Dilaudid 2mg Tablets

Manufacturer RHODES PHARMACEUTICAL 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 available
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FDA Approved
Jan 1942
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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 by changing how your brain and nervous system respond to pain. It's important to take it exactly as prescribed because it can be habit-forming and cause serious side effects like 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, protected from light and moisture. Keep it in a dry place, away from bathrooms. To prevent accidental ingestion, store it in a secure location where children and pets cannot access it. Consider using a locked box or area to keep it safe. Keep all medications out of reach of pets. 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. Consult your pharmacist for guidance on proper disposal, and check if there are drug take-back programs in your area.

Missing a Dose

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. Do not take two doses at once or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than prescribed.
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Lifestyle & Tips

  • Do not drink alcohol while taking this medication.
  • Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause drowsiness and dizziness.
  • To prevent constipation, increase fluid intake, eat fiber-rich foods, and consider a stool softener or laxative as recommended by your doctor.
  • Store this medication securely away from children and pets, as accidental ingestion can be fatal.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial 2 mg orally every 4 to 6 hours as needed for pain.
Dose Range: 2 - 8 mg

Condition-Specific Dosing:

moderate_to_severe_pain: 2-4 mg orally every 4-6 hours as needed. May be titrated based on pain relief and tolerability.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (use generally avoided due to high potency and risk)
Child: Not established (use generally avoided due to high potency and risk, if used, highly individualized and cautious titration)
Adolescent: Similar to adult dosing, but with extreme caution and individualized titration, starting at the lowest effective dose.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, but monitor closely.
Moderate: Reduce initial dose by 50% and extend dosing interval. Monitor for increased sedation and respiratory depression due to accumulation of hydromorphone and its active metabolite (hydromorphone-3-glucuronide).
Severe: Reduce initial dose by 75% or more and extend dosing interval significantly. Avoid if possible. Monitor closely for toxicity.
Dialysis: Hydromorphone and its metabolites are not significantly removed by hemodialysis. Dose adjustment is necessary, and careful monitoring is crucial.

Hepatic Impairment:

Mild: No specific adjustment, but monitor closely.
Moderate: Reduce initial dose by 50% and extend dosing interval. Monitor for increased sedation and respiratory depression.
Severe: Reduce initial dose by 75% or more and extend dosing interval significantly. Avoid if possible. Monitor closely for toxicity.

Pharmacology

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Mechanism of Action

Hydromorphone is a full opioid agonist, primarily acting at the mu-opioid receptors in the central nervous system (CNS). Its analgesic effect is mediated by binding to these receptors, leading to inhibition of ascending pain pathways, altering the perception of and response to pain. It also produces CNS depression, respiratory depression, and gastrointestinal motility reduction.
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Pharmacokinetics

Absorption:

Bioavailability: 25-60%
Tmax: 0.5-1 hour
FoodEffect: Minimal effect on absorption, but may delay Tmax slightly.

Distribution:

Vd: 3-4 L/kg
ProteinBinding: 8-19%
CnssPenetration: Yes

Elimination:

HalfLife: 2-4 hours
Clearance: Not available
ExcretionRoute: Renal (primarily as H3G, with small amounts of unchanged drug)
Unchanged: 5-10%
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Pharmacodynamics

OnsetOfAction: 15-30 minutes (oral)
PeakEffect: 30-90 minutes (oral)
DurationOfAction: 4-5 hours

Safety & Warnings

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BLACK BOX WARNING

RISK OF ADDICTION, ABUSE, AND MISUSE; RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS. Hydromorphone exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Serious, life-threatening, or fatal respiratory depression may occur. Accidental ingestion of hydromorphone, especially by children, can result in a fatal overdose. Prolonged use of hydromorphone during pregnancy can result in neonatal opioid withdrawal syndrome. Concomitant use of opioids with benzodiazepines or other CNS depressants may result in profound sedation, respiratory depression, coma, and death.
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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 or 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
Abnormal heartbeat (fast, slow, or irregular)
Breathing difficulties, including:
+ Trouble breathing
+ Slow breathing
+ Shallow breathing
+ Noisy breathing
+ Sleep apnea (breathing problems during sleep)
Hallucinations (seeing or hearing things that are not there)
Mood changes
Seizures
Shakiness
Trouble passing urine
Inability to control eye movements or body movements
Changes in eyesight
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, upset stomach, or vomiting
Severe headache

Long-Term Use and Hormonal Changes

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 possible side effects:

Constipation
Diarrhea
Stomach pain
Upset stomach
Vomiting
Decreased appetite
Dizziness
Sleepiness
Tiredness
Weakness
Dry mouth
Flushing
Excessive sweating
Headache
Itching
Trouble sleeping

If any of these side effects bother you or persist, contact your doctor for guidance. 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:

  • Extreme drowsiness or difficulty waking up
  • Slow, shallow, or difficult breathing
  • Bluish lips or fingernails
  • Severe dizziness or lightheadedness
  • Confusion
  • Pinpoint pupils
  • Severe constipation or abdominal pain
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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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ Respiratory problems, including 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. To ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all prescription and over-the-counter medications, natural products, and vitamins you are taking
Discuss any health problems you have, as this will help determine whether it is safe to take this medication in conjunction with your other treatments
* 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.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, rise slowly from sitting or lying down to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.

