Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Aurolife Pharma, LLC
OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE 2.5 mg
ORAL
PRESCRIPTION DRUG
Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS ] , reserve Oxycodone 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 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 any other component of the product
Oxycodone and Acetaminophen Tablets, USP are supplied as follows: 2.5 mg/325 mg White to off-white, round tablets, debossed with “U14” on one side and plain on the other side. Bottles of 30 NDC 13107-043-30 Bottles of 100 NDC 13107-043-01 Bottles of 500 NDC 13107-043-05 Bottles of 1000 NDC 13107-043-99 5 mg/325 mg White to off-white, capsule-shaped tablets, debossed with “U15” on one side and break line on the other side. Bottles of 30 NDC 13107-044-30 Bottles of 100 NDC 13107-044-01 Bottles of 500 NDC 13107-044-05 Bottles of 1000 NDC 13107-044-99 7.5 mg/325 mg White to off-white, oval-shaped tablets, debossed with “U16” on one side and plain on the other side. Bottles of 30 NDC 13107-045-30 Bottles of 100 NDC 13107-045-01 Bottles of 500 NDC 13107-045-05 Bottles of 1000 NDC 13107-045-99 10 mg/325 mg White to off-white, capsule-shaped tablets, debossed with “U17” on one side and plain on the other side. Bottles of 30 NDC 13107-046-30 Bottles of 100 NDC 13107-046-01 Bottles of 500 NDC 13107-046-05 Bottles of 1000 NDC 13107-046-99 Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. Store Oxycodone and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/ Information for Patients]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). DEA Order Form Required. Dispense with Medication Guide available at https://www.aurobindousa.com/medication-guides/ Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Revised: 08/2020
Abbreviated New Drug Application
OXYCODONE AND ACETAMINOPHEN - OXYCODONE AND ACETAMINOPHEN TABLET Aurolife Pharma, LLC ---------- MEDICATION GUIDE Oxycodone and Acetaminophen Tablets, USP CII ok″se-ko´dōn and ass-eet-ah-MEE-noe-fen Oxycodone 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 and acetaminophen tablets: • Get emergency help or call 911 right away if you take too much oxycodone and acetaminophen tablets (overdose). When you first start taking oxycodone 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 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 and Acetaminophen Tablets. They could die from taking it. Selling or giving away Oxycodone and Acetaminophen Tablets are against the law. • Store Oxycodone 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 and acetaminophen tablets if you have: • Severe asthma, trouble breathing, or other lung problems. • A bowel blockage or have narrowin Прочетете целия документ
OXYCODONE AND ACETAMINOPHEN - OXYCODONE AND ACETAMINOPHEN TABLET AUROLIFE PHARMA, LLC ---------- OXYCODONE AND ACETAMINOPHEN TABLETS, USP CII 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 AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ADDICTION, ABUSE, AND MISUSE OXYCODONE AND ACETAMINOPHEN TABLETS EXPOSES 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 AND ACETAMINOPHEN TABLETS, AND MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS OR 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 AND ACETAMINOPHEN TABLETS. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF OXYCODONE AND ACETAMINOPHEN TABLETS OR FOLLOWING A DOSE INCREASE [SEE WARNINGS]. ACCIDENTAL INGESTION ACCIDENT Прочетете целия документ