Oxycodone 5mg/5ml Solution

Manufacturer HIKMA /ROXANE Active Ingredient Oxycodone Solution(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.Make sure you have the right drug; there is more than one strength. A lower strength may not ease pain well enough. A higher strength could lead to accidental overdose and death.Be sure that you know how to measure your dose. Dosing errors can lead to accidental overdose and death. If you have any questions, talk with your doctor or pharmacist. @ 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 1995
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Oxycodone is a strong pain medicine (an opioid) used to treat moderate to severe pain. It works in your brain to change how your body feels and responds to pain. It comes as a liquid solution that you take by mouth.
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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, as directed. Do not inject or snort this medication, as this can cause severe side effects, including breathing difficulties and overdose, which can be fatal.

When taking the liquid form of this medication, measure your dose carefully using the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device. Avoid using a household teaspoon or tablespoon to measure your dose, as this can lead to taking too much medication.

Storing and Disposing of Your Medication

Store this medication at room temperature, protected from light and moisture. Keep it in a dry place, away from bathrooms. Store the 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 to keep the medication safe.

When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method. You may also want to check if there are any 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. However, 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 the same time or take extra doses.

If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Do not drink alcohol while taking oxycodone, as it can increase the risk of serious side effects like extreme 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 directed by your doctor.
  • Store this medication securely to prevent accidental ingestion by children or pets, and to prevent misuse or abuse by others.
  • Do not share this medication with anyone else, as it can be dangerous and is against the law.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial dose: 5 mg every 4-6 hours as needed for pain. Titrate to effect.
Dose Range: 5 - 20 mg

Condition-Specific Dosing:

opioid_naive: Initial dose 5 mg every 4-6 hours.
chronic_pain: Titrate dose based on individual response and tolerability, considering total daily opioid dose.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not generally recommended for routine use; consult specialist for severe pain (e.g., cancer pain) with careful titration. Dosing typically 0.05-0.15 mg/kg/dose every 4-6 hours.
Adolescent: Similar to adult dosing, starting with 5 mg every 4-6 hours, titrate to effect.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed, but monitor closely.
Moderate: Consider reducing initial dose by 50% (e.g., 2.5 mg every 4-6 hours) and titrate carefully.
Severe: Consider reducing initial dose by 50% or more (e.g., 2.5 mg every 4-6 hours) and extend dosing interval. Monitor closely for respiratory depression and sedation.
Dialysis: Oxycodone is not significantly removed by dialysis. Dose adjustment needed, monitor closely.

Hepatic Impairment:

Mild: Consider reducing initial dose by 50% (e.g., 2.5 mg every 4-6 hours) and titrate carefully.
Moderate: Consider reducing initial dose by 50% or more (e.g., 2.5 mg every 4-6 hours) and extend dosing interval. Monitor closely for respiratory depression and sedation.
Severe: Contraindicated or use with extreme caution at significantly reduced doses (e.g., 2.5 mg every 6-8 hours) and extended intervals. Monitor closely for respiratory depression and sedation.

Pharmacology

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Mechanism of Action

Oxycodone is a full opioid agonist that acts primarily at the mu-opioid receptors in the central nervous system (CNS). It produces analgesia by binding to these receptors, inhibiting ascending pain pathways, and altering the perception of and response to pain. It also produces CNS depression, respiratory depression, miosis, euphoria, and physical dependence.
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Pharmacokinetics

Absorption:

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

Distribution:

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

Elimination:

HalfLife: 3.2 hours (range 2-4 hours)
Clearance: Not available
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: <19% (as unchanged drug in urine)
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Pharmacodynamics

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

Safety & Warnings

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BLACK BOX WARNING

Addiction, Abuse, and Misuse; 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 be signs of a severe bowel problem
Trouble breathing, slow breathing, or shallow breathing
Noisy breathing
Breathing problems during sleep (sleep apnea)
Trouble passing urine
Fast, slow, or abnormal heartbeat
Seizures
Shakiness
Change 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 of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical help right away if you experience:

Agitation
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Sweating a lot
Severe diarrhea
Upset stomach
Throwing up
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 immediately if you experience:

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

Long-Term Use and Hormone Levels

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

Lowered interest in sex
Fertility problems
No menstrual period
Ejaculation problems

Other Side Effects

While many people taking this medication do not experience side effects or only have minor side effects, some may occur. Contact your doctor or seek medical help if you experience any of the following:

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

Reporting Side Effects

If you have questions about side effects or experience any side effects that bother you or do not go away, 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.
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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 or disorientation
  • Severe constipation or inability to have a bowel movement
  • Signs of an allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
  • Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, 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, including any symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems, such as asthma, breathing difficulties, or sleep apnea
+ Elevated levels of carbon dioxide 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 very high blood pressure
Current use of certain medications, such as buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine

Please note that this is not an exhaustive list of all potential interactions. To ensure your safety, it is crucial to inform your doctor and pharmacist about:

All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including all health problems

Do not start, stop, or change the dosage of any medication without first consulting your doctor to confirm that it is safe to do so in conjunction with this medication.
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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 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 are 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.

Additionally, long-term or 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 dosage, and follow their instructions carefully. Report any increased pain, mood changes, suicidal thoughts, or other adverse effects to your doctor.

Concomitant Use with Alcohol
Do not consume alcohol or products containing alcohol while taking this medication, as this may lead to 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 for Older Adults
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.

