September 2, 2015
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Dilaudid

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Dilaudid




Indications
Dosage
How Supplied

INDICATIONS

DILAUDID ORAL LIQUID and DILAUDID TABLETS are indicated for the management of pain in patients where an opioid analgesic is appropriate.

DOSAGE AND ADMINISTRATION

Dilaudid Oral Liquid

The usual adult oral dosage of DILAUDID ORAL LIQUID is one-half (2.5 mL) to two teaspoonfuls (10 mL) (2.5 mg - 10 mg) every 3 to 6 hours as directed by the clinical situation. Oral dosages higher than the usual dosages may be required in some patients.

Dilaudid Tablets

The usual starting dose for DILAUDID tablets is 2 mg to 4 mg, orally, every 4 to 6 hours. Appropriate use of the DILAUDID TABLETS must be decided by careful evaluation of each clinical situation.

A gradual increase in dose may be required if analgesia is inadequate, as tolerance develops, or if pain severity increases. The first sign of tolerance is usually a reduced duration of effect. Patients with hepatic and renal impairment should be started on a lower starting dose (See CLINICAL PHARMACOLOGY - Pharmacokinetics and Metabolism).

Individualization Of Dosage

The dosage of opioid analgesics like hydromorphone hydrochloride 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.

In non-opioid-tolerant patients, therapy with hydromorphone is typically initiated at an oral dose of 2-4 mg every four hours, but elderly patients may require lower doses (see PRECAUTIONS -Geriatric Use).

In patients receiving opioids, both the dose and duration of analgesia will vary substantially depending on the patient's opioid tolerance. The dose should be selected and adjusted so that at least 3-4 hours of pain relief may be achieved. In patients taking opioid analgesics, the starting dose of DILAUDID should be based on prior opioid usage. This should be done by converting the total daily usage of the previous opioid to an equivalent total daily dosage of oral DILAUDID using an equianalgesic table (see below). For opioids not in the table, first estimate the equivalent total daily usage of oral morphine, then use the table to find the equivalent total daily dosage of DILAUDID.

Once the total daily dosage of DILAUDID has been estimated, it should be divided into the desired number of doses. Since there is individual variation in response to different opioid drugs, only ½ to 2/3 of the estimated dose of DILAUDID calculated from equivalence tables should be given for the first few doses, then increased as needed according to the patient's response.

Since the pharmacokinetics of hydromorphone are affected in hepatic and renal impairment with a consequent increase in exposure, patients with hepatic and renal impairment should be started on a lower starting dose (See CLINICAL PHARMACOLOGY - Pharmacokinetics and Metabolism).

In chronic pain, doses should be administered around-the-clock. A supplemental dose of 5-15% of the total daily usage may be administered every two hours on an “as-needed” basis.

Periodic reassessment after the initial dosing is always required. If pain management is not satisfactory and in the absence of significant opioid-induced adverse events, the hydromorphone dose may be increased gradually. If excessive opioid side effects are observed early in the dosing interval, the hydromorphone dose should be reduced. 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 than the absolute dose of opioid employed.

OPIOID ANALGESIC EQUIVALENTS WITH APPROXIMATELY EQUIANALGESIC POTENCY*

Nonproprietary (Trade) Name IM or SC Dose ORAL Dose
Morphine sulfate 10 mg 40-60 mg
Hydromorphone HCl (DILAUDID) 1.3-2 mg 6.5-7.5 mg
Oxymorphone HCl (Numorphan) 1-1.1 mg 6.6 mg
Levorphanol tartrate (Levo-Dromoran) 2-2.3 mg 4 mg
Meperidine, pethidine HCl (Demerol) 75-100 mg 300-400 mg
Methadone HCl (Dolophine) 10 mg 10-20 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.

Safety And Handling Instructions

DILAUDID ORAL LIQUID and DILAUDID TABLETS 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. Significant absorption from dermal exposure is unlikely; accidental dermal exposure to DILAUDID ORAL LIQUID should be treated by removal of any contaminated clothing and rinsing the affected area with cool water. Patients and their families should be instructed to flush any DILAUDID ORAL LIQUID and DILAUDID TABLETS that are no longer needed.

Access to abuseable drugs such as DILAUDID ORAL LIQUID and DILAUDID TABLETS 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 selfadministration by health care providers.

HOW SUPPLIED

DILAUDID ORAL LIQUID is a clear, sweet, slightly viscous liquid. It is available in: Bottles of 1 pint (473 mL) - NDC # 59011-451-01

DILAUDID 2 mg TABLETS are light orange, round, flat-faced tablets, with beveled edges, debossed with a “P” on one side and the number “2” on the opposite side. They are available in:

Bottles of 100 - NDC # 59011-452-10
Unit Dose Packages of 100 (4x25) - NDC # 59011-452-01

DILAUDID 4 mg TABLETS are light yellow, round, flat-faced tablets, with beveled edges, debossed with a “P” on one side and the number “4” on the opposite side. They are available in:

Bottles of 100 - NDC # 59011-454-10
Unit Dose Packages of 100 (4x25) - NDC # 59011-454-01
Bottles of 500 - NDC # 59011-454-05

DILAUDID 8 mg TABLETS are white, triangular shaped tablets debossed with a “P” and an inverted “P” separated with a bisect on one side of the tablet and debossed with the number “8” on the other side of the tablet. They are available in:

Bottles of 100 - NDC # 59011-458-10

Healthcare professionals can telephone Purdue Pharma's Medical Services Department (1-888- 726-7535) for information on this product.

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 is Required.

Manufactured for Purdue Pharma L.P. Stamford, CT 06901-3431. By Halo Pharmaceutical, Inc., Whippany, NJ 07981. Revised: 6/2013

Last reviewed on RxList: 7/16/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

Dilaudid - User Reviews

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