Hydromorphone hydrochloride extended-release tablets (CII) 32 mg
This information is intended for U.S. healthcare professionals only.
INDICATIONS AND USAGE
Hydromorphone hydrochloride extended-release tablets (CII) are indicated for the management of pain in opioid-tolerant patients severe enough to require daily, around-the clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Patients considered opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydromorphone hydrochloride extended release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Hydromorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic.
IMPORTANT RISK INFORMATION
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; and NEONATAL OPIOID WITHDRAWAL SYNDROME
Addiction, Abuse, and Misuse
Hydromorphone hydrochloride extended-release tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing hydromorphone hydrochloride extended-release tablets, and monitor all patients regularly for the development of these behaviors or conditions.
Life-threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of hydromorphone hydrochloride extended-release tablets. Monitor for respiratory depression, especially during initiation of hydromorphone hydrochloride extended-release tablets or following a dose increase. Instruct patients to swallow hydromorphone hydrochloride extended-release tablets whole; crushing, chewing, or dissolving hydromorphone hydrochloride extended-release tablets can cause rapid release and absorption of a potentially fatal dose of hydromorphone.
Accidental ingestion of hydromorphone hydrochloride extended-release tablets, especially in children, can result in a fatal overdose of hydromorphone.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of hydromorphone hydrochloride extended-release tablets 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.
- Hydromorphone hydrochloride extended-release tablets are contraindicated in:
- Opioid non-tolerant patients. Fatal respiratory depression could occur in patients who are not opioid tolerant.
- Patients with significant respiratory depression
- Patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
- Patients with known or suspected paralytic ileus
- Patients who have had surgical procedures and/or underlying disease resulting in narrowing of the gastrointestinal tract, or have “blind loops” of the gastrointestinal tract or gastrointestinal obstruction
- Patients with hypersensitivity (e.g., anaphylaxis) to hydromorphone or sulfite-containing medications
WARNINGS AND PRECAUTIONS
- Hydromorphone hydrochloride extended-release tablets contain hydromorphone, a Schedule II controlled substance. As an opioid, hydromorphone hydrochloride extended-release tablets expose users to the risks of addiction, abuse, and misuse. As modified-release products such as hydromorphone hydrochloride extended-release tablets deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydromorphone present. With intravenous abuse, the tablet excipients, especially polyethylene oxide, can be expected to result in necrosis and inflammation of cardiac tissues. In addition, parenteral drug abuse is commonly associated with transmission of infectious disease such as hepatitis and HIV.
- While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of hydromorphone hydrochloride extended-release tablets, the risk is greatest during the initiation of therapy or following a dose increase. Overestimating the hydromorphone hydrochloride extended-release tablet dose when converting patients from another opioid product can result in fatal overdose with the first dose. Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients. In patients with significant chronic obstructive pulmonary disease or cor pulmonale, and patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression, hydromorphone hydrochloride extended-release tablets may decrease respiratory drive to the point of apnea, particularly when initiating therapy and titrating with hydromorphone hydrochloride extended-release tablets, even usual therapeutic doses.
- Hypotension, profound sedation, coma, respiratory depression, and death may result if hydromorphone hydrochloride extended-release tablets are used concomitantly with alcohol or other central nervous system (CNS) depressants (e.g., sedatives, anxiolytics, hypnotics, neuroleptics, or other opioids).
- Hydromorphone hydrochloride extended-release tablets may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is an increased risk in patients whose ability to maintain blood pressure has already been compromised.
- In patients with head injury or increased intracranial pressure, hydromorphone hydrochloride extended-release tablets may reduce respiratory drive, and the resultant CO2 retention can further increase intracranial pressure. Opioids may also obscure the clinical course in a patient with a head injury.
- Hydromorphone hydrochloride extended-release tablets may cause spasm of the sphincter of Oddi.
- May aggravate convulsions in patients with convulsive disorders; may induce or aggravate seizures in some clinical settings.
- Do not abruptly discontinue hydromorphone hydrochloride extended-release tablets. The use of mixed agonist/antagonist (i.e., pentazocine, nalbuphine, and butorphanol) or partial agonist (buprenorphine) analgesics in patients who have received or are receiving hydromorphone hydrochloride extended-release tablets may reduce the analgesic effect and/or may precipitate withdrawal symptoms
- Hydromorphone hydrochloride extended-release tablets may impair the ability to drive a car or operate machinery.
- Serious adverse events include respiratory depression, overdose, and death. Hypersensitivity reactions, angioedema, and urticaria have been identified during post-approval use of hydromorphone hydrochloride extended-release tablets.
- The most common adverse events (>10%) seen in clinical studies (N=2474) were: constipation, nausea, vomiting, somnolence, headache, asthenia/fatigue, and dizziness.
USE IN SPECIFIC POPULATIONS
- Pregnancy: Opioids cross the placenta and may produce respiratory depression in neonates. Prolonged use of hydromorphone hydrochloride extended-release tablets during pregnancy can result in withdrawal syndrome in the neonate, which can be life threatening.
- Breastfeeding: Nursing should not be undertaken while a patient is receiving hydromorphone hydrochloride extended-release tablets since hydromorphone is excreted in the milk.
- Pediatrics: The safety and effectiveness of hydromorphone hydrochloride extended-release tablets in patients 17 years of age and younger have not been established.
- Patients with moderate renal or hepatic impairment have been shown to have increased plasma concentrations of hydromorphone. These patients should be closely monitored for respiratory and central nervous system depression. Use of alternate analgesics is recommended in patients with severe hepatic impairment and alternate analgesics which permit greater dosing flexibility should be considered in patients with severe renal impairment.
||White round, biconvex tablet
||“EXH 32” on one side
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