Hydromorphone Hcl (hydromorphone HCl/PF)

Hydromorphone hydrochloride should be given at the lowest effective dosage and for the shortest duration of therapy consistent with the treatment goals of the patient. Reduced dosage is indicated in geriatric or debilitated patients and in patients with hepatic or renal impairment. If concomitant therapy with other CNS depressants is required, the lowest effective dosages and shortest possible duration of concomitant therapy should be used.

For acute pain not related to trauma or surgery, the prescribed quantity should be limited to the amount needed for the expected duration of pain severe enough to require opiate analgesia (generally 3 days or less and rarely more than 7 days). When opiate analgesics are used for the management of chronic noncancer pain, the US Centers for Disease Control and Prevention (CDC) recommends that primary care clinicians carefully reassess individual benefits and risks before prescribing dosages equivalent to 50 mg or more of morphine sulfate daily (approximately 12.5 mg or more of hydromorphone hydrochloride daily) and avoid dosages equivalent to 90 mg or more of morphine sulfate daily (approximately 22.5 mg or more of hydromorphone hydrochloride daily) or carefully justify their decision to titrate the dosage to such levels. Other experts recommend consulting a pain management specialist before exceeding a dosage equivalent to 80-120 mg of morphine sulfate daily.

Dosage of hydromorphone hydrochloride should be individualized to provide adequate analgesia and to minimize adverse effects. When selecting an initial dosage, consideration should be given to the severity of the patient's pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse. There is substantial interpatient variability in the relative potency of opiate analgesics and analgesic formulations; therefore, in patients who are being transferred to hydromorphone from other opiate therapy, it is preferable to underestimate the patient's 24-hour opiate requirements than to overestimate the requirements and manage an adverse reaction.

Appropriate dosage selection and titration are essential to reduce the risk of respiratory depression. Patients should be monitored closely for respiratory depression, especially during the first 24-72 hours of therapy and following any increase in dosage.

Patients receiving opiate analgesia should be reevaluated continually for adequacy of pain control and for adverse effects, as well for the development of addiction, abuse, or misuse. During long-term therapy, the continued need for opiate analgesics should be periodically reevaluated. Frequent communication among the prescriber, other members of the healthcare team, the patient, and the patient's caregiver or family is important during periods of changing analgesic requirements, including the initial dosage titration period. If the level of pain increases after dosage stabilization, an attempt should be made to identify the source of increased pain before increasing the hydromorphone hydrochloride dosage.

Because of the potential for increased drug exposure, dosage of hydromorphone hydrochloride should be reduced in patients with renal or hepatic impairment based on the degree of impairment. Patients with hepatic or renal impairment should be closely monitored during initiation of therapy and dosage titrations.

Hydromorphone hydrochloride may be administered by subcutaneous, IM, or slow IV injection; the drug also may be administered orally as conventional (immediate-release) or extended-release tablets or as an oral solution. If rapid onset and shorter duration of analgesia are required, the drug may be given IV at a very slow rate (over at least 2-3 minutes depending on the dose) with special attention to the possibility of respiratory depression and hypotension. Hydromorphone hydrochloride has been administered as a continuous subcutaneous or IV infusion in selected opiate-tolerant patients with chronic pain conditions; extreme caution is advised when administering continuous infusions of opiates to patients with no prior exposure to opiate analgesics. The drug also has been administered IV via a controlled-delivery device for patient-controlled analgesia (PCA). Hydromorphone hydrochloride also has been administered epidurally+.

No dosing information is available for this tab.

No dosing information is available for this tab.

In vitro data suggest that hydromorphone has minimal potential to inhibit the activity of hepatic cytochrome P-450 (CYP) enzymes, including CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 3A4, and 4A11, at clinically relevant concentrations.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Safe use of hydromorphone in pregnancy has not been established. Results of animal studies suggest the potential for fetal risk. In animal studies, neural tube defects were observed in hamsters, soft tissue and skeletal abnormalities were observed in mice, and reduced postnatal survival of pups, developmental delays, and altered behavioral responses were observed in rats following subcutaneous injection, continuous subcutaneous infusion, or oral administration of hydromorphone hydrochloride in these respective species at dosages of 4.8, 2.3, or 2.1 times, respectively, a human dosage of 32 mg daily. No malformations were observed in rats or rabbits at dosages of 2.1 or 17 times, respectively, this human dosage.

The manufacturers state that hydromorphone hydrochloride should not be used during and immediately prior to labor and delivery.

Low concentrations of hydromorphone have been detected in human milk. The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for hydromorphone and any potential adverse effects on the breast-fed infant from the drug or from the underlying maternal condition. The manufacturer states that women receiving hydromorphone hydrochloride extended-release tablets should not breast-feed infants.

No enhanced messaging available.