Hydromorphone Hcl 2mg Tablets
Overview
What is this medicine?
How to Use This Medicine
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. You can take this medication with or without food, but if it causes stomach upset, take it with food. It's essential to take this medication by mouth only. Do not inject or snort it, as this can lead to severe side effects, including breathing difficulties and overdose, which can be fatal.
Storing and Disposing of Your Medication
Store this medication at room temperature, away from light and moisture. Keep it in a dry place, and avoid storing it in a bathroom. To prevent accidental ingestion, store this medication in a secure location where children and pets cannot access it. Consider using a locked box or area to keep it safe. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method or explore local drug take-back programs.
Managing Missed Doses
If you take this medication regularly, take a missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Avoid taking two doses at the same time or taking extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Do not drink alcohol while taking hydromorphone, as it can increase the risk of serious side effects like extreme drowsiness and breathing problems.
- Avoid driving or operating heavy machinery until you know how this medication affects you, as it can cause dizziness and drowsiness.
- To prevent constipation, drink plenty of fluids, eat fiber-rich foods, and consider using a stool softener or laxative as recommended by your doctor.
- Store this medication securely away from children and pets, preferably in a locked cabinet, to prevent accidental ingestion.
- Do not share this medication with anyone else, as it can be dangerous and is against the law.
Available Forms & Alternatives
Available Strengths:
- Hydromorphone 3mg Rectal Supp
- Hydromorphone 2mg/ml Inj, 20ml Vial
- Hydromorphone 4mg Tablets
- Hydromorphone Hcl 2mg Tablets
- Hydromorphone 8mg Tablets
- Hydromorphone 4mg/ml Inj, 1ml
- Hydromorphone 2mg/ml Inj, 1ml (pf)
- Hydromorphone 10mg/ml Inj, 5ml
- Hydromorphone 50mg/5ml Inj, 5ml
- Hydromorphone 1mg/ml Liquid
- Hydromorphone 1mg/ml Inj, 1ml
- Hydromorphone 10mg/ml Inj, 1ml
- Hydromorphone 10mg/ml Inj, 50ml
- Hydromorphone 2mg/ml Inj, 1ml
- Hydromorphone 32mg ER Tablets
- Hydromorphone 8mg ER Tablets
- Hydromorphone 12mg ER Tablets
- Hydromorphone 16mg ER Tablets
- Hydromorphone 1mg/ml Pf Inj, 0.5ml
- Hydromorphone 0.25mg/0.5ml Pf Inj
- Hydromorphone 0.2mg/ml Pf Inj, 1ml
- Hydromorphone 8mg ER Tablets
- Hydromorphone 16mg ER Tablets
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Addiction, Abuse, and Misuse: Hydromorphone exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patientβs risk prior to prescribing hydromorphone, and monitor all patients regularly for the development of these behaviors and conditions.
Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur. Monitor for respiratory depression, especially during initiation or following a dose increase.
Accidental Ingestion: Accidental ingestion of even one dose of hydromorphone, especially by children, can result in a fatal overdose.
Neonatal Opioid Withdrawal Syndrome: Prolonged use of hydromorphone during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Side Effects
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
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 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 Effects
Prolonged use of opioid medications like this one may lead to decreased sex hormone levels. If you experience any of the following, consult 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, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Slow, shallow, or difficult breathing
- Extreme drowsiness or difficulty waking up
- Bluish lips or fingernails
- Severe dizziness or lightheadedness
- Confusion
- Pinpoint pupils
- Severe constipation or abdominal pain (signs of ileus)
- Hives, rash, or swelling of the face, lips, tongue, or throat (allergic reaction)
Before Using This Medicine
It is crucial 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.
Certain health conditions, such as:
+ 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, including 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 essential 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. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position. Be cautious 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 duration, may increase the risk of severe side effects.
Interactions with Other Medications
Do not take this medication with other strong pain medications or use a pain patch without consulting your doctor first.
Monitoring and Follow-up
If your pain worsens, you experience increased sensitivity to pain, or you develop new pain after taking this medication, contact your doctor immediately. Do not take more than the prescribed dose.
Long-term Use and Blood Work
If you are taking this medication for an extended period, discuss with your doctor the need for regular blood work checks.
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, 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. Suddenly stopping or reducing the dose may increase the risk of withdrawal or other severe problems. Consult your doctor before changing your dosage. Follow your doctor's instructions carefully and report any adverse effects, such as increased pain, mood changes, or suicidal thoughts.
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. 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
Inform your doctor if you are breastfeeding, 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.
Overdose Information
Overdose Symptoms:
- Pinpoint pupils
- Extreme drowsiness or unresponsiveness
- Slowed or stopped breathing
- Bluish skin, especially around the lips and fingernails
- Limp muscles
- Cold, clammy skin
- Loss of consciousness
- Coma
What to Do:
If you suspect an overdose, call 911 immediately. Administer naloxone if available and you are trained to do so. Stay with the person until emergency medical help arrives. Provide rescue breathing if necessary. Call 1-800-222-1222 (Poison Control) for additional guidance.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or use within 14 days of MAOI therapy (risk of serotonin syndrome, severe respiratory depression, coma, death)
Major Interactions
- 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.
