Oxycodone 10mg Immediate Rel Tabs

Manufacturer KVK TECH Active Ingredient Oxycodone Capsules and Tablets(oks i KOE done) Pronunciation oks i KOE done
WARNING: This is an opioid drug. Opioid drugs can put you at risk for drug use disorder. These can lead to overdose and death. You will be watched closely while taking this drug.Severe breathing problems may happen with this drug. The risk is highest when you first start taking this drug or any time your dose is raised. These breathing problems can be deadly. Call your doctor right away if you have slow, shallow, or trouble breathing. Even one dose of this drug may be deadly if it is taken by someone else or by accident, especially in children. If this drug is taken by someone else or by accident, get medical help right away.Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.Severe side effects have happened when opioid drugs were used with benzodiazepines, alcohol, marijuana, other forms of cannabis, or street drugs. This includes severe drowsiness, breathing problems, and death. Benzodiazepines include drugs like alprazolam, diazepam, and lorazepam. If you have questions, talk with the doctor.Many drugs interact with this drug and can raise the chance of side effects like deadly breathing problems. Talk with your doctor and pharmacist to make sure it is safe to use this drug with all of your drugs.Get medical help right away if you feel very sleepy, very dizzy, or if you pass out. Caregivers or others need to get medical help right away if the patient does not respond, does not answer or react like normal, or will not wake up.If you are pregnant or plan to get pregnant, talk with your doctor right away about the benefits and risks of using this drug during pregnancy. Using this drug for a long time during pregnancy may lead to withdrawal in the newborn baby. Withdrawal in the newborn can be life-threatening if not treated. @ COMMON USES: It is used to manage pain when non- opioid pain drugs do not treat your pain well enough or you cannot take them.
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Drug Class
Opioid Analgesic
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Pharmacologic Class
Opioid Agonist
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Pregnancy Category
Not available
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FDA Approved
May 1976
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Oxycodone is a strong pain medicine that belongs to a group of drugs called opioids. It works in your brain to change how your body feels and responds to pain. It is used to treat moderate to severe pain.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions and read all the information provided.

Take this medication by mouth only. Do not inject or snort it, as this can cause severe side effects, including breathing difficulties and overdose, which can be fatal.
For Oxaydo and Roxybond tablets:
+ Swallow the tablets whole without chewing, breaking, or crushing them.
+ If your dose requires more than one tablet, take them one at a time.
+ Do not lick or wet the tablet before placing it in your mouth.
+ Swallow the tablet with a full glass of water immediately after putting it in your mouth.
+ If you have trouble swallowing, consult your doctor.
+ Do not administer this medication through a feeding tube.

Storing and Disposing of Your Medication

Store this medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep this medication in a secure location where children and pets cannot access it, and where others cannot easily find it. Consider using a locked box or area.
Dispose of unused or expired medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so. Consult your pharmacist for guidance on the best disposal method, and explore potential drug take-back programs in your area.

Missing a Dose

If you take this medication regularly and miss a dose, take it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at once or extra doses.
* If you take this medication as needed, do not take it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Do not drink alcohol or use other sedating medications (like tranquilizers or sleeping pills) while taking oxycodone, as this can lead to dangerous side effects, including severe drowsiness and breathing problems.
  • Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
  • To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and consider using a stool softener or laxative as recommended by your doctor.
  • Store this medication securely, out of reach of children and pets, to prevent accidental ingestion, which can be fatal.

Dosing & Administration

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Adult Dosing

Standard Dose: 5-15 mg orally every 4-6 hours as needed for pain
Dose Range: 5 - 30 mg

Condition-Specific Dosing:

acute_pain: Initial 5-15 mg every 4-6 hours; titrate to effect.
chronic_pain: Individualize dosing; consider conversion from other opioids cautiously.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for general use; limited data for post-operative pain (0.1-0.2 mg/kg/dose every 4-6 hours, max 10 mg/dose) in children >1 year.
Adolescent: Typically adult dosing for adolescents weighing >50 kg; otherwise, consider pediatric dosing guidelines.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, but monitor closely.
Moderate: Reduce initial dose by 50% and titrate cautiously. Extend dosing interval.
Severe: Reduce initial dose by 50% or more and titrate cautiously. Extend dosing interval.
Dialysis: Supplemental dose after dialysis may be needed, but data are limited. Monitor closely.

