"The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternat"...
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Serious adverse reactions associated with DILAUDID INJECTION and DILAUDID-HP INJECTION include respiratory depression and apnea and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest.
The following serious adverse reactions described elsewhere in the labeling include:
- Respiratory depression and secondary effects on intracranial pressure [see WARNINGS AND PRECAUTIONS]
- Hypotension [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal effects and effects in sphincter of Oddi [see WARNINGS AND PRECAUTIONS]
- Drug abuse, addiction, and dependence [see Drug Abuse And Dependence]
- Effects on the ability to drive and operate machinery [see WARNINGS AND PRECAUTIONS]
The most common adverse effects are lightheadedness, 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
Metabolism and nutrition disorders: decreased appetite
Musculoskeletal and connective tissue disorders: muscle rigidity
Renal and urinary disorders: urinary retention, urinary hesitation, antidiuretic effects
Respiratory, thoracic, and mediastinal disorders: bronchospasm, laryngospasm
Vascular disorders: flushing, hypotension, hypertension
The following adverse reactions have been identified during post-approval use of hydromorphone. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: anaphylactic reactions, confusional state, convulsions, drowsiness, dyskinesia, dyspnea, erectile dysfunction, fatigue, hepatic enzymes increased, hyperalgesia, hypersensitivity reaction, injection site reactions, lethargy, myoclonus, oropharyngeal swelling, peripheral edema, and somnolence.
Read the Dilaudid-HP (hydromorphone hydrochloride injection) Side Effects Center for a complete guide to possible side effects
Drug Interactions with other CNS Depressants
DILAUDID INJECTION and DILAUDID-HP INJECTION should be used with caution and in reduced dosages when administered to patients concurrently receiving other central nervous system depressants including sedatives or hypnotics, general anesthetics, phenothiazines, centrally acting anti-emetics, tranquilizers, and alcohol because respiratory depression, hypotension, and profound sedation or coma may result.
When such combined therapy is contemplated, the dose of one or both agents should be reduced. Opioid analgesics, including DILAUDID INJECTION and DILAUDID-HP INJECTION, may enhance the action of neuromuscular blocking agents and produce an increased degree of respiratory depression.
Interactions with Mixed Agonist/Antagonist Opioid Analgesics
Agonist/antagonist analgesics (e.g., pentazocine, nalbuphine, and butorphanol) and partial agonist analgesics (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 DILAUDID INJECTION and DILAUDID-HP INJECTION. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of DILAUDID INJECTION and DILAUDID-HP INJECTION and/or may precipitate withdrawal symptoms in these patients.
Monoamine Oxidase Inhibitors (MAOIs)
MAOIs may potentiate the action of DILAUDID INJECTION and DILAUDID-HP INJECTION. Allow at least 14 days after stopping treatment with MAOIs before initiating treatment with DILAUDID INJECTION and DILAUDID-HP INJECTION.
Anticholinergics or other medications with anticholinergic activity when used concurrently with DILAUDID INJECTION and DILAUDID-HP INJECTION may result in increased risk of urinary retention and severe constipation, which may lead to paralytic ileus.
Drug Abuse And Dependence
DILAUDID INJECTION and DILAUDID-HP INJECTION contain hydromorphone, which is a Schedule II controlled substance with an abuse liability similar to morphine. DILAUDID can be abused and is subject to criminal diversion.
DILAUDID INJECTION and DILAUDID-HP INJECTION are intended for parenteral use only under the direct supervision of an appropriately licensed health care professional.
Abuse of DILAUDID INJECTION and DILAUDID-HP INJECTION poses a hazard of overdose and death. This risk is increased with concurrent abuse of alcohol or other substances. Parenteral drug abuse is commonly associated with transmission of infectious diseases, such as hepatitis and HIV.
DILAUDID INJECTION and DILAUDID-HP INJECTION can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing, dispensing, ordering, or administering DILAUDID INJECTION or DILAUDID-HP INJECTION in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Prescribers should monitor all patients receiving opioids for signs of abuse, misuse, and addiction. Furthermore, patients should be assessed for their potential for opioid abuse prior to being prescribed opioid therapy. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse) or mental illness (e.g., depression). Opioids may still be appropriate for use in these patients, however, they will require intensive monitoring for indications of abuse.
Opioid drugs are sought by people with substance use disorders (abuse or addiction, the latter of which is also called “substance dependence”) and criminals who supply them by diverting medicines out of legitimate distribution channels. DILAUDID INJECTION and DILAUDID-HP INJECTION are targets for diversion.
“Drug-seeking” behavior is very common in persons with substance use disorders. Drug-seeking tactics include, but are not limited to, emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, altering or forging of 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 people with untreated substance use disorders and criminals who divert controlled substances.
The risks of misuse and abuse should be considered when prescribing or dispensing DILAUDID INJECTION or DILAUDID-HP INJECTION. Concerns about abuse and addiction, should not prevent the proper management of pain, however. Treatment of pain should be individualized, balancing the potential benefits and risks for each patient.
Addiction is defined as a chronic, neurobiological disorder with genetic, psychosocial, and environmental aspects, characterized by 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.
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 nonmedical purposes, often in combination with other psychoactive substances. 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, proper dispensing and correct storage and handling are appropriate measures that help to limit misuse and abuse of opioid drugs. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.
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.
Tolerance to opioids is demonstrated by the need for increasing doses to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance to different effects of opioids may develop to varying degrees and at varying rates in a given individual. There is also inter-patient variability in the rate and extent of tolerance that develops to various opioid effects, whether the effect is desirable (e.g., analgesia) or undesirable (e.g., nausea). In general, patients taking opioid analgesics that are appropriately titrated for pain control develop tolerance to the respiratory depressant effects fairly reliably. Conversely, tolerance to the constipating effects of opioids rarely develops, even when they are administered over long periods of time.
Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.
The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including: 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 used regularly should not be abruptly discontinued.
Last reviewed on RxList: 8/12/2011
This monograph has been modified to include the generic and brand name in many instances.
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