The major hazards of DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg 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 Adverse Reactions
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 pressure
Cardiovascular: Flushing of the face, chills, tachycardia, bradycardia, palpitation, faintness, syncope, hypotension, hypertension.
Respiratory: Bronchospasm and laryngospasm
Gastrointestinal: Constipation, biliary tract spasm, ileus, anorexia, diarrhea, cramps, taste alteration
Genitourinary:Urinary retention or hesitancy, antidiuretic effects
Dermatologic: Urticaria, other skin rashes, diaphoresis.
Drug Abuse And Dependence
DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 MG TABLETS contain hydromorphone, a Schedule II controlled opioid agonist. Schedule II opioid substances which include morphine, oxycodone, oxymorphone, fentanyl, and methadone have the highest potential for abuse and risk of fatal overdose. Hydromorphone can be abused and is subject to criminal diversion.
Opioid analgesics may cause psychological and physical dependence. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug. Physical dependence usually does not occur to a clinically significant degree until after several weeks of continued opioid usage, but it may occur after as little as a week of opioid use. Physical dependence and tolerance are separate and distinct from abuse and addiction.
Addiction is a 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.
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 DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS 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.
DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS are intended for oral use only. Misuse or abuse of DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS pose a risk of overdose and death. This risk is increased with concurrent abuse of alcohol and other CNS depressants. Parenteral drug abuse can potentially 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.
Safety And Handling Instructions
DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS pose little risk of direct exposure to health care personnel and should be handled and disposed of prudently in accordance with hospital or institutional policy. Significant absorption from dermal exposure is unlikely; accidental dermal exposure to DILAUDID (hydromorphone hydrochloride) ORAL LIQUID should be treated by removal of any contaminated clothing and rinsing the affected area with cool water. Patients and their families should be instructed to flush any DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS that are no longer needed.
Access to abuseable drugs such as DILAUDID (hydromorphone hydrochloride) ORAL LIQUID and DILAUDID (hydromorphone hydrochloride) 8 mg TABLETS presents an occupational hazard for addiction in the health care industry. Routine procedures for handling controlled substances developed to protect the public may not be adequate to protect health care workers. Implementation of more effective accounting procedures and measures to restrict access to drugs of this class (appropriate to the practice setting) may minimize the risk of self-administration by health care providers.