Oxycodone 5mg Immediate Rel Caps

Oxycodone is a full opioid agonist that acts primarily at mu-opioid receptors in the central nervous system (CNS). It produces analgesia by mimicking the actions of endogenous opioid peptides, leading to inhibition of ascending pain pathways, altering the perception of and response to pain, and producing generalized CNS depression.

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 low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or passing out
Feeling confused
Severe constipation or stomach pain, which may indicate a severe bowel problem
Breathing difficulties, such as:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Breathing problems during sleep (sleep apnea)
Trouble passing urine
Abnormal heartbeat (fast, slow, or irregular)
Seizures
Shakiness
Changes in eyesight
Chest pain or pressure
Hallucinations (seeing or hearing things that are not there)
Mood changes
Memory problems or loss
Trouble walking or speaking
Swelling in the arms or legs
Fever

Serotonin Syndrome: A Potentially Life-Threatening Condition

If you take this medication with certain other drugs, you may be at risk for serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:

Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach
Vomiting
Severe headache

Adrenal Gland Problems: A Rare but Serious Condition

Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Contact your doctor right away if you experience:

Extreme tiredness or weakness
Passing out
Severe dizziness
Upset stomach
Vomiting
Decreased appetite

Long-Term Use and Sex Hormone Levels

Long-term use of an opioid medication may affect sex hormone levels. If you experience any of the following, contact your doctor:

Decreased interest in sex
Fertility problems
No menstrual period
Ejaculation problems

Other Possible Side Effects

While many people may not experience side effects or may only have minor ones, it's essential to be aware of the following:

Feeling dizzy, sleepy, tired, or weak
Headache
Trouble sleeping
Itching
Dry mouth
Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite

If you're concerned about any side effects or have questions, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or visit 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, such as asthma, breathing difficulties, or sleep apnea
+ Elevated carbon dioxide levels in the blood
+ Stomach or bowel blockage or narrowing
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of severely high blood pressure
Current use of certain medications, such as buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine

This list is not exhaustive, and it is crucial to discuss all your medications (prescription and over-the-counter), natural products, vitamins, and health problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

Important Information About Your Medication

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

Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and other tasks that require your full attention. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be cautious when climbing stairs.

Dosage Instructions
Adhere strictly to the dosage instructions provided by your doctor. Do not exceed the recommended dose, frequency, or duration of treatment, as this may increase the risk of severe side effects.

Interactions with Other Medications
Before taking this medication with other strong pain relievers or using a pain patch, consult your doctor to avoid potential adverse interactions.

Monitoring Your Condition
If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not take more medication than prescribed.

Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, where the medication becomes less effective, or dependence. If you find that the medication is no longer working as well as it should, consult your doctor. Do not increase your dose without medical guidance. Stopping or reducing the dose of this medication abruptly may lead to withdrawal symptoms or other severe problems. Always follow your doctor's instructions for dose adjustments.

Special Warnings
Combining this medication with alcohol or products containing alcohol can have unsafe and potentially fatal consequences. Avoid such combinations altogether.

Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with a history of seizure disorders. Discuss your risk factors 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
Inform your doctor if you are breastfeeding, as this medication can pass into breast milk and potentially harm your baby. Seek immediate medical attention if your baby exhibits excessive sleepiness, limpness, or breathing difficulties.

• Monoamine Oxidase Inhibitors (MAOIs) within 14 days (risk of serotonin syndrome or severe respiratory depression)
• Concomitant use with benzodiazepines or other CNS depressants (unless benefits outweigh risks, due to profound sedation, respiratory depression, coma, and death)

• Other CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics, general anesthetics, phenothiazines, skeletal muscle relaxants, tricyclic antidepressants, other opioids) - increased risk of respiratory depression, hypotension, profound sedation, coma, death.
• CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice) - increased oxycodone plasma concentrations, leading to increased opioid effects.
• CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) - may decrease formation of oxymorphone, potentially reducing analgesic effect in some patients.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol, fentanyl, St. John's Wort) - risk of serotonin syndrome.
• Mixed agonist/antagonist and partial agonist opioids (e.g., butorphanol, nalbuphine, pentazocine, buprenorphine) - may precipitate withdrawal symptoms or reduce analgesic effect.

• CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort) - decreased oxycodone plasma concentrations, potentially leading to reduced efficacy or withdrawal symptoms.
• Anticholinergics (e.g., atropine, scopolamine) - increased risk of urinary retention and/or severe constipation.
• Diuretics - opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.

• Not specifically categorized as minor for oxycodone due to the severity of potential interactions.

• Respiratory depression (slow, shallow breathing)
• Excessive sedation/drowsiness
• Dizziness
• Nausea/vomiting
• Constipation
• Pruritus (itching)
• Confusion
• Pinpoint pupils
• Hypotension
• Signs of opioid withdrawal (if abruptly discontinued after prolonged use)

Use during pregnancy is generally not recommended unless the potential benefits outweigh the risks. Prolonged use during pregnancy can lead to neonatal opioid withdrawal syndrome (NOWS) in the newborn.

Oxycodone is excreted into breast milk. While generally considered compatible with breastfeeding for short-term, low-dose use, close monitoring of the infant for sedation and respiratory depression is crucial. Avoid if possible, especially in preterm infants or those with respiratory compromise.

Safety and efficacy have not been established in pediatric patients. Use in children should be limited to specific circumstances under expert supervision, with careful dose titration and monitoring due to increased sensitivity to respiratory depression.

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

• Oxycodone IR is typically used for acute pain or breakthrough pain in patients on chronic opioid therapy.
• Always assess the patient's opioid tolerance before initiating therapy to avoid overdose.
• Educate patients and caregivers thoroughly on the risks of respiratory depression, accidental ingestion, and safe storage.
• Implement a bowel regimen (e.g., stimulant laxative + stool softener) at the start of opioid therapy to prevent opioid-induced constipation.
• Consider co-prescribing naloxone for patients at high risk of opioid overdose (e.g., history of overdose, higher doses, concomitant CNS depressants).
• Tapering is necessary when discontinuing oxycodone after prolonged use to prevent withdrawal symptoms.

• Other opioid analgesics (e.g., hydrocodone, morphine, hydromorphone, fentanyl)
• Non-opioid analgesics (e.g., NSAIDs, acetaminophen)
• Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants for neuropathic pain)
• Non-pharmacological pain management (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, never share your medication with others or 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 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 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.