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Dilaudid-HP (Hydromorphone Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

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 PHARMACOLOGY - Pharmacokinetics 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.

STRONG ANALGESICS AND STRUCTURALLY RELATED DRUGS USED IN THE TREATMENT OF CANCER PAIN*
IM OR SC ADMINISTRATION
Nonproprietary (Trade) Names Dose, mg Equianalgesic to 10 mg of IM Morphine

*   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.)

Morphine sulfate10
Hydromorphone (DILAUDID) hydrochloride1.3
Oxymorphone (Numorphan) hydrochloride1.1
Nalbuphine (Nubain) hydrochloride12
Levorphanol (Levo-Dromoran) tartrate2.3
Butorphanol (Stadol) tartrate1.5-2.5
Pentazocine (Talwin) lactate or hydrochloride60
Meperidine, pethidine (Demerol) hydrochloride80
Methadone (Dolophine) hydrochloride10

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 250 mg

Reconstitute immediately prior to use with 25 mL of Sterile Water for Injection USP to provide a sterile solution containing 10 mg/mL.

HOW SUPPLIED

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.

HIGH POTENCY: 10 mg/1 mL* 50 mg/5 mL*500 mg/50 mL*lyophilized 250 mg

* FOR USE IN THE PREPARATION OF LARGE VOLUME PARENTERAL SOLUTIONS

Box of 10 ampulesBox of 10 ampulesSingle dose vialSingle Dose Vial
NDC 0074-2453-11NDC 0074-2453-27NDC 0074-2453-51NDC 0074-2455-31

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 CS-II Narcotic. DEA Order Form Required.

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