Hydromorphone 1mg/ml Pf Inj, 0.5ml

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 inhibits 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 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 indicate 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 serotonin syndrome, a severe and potentially deadly condition. Seek medical help immediately if you experience:

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
Vomiting
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 side effects or may only have mild side effects, 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 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 crucial 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 obstruction or narrowing
Recent use (within the last 14 days) of specific medications for depression or Parkinson's disease, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may lead to severely high blood pressure
Current use of certain medications, including buprenorphine, butorphanol, linezolid, methylene blue, nalbuphine, or pentazocine

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

Important Warnings and Cautions

Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When getting up from a sitting or lying down position, rise slowly to minimize the risk of dizziness or fainting. Be cautious when using stairs.

Adhere to your doctor's prescribed dosage and frequency instructions. Do not exceed the recommended dose, take it more frequently, or use it for a longer duration than prescribed, as this may increase the risk of severe side effects.

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

If you are taking this medication long-term, your doctor may recommend regular blood tests to monitor your health. Discuss this with your doctor.

If you have a sulfite allergy, inform your doctor, as some products contain sulfites. Avoid consuming alcohol or products containing alcohol while taking this medication, as this can lead to unsafe and potentially life-threatening effects.

Long-term or high-dose use of this medication can lead to tolerance, reducing its effectiveness. If you find that this medication is no longer working as well as it should, contact your doctor. Do not take more than the prescribed dose.

Prolonged or regular use of opioid medications like this one can cause dependence. If you need to reduce your dose or stop taking this medication, consult your doctor first, as suddenly stopping or lowering 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.

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

Taking an opioid medication like this one can 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.

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

If you are breastfeeding, inform your doctor, as this medication can pass into breast milk and harm your baby. Seek medical help immediately if your baby appears overly sleepy, limp, or has breathing difficulties.

• Monoamine Oxidase Inhibitors (MAOIs) within 14 days (risk of serotonin syndrome or severe respiratory depression)

• Benzodiazepines and other CNS depressants (e.g., other opioids, alcohol, sedatives, hypnotics, general anesthetics, phenothiazines, tranquilizers, skeletal muscle relaxants): Increased risk of profound sedation, respiratory depression, coma, and death.
• Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, trazodone, tramadol, fentanyl): Risk of serotonin syndrome.
• Muscle relaxants: Enhanced neuromuscular blockade.

• Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants): Increased risk of urinary retention and severe constipation/paralytic ileus.
• Diuretics: Opioids may reduce the efficacy of diuretics by inducing ADH release.

• Antihypertensives: May cause additive hypotensive effects.

• Respiratory depression (slow, shallow breathing, difficulty breathing, blue lips/fingernails)
• Excessive sedation or somnolence
• Dizziness or lightheadedness
• Nausea and vomiting
• Constipation
• Urinary retention
• Itching
• Confusion or disorientation

Use during pregnancy may cause neonatal opioid withdrawal syndrome (NOWS) in the newborn, which can be life-threatening if not recognized and treated. Prolonged use during pregnancy is not recommended. Discuss risks and benefits with a healthcare provider.

Hydromorphone is excreted into breast milk. Monitor breastfed infants for signs of sedation, respiratory depression, poor feeding, and withdrawal symptoms. A single dose may be acceptable, but chronic use is generally not recommended. Consult with a healthcare provider.

Use with caution. Pediatric patients, especially infants and young children, may be more sensitive to the respiratory depressant effects of opioids. Dosing must be carefully calculated based on weight and titrated to effect. Not recommended for routine use in neonates or infants due to lack of established safety and efficacy.

Start with lower doses and titrate slowly due to increased sensitivity to opioid effects (e.g., respiratory depression, sedation, constipation) and potential for decreased renal or hepatic function. Monitor closely for adverse effects.

• Hydromorphone is approximately 5-7 times more potent than morphine on a milligram-for-milligram basis. Always verify dose and concentration carefully to avoid overdose.
• Rapid IV administration can lead to severe respiratory depression, hypotension, and circulatory collapse. Administer slowly over at least 2-3 minutes.
• Patients with renal impairment are at increased risk of accumulation of hydromorphone-3-glucuronide (H3G), which can cause neuroexcitatory symptoms (e.g., myoclonus, seizures, delirium). Dose reduction is crucial.
• Tolerance and physical dependence can develop with prolonged use. Do not abruptly discontinue in physically dependent patients; taper gradually to avoid withdrawal symptoms.
• Naloxone should be readily available when administering hydromorphone, especially in opioid-naive patients or those at high risk of respiratory depression.

• Other Opioid Analgesics (e.g., Morphine, Fentanyl, Oxycodone, Codeine)
• Non-opioid Analgesics (e.g., NSAIDs, Acetaminophen)
• Adjuvant Analgesics (e.g., Gabapentin, Pregabalin, TCAs for neuropathic pain)
• Regional Anesthesia/Nerve Blocks
• Non-pharmacological pain management (e.g., physical therapy, heat/cold therapy, massage, acupuncture)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. 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 by your pharmacist. If you are unsure about the best disposal method, consult your pharmacist, as there may be drug take-back programs available in your area.

This medication is accompanied by a Medication Guide, which provides crucial information for safe use. 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 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 the medication taken, the amount, and the time it was taken. You can also contact your local poison control center or seek emergency medical care right away, providing the same detailed information about the overdose.