DILAUDID-HP is indicated for the relief of moderate-to-severe pain in opioid-tolerant patients who require larger than usual doses of opioids to provide adequate pain relief. Because DILAUDID-HP contains 10 mg of hydromorphone hydrochloride per mL, a smaller injection volume can be used than with other parenteral opioid formulations. Discomfort associated with the intramuscular or subcutaneous injection of an unusually large volume of solution can therefore be avoided.

Parenteral: DILAUDID-HP SHOULD BE GIVEN ONLY TO PATIENTS WHO ARE ALREADY RECEIVING LARGE DOSES OF OPIOIDS. DILAUDID-HP is indicated for relief of moderate-to-severe pain in opioid-tolerant patients. Thus, these patients will already have been treated with other opioid analgesics. If the patient is being changed from regular DILAUDID to DILAUDID-HP, similar doses should be used, depending on the patient's clinical response to the drug. If DILAUDID-HP is substituted for a different opioid analgesic, the following equivalency table should be used as a guide to determine the appropriate dose of DILAUDID-HP (hydromorphone hydrochloride). Patients with hepatic and renal impairment should be started on a lower starting dose (See CLINICAL PHARMAOCOLGY: PHARMCOKINETICS and METABOLISM). The dosage of DILAUDID-HP should be individualized for any given patient, since adverse events can occur at doses that may not provide complete freedom from pain

Safe and effective administration of opioid analgesics to patients with acute or chronic pain depends upon a comprehensive assessment of the patient. The nature of the pain (severity, frequency, etiology, and pathophysiology) as well as the concurrent medical status of the patient will affect selection of the starting dosage.

* From Beaver WT Management of cancer pain with parenteral medication. J. Am. Med. Assoc. 244:2653-2657 (1980).
^† (In terms of the area under the analgesic time-effect curve.)

In open clinical trials with DILAUDID-HP in patients with terminal cancer, doses ranged from 1-14 mg subcutaneously or intramuscularly; one patient received 30 mg subcutaneously on two occasions. In these trials, both subcutaneous and intramuscular injections of DILAUDID-HP were well-tolerated, with minimal pain and/or burning at the injection site. Mild erythema was rarely noted after intramuscular injection. There was no induration after either intramuscular or subcutaneous administration of DILAUDID-HP. Subcutaneous injections of DILAUDID-HP were particularly well accepted when administered with a short, 30 gauge needle.

Experience with administration of DILAUDID-HP by the intravenous route is limited. Should intravenous administration be necessary, the injection should be given slowly, over at least 2 to 3 minutes. The intravenous route is usually painless.

A gradual increase in dose may be required if analgesia is inadequate, tolerance occurs, or if pain severity increases. The first sign of tolerance is usually a reduced duration of effect.

NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. A slight yellowish discoloration may develop in DILAUDID-HP ampules. No loss of potency has been demonstrated. DILAUDID injection is physically compatible and chemically stable for at least 24 hours at 25°C protected from light in most common large volume parenteral solutions.

500 mg/50 mL Vial : To use this single dose presentation, do not penetrate the stopper with a syringe. Instead, remove both the aluminum flipseal and rubber stopper in a suitable work area such as under a laminar flow hood (or equivalent clean air compounding area). The contents may then be withdrawn for preparation of a single, large volume parenteral solution. Any unused portion should be discarded in an appropriate manner.

CAUTION: The packaging (vial stopper) of this product contains rubber latex which may cause allergic reactions.

Reconstitution of sterile lyophilized DILAUDID- HP 250mg: Reconstitute immediately prior to use with 25 mL of Sterile Water for Injection USP to provide a sterile solution containing 10 mg/mL.

Addiction is a chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

"Drug seeking" behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated "loss" of prescriptions, tampering with, forging or counterfeiting prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). "Doctor shopping" to obtain additional prescriptions is common among drug abusers, people suffering from untreated addiction and criminals seeking drugs to sell.

Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Since DILAUDID may be diverted for non-medical use, careful record keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

DILAUDID-HP is intended for parenteral use only under the direct supervision of an appropriately licensed health care provider. Misuse or abuse of DILAUDID-HP poses a risk of overdose and death. This risk is increased with concurrent abuse of alcohol and other substances. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

DILAUDID-HP poses little risk of direct exposure to health care personnel and should be handled and disposed of prudently in accordance with hospital or institutional policy. Patients and their families should be instructed to flush any DILAUDID-HP that is no longer needed.

Access to abusable drugs such as DILAUDID-HP 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-HP amber ampules and single dose vials contain 10 mg hydromorphone hydrochloride per mL with 0.2% sodium citrate and 0.2% citric acid solution. No added preservative.

NOTE: DILAUDID-HP ampules are amber in color.

The lyophilized DILAUDID- HP Single Dose Vial contains 250 mg of sterile, lyophilized hydromorphone HCl.

^* FOR USE IN THE PREPARATION OF LARGE VOLUME PARENTERAL SOLUTIONS

STORAGE: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. Protect from light.

A Schedule Narcotic.
DEA Order Form Required. © Abbott
All rights reserved.
ABBOTT LABORATORIES
NORTH CHICAGO, IL 60064, U.S.A.
PRINTED IN U.S.A.
FDA revision date: 06/08/06

Bookmark this page: