Oxycodone 30mg 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 works in your brain to change how your body feels and responds to pain. It's used for moderate to severe pain. Because it's a strong medicine, it can be habit-forming and has serious risks, including breathing problems.
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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 the medication at room temperature, protected from light and moisture. Avoid storing it in a bathroom.
Keep the medication in a secure location where children and others cannot access it. Consider using a locked box or area to prevent unauthorized use.
Keep all medications away from pets.
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 safe disposal methods, and consider participating in local drug take-back programs.

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 take 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 sedatives (like sleeping pills or tranquilizers) while taking oxycodone, as this can cause dangerous breathing problems or extreme drowsiness.
  • Do not drive or operate heavy machinery until you know how oxycodone 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 directed by your doctor.
  • Store oxycodone securely away from children and pets, and dispose of unused medication properly (e.g., drug take-back programs) to prevent accidental ingestion or misuse.

Dosing & Administration

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Adult Dosing

Standard Dose: For opioid-tolerant patients, 30 mg every 4-6 hours as needed for pain. Initial dose for opioid-naive patients is typically 5-15 mg every 4-6 hours.
Dose Range: 5 - 30 mg

Condition-Specific Dosing:

opioidNaive: Initial dose 5-15 mg every 4-6 hours.
opioidTolerant: Individualized based on previous opioid regimen, up to 30 mg per dose or higher for severe pain.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not generally recommended for routine use in children under 11 years. For children 11 years and older, dosing must be individualized and is typically weight-based (e.g., 0.05 to 0.15 mg/kg/dose every 4-6 hours), but 30mg is a very high single dose for pediatric patients.
Adolescent: Dosing must be individualized; typically lower initial doses than adults, titrated carefully.
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Dose Adjustments

Renal Impairment:

Mild: Start with a lower dose (e.g., 50% of usual initial dose) and titrate slowly.
Moderate: Start with a lower dose (e.g., 50% of usual initial dose) and titrate slowly. Monitor closely for respiratory depression and sedation.
Severe: Start with a significantly lower dose (e.g., 25-50% of usual initial dose) and extend dosing interval. Monitor closely for respiratory depression and sedation.
Dialysis: Oxycodone is not significantly removed by hemodialysis. Dose adjustment is still necessary due to impaired metabolism and excretion. Administer after dialysis.

Hepatic Impairment:

Mild: Start with a lower dose (e.g., 50% of usual initial dose) and titrate slowly.
Moderate: Start with a lower dose (e.g., 25-50% of usual initial dose) and titrate slowly. Monitor closely for respiratory depression and sedation.
Severe: Start with a significantly lower dose (e.g., 25% of usual initial dose) and extend dosing interval. Monitor closely for respiratory depression and sedation.

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. Binding to these receptors leads to inhibition of 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 (for IR tablets)
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 (for IR tablets)
Clearance: Not available
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: <19% (as unchanged drug in urine)
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Pharmacodynamics

OnsetOfAction: 10-30 minutes
PeakEffect: 1 hour
DurationOfAction: 4-6 hours

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; 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 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, including fast, slow, or irregular rhythms
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
Trouble 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
Throwing up
Severe headache

Adrenal Gland Problems: A Rare but Serious Condition

Long-term use of opioid medications like this one may lead to a rare but severe adrenal gland problem. If you experience any of the following symptoms, contact your doctor right away:

Feeling very tired or weak
Passing out
Severe dizziness
Very upset stomach
Throwing up
Decreased appetite

Hormonal Changes: A Potential Side Effect of Long-Term Use

Long-term use of opioid medications like this one may lead to lower sex hormone levels. If you experience any of the following symptoms, 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 potential side effects:

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

If you experience any of these side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention. You can also 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, shallow, or difficult breathing (signs of respiratory depression)
  • Extreme drowsiness or difficulty waking up
  • Dizziness or lightheadedness when standing up
  • Severe constipation or inability to have a bowel movement
  • Confusion or disorientation
  • Signs of an allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
  • Symptoms of serotonin syndrome (e.g., agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea)
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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.
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
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of certain medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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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 dosage prescribed by your doctor. Taking more than the recommended dose, or taking it more frequently or for a longer duration than prescribed, 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.

Alcohol Interactions
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 in some individuals, including those 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:

  • Pinpoint pupils
  • Slowed or stopped breathing
  • Extreme drowsiness or unresponsiveness
  • Limp muscles
  • Cold, clammy skin
  • 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 (Poison Control Center) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • 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

  • Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, alcohol): Increased risk of respiratory depression, profound sedation, coma, and death.
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice): Increased plasma concentrations of oxycodone, leading to increased opioid effects.
  • CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, bupropion): May decrease formation of oxymorphone, potentially reducing analgesic effect in some patients.
  • Mixed agonist/antagonist opioids (e.g., nalbuphine, butorphanol, pentazocine): May reduce the analgesic effect of oxycodone and/or precipitate withdrawal symptoms.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol): Risk of serotonin syndrome.
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Moderate Interactions

  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease plasma concentrations of oxycodone, leading to decreased efficacy.
  • Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants): Increased risk of urinary retention and/or severe constipation.
  • 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, character, location)

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

Sedation level

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

Timing: Prior to initiation of therapy

Bowel function

Rationale: To assess baseline bowel habits and anticipate opioid-induced constipation.

