Dilaudid 2mg/ml Pf Inj, 1ml

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.

Important Side Effects to Report to Your Doctor Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, seek medical attention right away:

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, 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
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 of developing serotonin syndrome, a severe and potentially deadly condition. Seek medical attention immediately 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
Throwing up
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
Throwing up
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 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, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Respiratory problems like 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, such as 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. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify the dosage of any medication without first 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 worsening pain, increased sensitivity to pain, or new pain, contact your doctor immediately. Do not take more than the prescribed dose.

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 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 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 increased pain, mood changes, suicidal thoughts, or other adverse effects.

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 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
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 overly sleepy, limp, or has breathing difficulties.

• Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of MAOI therapy (risk of serotonin syndrome, severe respiratory depression, coma, death)

• Benzodiazepines and other CNS depressants (e.g., other opioids, sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, alcohol): Increased risk of profound sedation, respiratory depression, coma, and death.
• Mixed opioid agonist/antagonists (e.g., pentazocine, nalbuphine, butorphanol): May reduce the analgesic effect of hydromorphone and/or precipitate withdrawal symptoms.
• Partial opioid agonists (e.g., buprenorphine): May reduce the analgesic effect of hydromorphone and/or precipitate withdrawal symptoms.

• Anticholinergic drugs (e.g., tricyclic antidepressants, antihistamines, antipsychotics, antiemetics): Increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, tramadol): Risk of serotonin syndrome (especially with MAOIs, but also with other serotonergic agents).

• Diuretics: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.

• Respiratory depression (slow, shallow breathing, cyanosis)
• Excessive sedation/somnolence
• Nausea and vomiting
• Constipation
• Pruritus (itching)
• Dizziness/lightheadedness
• Hypotension
• Urinary retention

Use during pregnancy is generally not recommended due to potential for fetal harm, including neonatal opioid withdrawal syndrome (NOWS). Prolonged use during pregnancy can lead to physical dependence in the fetus, resulting in NOWS after birth. NOWS can be life-threatening if not recognized and treated.

Hydromorphone is excreted into breast milk. While levels are generally low, there is a risk of sedation, respiratory depression, and poor feeding in the breastfed infant. Monitor infants closely for signs of sedation, difficulty breathing, or increased drowsiness. Use with caution, or consider alternative analgesics if possible. If used, use the lowest effective dose for the shortest duration.

Use with extreme caution due to increased sensitivity to respiratory depression. Dosing must be carefully calculated based on weight and titrated to effect. 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 and hepatic function, and increased risk of respiratory depression, sedation, and falls. Monitor closely for adverse effects.

• Hydromorphone is significantly more potent than morphine (approximately 5-7 times). Always verify dose calculations carefully to avoid overdose.
• Rapid IV administration can lead to severe respiratory depression, hypotension, and circulatory collapse. Administer IV doses slowly over at least 2-3 minutes.
• The metabolite hydromorphone-3-glucuronide (H3G) can accumulate in renal impairment, potentially causing neuroexcitatory symptoms (e.g., myoclonus, hyperalgesia, delirium). Monitor patients with renal dysfunction closely.
• Tolerance and physical dependence can develop with prolonged use. Do not abruptly discontinue in physically dependent patients; taper gradually to prevent withdrawal symptoms.
• Naloxone should be readily available for reversal of opioid-induced respiratory depression.
• Consider a bowel regimen (stool softener + stimulant laxative) proactively to prevent opioid-induced constipation.

• Other opioid analgesics (e.g., morphine, fentanyl, oxycodone, hydrocodone)
• Non-opioid analgesics (e.g., NSAIDs, acetaminophen)
• Regional anesthesia/nerve blocks
• Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants for neuropathic pain)
• Non-pharmacological pain management (e.g., physical therapy, heat/cold therapy, massage, acupuncture)

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, never share your medication with others, and do not take anyone else's medication. Store all medications in a secure location, out of reach of children and pets. Properly dispose of unused or expired medications by throwing them away. However, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist or healthcare provider. If you are unsure about the best method for disposing of medications, consult with your pharmacist, who can also inform you about potential drug take-back programs in your area.

This medication is accompanied by a Medication Guide, which provides crucial information for patients. Read this guide carefully and review it again each time your prescription is refilled. 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 used as part of the treatment. Consult with your doctor or pharmacist about obtaining and using naloxone. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. Be prepared to provide information about what was taken, the amount, and the time it happened.

In case of a suspected overdose, contact your local poison control center or seek medical care immediately. When seeking help, be ready to provide details about the medication, including the dose taken and the time of the incident.