoxicity. Opioid-containing products should be used with extreme caution and only if alternative pain management strategies are inadequate. Individualize dosing carefully based on weight and age, if used.

Use with caution. 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.

• This combination product carries significant risks due to both the opioid (hydrocodone) and acetaminophen components. Always consider the total daily dose of acetaminophen from all sources to avoid exceeding 4000 mg (or 3000 mg in some guidelines/products) to prevent hepatotoxicity.
• Due to the opioid component, this drug has a high potential for abuse, addiction, and diversion. Prescribe the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
• Counsel patients extensively on the risks of respiratory depression, especially when combined with other CNS depressants like benzodiazepines or alcohol.
• Be aware of CYP2D6 polymorphism: ultra-rapid metabolizers may experience increased opioid effects, while poor metabolizers may have reduced efficacy.
• Naloxone should be considered for co-prescription in patients at high risk of opioid overdose.
• Educate patients on safe storage and disposal of unused medication.

• NSAIDs (e.g., ibuprofen, naproxen) for mild to moderate pain
• Acetaminophen alone for mild pain
• Other non-opioid analgesics (e.g., gabapentin, pregabalin for neuropathic pain)
• Topical analgesics
• Physical therapy
• Acupuncture
• Cognitive behavioral therapy (CBT)

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 to someone else.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is important to read this guide carefully and review it again each time 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 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 seeking help, be prepared to provide information about the substance taken, the quantity, and the time of the incident.