国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Zydus Pharmaceuticals (USA) Inc.
ORAL
PRESCRIPTION DRUG
Oxycodone Hydrochloride and Acetaminophen Tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve Oxycodone Hydrochloride and Acetaminophen Tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - Have not been tolerated, or are not expected to be tolerated, - Have not provided adequate analgesia, or are not expected to provide adequate analgesia Oxycodone Hydrochloride and Acetaminophen Tablets are contraindicated in patients with: - Significant respiratory depression [see WARNINGS] - Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS] - Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS] - Hypersensitivity to oxycodone, acetaminophen, or
Oxycodone Hydrochloride and Acetaminophen Tablets, USP are supplied as follows: 2.5 mg/325 mg White to off-white, oval tablet, debossed with "1327" on one side and plain on the other. Bottles of 100……………………..NDC 70710-1327-1 5 mg/325 mg White to off-white, round tablet, debossed with "1328" on one side and bisect on the other. Bottles of 100……………………..NDC 70710-1328-1 Bottles of 500……………………..NDC 70710-1328-5 7.5 mg/325 mg White to off-white, oval shaped tablet, debossed with "1329" on one side and plain on the other. Bottles of 100……………………..NDC 70710-1329-1 Bottles of 500……………………..NDC 70710-1329-5 10 mg/325 mg White to off-white, capsule shaped tablet, debossed with "1330" on one side and plain on the other. Bottles of 100……………………..NDC 70710-1330-1 Bottles of 500……………………..NDC 70710-1330-5 Store Oxycodone Hydrochloride and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/Information for Patients] . Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). DEA Order Form Required. Keep this and all drugs out of the reach of children. Manufactured By: Nesher Pharmaceuticals USA LLC St. Louis, MO 63044 Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 PI-Rasub-7 August 2020 For additional copies of the printed patient information/medication guide, please visit www.zydus.com or call 1-877-993-8779.
Abbreviated New Drug Application
Zydus Pharmaceuticals (USA) Inc. ---------- Medication Guide Oxycodone Hydrochloride (ox" i koe' done hye" droe klor' ide) and Acetaminophen (a seet" a min' oh fen) Tablets, CII Oxycodone Hydrochloride and Acetaminophen Tablets are: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate and when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them. • An 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. Important information about Oxycodone Hydrochloride and Acetaminophen Tablets: • Get emergency help or call 911 right away if you take too many Oxycodone Hydrochloride and Acetaminophen Tablets (overdose) . When you first start taking Oxycodone Hydrochloride and Acetaminophen 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. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose. • Taking Oxycodone Hydrochloride and Acetaminophen 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 else your Oxycodone Hydrochloride and Acetaminophen Tablets. They could die from taking it. Selling or giving away Oxycodone Hydrochloride and Acetaminophen Tablets is against the law. • Store Oxycodone Hydrochloride and Acetaminophen Tablets securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Do not take Oxycodone Hydrochloride and Acetaminophen Tablets if you have 阅读完整的文件
OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET ZYDUS PHARMACEUTICALS (USA) INC. ---------- OXYCODONE AND ACETAMINOPHEN TABLETS, USP CII REVISED: AUGUST 2020 WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME, CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY, AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ADDICTION, ABUSE, AND MISUSE OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS EXPOSE PATIENTS AND OTHER USERS TO THE RISKS OF OPIOID ADDICTION, ABUSE, AND MISUSE, WHICH CAN LEAD TO OVERDOSE AND DEATH. ASSESS EACH PATIENT'S RISK PRIOR TO PRESCRIBING OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS, AND MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS [SEE WARNINGS]. OPIOID ANALGESIC RISK EVALUATION AND MITIGATION STRATEGY (REMS) 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 REMS FOR THESE PRODUCTS [_SEE _WARNINGS]. UNDER THE REQUIREMENTS OF THE REMS, DRUG COMPANIES WITH APPROVED OPIOID ANALGESIC PRODUCTS MUST MAKE REMS-COMPLIANT EDUCATION PROGRAMS AVAILABLE TO HEALTHCARE PROVIDERS. HEALTHCARE PROVIDERS ARE STRONGLY ENCOURAGED TO - COMPLETE A REMS-COMPLIANT EDUCATION PROGRAM, - COUNSEL PATIENTS AND/OR THEIR CAREGIVERS, WITH EVERY PRESCRIPTION, ON SAFE USE, SERIOUS RISKS, STORAGE, AND DISPOSAL OF THESE PRODUCTS, - EMPHASIZE TO PATIENTS AND THEIR CAREGIVERS THE IMPORTANCE OF READING THE MEDICATION GUIDE EVERY TIME IT IS PROVIDED BY THEIR PHARMACIST, AND - CONSIDER OTHER TOOLS TO IMPROVE PATIENT, HOUSEHOLD, AND COMMUNITY SAFETY. LIFE-THREATENING RESPIRATORY DEPRESSION SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR WITH USE OF OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLETS. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF OXYCODONE HYDROCHLORIDE AND ACET 阅读完整的文件