OXYMORPHONE HYDROCHLORIDE tablet, film coated, extended release
국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
환자 정보 전단 유효 성분:
OXYMORPHONE HYDROCHLORIDE (UNII: 5Y2EI94NBC) (OXYMORPHONE - UNII:9VXA968E0C)
제공처:
Ranbaxy Pharmaceuticals Inc.
INN (International Name):
OXYMORPHONE HYDROCHLORIDE
구성:
OXYMORPHONE HYDROCHLORIDE 5 mg
관리 경로:
ORAL
처방전 유형:
PRESCRIPTION DRUG
치료 징후:
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: Clinical Considerations Fetal/neonatal adverse reactions Prolonged use of opioid analgesics during pregnanc
제품 요약:
Oxymorphone hydrochloride extended-release tablets are supplied as follows: 5 mg Pink to light pink, round, biconvex film-coated tablets, debossed with ‘RH 29 ’ on one side and plain on the other side. NDC 63304-218-30 Bottles of 30 with child-resistant closure NDC 63304-218-05 Bottles of 500 7.5 mg Gray to light gray, round, biconvex film-coated tablets, debossed with ‘RI 36 ’ on one side and plain on the other side. NDC 63304-219-30 Bottles of 30 with child-resistant closure NDC 63304-219-05 Bottles of 500 10 mg Orange to light orange, round, biconvex film-coated tablets, debossed with ‘RH 30 ’ on one side and plain on the other side. NDC 63304-220-30 Bottles of 30 with child-resistant closure NDC 63304-220-05 Bottles of 500 15 mg White to off-white, round, biconvex film-coated tablets, debossed with ‘RI 37 ’ on one side and plain on the other side. NDC 63304-221-30 Bottles of 30 with child-resistant closure NDC 63304-221-05 Bottles of 500 20 mg Green to light green, round, biconvex film-coated tablets, debossed with ‘RH 31 ’ on one side and plain on the other side. NDC 63304-222-30 Bottles of 30 with child-resistant closure NDC 63304-222-05 Bottles of 500 30 mg Reddish brown, round, biconvex film-coated tablets, debossed with ‘RI 38 ’ on one side and plain on the other side. NDC 63304-223-30 Bottles of 30 with child-resistant closure NDC 63304-223-05 Bottles of 500 40 mg Yellow to light yellow, round, biconvex film-coated tablets, debossed with ‘RH 32 ’ on one side and plain on the other side. NDC 63304-224-30 Bottles of 30 with child-resistant closure NDC 63304-224-05 Bottles of 500 Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Dispense in tight container as defined in the USP, with a child-resistant closure (as required).
승인 상태:
Abbreviated New Drug Application
환자 정보 전단
OXYMORPHONE HYDROCHLORIDE- OXYMORPHONE HYDROCHLORIDE TABLET, FILM
COATED,
EXTENDED RELEASE
Ranbaxy Pharmaceuticals Inc.
Reference Label Set Id: 565fd727-e53c-4fd2-b10a-9c98018f1437
----------
MEDICATION GUIDE
OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE, CII
Rx only
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 hydroch
전체 문서 읽기
제품 특성 요약
OXYMORPHONE HYDROCHLORIDE- OXYMORPHONE HYDROCHLORIDE TABLET, FILM
COATED,
EXTENDED RELEASE
RANBAXY PHARMACEUTICALS INC.
REFERENCE LABEL SET ID: 565FD727-E53C-4FD2-B10A-9C98018F1437
----------
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._
•
•
•
•
•
RECENT MAJOR CHANGES
Boxed Warning 4/2014
Indications and Usage (1) 4/2014
Dosage and Administration (2) 4/2014
Warnings and Precautions (5) 4/2014
INDICATIONS AND USAGE
Oxymorphone hydrochloride extended-release tablets are an opioid
agonist 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. (1) (1)
Limitations of Use (1)
•
•
DOSAGE AND ADMINISTRATION
•
•
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 H
전체 문서 읽기
