Endocet 10/325mg Tablets (yellow)

Oxycodone is a full mu-opioid receptor agonist, producing analgesia by binding to opioid receptors in the central nervous system (CNS) and altering the perception and response to pain. Acetaminophen produces analgesia by inhibiting prostaglandin synthesis in the CNS and peripherally blocks pain impulse generation; it also acts on the hypothalamic heat-regulating center to produce antipyresis.

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 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 liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of low blood sugar, such as:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Urination problems, including inability to pass urine or changes in urine output
Severe dizziness or fainting
Breathing difficulties, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Confusion
Hallucinations (seeing or hearing things that are not there)
Mood changes
Severe constipation or stomach pain, which may be signs of a severe bowel problem
Abnormal heartbeat, including fast, slow, or irregular rhythms
Fever, chills, sore throat, unexplained bruising or bleeding, or feeling extremely tired or weak
Seizures
Chest pain
Trouble walking
Severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), characterized by:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Adrenal gland problems, which may cause:
+ Extreme tiredness or weakness
+ Fainting
+ Severe dizziness
+ Upset stomach
+ Vomiting
+ Decreased appetite

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Constipation
Stomach pain
Dizziness
Sleepiness
Tiredness
Weakness
Headache
Upset stomach
Vomiting

Reporting 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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, such as:
+ Respiratory problems, including asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage or narrowing
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
If you are currently taking any of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine

Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, 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
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, 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 may lead to withdrawal or severe problems. Follow your doctor's instructions carefully and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.

Interactions with Other Substances
Do not consume alcohol or products containing alcohol while taking this medication, as it may cause unsafe and potentially fatal effects.

Acetaminophen Precautions
Avoid taking other products that contain acetaminophen, and carefully check the labels of any medications or supplements you are using. Exceeding the recommended daily dose of acetaminophen can cause liver damage. Follow the instructions exactly, and do not take more than 4,000 mg (milligrams) of acetaminophen per day, unless 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 dose for you, consult your doctor or pharmacist. If you have taken too much acetaminophen, contact your doctor immediately, even if you feel well.

Serotonin Syndrome Warning
A potentially life-threatening condition called serotonin syndrome can occur if you take this medication with certain other drugs. Seek medical attention immediately if you experience agitation, balance problems, confusion, hallucinations, fever, abnormal heartbeat, flushing, muscle twitching or stiffness, seizures, shivering or shaking, excessive sweating, severe diarrhea, nausea, vomiting, or severe headache.

Hormonal Effects
Long-term use of opioid medications like this one may lead to decreased sex hormone levels. If you experience a decrease in libido, fertility problems, irregular menstrual periods, or ejaculation difficulties, contact your doctor.

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.

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

Breastfeeding Warning
This medication passes into breast milk and may harm your baby. If you are breastfeeding, contact your doctor. Seek medical help immediately if your baby appears overly sleepy, limp, or has breathing difficulties.

• Monoamine Oxidase Inhibitors (MAOIs) (within 14 days of use) - risk of serotonin syndrome or severe respiratory depression
• Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) - risk of increased oxycodone plasma concentrations and respiratory depression
• Strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - risk of decreased oxymorphone formation and potentially reduced efficacy, or increased oxycodone levels if CYP3A4 is also inhibited

• Other CNS depressants (e.g., benzodiazepines, other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants) - risk of profound sedation, respiratory depression, coma, and death
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans) - risk of serotonin syndrome
• Anticholinergic drugs (e.g., atropine, scopolamine) - risk of paralytic ileus and/or urinary retention
• Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol) - may reduce analgesic effect and/or precipitate withdrawal symptoms
• Opioid antagonists (e.g., naltrexone, naloxone) - may precipitate withdrawal symptoms
• Drugs that affect gastric emptying (e.g., metoclopramide, propantheline) - may alter absorption of oxycodone

• Moderate CYP3A4 inhibitors/inducers
• Moderate CYP2D6 inhibitors/inducers
• Hepatotoxic drugs (e.g., isoniazid, methotrexate) - increased risk of acetaminophen-induced hepatotoxicity
• Warfarin - increased risk of bleeding with chronic high-dose acetaminophen

• Not typically listed as minor for this combination due to significant risks associated with major/contraindicated interactions.

• Respiratory depression (slow, shallow breathing)
• Excessive sedation or somnolence
• Confusion or disorientation
• Pinpoint pupils
• Nausea and vomiting
• Constipation
• Pruritus (itching)
• Dizziness or lightheadedness
• Signs of liver injury (yellowing of skin/eyes, dark urine, severe abdominal pain, fatigue)

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

Oxycodone is excreted into breast milk and can cause serious adverse reactions in breastfed infants, including sedation and respiratory depression. Acetaminophen is generally considered safe for use during breastfeeding at usual doses. Due to the oxycodone component, it is generally not recommended for use in breastfeeding mothers. If use is unavoidable, monitor the infant closely for signs of sedation, difficulty feeding, and breathing problems.

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended due to the risks of respiratory depression and potential for overdose, especially in very young children. If used in adolescents, extreme caution and careful monitoring are required.

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 CNS and respiratory depression.

• Always counsel patients on the maximum daily dose of acetaminophen (4000 mg, or 3000 mg for chronic use/hepatic risk) to prevent hepatotoxicity.
• Emphasize the risk of addiction, abuse, and misuse, and the importance of proper storage and disposal.
• Educate patients on the signs of respiratory depression and the importance of seeking immediate medical attention.
• Prophylactic treatment for opioid-induced constipation should be initiated at the start of therapy.
• Caution patients about concomitant use of alcohol or other CNS depressants.
• Consider prescribing naloxone for patients at increased risk of opioid overdose (e.g., history of overdose, concomitant benzodiazepine use, higher doses).

• Non-opioid analgesics (e.g., NSAIDs like ibuprofen, naproxen; celecoxib)
• Other opioid analgesics (e.g., morphine, hydromorphone, fentanyl - for severe pain)
• Tramadol
• Non-pharmacological pain management (e.g., physical therapy, acupuncture, massage, heat/cold therapy, cognitive behavioral therapy)

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 each time 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. 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 reporting the incident, be prepared to provide the necessary information, including what was taken, how much, and when it happened, to ensure prompt and effective treatment.