OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE- oxymorphone hydrochloride tablet, extended release
国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
资料单张 有效成分:
OXYMORPHONE HYDROCHLORIDE (UNII: 5Y2EI94NBC) (OXYMORPHONE - UNII:9VXA968E0C)
可用日期:
SpecGx LLC
INN（国际名称）:
OXYMORPHONE HYDROCHLORIDE
组成:
OXYMORPHONE HYDROCHLORIDE 5 mg
给药途径:
ORAL
处方类型:
PRESCRIPTION DRUG
疗效迹象:
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. 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 tr
產品總結:
Oxymorphone hydrochloride extended-release tablets are supplied as follows: 5 mg Pink octagonal tablets debossed “8091” on one side and “M” in a box on the other side. Bottles of 100 with child-resistant closure…………NDC 0406-8091-01 7.5 mg Gray octagonal tablets debossed “8095” on one side and “M” in a box on the other side. Bottles of 100 with child-resistant closure…………NDC 0406-8095-01 10 mg Light orange octagonal tablets debossed “8092” on one side and “M” in a box on the other side. Bottles of 100 with child-resistant closure…………NDC 0406-8092-01 15 mg White octagonal tablets debossed “8096” on one side and “M” in a box on the other side. Bottles of 100 with child-resistant closure…………NDC 0406-8096-01 20 mg Light blue octagonal tablets debossed “8093” on one side and “M” in a box on the other side. Bottles of 100 with child-resistant closure…………NDC 0406-8093-01 30 mg Red octagonal tablets debossed “8097” on one side and “M” in a box on the other side. Bottles of 100 with child-resistant closure…………NDC 0406-8097-01 40 mg Yellow octagonal tablets debossed “8094” on one side and “M” in a box on the other side. Bottles of 100 with child-resistant closure…………NDC 0406-8094-01 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
授权状态:
Abbreviated New Drug Application
资料单张
EXTENDED RELEASE
SpecGx LLC
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MEDICATION GUIDE
Medication Guide
Oxymorphone Hydrochloride (ox" i mor' fone hye" droe klor' 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 many 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 them. 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 prob
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产品特点
OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE- OXYMORPHONE
HYDROCHLORIDE TABLET, EXTENDED RELEASE
SPECGX LLC
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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 OR 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 FOR DEVELOPMENT OF THESE BEHAVIORS OR 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 IN 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,
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