Hepatic Impairment:

Mild: Reduce initial dose by 50% and titrate cautiously.
Moderate: Reduce initial dose by 50-67% and titrate cautiously.
Severe: Reduce initial dose by 50-67% or more and titrate cautiously.
Confidence: Medium

Pharmacology

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Mechanism of Action

Oxycodone is a full opioid agonist that binds to mu-opioid receptors in the central nervous system (CNS), periphery, and gastrointestinal tract. This binding inhibits ascending pain pathways, altering the perception of and response to pain. It also produces generalized CNS depression, including respiratory depression, sedation, and euphoria.
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Pharmacokinetics

Absorption:

Bioavailability: 60-87%
Tmax: 1-1.5 hours
FoodEffect: Food can delay Tmax but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: 2.6 L/kg
ProteinBinding: 45%
CnssPenetration: Yes

Elimination:

HalfLife: 3-4.5 hours
Clearance: Not available
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: Approximately 8-14% (as unchanged oxycodone)
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Pharmacodynamics

OnsetOfAction: 10-30 minutes
PeakEffect: 1 hour
DurationOfAction: 3-6 hours

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; REMS; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.
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Side Effects

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 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
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
+ Sleep apnea (breathing problems during sleep)
Urination problems
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 Rare but Serious Condition

If you take this medication with certain other drugs, you may be at risk for serotonin syndrome, a potentially life-threatening 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, or 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. Seek medical help immediately if you experience:

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

Long-term Use and 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 any side effects or only 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, or decreased appetite

If any of these side effects bother you or persist, contact your doctor or seek medical help. This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor.

Reporting Side Effects

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Slow or shallow breathing
  • Extreme drowsiness or difficulty waking up
  • Dizziness or lightheadedness when standing up
  • Confusion
  • Pinpoint pupils
  • Severe constipation or abdominal pain
  • Hives, rash, or swelling of the face, lips, tongue, or throat (signs of allergic reaction)
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Before Using This Medicine

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
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of severely high blood pressure
If you are currently taking any of the following medications: buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to ensure it is safe for you to take this medication. Do not initiate, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

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.

Dosage and Administration
Do not exceed the dose prescribed by your doctor. Taking more than the recommended dose, or taking it more frequently or for a longer period than directed, may increase the risk of severe side effects.

Interactions with Other Medications
Before taking this medication with other strong pain medications or using a pain patch, consult your doctor. If you experience worsening pain, increased sensitivity to pain, or new pain, contact your doctor immediately. Do not take more than the prescribed dose.

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, consult your doctor. Do not take more than the prescribed dose.

Dependence and Withdrawal
Regular use of opioid medications like this one may cause dependence. Suddenly stopping or reducing the dose may increase the risk of withdrawal or other severe problems. Consult your doctor before changing your dose or stopping the medication, and follow their instructions. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.

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

Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Consult your doctor to determine if you are at a higher risk of seizures while taking this medication.

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

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

Overdose Symptoms:

  • Slowed or stopped breathing (respiratory depression)
  • Extreme drowsiness or unresponsiveness
  • Cold, clammy skin
  • Pinpoint pupils
  • Limp muscles
  • Bluish discoloration of lips and fingernails
  • Loss of consciousness
  • Coma

What to Do:

Seek immediate emergency medical attention. Call 911 or your local emergency number. Administer naloxone if available and trained to do so. Call 1-800-222-1222 for poison control advice.

Drug Interactions

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Contraindicated Interactions

  • Concomitant use with benzodiazepines or other CNS depressants (unless benefits outweigh risks, and only with careful monitoring)
  • Patients with significant respiratory depression
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Known or suspected paralytic ileus
  • Hypersensitivity to oxycodone
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Major Interactions

  • Other CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, other opioids): Increased risk of respiratory depression, profound sedation, coma, and death.
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice): Increase oxycodone plasma concentrations, potentially leading to increased opioid effects and respiratory depression.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): Decrease oxycodone plasma concentrations, potentially leading to reduced efficacy or withdrawal symptoms.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, MAOIs): Risk of serotonin syndrome.
  • Mixed agonist/antagonist opioids (e.g., butorphanol, nalbuphine, pentazocine): May reduce the analgesic effect of oxycodone and/or precipitate withdrawal symptoms.
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Moderate Interactions

  • Anticholinergics (e.g., atropine, scopolamine): Increased risk of severe constipation and/or paralytic ileus.
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine): May decrease the formation of oxymorphone, potentially reducing the analgesic effect in some patients.
  • Diuretics: Opioids may reduce the efficacy of diuretics by causing the release of antidiuretic hormone.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Pain assessment (intensity, location, quality)

Rationale: To establish baseline pain level and guide initial dosing.

