This dosage information may not include all the information needed to use Hydromorphone safely and effectively. See additional information for Hydromorphone.
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Pain
Doses should be titrated to appropriate analgesic effects while minimizing adverse effects. When changing routes of administration, it should be noted that oral doses are less than one-half as effective as parenteral doses. Oral doses may be only one fifth as effective as parenteral doses.
Oral liquid: 2.5 to 10 mL every 3 to 6 hours, increasing gradually
Oral tablets: 2 to 4 mg every 4 to 6 hours, increasing gradually
Chronic pain: Oral: Patients taking opioids chronically may become tolerant and require doses higher than the usual dosage range to maintain the desired effect. Tolerance can be managed by appropriate dose titration. There is no optimal or maximal dose for hydromorphone in chronic pain. The appropriate dose is one that relieves pain throughout its dosing interval without causing unmanageable side effects.
IV: Care should be taken to avoid dosing errors due to confusion between the different concentrations and between mg and mL. Hydromorphone HP injection should never be administered to opioid-naÃ¯ve patients.
Subcutaneous or IM initial dose: 0.2 to 1 mg given slowly every 2 to 3 hours as needed (Lower doses may be used in opioid-naÃ¯ve patients)
IV initial dose: 0.2 to 1 mg every 2 to 3 hours (given slowly over at least 2 to 3 minutes). The initial dose should be reduced in the elderly or debilitated and may be lowered to 0.2 mg.
Hydromorphone extended release tablets:
Hydromorphone extended release tablets are indicated for opioid tolerant patients only. Patient must not be started on hydromorphone extended release tablets as their first opioid.
Hydromorphone extended release tablets should be swallowed whole and should not be broken, crushed, dissolved, or chewed before swallowing. The tablets are to be administered every 24 hours with or without food.
The dose range of hydromorphone extended release tablets studied in clinical trials is 8 mg to 64 mg.
Patients receiving oral immediate-release hydromorphone may be converted to hydromorphone extended release tablets by administering a starting dose equivalent to the patient's total daily oral hydromorphone dose, taken once daily. The dose of hydromorphone extended release tablets can be titrated every 3 to 4 days until adequate pain relief with tolerable side effects has been achieved.
It is critical to accurately initiate the dosing regimen individually for each patient. Overestimating the hydromorphone extended release tablets dose when converting patients from another opioid medication can result in fatal overdose with the first dose. In the selection of the initial dose of hydromorphone extended release tablets, the following should be noted:
-the daily dose, potency, and specific characteristics of the opioid the patient has been taking previously;
-the reliability of the relative potency estimate used to calculate the equivalent hydromorphone dose needed;
-the patient's degree of opioid tolerance;
-the age, general condition, and medical status of the patient;
-concurrent non-opioid analgesics and other medications, such as those with central nervous system activity;
-the type and severity of the patient pain;
-the balance between pain control and adverse effects;
-risk factors for abuse, addiction, or diversion, including a prior history of abuse, addiction, or diversion.
Dosing recommendations, therefore, can only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.
Conversion from oral opioids to hydromorphone extended release tablets:
For conversion from other opioids to hydromorphone extended release tablets, physicians and other healthcare professionals are advised to refer to published relative potency data, keeping in mind that conversion ratios are only approximate. In general, therapy with hydromorphone extended release tablets should be started by administering 50% of the calculated total daily dose of hydromorphone extended release tablets every 24 hours. The initial dose of hydromorphone extended release tablets can be titrated until adequate pain relief with tolerable side effects has been achieved.
Conversion from transdermal fentanyl to hydromorphone extended release tablets:
Eighteen hours following the removal of the transdermal fentanyl patch, hydromorphone extended release tablets treatment can be initiated. For each 25 mcg/hr fentanyl transdermal dose the equianalgesic dose of hydromorphone extended release tablets is 12 mg every 24 hours. An appropriate starting dose of hydromorphone extended release tablets is 50% of the calculated total daily dose every 24 hours.
Individualization of Dosage:
Once therapy is initiated, assess pain relief and other opioid adverse reactions frequently.
Titrate patients to adequate analgesia with dose increases not more often than every 3 to 4 days, in order to attain steady-state plasma concentrations of hydromorphone at each dose.
As a guideline, consider dosage increases of 25% to 50% of the current daily dose of hydromorphone extended release tablets for each titration step.
If more than two doses of rescue medication are needed within a 24 hour period for two consecutive days, the dose of hydromorphone extended release tablets may need to be titrated upward.
Administer hydromorphone extended release tablets no more frequently than every 24 hours.
During periods of changing analgesic requirements, including initial titration, maintain frequent contact between physician, other members of the healthcare team, the patient and the caregiver/family.
Maintenance of Therapy:
During chronic therapy with hydromorphone extended release tablets, assess the continued need for around-the-clock opioid therapy periodically. Continue to assess patients for their clinical risks for opioid abuse, addiction, or diversion particularly with high-dose formulations. If patients need to titrate while on maintenance therapy, follow the same method outlined above to reestablish pain control.
Renal Dose Adjustments
Patients with renal impairment should be started on a lower dose of hydromorphone oral forms depending upon the degree of impairment.
Patients with renal impairment should be started on one-fourth to one-half the usual hydromorphone injectable dose depending upon the degree of impairment.
Liver Dose Adjustments
Patients with hepatic impairment should be started on a lower dose of hydromorphone oral forms depending upon the degree of impairment.
Patients with hepatic impairment should be started on one-fourth to one-half the usual hydromorphone injectable dose depending upon the degree of impairment.
Factors such as age, disease state, concomitant drug therapy, and tolerance to narcotics can have variable but important effects on dose and response.
Elderly patients have been shown to be more sensitive to the adverse effects of hydromorphone extended release tablets compared to the younger population. Therefore, extra caution and a reduced initial dose are recommended when prescribing hydromorphone extended release tablets in elderly patients.
Caution should be used in patients with hepatic disease.
Hydromorphone extended-release is not for use:
--as an as needed analgesic
--for pain that is mild or not expected to persist for an extended period of time
--for postoperative pain, unless the patient is already receiving chronic opioid therapy prior to surgery, or if the postoperative pain is moderate to severe and persist for an extended period of time
Hydromorphone extended-release is indicated only for patients in whom tolerance to an opioid of comparable potency has been established.
Safety and effectiveness have not been established in pediatric patients (less than 18 years of age).
Data not available
The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioid analgesics. The REMS consists of a medication guide and elements to assure safe use. Additional information is available at www.fda.gov/Drugs/DrugSafety/postmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm.
Should intravenous administration be necessary, the injection should be given slowly, over at least 2 to 3 minutes, depending on the dose.
Patients with terminal cancer may be tolerant to narcotic analgesics and may, therefore, require higher doses for adequate pain relief.
Intravenous or subcutaneous administration is usually not painful.
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