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Dilaudid
Overview
What is Dilaudid?
DILAUDID (hydromorphone hydrochloride), a hydrogenated ketone of morphine, is an opioid agonist.
DILAUDID INJECTION is available as a sterile, aqueous solution in clear and colorless pre-filled syringes for slow intravenous, subcutaneous, or intramuscular administration. Each 1 mL of solution contains 1 mg or 2 mg of hydromorphone hydrochloride.
The chemical name of DILAUDID is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular weight is 321.80. Its molecular formula is CHNO·HCl, and it has the following chemical structure:
Hydromorphone hydrochloride is a white or almost white crystalline powder that is freely soluble in water, very slightly soluble in ethanol (96%), and practically insoluble in methylene chloride.
The inactive ingredients in DILAUDID (hydromorphone hydrochloride) include: 0.2% sodium citrate and 0.2% citric acid added as a buffer to maintain a pH between 3.5 and 5.5.
What does Dilaudid look like?
What are the available doses of Dilaudid?
DILAUDID INJECTION:Each pre-filled syringe contains 0.5 mg/0.5 mL, 1 mg/mL or 2 mg/mL of hydromorphone hydrochloride in a sterile, aqueous solution.
What should I talk to my health care provider before I take Dilaudid?
How should I use Dilaudid?
DILAUDID INJECTION is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.
Limitations of Use:
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses , reserve DILAUDID INJECTION for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse. ()
Initial Dosage:
Intramuscular or Subcutaneous Use:
Intravenous Use
Hepatic Impairment:
Renal Impairment:
Do not stop DILAUDID INJECTION abruptly in a physically-dependent patient ()
What interacts with Dilaudid?
Sorry No Records found
What are the warnings of Dilaudid?
Sorry No Records found
What are the precautions of Dilaudid?
Sorry No Records found
What are the side effects of Dilaudid?
Sorry No records found
What should I look out for while using Dilaudid?
DILAUDID INJECTION is contraindicated in patients with:
What might happen if I take too much Dilaudid?
Clinical Presentation
[see Clinical Pharmacology ()]
Treatment of Overdose
The opioid antagonists, naloxone or nalmefene are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to hydromorphone overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to hydromorphone overdose.
Because the duration of opioid reversal is expected to be less than the duration of hydromorphone in DILAUDID INJECTION, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.
How should I store and handle Dilaudid?
Store olanzapine tablets at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Protect olanzapine tablets from light and moisture. Store olanzapine tablets at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Protect olanzapine tablets from light and moisture. DILAUDID INJECTION (hydromorphone hydrochloride) is supplied in clear and colorless pre-filled syringes. Each pre-filled syringe of sterile, aqueous solution contains 0.5 mg, 1 mg or 2 mg hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. DILAUDID INJECTION contains no added preservative and is supplied as follows: 0.5 mg/0.5mL pre-filled disposable syringe, NDC 76045-009-051 mg/mL pre-filled disposable syringe, NDC 76045-009-102 mg/mL pre-filled disposable syringe, NDC 76045-010-10Available in a carton of twenty-four (24) syringes for each strength. PROTECT FROM LIGHT.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Safety and Handling InstructionsAccess to drugs with a potential for abuse such as DILAUDID INJECTION 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.DILAUDID INJECTION (hydromorphone hydrochloride) is supplied in clear and colorless pre-filled syringes. Each pre-filled syringe of sterile, aqueous solution contains 0.5 mg, 1 mg or 2 mg hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. DILAUDID INJECTION contains no added preservative and is supplied as follows: 0.5 mg/0.5mL pre-filled disposable syringe, NDC 76045-009-051 mg/mL pre-filled disposable syringe, NDC 76045-009-102 mg/mL pre-filled disposable syringe, NDC 76045-010-10Available in a carton of twenty-four (24) syringes for each strength. PROTECT FROM LIGHT.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Safety and Handling InstructionsAccess to drugs with a potential for abuse such as DILAUDID INJECTION 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.DILAUDID INJECTION (hydromorphone hydrochloride) is supplied in clear and colorless pre-filled syringes. Each pre-filled syringe of sterile, aqueous solution contains 0.5 mg, 1 mg or 2 mg hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. DILAUDID INJECTION contains no added preservative and is supplied as follows: 0.5 mg/0.5mL pre-filled disposable syringe, NDC 76045-009-051 mg/mL pre-filled disposable syringe, NDC 76045-009-102 mg/mL pre-filled disposable syringe, NDC 76045-010-10Available in a carton of twenty-four (24) syringes for each strength. PROTECT FROM LIGHT.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Safety and Handling InstructionsAccess to drugs with a potential for abuse such as DILAUDID INJECTION 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.DILAUDID INJECTION (hydromorphone hydrochloride) is supplied in clear and colorless pre-filled syringes. Each pre-filled syringe of sterile, aqueous solution contains 0.5 mg, 1 mg or 2 mg hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. DILAUDID INJECTION contains no added preservative and is supplied as follows: 0.5 mg/0.5mL pre-filled disposable syringe, NDC 76045-009-051 mg/mL pre-filled disposable syringe, NDC 76045-009-102 mg/mL pre-filled disposable syringe, NDC 76045-010-10Available in a carton of twenty-four (24) syringes for each strength. PROTECT FROM LIGHT.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Safety and Handling InstructionsAccess to drugs with a potential for abuse such as DILAUDID INJECTION 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.DILAUDID INJECTION (hydromorphone hydrochloride) is supplied in clear and colorless pre-filled syringes. Each pre-filled syringe of sterile, aqueous solution contains 0.5 mg, 1 mg or 2 mg hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. DILAUDID INJECTION contains no added preservative and is supplied as follows: 0.5 mg/0.5mL pre-filled disposable syringe, NDC 76045-009-051 mg/mL pre-filled disposable syringe, NDC 76045-009-102 mg/mL pre-filled disposable syringe, NDC 76045-010-10Available in a carton of twenty-four (24) syringes for each strength. PROTECT FROM LIGHT.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Safety and Handling InstructionsAccess to drugs with a potential for abuse such as DILAUDID INJECTION 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.DILAUDID INJECTION (hydromorphone hydrochloride) is supplied in clear and colorless pre-filled syringes. Each pre-filled syringe of sterile, aqueous solution contains 0.5 mg, 1 mg or 2 mg hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. DILAUDID INJECTION contains no added preservative and is supplied as follows: 0.5 mg/0.5mL pre-filled disposable syringe, NDC 76045-009-051 mg/mL pre-filled disposable syringe, NDC 76045-009-102 mg/mL pre-filled disposable syringe, NDC 76045-010-10Available in a carton of twenty-four (24) syringes for each strength. PROTECT FROM LIGHT.Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].Safety and Handling InstructionsAccess to drugs with a potential for abuse such as DILAUDID INJECTION 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.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Hydromorphone is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of hydromorphone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with morphine. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.
The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
Non-Clinical Toxicology
DILAUDID INJECTION is contraindicated in patients with:The induction dose requirements of propofol injectable emulsion may be reduced in patients with intramuscular or intravenous premedication, particularly with narcotics (e.g., morphine, meperidine, and fentanyl, etc.) and combinations of opioids and sedatives (e.g., benzodiazepines, barbiturates, chloral hydrate, droperidol, etc.). These agents may increase the anesthetic or sedative effects of propofol injectable emulsion and may also result in more pronounced decreases in systolic, diastolic, and mean arterial pressures and cardiac output.
During maintenance of anesthesia or sedation, the rate of propofol injectable emulsion administration should be adjusted according to the desired level of anesthesia or sedation and may be reduced in the presence of supplemental analgesic agents (e.g., nitrous oxide or opioids). The concurrent administration of potent inhalational agents (e.g., isoflurane, enflurane, and halothane) during maintenance with propofol injectable emulsion has not been extensively evaluated. These inhalational agents can also be expected to increase the anesthetic or sedative and cardiorespiratory effects of propofol injectable emulsion.
The concomitant use of valproate and propofol may lead to increased blood levels of propofol. Reduce the dose of propofol when co-administering with valproate. Monitor patients closely for signs of increased sedation or cardiorespiratory depression.
Propofol injectable emulsion does not cause a clinically significant change in onset, intensity or duration of action of the commonly used neuromuscular blocking agents (e.g., succinylcholine and nondepolarizing muscle relaxants).
No significant adverse interactions with commonly used premedications or drugs used during anesthesia or sedation (including a range of muscle relaxants, inhalational agents, analgesic agents, and local anesthetic agents) have been observed in adults. In pediatric patients, administration of fentanyl concomitantly with propofol injectable emulsion may result in serious bradycardia.
DILAUDID INJECTION contains hydromorphone, a Schedule II controlled substance. As an opioid, DILAUDID INJECTION exposes users to the risks of addiction, abuse, and misuse .
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed DILAUDID INJECTION. Addiction can occur at recommended dosages and if the drug is misused or abused.
Assess each patient’s risk for opioid addiction, abuse, or misuse prior to prescribing DILAUDID INJECTION and monitor all patients receiving DILAUDID INJECTION for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as DILAUDID INJECTION but use in such patients necessitates intensive counseling about the risks and proper use of DILAUDID INJECTION along with intensive monitoring for signs of addiction, abuse, and misuse.
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing DILAUDID INJECTION. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
The following serious adverse reactions are described, or described in greater detail, in other sections:
The following adverse reactions associated with the use of hydromorphone were identified in clinical studies or postmarketing reports. Because some of these reactions were 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.
Serious adverse reactions associated with DILAUDID INJECTION include respiratory depression and apnea and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest.
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
Cardiac disorders:
Eye disorders
Gastrointestinal disorders:
General disorders and administration site conditions:
Hepatobiliary disorders:
Immune system disorders:
Investigations:
Metabolism and nutrition disorders:
Musculoskeletal and connective tissue disorders:
Nervous system disorders:
Psychiatric disorders:
Renal and urinary disorders:
Reproductive system and breast disorders:
Respiratory, thoracic, and mediastinal disorders:
Skin and subcutaneous tissue disorders:
Vascular disorders:
Serotonin syndrome
Adrenal insufficiency
Anaphylaxis
Androgen deficiency
[see Clinical Pharmacology ()]
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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