- Mixed agonist/antagonist opioids (e.g., nalbuphine, butorphanol, pentazocine) - may reduce analgesic effect and/or precipitate withdrawal symptoms.
Moderate Interactions
- Anticholinergics (e.g., tricyclic antidepressants, antihistamines, antipsychotics) - increased risk of severe constipation and/or paralytic ileus.
- Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans) - theoretical risk of serotonin syndrome, though less common with hydromorphone than other opioids.
Minor Interactions
- Not many specific minor interactions are clinically significant for hydromorphone due to its primary metabolism via glucuronidation rather than CYP450.
Monitoring
Baseline Monitoring
Rationale: To establish baseline pain level and guide initial dosing.
Timing: Prior to initiation of therapy.
Rationale: To assess baseline respiratory function and identify risk factors for respiratory depression.
Timing: Prior to initiation of therapy.
Rationale: To assess baseline CNS effects and guide initial dosing.
Timing: Prior to initiation of therapy.
Rationale: To establish baseline and anticipate opioid-induced constipation.
Timing: Prior to initiation of therapy.
Rationale: To assess risk for addiction, abuse, and misuse.
Timing: Prior to initiation of therapy.
Routine Monitoring
Frequency: Regularly, especially during dose titration and with changes in pain.
Target: Patient-specific, aiming for acceptable pain control with minimal side effects.
Action Threshold: Inadequate pain control may require dose adjustment; excessive pain relief may indicate over-sedation.
Frequency: Regularly, especially during initiation and dose titration (e.g., every 1-2 hours initially, then every 4-6 hours or as clinically indicated).
Target: Respiratory rate >10-12 breaths/min, SpO2 >92-94%.
Action Threshold: Respiratory rate <10 breaths/min, shallow breathing, or SpO2 <90% requires immediate intervention (e.g., naloxone, respiratory support).
Frequency: Regularly, especially during initiation and dose titration (e.g., every 1-2 hours initially, then every 4-6 hours or as clinically indicated).
Target: Alert or mildly drowsy, easily aroused.
Action Threshold: Moderate to severe sedation (e.g., difficult to arouse, somnolent) requires immediate intervention (e.g., naloxone, hold dose).
Frequency: Daily
Target: Regular bowel movements (e.g., every 1-2 days).
Action Threshold: No bowel movement for 2-3 days requires intervention (e.g., laxatives, stool softeners).
Symptom Monitoring
- Respiratory depression (slow, shallow breathing)
- Excessive sedation or somnolence
- Dizziness or lightheadedness
- Nausea and vomiting
- Constipation
- Pruritus (itching)
- Urinary retention
- Confusion or disorientation
Special Patient Groups
Pregnancy
Prolonged use of hydromorphone during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS), which may be life-threatening if not recognized and treated. Advise pregnant patients of the risk of NOWS and ensure appropriate treatment will be available. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
Lactation
Hydromorphone is excreted into breast milk. Monitor breastfed infants for signs of sedation, respiratory depression (e.g., increased sleepiness, difficulty breathing, limpness), and poor feeding. If opioid use is necessary, use the lowest effective dose for the shortest duration. Consider alternative pain management strategies if possible.
Pediatric Use
Use with extreme caution in pediatric patients, especially opioid-naive children, due to increased risk of respiratory depression. Not generally recommended for routine use in tablet form. Dosing must be individualized and carefully titrated by a specialist for severe pain in opioid-tolerant children.
Geriatric Use
Start with lower doses and titrate slowly due to increased sensitivity to opioids, decreased renal and hepatic function, and increased risk of respiratory depression and falls. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Hydromorphone is a potent opioid; 2 mg oral hydromorphone is approximately equipotent to 10-15 mg oral morphine.
- Due to its relatively short half-life, it is suitable for acute pain or breakthrough pain in patients on long-acting opioids.
- Accumulation of the active metabolite, hydromorphone-3-glucuronide (H3G), can occur in patients with renal impairment, leading to neuroexcitatory symptoms (e.g., myoclonus, hyperalgesia, delirium). Dose reduction is crucial in renal dysfunction.
- Patients should be educated on the risks of addiction, abuse, and misuse, and proper storage and disposal of the medication.
- Always have naloxone readily available for patients at high risk of overdose (e.g., concomitant CNS depressant use, history of overdose, higher doses).
Alternative Therapies
- Other strong opioid analgesics (e.g., morphine, oxycodone, fentanyl, oxymorphone)
- Tramadol (for moderate to moderately severe pain)
- Non-opioid analgesics (e.g., NSAIDs, acetaminophen) for milder pain or as adjuncts
- Adjuvant analgesics (e.g., gabapentin, pregabalin, tricyclic antidepressants) for neuropathic pain
- Regional anesthesia or nerve blocks
- Non-pharmacological pain management (e.g., physical therapy, acupuncture, cognitive behavioral therapy)
Cost & Coverage
General Drug Facts
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is essential to read this guide carefully and review it again each time 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 used as an emergency treatment. Discuss the availability and use of naloxone with your doctor or pharmacist. If you suspect an overdose has occurred, seek immediate medical attention, even if naloxone has been administered. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken.
In case of a suspected overdose, contact your local poison control center or seek emergency medical care right away. Be prepared to provide detailed information about the medication, including the dose and time of administration, to ensure you receive appropriate treatment.