"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
DILAUDID INJECTION is indicated for the management of pain in patients where an opioid analgesic is appropriate.
DILAUDID-HP INJECTION is indicated for the management of moderate-to-severe pain in opioid-tolerant patients who require higher doses of opioids.
DOSAGE AND ADMINISTRATION
General Dosing Considerations
Take care when prescribing and administering Dilaudid and Dilaudid-HP Injection to avoid dosing errors due to confusion between the different concentrations and between mg and mL, which could result in accidental overdose and death. Take care to ensure the proper dose is communicated and dispensed. When writing prescriptions, include both the total dose in mg and the total volume of the dose.
Selection of patients and administration of Dilaudid and Dilaudid-HP injection should be governed by the same principles that apply to the use of similar opioid analgesics to treat patients with acute or chronic pain, and depends upon a comprehensive assessment of the patient. Individualize treatment in every case, using non-opioid analgesics, opioids on an as needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as outlined by the World Health Organization, the Agency for Healthcare Research and Quality, and the American Pain Society.
The nature of the pain (severity, frequency, etiology, and pathophysiology), as well as the medical status of the patient, will affect selection of the starting dosage. Opioid analgesics, including DILAUDID INJECTION and DILAUDID-HP INJECTION, have a narrow therapeutic index in certain patient populations, especially when combined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks.
Individualization of Dosing
Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment. Give attention to the following:
- the age, general condition, and medical status of the patient;
- the patient's degree of opioid tolerance;
- the daily dose, potency, and specific characteristics of the opioid the patient has been taking previously;
- concurrent medications
- the type and severity of the patient's pain
- risk factors for abuse or addiction; including whether the patient has a previous or current substance abuse problem, a family history of substance abuse, or a history of mental illness or depression;
- the balance between pain control and adverse reactions.
Periodic reassessment after the initial dosing of DILAUDID INJECTION and DILAUDID-HP INJECTION is required. If pain management is not satisfactory, and opioid-induced adverse events are tolerable, the hydromorphone dose may be increased gradually. If excessive opioid side effects are observed early in the dosing interval, reduce the hydromorphone hydrochloride dose. If this results in breakthrough pain at the end of the dosing interval, the dosing interval may need to be shortened. Dose titration should be guided more by the need for analgesia and the severity of adverse events than the absolute dose of opioid employed.
Initiation of Therapy in Opioid-Na´ve Patients
Always initiate dosing in opioid-na´ve patients using Dilaudid Injection. Never administer Dilaudid-HP injection to opioid-na´ve patients.
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 na´ve. Adjust the dose according to the severity of pain, the severity of adverse events, as well as the patient's underlying disease and age.
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. Titrate the dose to achieve acceptable analgesia and tolerable adverse events. The initial dose should be reduced in the elderly or debilitated and may be lowered to 0.2 mg.
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, Pharmacokinetics].
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, Pharmacokinetics].
Conversion From Prior Opioid
Use the equianalgesic dose table below (Table 1) as a guide to determine the appropriate dose of DILAUDID INJECTION. 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-threehour dosing). Titrate the dose according to the patient's response. For opioids not in Table 1, first estimate the daily amount of morphine that is equivalent to the current total daily amount of other opioid(s) received, then use Table 1 to find the approximate equivalent total daily dose of DILAUDID INJECTION.
Table 1: OPIOID ANALGESIC EQUIVALENTS WITH APPROXIMATELY
EQUIANALGESIC POTENCY FOR CONVERSION TO DILAUDID INJECTION*
|DRUG SUBSTANCE||PARENTERAL DOSE||ORAL DOSE|
|Morphine sulfate||10 mg||40 – 60 mg|
|Hydromorphone HCl||1.3 – 2 mg||6.5 – 7.5 mg|
|Oxymorphone HCl||1 – 1.1 mg||6.6 mg|
|Levorphanol tartrate||2 – 2.3 mg||4 mg|
|Meperidine HCl (Pethidine HCl)||75 – 100 mg||300 – 400 mg|
|Methadone HCl||10 mg||10 – 20 mg|
|Nalbuphine HCl||10 – 12 mg||–|
|Butorphanol tartrate||1.5 – 2.5 mg||–|
|* Dosages, and ranges of dosages represented, are a compilation of estimated equipotent dosages from published references comparing opioid analgesics in cancer and severe pain.|
DILAUDID-HP Injection (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. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid for one week or longer.
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 as described above in Section 2.4 Conversion From Prior Opioid and Table 1.
Administration and Reconstitution
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 ampules. 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.
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. Discard any unused portion in an appropriate manner.
Reconstitution of Sterile Lyophilized DILAUDID-HP INJECTION 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 of hydromorphone hydrochloride.
Dosage Forms And Strengths
DILAUDID INJECTION: Each 1 mL colorless ampule contains 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 amber ampule and amber single-dose vial contains 10 mg/mL of hydromorphone hydrochloride in a sterile, aqueous solution and is available in 1 mL or 5 mL ampules or in 50 mL single-dose vials† .
DILAUDID-HP INJECTION Sterile Lyophilized Powder: Each amber, single-dose vial† contains 250 mg of sterile, lyophilized hydromorphone hydrochloride to be reconstituted with 25 mL of Sterile Water for Injection USP to provide a solution containing 10 mg/mL.
†The Stoppers Of These Products Contain Natural Rubber Latex.
Storage And Handling
Safety And Handling Instructions
DILAUDID INJECTION and DILAUDID-HP INJECTION pose little risk of direct exposure to health care personnel and should be handled and disposed of prudently in accordance with hospital or institutional policy. When DILAUDID INJECTION or DILAUDID-HP INJECTION is no longer needed, any unused liquid should be destroyed by flushing it down the toilet.
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.
DILAUDID INJECTION (hydromorphone hydrochloride) is supplied in COLORLESS ampules. Each 1 mL of sterile, aqueous solution contains 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:
NDC 59011-441-10: Box of ten 1 mL (1 mg/mL) ampules
NDC 59011-442-10: Box of ten 1 mL (2 mg/mL) ampules
NDC 59011-442-25: Box of twenty-five 1 mL (2 mg/mL) ampules
NDC 59011-444-10: Box of ten 1 mL (4 mg/mL) ampules
DILAUDID-HP INJECTION (hydromorphone hydrochloride) is supplied in AMBER ampules, and AMBER single-dose vials. Each ampule and single-dose vial of sterile aqueous solution contains 10 mg of hydromorphone hydrochloride with 0.2% sodium citrate and 0.2% citric acid solution.
DILAUDID-HP INJECTION Sterile Lyophilized Powder is supplied in an AMBER single-dose vial. Each vial contains 250 mg of sterile, lyophilized hydromorphone hydrochloride.
DILAUDID-HP INJECTION contains no added preservative and is supplied as follows:
NDC 59011-445-01: Box of ten 1 mL (10 mg/mL) ampules
NDC 59011-445-05: Box of ten 5 mL (10 mg/mL) ampules
†NDC 59011-445-50: One 50 mL (10 mg/mL) single-dose vial with black rubber stopper and white flip-top/tear-off seal.
†NDC 59011-446-25: One 250 mg single-dose vial with black rubber stopper and black flip-top seal.
†The Stoppers for These Products Contain Natural Rubber Latex
PROTECT FROM LIGHT.
Keep covered in carton 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].
Healthcare professionals can telephone Purdue Pharma L.P.'s Medical Services Department (1-888-726-7535) for information on this product.
CAUTION: DEA Order Form Required.
Manufactured by Hospira, Inc., Lake Forest, IL 60045, U.S.A. For Purdue Pharma L.P. Stamford, CT 06901-3431. Revised: xx/2011
Last reviewed on RxList: 8/12/2011
This monograph has been modified to include the generic and brand name in many instances.
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