País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Par Pharmaceutical
OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE 5 mg
ORAL
PRESCRIPTION DRUG
Oxycodone Hydrochloride and Acetaminophen Tablets is 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 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 is 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
Oxycodone Hydrochloride and Acetaminophen Tablets, USP, 5 mg/325 mg, supplied as a white round tablet, with one face, scored debossed 4839 and V, and the other plain, are available as follows: 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. DEA Order Form Required. Store Oxycodone Hydrochloride and Acetaminophen Tablets securely and dispose of properly [see PRECAUTIONS/Information for Patients ].
Abbreviated New Drug Application
Par Pharmaceutical ---------- 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 right away if you take too much 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. 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: • Severe asthma, trouble breathing, or other lung problems. • A bowel blockage or have narrowing of the stomach or intestines • known Llegiu el document complet
OXYCODONE AND ACETAMINOPHEN- OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN TABLET PAR PHARMACEUTICAL ---------- OXYCODONE AND ACETAMINOPHEN TABLETS, USP 5 MG/325 MG CII RX ONLY Revised: AUGUST 2019 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 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 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 HYDROCHL Llegiu el document complet