OXYMORPHONE HYDROCHLORIDE tablet, film coated, extended release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Quality Care Products, LLC

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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 [see Warnings and Precautions (5.1)] , 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 [see Warnings and Precaution

Podsumowanie produktu:

Oxymorphone hydrochloride extended-release tablets, USP are supplied as the following strengths: Oxymorphone Hydrochloride Extended-release Tablets USP, 5 mg are purple, round, film-coated extended-release tablets debossed with “G71” on one side and blank on the other side. They are available as follows: Oxymorphone Hydrochloride Extended-release Tablets USP, 7.5 mg are gray, round, film-coated extended-release tablets debossed with “G75” on one side and blank on the other side. They are available as follows: Oxymorphone Hydrochloride Extended-release Tablets USP, 10 mg are orange, round, film-coated extended-release tablets debossed with “G72” on one side and blank on the other side. They are available as follows: Bottles of 60:                                                   NDC 55700-788-60 Oxymorphone Hydrochloride Extended-release Tablets USP, 15 mg are white, round, film-coated extended-release tablets debossed with “G76” on one side and blank on the other side. They are available as follows: Oxymorphone Hydrochloride Extended-release Tablets USP, 20 mg are green, round, film-coated extended-release tablets debossed with “G73” on one side and blank on the other side. They are available as follows: Oxymorphone Hydrochloride Extended-release Tablets USP, 30 mg are brown, round, film-coated extended-release tablets debossed with “G77” on one side and blank on the other side. They are available as follows: Oxymorphone Hydrochloride Extended-release Tablets USP, 40 mg are orange, round, film-coated extended-release tablets debossed with “G74” on one side and blank on the other side. They are available as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure (as required).

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

OXYMORPHONE HYDROCHLORIDE- OXYMORPHONE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED
RELEASE
Quality Care Products, LLC
----------
MEDICATION GUIDE
Oxymorphone Hydrochloride (ox” i mor’ fone hye” droe klor’
ide) Extended-Release Tablets, USP, 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.
•
Taking oxymorphone hydrochloride extended-release 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 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 i

Charakterystyka produktu

OXYMORPHONE HYDROCHLORIDE- OXYMORPHONE HYDROCHLORIDE TABLET, FILM
COATED, EXTENDED RELEASE
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; RISK EVALUATION AND MITIGATION
STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL
INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH
ALCOHOL;
AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES AND OTHER CNS
DEPRESSANTS.
_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 THESE
BEHAVIORS AND
CONDITIONS. (5.1)
TO ENSURE THAT THE BENEFITS OF OPIOID ANALGESICS OUTWEIGH THE RISKS OF
ADDICTION,
ABUSE, AND MISUSE, THE FOOD AND DRUG ADMINISTRATION (FDA) HAS REQUIRED
A RISK
EVALUATION AND MITIGATION STRATEGY (REMS) FOR THESE PRODUCTS. (5.2)
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. (5.3)
ACCIDENTAL INGESTION OF OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE
TABLETS,
ESPECIALLY BY CHILDREN, CAN RESULT IN FATAL OVERDOSE OF OXYMORPHONE.
(5.3)
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, ADVI