Hydromorphone Hcl 2mg Tablets

Manufacturer MALLINCKRODT CHEM Active Ingredient Hydromorphone Tablets(hye droe MOR fone) Pronunciation hye droe MOR fone
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 assigned (older Category C/D); Risk-benefit assessment, potential for Neonatal Opioid Withdrawal Syndrome (NOWS)
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FDA Approved
Mar 1926
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DEA Schedule
Schedule II

Overview

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What is this medicine?

Hydromorphone is a strong pain medicine, similar to morphine, used to treat moderate to severe pain. It works in your brain and nervous system to change how your body feels and responds to pain. It is important to take it exactly as prescribed because it can be habit-forming and cause serious side effects like very slow breathing.
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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. You can take this medication with or without food, but if it causes stomach upset, take it with food. It's essential to take this medication by mouth only. Do not inject or snort it, as this can lead to severe side effects, including breathing difficulties and overdose, which can be fatal.

Storing and Disposing of Your Medication

Store this medication at room temperature, away from light and moisture. Keep it in a dry place, and avoid storing it in a bathroom. To prevent accidental ingestion, store this medication in a secure location where children and pets cannot access it. Consider using a locked box or area to keep it 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 or explore local drug take-back programs.

Managing Missed Doses

If you take this medication regularly, take a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Avoid taking two doses at the same time or taking 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 while taking hydromorphone, 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 recommended by your doctor.
  • Store this medication securely away from children and pets, preferably in a locked cabinet, to prevent accidental ingestion.
  • 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 2-4 mg orally every 4 to 6 hours as needed for pain
Dose Range: 2 - 8 mg

Condition-Specific Dosing:

opioid_tolerant: Higher doses may be required for patients tolerant to opioids, titrated to effect.
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Pediatric Dosing

Neonatal: Not established for routine use; extreme caution and specialist consultation for severe pain in opioid-tolerant neonates.
Infant: Not established for routine use; extreme caution and specialist consultation for severe pain in opioid-tolerant infants.
Child: Not generally recommended for opioid-naive children; specific dosing (e.g., 0.03-0.08 mg/kg/dose every 4-6 hours) for severe pain in opioid-tolerant children under specialist supervision.
Adolescent: Not generally recommended for opioid-naive adolescents; specific dosing for severe pain in opioid-tolerant adolescents under specialist supervision.
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Dose Adjustments

Renal Impairment:

Mild: Consider dose reduction and/or extended dosing interval.
Moderate: Reduce initial dose by 50% or extend dosing interval; titrate carefully.
Severe: Reduce initial dose by 75% or extend dosing interval significantly; titrate very carefully due to accumulation of active metabolites (e.g., hydromorphone-3-glucuronide).
Dialysis: Hydromorphone is not significantly removed by hemodialysis. Administer after dialysis. Monitor closely for prolonged effects.

Hepatic Impairment:

Mild: Consider dose reduction and/or extended dosing interval.
Moderate: Reduce initial dose by 50%; titrate carefully.
Severe: Reduce initial dose by 75%; titrate very carefully due to impaired metabolism.

Pharmacology

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Mechanism of Action

Hydromorphone is a full opioid agonist that binds to and activates mu-opioid receptors in the central nervous system (CNS), peripheral nervous system, 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 antitussive effects.
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Pharmacokinetics

Absorption:

Bioavailability: Oral: Approximately 30-60%
Tmax: Oral: 0.5-1 hour
FoodEffect: Food may delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: Approximately 4 L/kg
ProteinBinding: Low (8-19%)
CnssPenetration: Yes, readily crosses the blood-brain barrier.

Elimination:

HalfLife: Oral: Approximately 2-4 hours
Clearance: Not available (highly variable)
ExcretionRoute: Primarily renal (as metabolites, mainly H3G)
Unchanged: Less than 10% of the dose is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Oral: 15-30 minutes
PeakEffect: Oral: 30-90 minutes
DurationOfAction: Oral: 3-5 hours
Confidence: Medium

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; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS.

Addiction, Abuse, and Misuse: Hydromorphone exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing hydromorphone, and monitor all patients regularly for the development of these behaviors and conditions.

Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase.

Accidental Ingestion: Accidental ingestion of even one dose of hydromorphone, especially by children, can result in a fatal overdose.

