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Hydromorphone (Hydromorphone Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Hydromorphone hydrochloride tablets are indicated for the management of pain in patients where an opioid analgesic is appropriate.

DOSAGE AND ADMINISTRATION

Hydromorphone hydrochloride tablets (2 mg, 4 mg, 8 mg): The usual starting dose for hydromorphone hydrochloride tablets is 2 mg to 4 mg, orally, every 4 to 6 hours. Appropriate use of the hydromorphone hydrochloride 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 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 hydromorphone hydrochloride 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 hydromorphone hydrochloride using an equianalgesic table (see below). For opioids not in the table, first estimate the equivalent total daily usage of oral usage of oral morphine, then use the table to find the equivalent total daily dosage of hydromorphone hydrochloride.

Once the total daily dosage of hydromorphone hydrochloride 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 ⅔ of the estimated dose of hydromorphone hydrochloride 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 CLINCIAL PHARMCOLOGY: 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*
*Dosages, and ranges of dosages represented, are a compilation of estimated equipotent dosages from published references comparing opioid analgesics in cancer and severe pain.
Nonproprietary
(Trade) Name
IM or SC
Dose
ORAL
Dose
Morphine sulfate10 mg40-60 mg
Hydromorphone HCl1.3-2 mg6.5-7.5 mg
Oxymorphone HCl
(Numorphan)
1-1.1 mg6.6 mg
Levorphanol tartrate
(Levo-Dromoran)
2-2.3 mg4 mg
Meperidine, pethidine HCl
(Demerol)
75-100 mg300-400 mg
Methadone HCl
(Dolophine)
10 mg10-20 mg

HOW SUPPLIED

Hydromorphone hydrochloride tablets, USP, for oral administration, are supplied as follows:

2 mg: Round, flat face, beveled-edge blue tablet, debossed “E” on one side and “2” on the other side.
100 Count Bottle…………………………..NDC 58177-620-04
1000 Count Bottle…………………………NDC 58177-620-09
100 Count Unit Dose Packs……………….NDC 58177-620-11

4 mg: Round, flat face, beveled-edge tan tablet, debossed “E” on one side and “4” on the other side.
100 Count Bottles…………………………NDC 58177-621-04
1000 Count Bottles……………………….NDC 58177-621-09
100 Count Unit Dose Packs………………NDC 58177-621-11

8 mg: Round, flat face, beveled-edge white tablet, debossed “E” on one side and “8” through partial bisect on the other side.
100 Count Bottle…………………………..NDC 58177-449-04
1000 Count Bottle…………………………NDC 58177-449-09
100 Count Unit Dose Packs………………NDC 58177-449-11

STORAGE

Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). [See USP Controlled Room Temperature.] Protect from light.

A Schedule CII Narcotic. DEA Order Form Is Required.

Manufactured by
KV Pharmaceutical Co. for
ETHEX Corporation
St. Louis, MO  63044

P4953-1                            10/06

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