Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
OXYMORPHONE HYDROCHLORIDE (UNII: 5Y2EI94NBC) (OXYMORPHONE - UNII:9VXA968E0C)
SpecGx LLC
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. 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
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).
Abbreviated New Drug Application
EXTENDED RELEASE SpecGx LLC ---------- 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 Прочетете целия документ
OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE- OXYMORPHONE HYDROCHLORIDE TABLET, EXTENDED RELEASE SPECGX 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 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, Прочетете целия документ