Timing: Prior to initiation of therapy

History of substance abuse or mental health disorders

Rationale: To identify patients at increased risk for opioid use disorder.

Timing: Prior to initiation of therapy

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Routine Monitoring

Pain assessment

Frequency: Regularly, as clinically indicated (e.g., daily, weekly, or at each visit)

Target: Individualized, aiming for acceptable pain control with minimal side effects.

Action Threshold: Inadequate pain control or worsening pain requires re-evaluation of dose or therapy.

Respiratory rate and depth

Frequency: Regularly, especially during initiation and dose titration; less frequently once stable.

Target: Typically >10-12 breaths/min, regular rhythm.

Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or signs of hypoventilation require immediate intervention.

Sedation level

Frequency: Regularly, especially during initiation and dose titration.

Target: Alert or mildly drowsy, easily aroused.

Action Threshold: Excessive sedation (e.g., difficult to arouse, somnolent) requires dose reduction or discontinuation.

Bowel function

Frequency: Daily

Target: Regular bowel movements (e.g., every 1-2 days).

Action Threshold: Constipation (e.g., no bowel movement for >3 days) requires intervention (e.g., laxatives).

Signs of opioid use disorder (e.g., craving, drug-seeking behavior, loss of control)

Frequency: Regularly, at each visit.

Target: Absence of signs of misuse or abuse.

Action Threshold: Presence of signs requires re-evaluation of therapy, referral for addiction treatment.

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing, cyanosis)
  • Excessive sedation/somnolence
  • Dizziness, lightheadedness
  • Nausea, vomiting
  • Constipation
  • Pruritus (itching)
  • Urinary retention
  • Confusion, disorientation
  • Signs of opioid withdrawal (if abruptly discontinued after chronic use)

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Limited data, but potential for congenital malformations with opioid exposure, though specific risk with oxycodone is not well-established.
Second Trimester: Risk of NOWS increases with prolonged exposure.
Third Trimester: Highest risk of NOWS if used chronically. Risk of respiratory depression in the neonate if used close to delivery.
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Lactation

Oxycodone is excreted into breast milk. Monitor breastfed infants for signs of sedation, respiratory depression (e.g., increased sleepiness, difficulty feeding, limpness, breathing difficulties). Use the lowest effective dose for the shortest duration possible. Consider alternative analgesics if possible.

Infant Risk: Moderate risk (L3). Potential for infant sedation, respiratory depression, and withdrawal symptoms if maternal dose is high or prolonged.
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Pediatric Use

Safety and effectiveness have not been established for routine use in pediatric patients under 11 years of age. Use in adolescents should be with extreme caution, individualized dosing, and close monitoring due to increased sensitivity to opioids and risk of respiratory depression.

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Geriatric Use

Start with lower doses and titrate slowly due to increased sensitivity to opioids, decreased renal and hepatic function, and increased risk of respiratory depression and falls. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Oxycodone 30mg IR is a high single dose and should generally be reserved for opioid-tolerant patients or those with severe, acute pain requiring rapid onset.
  • Always assess the patient's opioid tolerance before prescribing or administering 30mg IR to avoid accidental overdose and respiratory depression.
  • Educate patients and caregivers about the risks of addiction, abuse, and misuse, and the importance of proper storage and disposal.
  • Co-prescribe naloxone for patients at increased risk of overdose (e.g., concomitant CNS depressant use, higher doses, history of substance use disorder).
  • Aggressively manage opioid-induced constipation with prophylactic bowel regimens (e.g., stimulant laxative + stool softener).
  • Warn patients about the dangers of crushing, chewing, or dissolving tablets, as this can lead to rapid absorption of a potentially fatal dose.
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Alternative Therapies

  • Other strong opioid agonists (e.g., Morphine, Hydromorphone, Fentanyl)
  • Other moderate opioid agonists (e.g., Hydrocodone, Tramadol)
  • Non-opioid analgesics (e.g., NSAIDs, Acetaminophen)
  • Adjuvant analgesics (e.g., Gabapentin, Pregabalin, TCAs for neuropathic pain)
  • Regional anesthesia or nerve blocks
  • Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
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Cost & Coverage

Average Cost: $0.50 - $2.00 per 30 mg tablet
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 for generic; Tier 3 or higher for brand-name products, often requiring prior authorization.
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General Drug Facts

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, which provides crucial information for patients. 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 provide the necessary information, including what was taken, the quantity, and the time of the incident.