Strength-Specific Warnings
Certain strengths of this medication are only suitable for individuals who have previously taken similar medications and are tolerant of their effects. Using these strengths in opioid-naive individuals may cause severe and potentially fatal respiratory problems. Consult your doctor to determine the appropriate strength and usage of this medication.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Seek immediate emergency medical attention. Call 911 or your local emergency number. If naloxone (Narcan) is available and you are trained to use it, administer it as directed. Stay with the person until emergency help arrives. Call 1-800-222-1222 (Poison Control) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) within 14 days (risk of serotonin syndrome or severe CNS depression)
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Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., other opioids, alcohol, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines): Increased risk of profound sedation, respiratory depression, coma, and death.
  • CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice): Increased oxycodone plasma concentrations, leading to increased opioid effects.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): Decreased oxycodone plasma concentrations, leading to reduced efficacy or withdrawal symptoms.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, tramadol, fentanyl, linezolid, methylene blue): 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.
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Moderate Interactions

  • Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants): Increased risk of urinary retention and severe constipation.
  • Diuretics: Opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
  • Antihypertensives: May cause additive hypotensive effects.
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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

Bowel function

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

Timing: Prior to initiation of therapy

Renal and hepatic function tests (CrCl, LFTs)

Rationale: To identify potential need for dose adjustment in patients with organ impairment.

Timing: Prior to initiation of therapy, if clinically indicated

Risk assessment for opioid abuse/misuse

Rationale: To identify patients at higher risk and implement appropriate monitoring strategies.

Timing: Prior to initiation of therapy

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Routine Monitoring

Pain relief

Frequency: Regularly, especially during titration and with dose changes (e.g., daily, weekly)

Target: Acceptable pain level for the patient

Action Threshold: Inadequate pain control or excessive side effects

Respiratory rate and depth

Frequency: Regularly, especially during initiation and dose escalation (e.g., every 4-6 hours initially, then daily)

Target: Normal for patient (typically >10-12 breaths/min)

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

Level of consciousness/sedation

Frequency: Regularly, especially during initiation and dose escalation (e.g., every 4-6 hours initially, then daily)

Target: Alert and oriented, or easily aroused

Action Threshold: Excessive sedation (e.g., somnolent, difficult to arouse), confusion, or disorientation

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), straining, hard stools

Signs of opioid abuse/misuse

Frequency: At each visit or refill

Target: Adherence to prescribed regimen

Action Threshold: Early refills, lost/stolen prescriptions, multiple prescribers, aberrant drug-related behaviors

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Symptom Monitoring

  • Drowsiness
  • Dizziness
  • Nausea
  • Vomiting
  • Constipation
  • Itching
  • Headache
  • Dry mouth
  • Sweating
  • Difficulty urinating
  • Signs of respiratory depression (slow, shallow breathing, blue lips/skin)
  • Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, muscle rigidity, incoordination, nausea, vomiting, diarrhea)

Special Patient Groups

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Pregnancy

Use during pregnancy is generally not recommended due to risks to the fetus, including neonatal opioid withdrawal syndrome (NOWS) if used for prolonged periods during pregnancy. Discuss risks and benefits with a healthcare provider.

Trimester-Specific Risks:

First Trimester: Limited data on major birth defects. Potential for increased risk of neural tube defects, heart defects, and gastroschisis, but causality not definitively established.
Second Trimester: Risk of fetal growth restriction and premature birth with prolonged use.
Third Trimester: Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS) in the neonate, which may be life-threatening if not recognized and treated. Respiratory depression may occur in the neonate if used close to delivery.
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Lactation

Oxycodone is excreted into breast milk. Monitor infants for signs of sedation, respiratory depression, poor feeding, and poor weight gain. Use with caution, or consider alternative analgesics, especially in preterm infants or those with respiratory compromise. Short-term, low-dose use may be acceptable with close infant monitoring.

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

Not generally recommended for routine pain management in young children due to lack of established safety and efficacy data, and high risk of respiratory depression. Use in children should be under specialist supervision for severe pain (e.g., cancer pain) with careful dose titration and monitoring. Accidental ingestion in children can be fatal.

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Geriatric Use

Start with lower doses and titrate slowly due to increased sensitivity to opioid effects (e.g., respiratory depression, sedation, constipation) and potential for decreased renal and hepatic function. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Oxycodone oral solution is an immediate-release formulation, providing rapid onset of action suitable for acute pain or breakthrough pain.
  • Dosing must be individualized and titrated to effect, balancing pain relief with side effects. Always start with the lowest effective dose.
  • Educate patients and caregivers thoroughly on safe storage, administration, and disposal to prevent accidental ingestion, abuse, and misuse.
  • Counsel patients on the risks of respiratory depression, especially when initiating therapy, increasing dose, or co-administering with other CNS depressants.
  • Prophylactic treatment for opioid-induced constipation (OIC) should be initiated at the start of therapy.
  • Be aware of drug interactions, particularly with CYP3A4 inhibitors/inducers and other CNS depressants, which can significantly alter oxycodone levels and effects.
  • Regularly assess for signs of addiction, abuse, and misuse, and consider using risk assessment tools.
  • Naloxone should be considered for co-prescription, especially for patients at high risk of overdose.
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Alternative Therapies

  • Other opioid analgesics (e.g., morphine, hydromorphone, hydrocodone, fentanyl)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for mild to moderate pain
  • Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants) for neuropathic pain
  • Regional anesthesia or nerve blocks
  • Non-pharmacological pain management strategies (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
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Cost & Coverage

Average Cost: Varies widely, typically $0.50 - $2.00 per 5mg/5ml dose
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
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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, and do not take medication prescribed to someone else.

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 whenever 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 an overdose is suspected, 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 or show what was taken, the quantity, and the time of the incident to ensure timely and effective treatment.