Generic name: hydromorphone hydrochloride 5mg in 5mL
Dosage form: oral liquid, tablets
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Important Dosage and Administration Instructions
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.
Do not use household teaspoons or tablespoons to measure DILAUDID Oral Solution, as using a tablespoon instead of a teaspoon could lead to overdosage [see Warnings and Precautions (5.1)].
- Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].
- 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 (5.2)].
- Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with DILAUDID Oral Solution or DILAUDID Tablets and adjust the dosage accordingly[see Warnings and Precautions (5.3)].
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 3-6 hours for DILAUDID Oral Solution; and every 4-6 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 and Administration (2.4)].
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
Dosage Modifications in Patients with Renal Impairment
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 (5.2)]. 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.
Discontinuation of DILAUDID Oral Solution or DILAUDID Tablets
When a patient who has been taking DILAUDID Oral Solution or DILAUDID Tablets regularly and may be physically dependent no longer requires therapy with DILAUDID, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs and symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both . Do not abruptly discontinue DILAUDID Oral Solution or DILAUDID Tablets in a physically dependent patient. [see Warnings and Precautions (5.12), Drug Abuse and Dependence (9.3)].
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- Drug class: narcotic analgesics