Adhere strictly to your doctor's prescribed dosage and frequency. Taking more than prescribed, or taking it more frequently or for a longer duration than recommended, may increase the risk of severe side effects.

Do not combine this medication with other strong pain medications or use a pain patch without first consulting your doctor. 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 exceed the prescribed dosage.

If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your health. Discuss this with your doctor.

If you have a sulfite allergy, inform your doctor, as some formulations of this medication may contain sulfites.

Avoid consuming alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially fatal interactions.

Long-term or high-dose use of this medication can lead to tolerance, where the medication becomes less effective, and you may require higher doses to achieve the same pain relief. If you find that this medication is no longer effective, contact your doctor. Do not increase your dosage without medical guidance.

Prolonged or regular use of opioid medications like this one can result in dependence. Suddenly reducing the dose or stopping the medication can increase the risk of withdrawal or other severe complications. Consult your doctor before making any changes to your dosage. Follow your doctor's instructions carefully and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.

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

Opioid medications like this one can rarely cause a severe adrenal gland problem. Seek immediate medical attention if you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite.

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

Breastfeeding mothers should inform their doctor, as this medication can pass into breast milk and potentially harm the baby. If your baby appears overly sleepy, limp, or has breathing difficulties, seek medical help immediately.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Call 911 immediately. Administer naloxone (Narcan) if available and trained to do so. Stay with the person until emergency medical help arrives. Call 1-800-222-1222 (Poison Control) for additional guidance.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy (risk of serotonin syndrome or severe respiratory depression)
  • Significant respiratory depression
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Known or suspected paralytic ileus or gastrointestinal obstruction
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Major Interactions

  • Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants, alcohol): Increased risk of respiratory depression, profound sedation, coma, and death.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, linezolid, methylene blue): Risk of serotonin syndrome.
  • Anticholinergics: Increased risk of urinary retention and/or severe constipation/paralytic ileus.
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Moderate Interactions

  • Diuretics: Opioids may reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.
  • Mixed agonist/antagonist and partial agonist opioids (e.g., pentazocine, nalbuphine, butorphanol, buprenorphine): May precipitate withdrawal symptoms or reduce analgesic effect.

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 factors for respiratory depression.

Timing: Prior to initiation of therapy

Level of consciousness/sedation

Rationale: To assess baseline mental status and identify risk factors 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 (e.g., SCr, BUN, LFTs)

Rationale: To identify impairment that may necessitate dose adjustment.

Timing: Prior to initiation of therapy, especially in elderly or those with comorbidities

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Routine Monitoring

Pain relief and adverse effects (e.g., sedation, respiratory depression, constipation, nausea)

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

Target: Acceptable pain control with tolerable side effects

Action Threshold: Inadequate pain control, excessive sedation (e.g., Pasero Opioid-Induced Sedation Scale >2), respiratory depression (RR <10 breaths/min), or severe adverse effects warrant dose adjustment or intervention.

Vital signs (respiratory rate, heart rate, blood pressure)

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

Target: Within patient's normal range

Action Threshold: Significant decrease in respiratory rate, hypotension, or bradycardia.

Bowel movements

Frequency: Daily

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

Action Threshold: No bowel movement for 2-3 days warrants intervention for opioid-induced constipation.

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Symptom Monitoring

  • Respiratory depression (slow, shallow breathing)
  • Excessive sedation/drowsiness
  • Dizziness
  • Nausea and vomiting
  • Constipation
  • Pruritus (itching)
  • Urinary retention
  • Confusion
  • Pinpoint pupils

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. 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: High 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 in breast milk. Monitor infants for signs of sedation, respiratory depression, poor feeding, and withdrawal symptoms if the mother discontinues the drug. Use with caution, or consider alternative analgesics if possible.

Infant Risk: L3 (Moderately safe; monitor infant for adverse effects)
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Pediatric Use

Safety and efficacy have not been established in pediatric patients, particularly those under 6 months of age. Use in children should be highly individualized, with extreme caution, and only when benefits outweigh risks, due to the high potency and risk of respiratory depression. Not recommended for routine use in children.

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Geriatric Use

Elderly patients may be more sensitive to the analgesic and adverse effects of hydromorphone, particularly respiratory depression. Start with lower doses and titrate slowly. Monitor closely for sedation, respiratory depression, and constipation. Consider age-related decline in renal and hepatic function.

Clinical Information

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Clinical Pearls

  • Hydromorphone is significantly more potent than morphine (approximately 5-7 times). Always verify dose and formulation to avoid overdose.
  • Due to its short half-life, frequent dosing is required for sustained pain control, which can increase the risk of dose stacking and adverse effects if not carefully managed.
  • 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 these patients.
  • Always have naloxone readily available when prescribing or administering hydromorphone, especially in outpatient settings.
  • Educate patients and caregivers thoroughly on safe storage, administration, and disposal of hydromorphone to prevent accidental ingestion and diversion.
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Alternative Therapies

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

Average Cost: Varies widely, typically $10-$50 per 30 tablets
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 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. Please read this guide carefully and review it again each time you receive a refill of this medication. 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 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 medical care immediately. When seeking help, be prepared to provide details about the overdose, including the substance taken, the quantity, and the time of the incident.