OPANA 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:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

INN (שם בינלאומי):

OXYMORPHONE HYDROCHLORIDE

הרכב:

OXYMORPHONE HYDROCHLORIDE 5 mg

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

New Drug Application

מאפייני מוצר

OPANA- OXYMORPHONE HYDROCHLORIDE TABLET
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OPANA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR OPANA.
OPANA (OXYMORPHONE HYDROCHLORIDE) TABLETS, CII
INITIAL U.S. APPROVAL: 1959
INDICATIONS AND USAGE
OPANA is 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 based on individual response. (2.1)
OPANA 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 OPANA: 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 OPANA,
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: OPANA 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 illicit drugs. (5.3)
Head injury: Effects may be markedly exaggerated. Administer with
extreme caution. (5.4)
Hypotensive effect: