DILAUDID (hydromorphone hydrochloride), a hydrogenated ketone of morphine, is an opioid agonist.

DILAUDID Tablets are supplied in 2 mg, 4 mg, and 8 mg tablets for oral administration. The tablet strengths describe the amount of hydromorphone hydrochloride in each tablet.

DILAUDID Oral Solution is supplied as 5mg/5 mL (1 mg/mL) viscous liquid.

The chemical name is 4,5α-epoxy-3-hydroxy-17-methylmorphinan-6-one hydrochloride. The molecular Weight is 321.80. Its molecular formula is C₁₇H₁₉NO₃·HCl, and it has the following chemical structure:

Ensure accuracy when prescribing, dispensing, and administering DILAUDID Oral Solution to avoid dosing errors due to confusion between mg and mL, which could result in accidental overdose and death. Ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total dose in volume.

Instruct patients to obtain a calibrated measuring cup/syringe for administering DILAUDID Oral Solution to ensure that the dose is measured and administered accurately.

Do not use household teaspoons or tablespoons to measure DILAUDID Oral Solution, as using aWARNINGS AND PRECAUTIONS].

• Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see WARNINGS AND PRECAUTIONS].
• Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see WARNINGS AND PRECAUTIONS].
• Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with DILAUDID Oral Solution or DILAUDID Tablets and adjust the dosage accordingly [see WARNINGS AND PRECAUTIONS].

Initial Dosage

Initiating Treatment With DILAUDID Oral Solution Or DILAUDID Tablets

Dilaudid Oral Solution

Initiate treatment with DILAUDID Oral Solution in a dosing range of one-half (2.5 mL) to two teaspoonsful (10 mL), 2.5 mg to 10 mg, every 3 to 6 hours as needed for pain.

Dilaudid Tablets

Initiate treatment with DILAUDID Tablets in a dosing range of 2 mg to 4 mg, orally, every 4 to 6 hours.

Conversion From Other Opioids To DILAUDID Oral Solution Or DILAUDID Tablets

There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of DILAUDID Oral Solution or DILAUDID Tablets. It is safer to underestimate a patient’s 24-hour DILAUDID dosage than to overestimate the 24-hour dosage and manage an adverse reaction due to overdose.

In general, it is safest to start DILAUDID therapy by administering half of the usual starting dose every 3 to 6 hours for DILAUDID Oral Solution; and every 4 to 6 hours for DILAUDID Tablets. The dose of DILAUDID can be gradually adjusted until adequate pain relief and acceptable side effects have been achieved [see Dosage Modifications In Patients With Renal Impairment].

Conversion From DILAUDID Oral Solution Or DILAUDID Tablets To Extended-Release Hydromorphone Hydrochloride

The relative bioavailability of DILAUDID Oral Solution and DILAUDID Tablets compared to extended-release hydromorphone hydrochloride is unknown, so conversion to extended-release tablets must be accompanied by close observation for signs of excessive sedation and respiratory depression.

Dosage Modifications In Patients With Hepatic Impairment

Initiate treatment with one-fourth to one-half the usual DILAUDID starting dose depending on the degree of impairment [see Use In Specific Populations, and CLINICAL PHARMACOLOGY].

Dosage Modifications In Patients With Renal Impairment

Initiate treatment with one-fourth to one-half the usual DILAUDID starting dose depending on the degree of impairment [see Use In Specific Populations, and CLINICAL PHARMACOLOGY].

Titration And Maintenance Of Therapy

Individually titrate DILAUDID Oral Solution or DILAUDID Tablets to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving DILAUDID Oral Solution or DILAUDID Tablets to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see WARNINGS AND PRECAUTIONS]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.

If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the DILAUDID Oral Solution or DILAUDID Tablets dosage. If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

For chronic pain, doses should be administered around-the-clock. A supplemental dose of 5 to 15% of the total daily usage may be administered every two hours on an as-needed basis.

The following serious adverse reactions are described, or described in greater detail, in other sections:

• Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
• Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
• Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
• Interactions with Benzodiazepines or Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
• Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]
• Severe Hypotension [see WARNINGS AND PRECAUTIONS]
• Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
• Seizures [see WARNINGS AND PRECAUTIONS]
• Withdrawal [see WARNINGS AND PRECAUTIONS]

Clinical Trial Experience

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 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: tachycardia, bradycardia, palpitations

Eye disorders: vision blurred, diplopia, miosis, visual impairment

Gastrointestinal disorders: constipation, ileus, diarrhea, abdominal pain

General disorders and administration site conditions: weakness, feeling abnormal, chills

Hepatobiliary disorders: biliary colic

Metabolism and nutrition disorders: decreased appetite

Musculoskeletal and connective tissue disorders: muscle rigidity

Nervous system disorders: headache, tremor, paraesthesia, nystagmus, increased intracranial pressure, syncope, taste alteration, involuntary muscle contractions, presyncope

Psychiatric disorders: agitation, mood altered, nervousness, anxiety, depression, hallucination, disorientation, insomnia, abnormal dreams

Renal and urinary disorders: urinary retention, urinary hesitation, antidiuretic effects

Respiratory, thoracic, and mediastinal disorders: bronchospasm, laryngospasm

Skin and subcutaneous tissue disorders: urticaria, rash, hyperhidrosis

Vascular disorders: flushing, hypotension, hypertension

Postmarketing Experience

The following adverse reactions have been identified during post approval use of hydromorphone. Because these reactions 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.

Confusional state, convulsions, drowsiness, dyskinesia, dyspnea, erectile dysfunction, fatigue, hepatic enzymes increased, hyperalgesia, hypersensitivity reaction, lethargy, myoclonus, oropharyngeal swelling, peripheral edema, and somnolence.

Serotonin Syndrome

Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Adrenal Insufficiency

Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Anaphylaxis

Anaphylaxis has been reported with ingredients contained in DILAUDID Oral Solution or DILAUDID Tablets.