Timing: Prior to initiation of therapy

Respiratory rate and depth

Rationale: To assess baseline respiratory function and identify risk for respiratory depression.

Timing: Prior to initiation of therapy

Level of consciousness/sedation

Rationale: To assess baseline mental status and identify risk for excessive sedation.

Timing: Prior to initiation of therapy

Renal and hepatic function tests (e.g., BUN, creatinine, LFTs)

Rationale: To identify potential impairment that may require dose adjustment.

Timing: Prior to initiation of therapy, especially in patients with suspected impairment

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Routine Monitoring

Pain assessment

Frequency: Regularly, based on clinical need (e.g., before each dose, daily for chronic pain)

Target: Acceptable pain level as defined by patient and clinician

Action Threshold: Uncontrolled pain or adverse effects requiring dose adjustment

Respiratory rate and depth

Frequency: Regularly, especially during initiation and dose titration (e.g., every 1-2 hours initially, then daily)

Target: >10-12 breaths/minute, regular rhythm

Action Threshold: <10 breaths/minute, shallow breathing, or signs of respiratory distress

Level of consciousness/sedation (e.g., Pasero Opioid-Induced Sedation Scale)

Frequency: Regularly, especially during initiation and dose titration (e.g., every 1-2 hours initially, then daily)

Target: Alert or mildly drowsy, easily aroused

Action Threshold: Difficult to arouse, somnolent, or unarousable

Bowel function (e.g., frequency of bowel movements, presence of constipation)

Frequency: Daily

Target: Regular bowel movements

Action Threshold: Constipation, abdominal distension, or signs of ileus

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Symptom Monitoring

  • Excessive sedation
  • Dizziness
  • Nausea
  • Vomiting
  • Constipation
  • Pruritus
  • Respiratory depression (slow, shallow breathing)
  • Confusion
  • Pinpoint pupils
  • Signs of opioid withdrawal (if abruptly discontinued)

Special Patient Groups

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Pregnancy

Use during pregnancy is generally not recommended due to the risk of neonatal opioid withdrawal syndrome (NOWS) in the newborn. It should only be used if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for congenital malformations, though data are mixed and often confounded by polysubstance use.
Second Trimester: Risk of fetal growth restriction and preterm birth.
Third Trimester: High risk of neonatal opioid withdrawal syndrome (NOWS) if used chronically. Symptoms include irritability, hyperactivity, abnormal sleep patterns, high-pitched cry, tremor, vomiting, diarrhea, and poor feeding.
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Lactation

Oxycodone is excreted into breast milk. Monitor breastfed infants for signs of sedation, respiratory depression, poor feeding, and poor weight gain. If chronic use is necessary, consider alternative feeding methods or close monitoring.

Infant Risk: Moderate risk (L3). Potential for sedation, respiratory depression, and withdrawal symptoms in the infant if the mother's dose is high or if the infant is particularly sensitive.
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Pediatric Use

Safety and efficacy have not been established for general use in pediatric patients, especially those under 1 year of age. Use in older children for acute pain should be done with extreme caution, individualized dosing, and close monitoring due to variability in metabolism and increased sensitivity to respiratory depression.

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Geriatric Use

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.

Clinical Information

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Clinical Pearls

  • Oxycodone IR has a rapid onset and relatively short duration, making it suitable for acute pain or breakthrough pain in chronic pain management.
  • Always counsel patients on the risks of addiction, abuse, and misuse, and the importance of safe storage and disposal.
  • Co-prescribing naloxone should be considered for patients at increased risk of opioid overdose (e.g., history of overdose, concomitant CNS depressant use, higher doses).
  • Educate patients on the signs of respiratory depression and overdose, and when to seek emergency medical attention.
  • Prophylactic treatment for opioid-induced constipation should be initiated concurrently with oxycodone therapy for chronic use.
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Alternative Therapies

  • Other opioid analgesics (e.g., hydrocodone, morphine, hydromorphone, fentanyl)
  • Non-opioid analgesics (e.g., NSAIDs like ibuprofen, naproxen; acetaminophen)
  • Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants for neuropathic pain)
  • Regional anesthesia
  • Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
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Cost & Coverage

Average Cost: $10-$30 per 30 tablets (10mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health issues 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, which 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 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 seeking help, be prepared to provide information about the substance involved, the quantity taken, and the time of the incident.