Dilaudid 8mg Tablets
Overview
What is this medicine?
How to Use This Medicine
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 this medication, 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 this medication in a secure location where children and pets cannot access it. Consider using a locked box or area to keep it safe. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
What to Do If You Miss 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 the same time or take extra doses. If you take this medication as needed, do not take it more frequently than prescribed by your doctor.
Lifestyle & Tips
- Avoid alcohol and other sedating medications (e.g., tranquilizers, sleeping pills) while taking this medication, as this can increase the risk of serious side effects like extreme drowsiness and breathing problems.
- Do not drive or operate 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 stool softeners or laxatives as recommended by your doctor.
- Store this medication securely away from children and pets, as accidental ingestion can be fatal.
- Do not share this medication with anyone else, even if they have similar pain.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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
Abnormal heartbeat, including fast, slow, or irregular rhythms
Breathing difficulties, such as:
+ 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
Trouble controlling body movements
Changes in eyesight
Chest pain or pressure
Changes in balance
Memory problems or loss
Thoughts of hurting yourself 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 a severe and potentially deadly condition called serotonin syndrome. Seek medical help right away if you experience any of the following symptoms:
Agitation
Changes in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea, upset stomach, or vomiting
Severe headache
Long-Term Use and Hormonal Changes
Long-term use of an opioid medication 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 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 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.
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
- Bluish lips or fingernails
- Severe constipation or abdominal pain
- Difficulty urinating
- Signs of allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
Before Using This Medicine
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 carbon dioxide levels in the blood
+ Stomach or bowel obstruction 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 severely 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 medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins
Discuss all your health problems with your doctor
Verify that it is safe to take this medication with your existing medications and health conditions
Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & 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.
Laboratory Monitoring
If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your health.
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 use products containing alcohol while taking this medication, as this 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. If you need to reduce the dose or stop taking this medication, consult your doctor to avoid withdrawal or other severe problems. 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 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
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 breathing difficulties.
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
- Slowed heart rate
- Low blood pressure
- Coma
What to Do:
If you suspect an overdose, call 911 immediately. Administer naloxone (Narcan) if available and you are trained to do so. Stay with the person until emergency medical help arrives. Call 1-800-222-1222 (Poison Control Center) for additional guidance.
Drug Interactions
Contraindicated Interactions
- Concurrent use with monoamine oxidase inhibitors (MAOIs) or within 14 days of MAOI discontinuation (risk of serotonin syndrome or severe respiratory depression).
Major Interactions
- Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, fentanyl): Risk of serotonin syndrome.
- Mixed agonist/antagonist opioids (e.g., butorphanol, nalbuphine, pentazocine): May precipitate withdrawal symptoms or reduce analgesic effect.
- Anticholinergic drugs (e.g., tricyclic antidepressants, antihistamines, antipsychotics, muscle relaxants): Increased risk of urinary retention and/or severe constipation, paralytic ileus.
Moderate Interactions
- CYP3A4 inhibitors (e.g., clarithromycin, ketoconazole, ritonavir): May increase hydromorphone plasma concentrations (though CYP3A4 is a minor pathway for hydromorphone).
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease hydromorphone plasma concentrations.
- Diuretics: Opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: To establish baseline pain level and guide initial dosing.
Timing: Prior to initiation of therapy
Rationale: To assess baseline respiratory function and identify risk for respiratory depression.
Timing: Prior to initiation of therapy
Rationale: To assess baseline neurological status and identify risk for excessive sedation.
Timing: Prior to initiation of therapy
Rationale: To assess baseline bowel habits and anticipate opioid-induced constipation.
Timing: Prior to initiation of therapy
Rationale: To identify potential impairment requiring dose adjustment.
Timing: Prior to initiation of therapy, especially in patients with known or suspected impairment
Routine Monitoring
Frequency: Regularly, especially after dose changes and before subsequent doses
Target: Acceptable pain control with minimal side effects
Action Threshold: Uncontrolled pain or excessive side effects warrant dose adjustment or alternative therapy.
Frequency: Frequently during initiation and titration, then periodically
Target: >10-12 breaths/min, regular rhythm
Action Threshold: <10 breaths/min, shallow breathing, or signs of hypoventilation (e.g., cyanosis, somnolence) require immediate intervention (e.g., naloxone, respiratory support).
Frequency: Frequently during initiation and titration, then periodically
Target: Awake and alert or mildly drowsy, easily aroused
Action Threshold: Difficult to arouse, somnolent, or unarousable requires immediate intervention.
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, stool softeners).
Frequency: Periodically, especially with long-term use or dose escalation
Target: Not applicable
Action Threshold: Increased pain despite dose escalation, or pain in new areas, may indicate hyperalgesia or tolerance requiring re-evaluation of pain management strategy.
Symptom Monitoring
- Excessive sedation
- Dizziness
- Nausea
- Vomiting
- Constipation
- Pruritus
- Urinary retention
- Confusion
- Respiratory depression (shallow breathing, slow breathing)
- Signs of opioid withdrawal (in case of abrupt discontinuation)
Special Patient Groups
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:
Lactation
Hydromorphone is excreted into breast milk. Monitor infants for signs of sedation, respiratory depression, poor feeding, and withdrawal symptoms. Use with caution, or consider alternative analgesics. The American Academy of Pediatrics considers hydromorphone to be a drug for which the effect on a nursing infant is unknown but may be of concern.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Use with extreme caution and individualized dosing, if at all, due to increased risk of respiratory depression and other adverse effects. Not recommended for routine use in children.
Geriatric Use
Elderly patients may be more sensitive to the analgesic and adverse effects of hydromorphone (e.g., respiratory depression, sedation, constipation) due to decreased renal and hepatic function, and polypharmacy. Start with lower doses and titrate slowly. Monitor closely.
Clinical Information
Clinical Pearls
- Hydromorphone is approximately 5-7 times more potent than oral morphine. Always ensure correct dose conversion when switching from other opioids.
- Oral hydromorphone has a relatively rapid onset and short duration of action, making it suitable for acute pain or breakthrough pain in opioid-tolerant patients.
- The 8mg tablet is a high dose for opioid-naive patients and should be used with extreme caution, if at all, as an initial dose.
- Educate patients and caregivers on the safe storage and disposal of hydromorphone to prevent accidental ingestion and diversion.
- Always have naloxone readily available when prescribing opioids, especially for patients at high risk of overdose.
- Opioid-induced constipation is a common and persistent side effect; proactive management with bowel regimens is crucial.
Alternative Therapies
- Other strong opioid agonists (e.g., morphine, oxycodone, fentanyl)
- Tramadol (for moderate pain)
- NSAIDs (e.g., ibuprofen, naproxen, celecoxib - for mild to moderate pain, often used as adjuncts)
- Acetaminophen (for mild to moderate pain, often used as adjunct)
- Non-pharmacological therapies (e.g., physical therapy, acupuncture, cognitive behavioral therapy, nerve blocks)
Cost & Coverage
General Drug Facts
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. Read this guide carefully when you first receive your medication, and review it again each time your prescription is refilled. If you have any questions or concerns about your 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 its effects. Discuss obtaining and using naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. When seeking help, be prepared to provide information about what was taken, the quantity, and the time of the incident.