Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
OXYMORPHONE HYDROCHLORIDE (UNII: 5Y2EI94NBC) (OXYMORPHONE - UNII:9VXA968E0C)
Quality Care Products, LLC
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 [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
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).
Abbreviated New Drug Application
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 Baca dokumen lengkapnya
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 Baca dokumen lengkapnya