OXYMORPHONE HYDROCHLORIDE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

OXYMORPHONE HYDROCHLORIDE (UNII: 5Y2EI94NBC) (OXYMORPHONE - UNII:9VXA968E0C)

זמין מ:

Physicians Total Care, Inc.

INN (שם בינלאומי):

OXYMORPHONE HYDROCHLORIDE

הרכב:

OXYMORPHONE HYDROCHLORIDE 10 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Oxymorphone Hydrochloride Tablets are indicated for the relief of moderate to severe acute pain where the use of an opioid is appropriate. - Oxymorphone Hydrochloride Tablets are contraindicated in patients with a known hypersensitivity to oxymorphone or to any of the other ingredients in Oxymorphone Hydrochloride Tablets, or with known hypersensitivity to morphine analogs such as codeine. - Oxymorphone Hydrochloride Tablets are contraindicated in patients with respiratory depression, except in monitored settings and in the presence of resuscitative equipment. - Oxymorphone Hydrochloride Tablets are contraindicated in patients with acute or severe bronchial asthma or hypercarbia. - Oxymorphone Hydrochloride Tablets are contraindicated in any patient who has or is suspected of having paralytic ileus [see Warning and Precautions (5.8)] . - Oxymorphone Hydrochloride Tablets are contraindicated in patients with moderate or severe hepatic impairment [see Warnings and Precautions (5.6)] . The safety of using oxymor

leaflet_short:

Oxymorphone Hydrochloride Tablets are supplied as follows: 10 mg Tablet: White to off-white, round, standard convex debossed with “54 814” on one side an plain on the other. Oxymorphone hydrochloride may be targeted for theft and diversion. Healthcare professionals should contact their State Medical Board, State Board of Pharmacy, or State Control Board for information on how to detect or prevent diversion of this product, and security requirements for storing and handling of oxymorphone hydrochloride. Healthcare professionals should advise patients to store oxymorphone hydrochloride in a secure place, preferably locked and out of the reach of children and other noncaregivers. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure (as required). Advise patients to dispose of any unused tablets from a prescription by flushing them down the toilet as soon as they are no longer needed [see Patient Counseling Information (17)] .

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

OXYMORPHONE HYDROCHLORIDE - OXYMORPHONE HYDROCHLORIDE TABLET
PHYSICIANS TOTAL CARE, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYMORPHONE HYDROCHLORIDE TABLETS SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXYMORPHONE
HYDROCHLORIDE TABLETS, CII.
INITIAL U.S. APPROVAL: 1959
INDICATIONS AND USAGE
Oxymorphone Hydrochloride Tablets are an opioid agonist indicated for
the relief of moderate to severe acute pain where
the use of an opioid is appropriate. (1)
DOSAGE AND ADMINISTRATION
Titrate the dose base on individual response. (2.1)
Oxymorphone hydrochloride should be taken on an empty stomach, at
least one hour prior to or two hours after eating.
(2.2)
_Opioid-Naïve Patients_: 10 to 20 mg orally every four to six hours.
INITIATION OF THERAPY WITH DOSES HIGHER THAN 20 MG IS NOT RECOMMENDED.
If necessary, may be initiated with 5 mg (e.g., for renal or hepatic
impairment, geriatric patients). (2)
_Conversion to Oxymorphone Hydrochloride Tablets_: Follow
recommendations for conversion from other opioids or
parenteral oxymorphone. (2.2)
_Cessation of Therapy_: Taper gradually. (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg and 10 mg. (3)
CONTRAINDICATIONS
Known hypersensitivity to oxymorphone, any other ingredients in
Oxymorphone Hydrochloride Tablets, or morphine
analogs (4)
Respiratory depression in the absence of resuscitative equipment (4)
Acute or severe bronchial asthma or hypercarbia (4)
Paralytic ileus (4)
Moderate or severe hepatic impairment (4)
WARNINGS AND PRECAUTIONS
Respiratory depression: Increased risk in elderly, debilitated
patients, and those suffering from conditions accompanied
by hypoxia, hypercapnia, or decreased respiratory reserve. (5.1)
Misuse, abuse, and diversion: Oxymorphone Hydrochloride is an opioid
agonist and a Schedule II controlled substance
with an abuse liability similar to morphine. (5.2)
CNS effects: Additive CNS-depressive effects when used in conjunction
with alcohol, other opioids, or il