Hydrocod/acetaminophen 10-325/15ml

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 when 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
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, which can be life-threatening
Signs of severe skin reactions include:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Skin irritation
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
A potentially life-threatening condition called serotonin syndrome may occur if you take 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

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that concern you, contact your doctor or seek medical attention:

Constipation
Upset stomach or vomiting
Stomach pain or heartburn
Dizziness
Drowsiness
Fatigue
Weakness
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.
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 they may cause a sudden increase in blood pressure
All your prescription and over-the-counter medications, natural products, vitamins, and health problems. This is not an exhaustive list, and it is crucial to discuss all your medications and health conditions with your doctor to ensure safe use.

Remember to consult your doctor and pharmacist before starting, stopping, or changing the dose of any medication to guarantee your safety while taking this drug.

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 tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and 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 needed 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 sudden changes 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. Carefully check the labels of other medications and ask your doctor or pharmacist if you are unsure.

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
Monitor for 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, including 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.

Breast-Feeding
If you are breast-feeding, inform your doctor, as this medication can pass into breast milk and harm your baby. If your baby appears extremely sleepy, limp, or has breathing difficulties, seek medical help immediately.

• Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy (risk of serotonin syndrome, severe respiratory depression)
• Other acetaminophen-containing products (risk of overdose)
• Severe respiratory depression or acute/severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Known or suspected paralytic ileus

• Other CNS depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, 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.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol, fentanyl) - risk of serotonin syndrome.
• Mixed agonist/antagonist and partial agonist opioids (e.g., pentazocine, nalbuphine, butorphanol, buprenorphine) - may precipitate withdrawal symptoms or reduce analgesic effect.
• Drugs that affect gastric emptying (e.g., anticholinergics) - may alter absorption of hydrocodone.
• Hepatotoxic drugs (e.g., isoniazid, methotrexate) - increased risk of acetaminophen-induced hepatotoxicity.

• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin) - decreased hydrocodone plasma concentrations, potentially reducing analgesic effect and leading to withdrawal in opioid-dependent patients.
• Anticholinergic drugs - increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
• Diuretics - opioids may reduce the efficacy of diuretics by causing the release of antidiuretic hormone.
• Anticoagulants (e.g., warfarin) - acetaminophen may enhance the anticoagulant effect, increasing bleeding risk (especially with chronic high doses).

• Cholestyramine - reduces acetaminophen absorption if given within 1 hour.

• Respiratory depression (slow, shallow breathing)
• Excessive sedation or somnolence
• Dizziness, lightheadedness
• Nausea, vomiting
• Constipation
• Pruritus (itching)
• Signs of liver injury (yellowing skin/eyes, dark urine, severe abdominal pain, unusual tiredness)
• Signs of allergic reaction (rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)

Generally not recommended during pregnancy, especially in the third trimester, due to potential for neonatal opioid withdrawal syndrome (NOWS) and respiratory depression in the newborn. Acetaminophen is generally considered safe for occasional use during pregnancy, but the combination with hydrocodone outweighs this.

Hydrocodone and its active metabolite (hydromorphone) are excreted into breast milk. Acetaminophen is also excreted but in small amounts. Due to the risk of serious adverse reactions in breastfed infants (e.g., sedation, respiratory depression, poor feeding), use is generally not recommended. If use is unavoidable, monitor the infant closely for signs of sedation, difficulty breathing, or poor feeding. Consider alternative analgesics.

Use in children younger than 12 years is generally not recommended due to the risks of hydrocodone, especially respiratory depression. For adolescents 12 years and older, use with caution and monitor closely. Avoid in adolescents undergoing tonsillectomy/adenoidectomy due to increased risk of respiratory depression.

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, as these may be impaired in older adults, affecting drug clearance.

• This product contains acetaminophen; ensure patients are not taking other acetaminophen-containing products to avoid exceeding the maximum daily dose and risking hepatotoxicity.
• Counsel patients on the risks of addiction, abuse, and misuse, and the importance of proper storage and disposal.
• Warn patients about the dangers of combining this medication with alcohol or other CNS depressants.
• Be aware of the potential for neonatal opioid withdrawal syndrome if used during pregnancy.
• Monitor for signs of respiratory depression, especially during initiation or dose escalation.
• Opioid-induced constipation is common; proactively manage with bowel regimens.
• Genetic variations in CYP2D6 can affect hydrocodone metabolism, leading to varied analgesic effects or increased toxicity.

• NSAIDs (e.g., ibuprofen, naproxen) for mild to moderate pain
• Non-opioid analgesics (e.g., acetaminophen alone)
• Other opioids (e.g., morphine, hydromorphone) for severe pain, if appropriate
• Regional anesthesia or nerve blocks
• Non-pharmacological therapies (e.g., physical therapy, heat/cold therapy, massage, 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 counteract the effects. 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.