March 24, 2017
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Dilaudid

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Dilaudid




Indications
Dosage
How Supplied

INDICATIONS

DILAUDID INJECTION is indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

DILAUDID-HP INJECTION is indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

Patients considered opioid tolerant are those who are taking for one week or longer,around-the-clock medicine consisting of at least 60 mg oral morphine per day, or at least 25 mcg transdermal fentanyl per hour, or at least 30 mg oral oxycodone per day, or at least 8 g oral hydromorphone per day, or at least 25 mg oral oxymorphone per day, or at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid for one week or longer. Patients must remain on around-the-clock opioids while administering DILAUDID-HP.

Limitations Of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see WARNINGS AND PRECAUTIONS], reserve DILAUDID INJECTION and DILAUDID-HP INJECTION for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:

  • Have not been tolerated, or are not expected to be tolerated
  • Have not provided adequate analgesia, or are not expected to provide adequate analgesia

DOSAGE AND ADMINISTRATION

Important Dosage And Administration Instructions

  • Always initiate dosing in opioid-naive patients using DILAUDID INJECTION. Never administer DILAUDIDHP INJECTION to opioid-naive patients.
  • 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 24-72 hours of initiating therapy and following dosage increases with DILAUDID INJECTION or DILAUDID-HP INJECTION and adjust the dosage accordingly [see WARNINGS AND PRECAUTIONS].
  • 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 naive.

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].

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].

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]. 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, Drug Abuse And Dependence].

HOW SUPPLIED

Dosage Forms And Strengths

DILAUDID INJECTION

Each 1 mL pre-filled syringe contains 0.5 mg/0.5 mL, 1 mg/mL, 2 mg/mL, or 4 mg/mL of hydromorphone hydrochloride in a sterile, aqueous solution.

DILAUDID-HP INJECTION (For Use In Opioid-Tolerant Patients Only)

Each 1 mL pre-filled syringe contains 10 mg/mL of hydromorphone hydrochloride in a sterile, aqueous solution.

Storage And Handling

DILAUDID INJECTION

DILAUDID INJECTION (hydromorphone hydrochloride) is supplied in clear and colorless pre-filled syringes. Each 1 mL pre-filled syringe of sterile, aqueous solution contains 0.5 mg, 1 mg, 2 mg, or 4 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 in a 1mL pre-filled disposable syringe, NDC 76045-009-05
1 mg/mL in a 1mL pre-filled disposable syringe, NDC 76045-009-10
2mg/mL in a 1mL pre-filled disposable syringe, NDC 76045-010-10
4mg/mL in a 1mL pre-filled disposable syringe, NDC 76045-011-10

Available in a carton of twenty-four (24) syringes for each strength.

DILAUDID-HP INJECTION

DILAUDID-HP INJECTION (hydromorphone hydrochloride) is supplied in clear pre-filled syringes with a dark grey plunger rod. Each 1 mL pre-filled syringe of sterile aqueous solution contains 10 mg of hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution. DILAUDID-HP INJECTION contains no added preservative and is supplied as follows:

10mg/mL in a 1mL pre-filled disposable syringe, NDC 76045-012-10

Available in a carton of twenty-four (24) syringes.

PROTECT FROM LIGHT.

Protect from light until time of use. 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 Instructions

Access to drugs with a potential for abuse such as DILAUDID INJECTION and DILAUDID-HP 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.

Distributed by: Fresenius Kabi, Lake Zurich, IL 60047. Revised: Feb 2017

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/20/2017

Indications
Dosage
How Supplied

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