OXYMORPHONE HYDROCHLORIDE- oxymorphone hydrochloride tablet, film coated, extended release

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Lake Erie Medical DBA Quality Care Products LLC

Designación común internacional (DCI):

OXYMORPHONE HYDROCHLORIDE

Composición:

OXYMORPHONE HYDROCHLORIDE 20 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Oxymorphone hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Limitations of Usage - Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve oxymorphone hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - Oxymorphone hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. Oxymorphone hydrochloride extended-release tablets are contraindicated in patients with: - Significant respiratory depression - Acute or severe bronchial asthma or hypercarbia - Known or suspe

Resumen del producto:

Oxymorphone hydrochloride extended-release tablets are supplied as follows: 5 mg Purple, round, film-coated extended-release tablets debossed with "G71" on one side and blank on the other side. 7.5 mg Gray, round, film-coated extended-release tablets debossed with "G75" on one side and blank on the other side. 10 mg Orange, round, film-coated extended-release tablets debossed with "G72" on one side and blank on the other side. 15 mg White, round, film-coated extended-release tablets debossed with "G76" on one side and blank on the other side. 20 mg Green, round, film-coated extended-release tablets debossed with "G73" on one side and blank on the other side. 55700-215-30 55700-215-60 30 mg Brown, round, film-coated extended-release tablets debossed with "G77" on one side and blank on the other side. 40 mg Orange, round, film-coated extended-release tablets debossed with "G74" on one side and blank on the other side. Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure (as required).

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

OXYMORPHONE HYDROCHLORIDE- OXYMORPHONE HYDROCHLORIDE TABLET, FILM
COATED,
EXTENDED RELEASE
Lake Erie Medical DBA Quality Care Products LLC
----------
MEDGUIDE SECTION
OXYMORPHONE HYDROCHLORIDE (ox” i mor’ fone hy” dro khlor’ ide)
extended-release tablets,
for oral use, CII
Oxymorphone hydrochloride extended-release tablets are:
A strong prescription pain medicine that contains an opioid (narcotic)
that is used to manage pain severe
enough to require daily around-the-clock, long-term treatment with an
opioid, when other pain treatments
such as non-opioid pain medicines or immediate-release opioid
medicines do not treat your pain well
enough or you cannot tolerate them.
A long-acting (extended-release) 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.
Not for use to treat pain that is not around-the-clock.
Important information about oxymorphone hydrochloride extended-release
tablets:
Get emergency help right away if you take too much oxymorphone
hydrochloride extended-release
tablets (overdose). When you first start taking oxymorphone
hydrochloride extended-release 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.
Never give anyone your oxymorphone hydrochloride extended-release
tablets. They could die from
taking it. Store oxymorphone hydrochloride extended-release tablets
away from children and in a safe
place to prevent stealing or abuse. Selling or giving away oxymorphone
hydrochloride extended-release
tablets is against the law.
Do not take oxymorphone hydrochloride extended-release tablets if you
have:
severe asthma, trouble breathing, or other lung problems.
a bowel blockage or have a narrowing of the stomach or intestines.
Before taking oxymorphone hydrochloride extended-release tablets, tell
your healthcare provider if you
have a history of:
head i

Ficha técnica

OXYMORPHONE HYDROCHLORIDE- OXYMORPHONE HYDROCHLORIDE TABLET, FILM
COATED,
EXTENDED RELEASE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXYMORPHONE HYDROCHLORIDE
EXTENDED-RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR OXYMORPHONE
HYDROCHLORIDE EXTENDED-RELEASE TABLETS.
OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE 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; AND
INTERACTION WITH
ALCOHOL
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS EXPOSE USERS TO
RISKS OF ADDICTION, ABUSE, AND
MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH PATIENT'S
RISK BEFORE PRESCRIBING, AND
MONITOR REGULARLY FOR DEVELOPMENT OF THESE BEHAVIORS OR CONDITIONS.
(5.1)
SERIOUS LIFE-THREATENING OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR FOLLOWING A DOSE INCREASE. INSTRUCT PATIENTS TO SWALLOW
OXYMORPHONE HYDROCHLORIDE
EXTENDED-RELEASE TABLETS WHOLE TO AVOID EXPOSURE TO A POTENTIALLY
FATAL DOSE OF OXYMORPHONE. (5.2)
ACCIDENTAL INGESTION OF OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE
TABLETS, ESPECIALLY IN CHILDREN,
CAN RESULT IN FATAL OVERDOSE OF OXYMORPHONE. (5.2)
PROLONGED USE OF OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS
DURING PREGNANCY CAN RESULT
IN NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING
IF NOT RECOGNIZED AND TREATED.
IF OPIOID USE IS REQUIRED FOR A PROLONGED PERIOD 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 EXTENDED-RELEASE TABLETS BECAUSE
CO-INGESTION CAN RESULT IN FATAL PLASMA