Neonatal Opioid Withdrawal Syndrome: Prolonged use of hydromorphone during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
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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 or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Severe dizziness or fainting
Confusion
Severe constipation or stomach pain, which may indicate a serious bowel problem
Abnormal heartbeat (fast, slow, or irregular)
Breathing difficulties, including:
+ Trouble breathing
+ Slow or shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Hallucinations (seeing or hearing things that are not there)
Mood changes
Seizures
Shakiness
Urination difficulties
Uncontrolled eye movements
Trouble controlling body movements
Changes in vision
Chest pain or pressure
Balance problems
Memory problems or loss
Thoughts of self-harm or suicide
Swelling in the arms or legs

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
Balance problems
Confusion
Hallucinations
Fever
Abnormal heartbeat (fast or irregular)
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, nausea, or vomiting
Severe headache

Long-Term Use and Hormonal Effects

Prolonged use of opioid medications like this one may lead to decreased sex hormone levels. If you experience any of the following, consult your doctor:

Decreased interest in sex
Fertility problems
Irregular or absent menstrual periods
Ejaculation problems

Other Possible Side Effects

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

Constipation
Diarrhea
Stomach pain
Nausea or vomiting
Decreased appetite
Dizziness
Drowsiness
Fatigue
Weakness
Dry mouth
Flushing
Excessive sweating
Headache
Itching
Sleep disturbances

If any of these side effects bother you or persist, consult 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, shallow, or difficult breathing
  • Extreme drowsiness or difficulty waking up
  • Bluish lips or fingernails
  • Severe dizziness or lightheadedness
  • Confusion
  • Pinpoint pupils
  • Severe constipation or abdominal pain (signs of ileus)
  • Hives, rash, or swelling of the face, lips, tongue, or throat (allergic reaction)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is crucial 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.
Certain health conditions, such as:
+ Respiratory problems like 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 essential 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. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

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.

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, may increase the risk of severe side effects.

Interactions with Other Medications
Do not take this medication with other strong pain medications or use a pain patch without consulting your doctor first.

Monitoring and Follow-up
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 than the prescribed dose.

Long-term Use and Blood Work
If you are taking this medication for an extended period, discuss with your doctor the need for regular blood work checks.

Allergies and Sensitivities
If you are allergic to sulfites, inform your doctor, as some products may contain sulfites.

Alcohol Interactions
Do not consume alcohol or products containing alcohol while taking this medication, as it may lead to unsafe and potentially life-threatening effects.

Tolerance and Dependence
Long-term or high-dose use of this medication may lead to tolerance, requiring higher doses to achieve the same effect. If you experience a decrease in the medication's effectiveness, contact 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 dosage. Follow your doctor's instructions carefully and report any adverse effects, such as increased pain, mood changes, or suicidal thoughts.

Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with a history of seizures. Discuss your risk with your doctor.

Adrenal Gland Problems
Taking an opioid medication like this one may lead to a rare but severe adrenal gland problem. Seek medical attention immediately if you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite.

Special Considerations
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 passes into breast milk and may harm your baby. Seek medical help immediately if your baby appears excessively sleepy, limp, or has difficulty breathing.
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Overdose Information

Overdose Symptoms:

  • Pinpoint pupils
  • Extreme drowsiness or unresponsiveness
  • Slowed or stopped breathing
  • Bluish skin, especially around the lips and fingernails
  • Limp muscles
  • Cold, clammy skin
  • Loss of consciousness
  • Coma

What to Do:

If you suspect an overdose, call 911 immediately. Administer naloxone if available and you are trained to do so. Stay with the person until emergency medical help arrives. Provide rescue breathing if necessary. Call 1-800-222-1222 (Poison Control) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or use within 14 days of MAOI therapy (risk of serotonin syndrome, severe respiratory depression, coma, death)
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Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants) - increased risk of profound sedation, respiratory depression, coma, and death.
  • Mixed agonist/antagonist opioids (e.g., nalbuphine, butorphanol, pentazocine) - may reduce analgesic effect and/or precipitate withdrawal symptoms.
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Moderate Interactions

  • Anticholinergics (e.g., tricyclic antidepressants, antihistamines, antipsychotics) - increased risk of severe constipation and/or paralytic ileus.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans) - theoretical risk of serotonin syndrome, though less common with hydromorphone than other opioids.
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Minor Interactions

  • Not many specific minor interactions are clinically significant for hydromorphone due to its primary metabolism via glucuronidation rather than CYP450.

