Hydromorphone Hydrochloride (Page 3 of 5)

Information for Patients/Caregivers

Patients receiving hydromorphone hydrochloride tablets or their caregivers should be given the following information by the physician, nurse, or pharmacist:

  1. Patients should be aware that hydromorphone hydrochloride tablets contain hydromorphone, which is a morphine-like substance and which could cause severe adverse effects including respiratory depression and even death if not taken according to the prescriber’s directions.
  2. Patients should be advised to report pain and adverse experiences occurring during therapy. Individualization of dosage is essential to make optimal use of this medication.
  3. Patients should be advised not to adjust the dose of hydromorphone hydrochloride tablets without consulting the prescribing professional.
  4. Patients should be advised that hydromorphone hydrochloride tablets may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).
  5. Patients should not combine hydromorphone hydrochloride tablets with alcohol or other central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, because dangerous additive effects may occur, resulting in serious injury or death.
  6. Women of childbearing potential who become, or are planning to become pregnant should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.
  7. Patients should be advised that hydromorphone hydrochloride tablets are a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
  8. Patients should be advised that if they have been receiving treatment with hydromorphone hydrochloride tablets for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the hydromorphone hydrochloride tablets dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.
  9. Patients should be instructed to keep hydromorphone hydrochloride tablets in a secure place out of the reach of children. When hydromorphone hydrochloride tablets are no longer needed, the unused tablets should be destroyed by flushing down the toilet.

Drug Interactions

Drug Interactions with Other CNS Depressants

The concomitant use of other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, tranquilizers and alcohol may produce additive depressant effects. Respiratory depression, hypotension and profound sedation or coma may occur. When such combined therapy is contemplated, the dose of one or both agents should be reduced. Hydromorphone hydrochloride tablets should not be taken with alcohol. Opioid analgesics, including hydromorphone hydrochloride tablets, may enhance the action of neuromuscular blocking agents and produce an excessive degree of respiratory depression.

Interactions with Mixed Agonist/Antagonist Opioid Analgesics

Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol, and buprenorphine) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as hydromorphone. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of hydromorphone and/or may precipitate withdrawal symptoms in these patients.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity studies have been conducted in animals.

Hydromorphone was not mutagenic in the in vitro Ames reverse mutation assay or the human lymphocyte chromosome aberration assay. Hydromorphone was not clastogenic in the in vivo mouse micronucleus assay.

No effects on fertility, reproductive performance, or reproductive organ morphology were observed in male or female rats given oral doses up to 7 mg/kg/day, which is equivalent to the human dose of 2.5-10 mg every 3 to 6 hours for oral liquid, and 3-fold higher than the human dose of 2-4 mg every 4 to 6 hours for the tablet on a body surface area basis.

Pregnancy

Teratogenic Effects: Pregnancy Category C

No effects on teratogenicity or embryotoxicity were observed in female rats given oral doses up to 7 mg/kg/day, which is approximately equivalent to the human dose of 2.5-10 mg every 3 to 6 hours for oral liquid, and 3-fold higher than the human dose of 2-4 mg every 4 to 6 hours for the tablet on a body surface area basis. Hydromorphone produced skull malformations (exencephaly and cranioschisis) in Syrian hamsters given oral doses up to 20 mg/kg during the peak of organogenesis (gestation days 8-9). The skull malformations were observed at doses approximately 2-fold higher the human dose of 2.5-10 mg every 3 to 6 hours for oral liquid, and 7-fold higher than the human dose of 2-4 mg every 4 to 6 hours for the tablet on a body surface area basis. There are no adequate and well-controlled studies of hydromorphone hydrochloride tablets in pregnant women.

Hydromorphone crosses the placenta, resulting in fetal exposure. Hydromorphone hydrochloride tablets should be used in pregnant women only if the potential benefit justifies the potential risk to the fetus (see Labor and Delivery and DRUG ABUSE AND DEPENDENCE).

Nonteratogenic effects

Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal. Approaches to the treatment of this syndrome have included supportive care and, when indicated, drugs such as paregoric or phenobarbital.

Labor and Delivery

Hydromorphone hydrochloride tablets are contraindicated in Labor and Delivery (see CONTRAINDICATIONS).

Nursing Mothers

Low levels of opioid analgesics have been detected in human milk. As a general rule, nursing should not be undertaken while a patient is receiving hydromorphone hydrochloride tablets since it, and other drugs in this class, may be excreted in the milk.

Pediatric Use

Safety and effectiveness in children have not been established.

Geriatric Use

Clinical studies of hydromorphone hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see INDIVIDUALIZATION OF DOSAGE and PRECAUTIONS).

ADVERSE REACTIONS

The major hazards of hydromorphone hydrochloride tablets include respiratory depression and apnea. To a lesser degree, circulatory depression, respiratory arrest, shock and cardiac arrest have occurred.

The most frequently observed adverse effects are light-headedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. These effects seem to be more prominent in ambulatory patients and in those not experiencing severe pain.

Less Frequently Observed with Opioid Analgesics

General and CNS

Weakness, headache, agitation, tremor, uncoordinated muscle movements, alterations of mood (nervousness, apprehension, depression, floating feelings, dreams), muscle rigidity, paresthesia, muscle tremor, blurred vision, nystagmus, diplopia and miosis, transient hallucinations and disorientation, visual disturbances, insomnia, increased intracranial

Cardiovascular

Flushing of the face, chills, tachycardia, bradycardia, palpitation, faintness, syncope, hypotension, hypertension

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