Hydromorphone 10mg/ml Inj, 50ml

Hydromorphone is a full opioid agonist that binds to mu-opioid receptors in the central nervous system (CNS), peripheral tissues, and gastrointestinal tract. Its primary therapeutic effects (analgesia, sedation) are mediated through activation of mu-opioid receptors. 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 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
+ Difficulty 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
+ Rapid 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:
+ 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, 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 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, 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 you experienced, including any symptoms that occurred.
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
Recent use of specific medications for depression or Parkinson's disease within the last 14 days, including:
+ Isocarboxazid
+ Phenelzine
+ Tranylcypromine
+ Selegiline
+ Rasagiline
Note: Combining these medications can lead to severely high blood pressure.
Current use of certain medications, such as:
+ Buprenorphine
+ Butorphanol
+ Linezolid
+ Methylene blue
+ Nalbuphine
+ Pentazocine

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any existing health problems. Your doctor and pharmacist need this information to ensure safe use of this medication. 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 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 down position, and be cautious when climbing stairs.

Dosage and Administration
Do not exceed the dose 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 increased pain, sensitivity to pain, or new pain after taking this medication, 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, 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, consult your doctor. Do not take more than the prescribed dose. Additionally, regular use of opioid medications like this one may cause dependence. If you need to reduce the dose or stop taking the medication, consult your doctor to avoid withdrawal or other severe problems.

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. If you experience extreme fatigue, weakness, fainting, severe dizziness, nausea, vomiting, or decreased appetite, contact your doctor immediately.

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 attention immediately if your baby appears overly sleepy, limp, or has breathing difficulties.

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

• Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, phenothiazines, alcohol): Increased risk of respiratory depression, profound sedation, 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 reduce analgesic effect or precipitate withdrawal symptoms.
• Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants): Increased risk of urinary retention and severe constipation/paralytic ileus.

• Diuretics: Opioids can reduce the efficacy of diuretics by causing release of antidiuretic hormone.
• Antihypertensives: May cause additive hypotensive effects.
• P-glycoprotein (P-gp) inhibitors/inducers: May alter hydromorphone concentrations, though hydromorphone is not a major P-gp substrate.

• Not specifically identified for minor interactions with significant clinical impact.

• Respiratory depression (slow, shallow breathing, cyanosis)
• Excessive sedation/somnolence
• Dizziness/lightheadedness
• Nausea/vomiting
• Constipation
• Pruritus
• Urinary retention
• Signs of allergic reaction (rash, hives, swelling)
• Signs of opioid withdrawal (in physically dependent patients if dose reduced or discontinued abruptly)

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. Monitor neonates for signs of NOWS.

Hydromorphone is excreted into breast milk. Monitor breastfed infants for signs of sedation, respiratory depression, poor feeding, and withdrawal symptoms. A single dose is generally considered low risk, but repeated doses or high doses are not recommended. Consider alternative analgesics or temporary cessation of breastfeeding.

Use with extreme caution due to increased sensitivity to respiratory depression. Dosing must be individualized and carefully titrated. Not recommended for neonates or infants due to lack of established safety and efficacy.

Start with lower doses and titrate slowly due to increased sensitivity to opioids, decreased renal/hepatic function, and increased risk of respiratory depression, sedation, and falls. Monitor closely.

• Hydromorphone 10mg/ml is a highly concentrated formulation, primarily intended for opioid-tolerant patients or those requiring rapid titration in acute severe pain (e.g., palliative care, critical care). Extreme caution is needed to prevent dosing errors.
• Always dilute the 10mg/ml concentration if administering via IV push, unless specifically ordered undiluted for rapid administration in specific clinical scenarios (e.g., rapid sequence intubation, severe acute pain in opioid-tolerant patients). Standard IV push concentration is often 0.2 mg/ml or 1 mg/ml.
• Hydromorphone has a rapid onset and relatively short duration of action, making it suitable for acute pain management and titration, but requiring frequent dosing for sustained analgesia.
• Patients with renal impairment are at higher risk for accumulation of the active metabolite H3G, which can cause neuroexcitatory symptoms (myoclonus, delirium, seizures). Dose reduction is crucial.
• Tolerance and physical dependence can develop with prolonged use. Do not abruptly discontinue in physically dependent patients to avoid withdrawal symptoms.
• Naloxone should be readily available when administering hydromorphone, especially in opioid-naive patients or those at high risk for respiratory depression.

• Morphine (IV, SC, IM)
• Fentanyl (IV, IM)
• Oxycodone (oral, not injectable for acute pain)
• Meperidine (limited use due to neurotoxic metabolite)
• Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for less severe pain or as adjuncts to reduce opioid dose.

It is essential to monitor your symptoms and health problems while taking this medication. If you notice no improvement or a worsening of your condition, contact your doctor promptly.

To ensure safe use, keep the following guidelines in mind:
- Do not share your medication with others, and never take someone else's medication.
- Store all medications in a secure location, out of reach of children and pets.
- Properly dispose of unused or expired medications. Unless instructed to do so, avoid flushing them down the toilet or pouring them down the drain. If you are unsure about the best disposal method, consult your pharmacist. You may also want to explore drug take-back programs available in your area.

This medication is accompanied by a Medication Guide, which provides crucial information. Read this guide carefully and review it each time you receive a refill. If you have any questions or concerns about this medication, discuss them with 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. Consult your doctor or pharmacist about obtaining or using naloxone. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been used. Be prepared to provide information about the medication taken, the amount, and the time it was taken.

If you believe an overdose has occurred, contact your local poison control center or seek medical care right away. When seeking help, be prepared to provide details about the medication, including the amount taken and the time of the incident.