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Palladone (Hydromorphone Hydrochloride) - Warnings and Precautions

 
 



WARNING:

Palladone™ (hydromorphone hydrochloride extended-release) Capsules are indicated for the management of persistent, moderate to severe pain in patients requiring continuous, around-the-clock analgesia with a high potency opioid for an extended period of time (weeks to months) or longer. Palladone™ Capsules should only be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a minimum total daily dose of opiate medication equivalent to 12 mg of oral hydromorphone. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, or at least 30 mg of oral oxycodone/day, or at least 8 mg oral hydromorphone/day, or an equianalgesic dose of another opioid, for a week or longer. Palladone™ Capsules should be administered once every 24 hours.

Appropriate patients for treatment with Palladone Capsules include patients who require high doses of potent opioids on an around-the-clock basis to improve pain control and patients who have difficulty attaining adequate analgesia with immediate-release opioid formulations.

Palladone Capsules are contraindicated for use on an as needed basis (i.e., prn).

Palladone™ Capsules are NOT intended to be used as the first opioid product prescribed for a patient, or in patients who require opioid analgesia for a short period of time.

Palladone™ Capsules are for use in OPIOID-TOLERANT patients ONLY. Use in non-opioid-tolerant patients may lead to FATAL RESPIRATORY DEPRESSION. Overestimating the Palladone dose when converting patients from another opioid medication can result in fatal overdose with the first dose. Due to the mean apparent 18-hour elimination half-life of Palladone, patients who receive an overdose will require an extended period of monitoring and treatment that may go beyond 18 hours. Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects.

Palladone™ Capsules contain the potent Schedule II opioid agonist, hydromorphone. Schedule II opioid agonists (which include hydromorphone, fentanyl, methadone, morphine, oxycodone, and oxymorphone), have the highest risk of fatal overdoses due to respiratory depression, as well as the highest potential for abuse. Palladone can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing Palladone in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion.

Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse, abuse and addiction. Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations; however these patients will require intensive monitoring for signs of misuse, abuse, or addiction.

Palladone capsules are to be swallowed whole and are not to be broken, chewed, opened, dissolved or crushed. Consuming alcohol while taking palladone™ capsules or taking broken, chewed, dissolved, or crushed palladone™ capsules or its contents can lead to the rapid release and absorption of a potentially fatal dose of hydromorphone. Overestimating the palladone dose when converting the patient from another opioid medication can result in fatal overdose with the first dose. With the long half-life of palladone (18 hours), patients who receive the wrong dose will require an extended period of monitoring and treatment that may go beyond 18 hours. Even in the face of improvement, continued medical monitoring is required because of the possibility of extended effects.

 

WARNINGS

Palladone Capsules are to be swallowed WHOLE and are not to be broken, chewed, OPENED, DISSOLVED OR CRUSHED. Consuming alcohol while taking Palladone Capsules or taking broken, chewed, dissolved, or crushed Palladone™ Capsules or capsule contents can lead to the rapid release and absorption of a potentially fatal dose of hydromorphone.

Palladone™ Capsules are for use in OPIOID-TOLERANT patients ONLY. Use in non-opioid-tolerant patients may lead to fatal respiratory depression.

Misuse, Abuse and Diversion of Opioids

Hydromorphone is an opioid agonist of the morphine type. Such drugs are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

Like other opioid agonists, legal or illicit, hydromorphone can be abused. This should be considered when prescribing or dispensing Palladone™ Capsules in situations where the healthcare professional is concerned about an increased risk of misuse, abuse, or diversion (see WARNINGS: Drug Abuse and Addiction).

Breaking, crushing, chewing, or dissolving the contents of a Palladone™ Capsule or consuming alcohol while taking Palladone Capsules can result in the uncontrolled delivery of the opioid and poses a significant risk of overdose and death (see Boxed WARNING).

Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. However, all patients treated with opioids require careful monitoring for signs of abuse and addiction, since use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

Healthcare professionals should contact their State Professional Licensing Board, or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

Hydromorphone may be expected to have additive effects, when used in conjunction with alcohol, other opioids, or drugs, whether legal or illicit, which cause central nervous system depression. Additionally, consuming alcohol while taking Palladone Capsules can cause significant increases in peak hydromorphone concentrations.

Palladone™ Capsules contain an opioid agonist (i.e., hydromorphone), that is a Schedule II controlled substance with high potential for abuse similar to fentanyl, methadone, morphine, oxycodone, and oxymorphone. Hydromorphone can be abused and is subject to criminal diversion. The high drug content in the extended-release formulation may add to the risk of adverse outcomes from abuse.

Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

“Drug-seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with, forging or counterfeiting prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers, people suffering from untreated addiction and criminals seeking drugs to sell.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Since Palladone™ Capsules may be diverted for non-medical use, careful record keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Palladone™ Capsules are intended for oral use only. Consumption of alcohol while taking Palladone Capsules or the use of the broken, crushed, chewed, opened, or dissolved capsule contents poses a hazard of overdose and death. This risk is increased with concurrent abuse of alcohol and other substances. Parenteral drug abuse can reasonably be expected to result in local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. In addition, parenteral abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

Respiratory depression is the chief hazard of opioid agonists, including hydromorphone, the active ingredient in Palladone™ Capsules. Respiratory depression is more likely to occur in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other drugs that depress respiration.

