Hydromorphone 32mg ER Tablets

Hydromorphone is a full opioid agonist with high affinity for mu-opioid receptors in the central nervous system (CNS). Its primary therapeutic action is analgesia. It also produces respiratory depression, miosis, euphoria, and physical dependence.

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 fainting
Confusion
Severe constipation or stomach pain, which may indicate a severe 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 of developing 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 Changes

Prolonged 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
Irregular or absent menstrual periods
Ejaculation problems

Other Possible Side Effects

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

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

If you notice something that looks like the tablet in your stool, do not be concerned – this is a normal occurrence.

Reporting Side Effects

If you experience any side effects that bother you or do not go away, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

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. Describe the allergic reaction and its symptoms.
Existing health conditions, such as:
+ Respiratory problems (e.g., asthma, breathing difficulties, sleep apnea)
+ High levels of carbon dioxide in the blood
+ Stomach or bowel blockage or narrowing
Recent use (within the last 14 days) of certain medications for depression or Parkinson's disease, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of medications such as buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine
If you are breastfeeding, as you should not breastfeed while taking this medication
Presence of gastrointestinal (GI) tract narrowing or other GI problems, including small bowel disease, short gut syndrome, or slow-moving esophagus or bowel tract
* History of certain health conditions, such as cystic fibrosis, long-term bowel pseudo-block, Meckel's diverticulum, or peritonitis

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your existing health conditions and medications. Never start, stop, or change the dose of any medication without consulting your doctor.

Important Information About Your Medication

It is crucial that you inform all of 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 activities that require you to be alert. To minimize the risk of dizziness or fainting, get up 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 amount can increase your risk of severe side effects.

Interactions with Other Medications
Before taking this medication with other strong pain relievers or using a pain patch, consult with your doctor. If you experience worsening pain, increased sensitivity to pain, or new pain, contact your doctor immediately. Do not take more medication than ordered.

Long-Term Use and Monitoring
If you are taking this medication for an extended period, your doctor may recommend regular blood tests to monitor your health. Discuss this with your doctor.

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 this can lead to unsafe and potentially life-threatening effects.

Tolerance and Dependence
Long-term or high-dose use of this medication can lead to tolerance, where the medication may not work as well, and you may require 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 amount.

Dependence and Withdrawal
Regular use of opioid medications like this one can lead to dependence. If you need to reduce the dose or stop taking this medication, consult with your doctor, as suddenly stopping or reducing the dose can increase the risk of withdrawal or other severe problems. Follow your doctor's instructions, and report any increased pain, mood changes, suicidal thoughts, or other adverse effects.

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

Adrenal Gland Problems
Taking an opioid medication like this one can lead to a rare but severe adrenal gland problem. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.

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

• Benzodiazepines and other CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, other opioids) - due to profound sedation, respiratory depression, coma, and death.
• Monoamine Oxidase Inhibitors (MAOIs) - within 14 days of use, due to risk of serotonin syndrome or opioid toxicity.
• Patients with significant respiratory depression, acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment.
• Patients with known or suspected paralytic ileus.
• Patients with gastrointestinal obstruction.
• Patients with hypersensitivity to hydromorphone or any component of the formulation.

• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol, fentanyl) - risk of serotonin syndrome.
• Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants) - risk of urinary retention and/or severe constipation which may lead to paralytic ileus.
• Mixed agonist/antagonist and partial agonist opioids (e.g., butorphanol, nalbuphine, pentazocine, buprenorphine) - may precipitate withdrawal symptoms or reduce analgesic effect.
• Diuretics - opioids may reduce the efficacy of diuretics by causing release of antidiuretic hormone.

• Drugs that affect gastric motility (e.g., metoclopramide) - may alter absorption of ER formulation.
• P-glycoprotein (P-gp) inhibitors/inducers - may alter hydromorphone exposure, though less significant than CYP interactions for other opioids.

• Not available

• Respiratory depression (slow, shallow breathing)
• Excessive sedation/drowsiness
• Dizziness
• Nausea/vomiting
• Constipation
• Pruritus
• Confusion
• Miosis (pinpoint pupils)
• Hypotension
• Signs of serotonin syndrome (agitation, hallucinations, tachycardia, fever, sweating, muscle rigidity, tremor, incoordination, nausea, vomiting, diarrhea)

Prolonged use 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.

Hydromorphone is excreted in breast milk. Infants exposed through breast milk are at risk for serious adverse reactions, including excess sedation and respiratory depression. Monitor infants for signs of sedation and respiratory depression. Consider alternatives or discontinue breastfeeding.

Safety and effectiveness have not been established in pediatric patients. Hydromorphone ER is not recommended for use in patients younger than 18 years of age due to the risk of fatal respiratory depression.

Use with caution in elderly patients, usually starting at the lower end of the dosing range, due to increased likelihood of decreased renal or hepatic function and greater sensitivity to adverse effects (e.g., respiratory depression, constipation). Monitor closely.

• Hydromorphone ER is for opioid-tolerant patients only. Prescribing to opioid-naive patients can result in fatal respiratory depression.
• Do not crush, chew, or dissolve the tablets. This can lead to rapid release of a potentially fatal dose of hydromorphone.
• Concomitant use with benzodiazepines or other CNS depressants significantly increases the risk of respiratory depression, profound sedation, coma, and death. Avoid concurrent use if possible; if not, use the lowest effective doses and shortest durations, and monitor closely.
• Patients should be educated on the risks of addiction, abuse, and misuse, and proper storage and disposal of the medication.
• Opioid-induced constipation is a common and persistent side effect; proactive management with laxatives is often necessary.
• Monitor for signs of respiratory depression, especially during initiation or dose escalation. Have naloxone readily available.
• Due to its long half-life, dose adjustments should be made cautiously and not more frequently than every 3 to 4 days.

• Other extended-release opioid analgesics (e.g., morphine ER, oxycodone ER, fentanyl transdermal, oxymorphone ER)
• Other strong opioid analgesics (e.g., methadone, tapentadol ER)
• Non-opioid pain management strategies (e.g., NSAIDs, acetaminophen, gabapentin, pregabalin, tricyclic antidepressants, SNRIs)
• Interventional pain procedures
• Physical therapy, occupational therapy, psychological therapies (e.g., CBT)

If your symptoms or health problems do not improve or worsen, contact your doctor immediately. It is essential to use your prescribed medication responsibly: do not share it with others, and never take someone else's medication.

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 used as an emergency treatment. 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 emergency medical care right away. When seeking help, be prepared to provide detailed information about the overdose, including the substance involved, the quantity taken, and the time of the incident.