OXYMORPHONE HYDROCHLORIDE- 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:

Par Pharmaceutical

INN (שם בינלאומי):

OXYMORPHONE HYDROCHLORIDE

הרכב:

OXYMORPHONE HYDROCHLORIDE 5 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Oxymorphone hydrochloride tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve oxymorphone hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia Oxymorphone hydrochloride tablets are contraindicated in patients with: - Significant respiratory depression [see Warnings and Precautions (5.2)] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.5)] - Known or suspected gastrointestinal obstruction, including paralytic ileus [see War

leaflet_short:

Oxymorphone hydrochloride tablets are supplied as follows: 5 mg Tablet: Blue, round, convex tablets debossed with E794 on one side and 5 on the other. Bottles of 100 tablets with child-resistant closure                    NDC 60951-794-70 Unit-Dose package of 100 tablets (5 blister cards of 20 tablets, not child-resistant, for hospital use only)                    NDC 60951-794-75 10 mg Tablet: Red, round, convex tablets debossed with E795 on one side and 10 on the other. Bottles of 100 tablets with child-resistant closure                    NDC 60951-795-70 Unit-Dose package of 100 tablets (5 blister cards of 20 tablets, not child-resistant, for hospital use only)                    NDC 60951-795-75 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).  [See USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure (as required).

מצב אישור:

New Drug Application Authorized Generic

עלון מידע

Par Pharmaceutical
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Medication Guide
Oxymorphone Hydrochloride Tablets, for oral use, CII
Oxymorphone hydrochloride tablets are:
•
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage
short-term (acute) pain when other pain treatments such as non-opioid
pain medicines do not treat
your pain well enough or you cannot tolerate them.
•
An opioid pain medicine that can put you at risk for overdose and
death. Even if you take your
dose correctly as prescribed you are at risk for opioid addiction,
abuse, and misuse that can lead
to death.
Important information about oxymorphone hydrochloride tablets:
•
Get emergency help right away if you take too much oxymorphone
hydrochloride tablets
(overdose). When you first start taking oxymorphone hydrochloride
tablets, when your dose is
changed, or if you take too much (overdose), serious or
life-threatening breathing problems that
can lead to death may occur.
•
Taking oxymorphone hydrochloride tablets with other opioid medicines,
benzodiazepines,
alcohol, or other central nervous system depressants (including street
drugs) can cause severe
drowsiness, decreased awareness, breathing problems, coma, and death.
•
Never give anyone your oxymorphone hydrochloride tablets. They could
die from taking it. Store
oxymorphone hydrochloride tablets away from children and in a safe
place to prevent stealing or
abuse. Selling or giving away oxymorphone hydrochloride tablets is
against the law.
Do not take oxymorphone hydrochloride tablets if you have:
•
severe asthma, trouble breathing, or other lung problems.
•
a bowel blockage or have narrowing of the stomach or intestines.
Before taking oxymorphone hydrochloride tablets, tell your healthcare
provider if you have a history of:
•
head injury, seizures
•
liver, kidney, thyroid problems
•
problems urinating
•
pancreas or gallbladder problems
•
abuse of street or prescription drugs, alcohol addiction, or mental
health problems.
Tell your healthcare provider if you are:

מאפייני מוצר

OXYMORPHONE HYDROCHLORIDE- OXYMORPHONE HYDROCHLORIDE TABLET
PAR PHARMACEUTICAL
----------
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.
OXYMORPHONE HYDROCHLORIDE TABLETS, FOR ORAL USE CII
INITIAL U.S. APPROVAL: 1959
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION
WITH
ALCOHOL; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER
CNS
DEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
OXYMORPHONE HYDROCHLORIDE TABLETS EXPOSES USERS TO RISKS OF ADDICTION,
ABUSE, AND MISUSE, WHICH CAN
LEAD TO OVERDOSE AND DEATH. ASSESS PATIENT’S RISK BEFORE PRESCRIBING
AND MONITOR REGULARLY FOR THESE
BEHAVIORS AND CONDITIONS. (5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. (5.2)
ACCIDENTAL INGESTION OF OXYMORPHONE HYDROCHLORIDE TABLETS, ESPECIALLY
BY CHILDREN, CAN RESULT IN A
FATAL OVERDOSE OF OXYMORPHONE. (5.2)
PROLONGED USE OF OXYMORPHONE HYDROCHLORIDE TABLETS DURING PREGNANCY
CAN RESULT IN NEONATAL OPIOID
WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED
AND TREATED. IF PROLONGED
OPIOID USE IS REQUIRED IN A PREGNANT WOMAN, ADVISE THE PATIENT OF THE
RISK OF NEONATAL OPIOID
WITHDRAWAL SYNDROME AND ENSURE THAT APPROPRIATE TREATMENT WILL BE
AVAILABLE. (5.3)
INSTRUCT PATIENTS NOT TO CONSUME ALCOHOL OR ANY PRODUCT CONTAINING
ALCOHOL WHILE TAKING
OXYMORPHONE HYDROCHLORIDE TABLETS BECAUSE CO-INGESTION CAN RESULT IN
FATAL PLASMA OXYMORPHONE
LEVELS. (5.4)
CONCOMITANT USE OF OPIOIDS WITH BENZODIAZEPINES OR OTHER CENTRAL
NERVOUS SYSTEM (CNS) DEPRESSANTS,
INCLUDING ALCOHOL, MAY RESULT IN PROFOUND SEDATION, RESPIRATORY
DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMITANT PRESCRIBING FOR USE IN PATIENTS FOR WHOM