Dilaudid Injection Dosage

Important Dosage and Administration Instructions

• Always initiate dosing in opioid-naïve patients using DILAUDID INJECTION. Never administer DILAUDID-HP INJECTION to opioid-naïve patients.
• 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 INJECTION or DILAUDID-HP INJECTION and adjust the dosage accordingly [see Warnings and Precautions (5.3)].
• Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. A slight yellowish discoloration may develop in DILAUDID INJECTION and DILAUDID-HP INJECTION. No loss of potency has been demonstrated. DILAUDID INJECTION and DILAUDID-HP INJECTION are physically compatible and chemically stable for at least 24 hours at 25°C, protected from light in most common large-volume parenteral solutions.
• Discard any unused portion in an appropriate manner.

Initial Dosage

Use of DILAUDID INJECTION or DILAUDID-HP INJECTION as the First Opioid Analgesic:
DILAUDID-HP Injection is for use in opioid tolerant patients only. Do not use DILAUDID-HP for patients who are not tolerant to the respiratory depressant or sedating effects of opioids.

Subcutaneous or Intramuscular Administration:

The usual starting dose of DILAUDID INJECTION is 1 mg to 2 mg every 2 to 3 hours as necessary. Depending on the clinical situation, the initial starting dose may be lowered in patients who are opioid naïve.

Intravenous Administration:

The initial starting dose is 0.2 to 1 mg every 2 to 3 hours. Intravenous administration should be given slowly, over at least 2 to 3 minutes, depending on the dose. The initial dose should be reduced in the elderly or debilitated and may be lowered to 0.2 mg.

Conversion From Other Opioids to DILAUDID INJECTION or DILAUDID-HP INJECTION:
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 INJECTION or DILAUDID-HP INJECTION. It is safer to underestimate a patient’s 24-hour DILAUDID INJECTION or DILAUDID-HP INJECTION dosage than to overestimate the 24-hour DILAUDID INJECTION or DILAUDID-HP INJECTION dosage and manage an adverse reaction due to overdose.

If the decision is made to convert to Hydromorphone Hydrochloride Injection from another opioid analgesic using publicly available data, convert the current total daily amount(s) of opioid(s) received to an equivalent total daily dose of DILAUDID INJECTION and reduce by one-half due to the possibility of incomplete cross tolerance. Divide the new total amount by the number of doses permitted based on dosing interval (e.g., 8 doses for every-three-hour dosing). Titrate the dose according to the patient's response.

Use DILAUDID-HP ONLY for patients who require the higher concentration and lower total volume of DILAUDID-HP. Because of its high concentration, the delivery of precise doses of DILAUDID-HP INJECTION may be difficult if low doses of hydromorphone are required. Therefore, use DILAUDID-HP INJECTION only if the amount of hydromorphone required can be delivered accurately with this formulation.

Base the starting dose for DILAUDID-HP INJECTION on the prior dose of DILAUDID INJECTION or on the prior dose of an alternate opioid.

Dosage Modifications in Patients with Hepatic Impairment

Start patients with hepatic impairment on one-fourth to one-half the usual DILAUDID INJECTION starting dose depending on the extent of impairment [see Clinical Pharmacology (12.3)].

Dosage Modifications in Patients with Renal Impairment

Start patients with renal impairment on one-fourth to one-half the usual DILAUDID INJECTION starting dose depending on the degree of impairment [see Clinical Pharmacology (12.3)].

Titration and Maintenance of Therapy

Individually titrate DILAUDID INJECTION or DILAUDID-HP INJECTION to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving DILAUDID INJECTION or DILAUDID-HP INJECTION 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 INJECTION or DILAUDID-HP INJECTION 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 INJECTION or DILAUDID-HP INJECTION

When a patient who has been taking DILAUDID INJECTION or DILAUDID-HP INJECTION regularly and may be physically dependent no longer requires therapy with DILAUDID INJECTION or DILAUDID-HP INJECTION, 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 or 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 INJECTION or DILAUDID-HP INJECTION in a physically-dependent patient [see Warnings and Precautions (5.12), Drug Abuse and Dependence (9.3)].