Monitoring

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Baseline Monitoring

Pain assessment (intensity, quality, location)

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

Timing: Prior to initiation of therapy.

Respiratory rate and depth, oxygen saturation

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

Timing: Prior to initiation of therapy.

Sedation level (e.g., Pasero Opioid-Induced Sedation Scale)

Rationale: To assess baseline CNS effects and guide initial dosing.

Timing: Prior to initiation of therapy.

Bowel function (frequency, consistency)

Rationale: To establish baseline and anticipate opioid-induced constipation.

Timing: Prior to initiation of therapy.

History of substance abuse or mental health disorders

Rationale: To assess risk for addiction, abuse, and misuse.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Pain level

Frequency: Regularly, especially during dose titration and with changes in pain.

Target: Patient-specific, aiming for acceptable pain control with minimal side effects.

Action Threshold: Inadequate pain control may require dose adjustment; excessive pain relief may indicate over-sedation.

Respiratory rate and depth, oxygen saturation

Frequency: Regularly, especially during initiation and dose titration (e.g., every 1-2 hours initially, then every 4-6 hours or as clinically indicated).

Target: Respiratory rate >10-12 breaths/min, SpO2 >92-94%.

Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or SpO2 <90% requires immediate intervention (e.g., naloxone, respiratory support).

Sedation level

Frequency: Regularly, especially during initiation and dose titration (e.g., every 1-2 hours initially, then every 4-6 hours or as clinically indicated).

Target: Alert or mildly drowsy, easily aroused.

Action Threshold: Moderate to severe sedation (e.g., difficult to arouse, somnolent) requires immediate intervention (e.g., naloxone, hold dose).

Bowel function

Frequency: Daily

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

Action Threshold: No bowel movement for 2-3 days requires intervention (e.g., laxatives, stool softeners).

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • Excessive sedation or somnolence
  • Dizziness or lightheadedness
  • Nausea and vomiting
  • Constipation
  • Pruritus (itching)
  • Urinary retention
  • Confusion or disorientation

Special Patient Groups

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Pregnancy

Prolonged use of hydromorphone during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated. Advise pregnant patients of the risk of NOWS and ensure appropriate treatment will be available. 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 for hydromorphone is not well-defined.
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

Hydromorphone is excreted into breast milk. Monitor breastfed infants for signs of sedation, respiratory depression (e.g., increased sleepiness, difficulty breathing, limpness), and poor feeding. If opioid use is necessary, use the lowest effective dose for the shortest duration. Consider alternative pain management strategies if possible.

Infant Risk: Risk level is moderate to high, especially with higher doses or prolonged use. Infants are particularly susceptible to respiratory depression.
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Pediatric Use

Use with extreme caution in pediatric patients, especially opioid-naive children, due to increased risk of respiratory depression. Not generally recommended for routine use in tablet form. Dosing must be individualized and carefully titrated by a specialist for severe pain in opioid-tolerant children.

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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

  • Hydromorphone is a potent opioid; 2 mg oral hydromorphone is approximately equipotent to 10-15 mg oral morphine.
  • Due to its relatively short half-life, it is suitable for acute pain or breakthrough pain in patients on long-acting opioids.
  • Accumulation of the active metabolite, hydromorphone-3-glucuronide (H3G), can occur in patients with renal impairment, leading to neuroexcitatory symptoms (e.g., myoclonus, hyperalgesia, delirium). Dose reduction is crucial in renal dysfunction.
  • Patients should be educated on the risks of addiction, abuse, and misuse, and proper storage and disposal of the medication.
  • Always have naloxone readily available for patients at high risk of overdose (e.g., concomitant CNS depressant use, history of overdose, higher doses).
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Alternative Therapies

  • Other strong opioid analgesics (e.g., morphine, oxycodone, fentanyl, oxymorphone)
  • Tramadol (for moderate to moderately severe pain)
  • Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for milder pain or as adjuncts
  • Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants) 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: $10 - $50 per 30 tablets (2mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

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, never share your medication with others, and do not take medication prescribed to someone else.

This medication is accompanied by a Medication Guide, which provides crucial information about its safe 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 used as an emergency treatment. 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. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken.

In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. Be prepared to provide detailed information about the medication, including the dose and time of administration, to ensure you receive appropriate treatment.