Respiratory depression from opioids is manifested by a reduced urge to breathe and a decreased rate of respiration, often associated with the “sighing” pattern of breathing (deep breaths separated by abnormally long pauses). Carbon dioxide retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. This makes overdoses involving drugs with sedative properties and opioids especially dangerous.

Hydromorphone should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of hydromorphone may decrease respiratory drive to the point of apnea. In these patients, alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.

The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure and may be markedly exaggerated in the presence of head injury, intracranial lesions, or other sources of pre-existing increased intracranial pressure. Hydromorphone produces effects on pupillary response and consciousness, which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries.

Palladone™ Capsules may cause severe hypotension. There is an added risk to individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume or who are concurrently taking drugs such as phenothiazines or other agents which compromise vasomotor tone. Hydromorphone may produce orthostatic hypotension in ambulatory patients. Hydromorphone, like all opioid analgesics of the morphine-type, should be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

PRECAUTIONS

Palladone™ Capsules are for use in OPIOID-TOLERANT patients ONLY. Use in non-opioid-tolerant patients may lead to fatal respiratory depression (see WARNINGS).

Patients should be instructed that the use of Palladone™ by anyone other than those to whom it is prescribed is unlawful and may have serious medical consequences, including death.

General

Opioid analgesics have a narrow therapeutic index in certain patient populations, especially when combined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension.

Use of Palladone™ Capsules is associated with increased potential risks and should be used only with caution in the following conditions: alcoholism, alcohol abuse or alcohol intoxication; drug abuse; history of drug or alcohol abuse; adrenocortical insufficiency (e.g., Addison's disease); CNS depression or coma; debilitated patients; kyphoscoliosis associated with respiratory depression; myxedema or hypothyroidism; prostatic hypertrophy or urethral stricture; severe impairment of hepatic, pulmonary or renal function; and toxic psychosis.

The administration of any opioid agonist, including hydromorphone, may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Hydromorphone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

Use in Pancreatic/Biliary Tract Disease

Hydromorphone may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids like hydromorphone may cause increases in the serum amylase concentration.

Tolerance

Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time. Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.

Physical Dependence

Physical dependence is a state of adaptation that is manifested by an opioid specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug, and/or administration of an antagonist.

The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, piloerection, myalgia, mydriasis, irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.

In general, opioids should not be abruptly discontinued (see DOSAGE AND ADMINISTRATION: Cessation of Therapy).

Information for Patients/Caregivers

The healthcare professional should explain the points listed below to caregivers and patients.

  1. Patients should be instructed to read the Medication Guide each time Palladone is dispensed because new information may be available. The complete text of the Medication Guide is reprinted at the end of this document.
  2. Patients should be aware that Palladone™ Capsules contain hydromorphone, which is a strong pain medication similar to fentanyl, methadone, morphine, oxycodone, and oxymorphone.
  3. Palladone™ Capsules are only to be swallowed whole. To prevent fatal overdose, the capsules and the pellets must not be broken, chewed, crushed, opened, or dissolved. Patients should be instructed not to consume alcohol while taking Palladone Capsules.
  4. Patients should talk to their doctor if pain persists or worsens while they are taking Palladone™ Capsules. Patients who have bothersome side effects should also let their doctors know. The amount of medicine the patient takes may have to be changed.
  5. Patients should NEVER change the amount of Palladone™ Capsules they take without speaking to their doctor first.
  6. Palladone™ Capsules can affect a person’s ability to perform activities that require a high level of attention (such as driving or using heavy machinery). Patients taking Palladone™ Capsules should be warned of these dangers and counseled accordingly.
  7. Patients should NOT combine Palladone™ Capsules with alcohol or other pain medications, sleep aids, or tranquilizers except by the orders of the prescribing physician, because dangerous additive effects may occur, resulting in serious injury or death.
  8. Women who become pregnant, or who plan to become pregnant, should ask their doctor about the effects that Palladone™ Capsules (or any medicine) may have on them and their unborn children.
  9. Patients should be advised that if they have been receiving treatment with Palladone™ Capsules for more than a few weeks and the medicine is no longer needed, they should contact their doctor who will advise them on how to gradually decrease the medication. When Palladone™ Capsules are no longer needed, the unused capsules should be flushed down the toilet.
  10. The active ingredient in Palladone™ Capsules is hydromorphone, which is a drug that some people abuse. Palladone™ Capsules should be taken only by the patient it was prescribed for, and it should be protected from theft or misuse in the work or home environment.
  11. Patients should be instructed to keep Palladone™ Capsules in a secure place out of the reach of children. Children, especially small children, exposed to Palladone™ Capsules are at high risk of FATAL RESPIRATORY DEPRESSION.

Use in Drug and Alcohol Addiction

Palladone™ Capsules are not approved for use in detoxification or maintenance treatment of opioid addiction. However, the history of an addictive disorder does not necessarily preclude the use of this medication for the treatment of chronic pain. These patients will require intensive monitoring for signs of misuse, abuse, or addiction.

Page last updated: 2006-01-04

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