Hydromorphone 3mg Rectal Supp

Hydromorphone is a full opioid agonist that binds to and activates mu-opioid receptors in the central nervous system (CNS), primarily in the brain and spinal cord. This binding leads to inhibition of ascending pain pathways, altering the perception of and response to pain. It also produces generalized CNS depression, including respiratory depression, sedation, and antitussive 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
Difficulty urinating
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 Changes

Prolonged use of opioid medications like this one may lead to decreased 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 possible side effects:

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, 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.

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 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

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

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 understand 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 exercise caution 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.

Monitoring and Maintenance
If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your condition.

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

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

Tolerance and Dependence
Prolonged or high-dose use of this medication may lead to tolerance, reducing its effectiveness. If you experience decreased efficacy, contact your doctor. Do not take more than the prescribed dose. Long-term or 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 minimize the risk of withdrawal or other severe problems.

Seizure Risk
This medication may increase the risk of seizures, particularly in individuals with a history of seizure disorders. 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
If you are breastfeeding, inform your doctor, 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.

• Concomitant use with benzodiazepines or other CNS depressants in patients for whom alternatives are inadequate (Black Box Warning)
• Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy (risk of serotonin syndrome or severe respiratory depression)

• Other CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, other opioids) - increased risk of respiratory depression, profound sedation, coma, and death.
• Mixed agonist/antagonist opioids (e.g., pentazocine, nalbuphine, butorphanol) - may reduce analgesic effect and/or precipitate withdrawal symptoms.
• Anticholinergic drugs - increased risk of urinary retention and/or severe constipation.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans) - risk of serotonin syndrome.

• Diuretics - opioids can reduce the efficacy of diuretics by causing release of antidiuretic hormone.
• Antihypertensives - additive hypotensive effects.
• Drugs that affect gastric emptying (e.g., metoclopramide) - may alter absorption of oral opioids (less relevant for rectal).

• Not available

• Respiratory depression (slow, shallow breathing)
• Excessive sedation/drowsiness
• Dizziness
• Nausea and vomiting
• Constipation
• Pruritus (itching)
• Urinary retention
• Hypotension
• Signs of opioid withdrawal (if abruptly discontinued)

Use during pregnancy is generally not recommended due to the risk of neonatal opioid withdrawal syndrome (NOWS) and potential for respiratory depression in the neonate. Benefits must outweigh risks.

Hydromorphone is excreted into breast milk. While levels are generally low, there is a risk of sedation, respiratory depression, and withdrawal symptoms in the infant. Use with caution, monitor infant closely, or consider alternative analgesics.

Safety and efficacy in pediatric patients have not been established for routine use of rectal suppositories. Use is generally limited to severe, acute pain in opioid-tolerant children under strict medical supervision, often in palliative care settings. Dosing must be highly individualized and carefully titrated.

Elderly patients may be more sensitive to the analgesic and adverse effects of opioids, particularly respiratory depression. Start with lower doses and titrate slowly. Monitor closely for sedation, respiratory depression, and constipation. Renal and hepatic impairment are more common in this population, requiring dose adjustments.

• Rectal bioavailability of hydromorphone can be variable, leading to unpredictable absorption. This makes dose titration challenging and may require careful monitoring.
• Hydromorphone is a potent opioid; 3 mg rectal is roughly equivalent to 15-20 mg oral morphine in terms of analgesic effect, but individual patient response varies.
• Due to the risk of respiratory depression, especially with concomitant CNS depressants, ensure patients and caregivers are educated on signs of overdose and have naloxone readily available if appropriate.
• Opioid-induced constipation is a common and often severe side effect; proactive bowel regimen (stool softener + stimulant laxative) should be initiated concurrently with opioid therapy.
• Hydromorphone-3-glucuronide (H3G), a metabolite, can accumulate in renal impairment and may cause neuroexcitatory symptoms (e.g., myoclonus, hyperalgesia, delirium), even if the parent drug levels are not excessively high.
• This formulation is less commonly used than oral or IV hydromorphone and may be reserved for situations where oral intake is not possible or IV access is difficult.

• Other strong opioid agonists (e.g., morphine, oxycodone, fentanyl, oxymorphone)
• Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for mild to moderate pain or as adjuncts
• Adjuvant analgesics (e.g., gabapentin, pregabalin for neuropathic pain; antidepressants for chronic pain)
• Regional anesthesia or nerve blocks
• Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy)

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 and effective use. It is essential 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 for clarification.

In the event of an overdose, a medication called naloxone can be administered to help counteract the effects. Discuss the availability and use of 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 right away. When reporting the incident, be prepared to provide the necessary information, including the substance involved, the quantity taken, and the time of the incident.