Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
OXYMORPHONE HYDROCHLORIDE (UNII: 5Y2EI94NBC) (OXYMORPHONE - UNII:9VXA968E0C)
Ranbaxy Pharmaceuticals Inc.
OXYMORPHONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
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
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).
Abbreviated New Drug Application
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 সম্পূর্ণ নথি পড়ুন
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 সম্পূর্ণ নথি পড়ুন