Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Proficient Rx LP
OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE 10 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 ] Oxycodone and acetaminophen tablets are contraindicated in patients with: Controlled Substance Oxycodone and acetaminophen tablet contains oxycodone and acetaminophen, a Schedule CII controlled substance. Abuse Oxycodone and Acetaminophen Tablets contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol. Oxycodone and Acetaminophen Tablets can be abused and is subject to misuse, addiction, and criminal diversion [see WARNINGS ]. All patients tr
Oxycodone and Acetaminophen Tablets, USP are supplied as follows: 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 15 NDC 63187-523-15 Bottles of 20 NDC 63187-523-20 Bottles of 30 NDC 63187-523-30 Bottles of 60 NDC 63187-523-60 Bottles of 90 NDC 63187-523-90 Store at 20° to 25°C (68° to 77°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). DEA Order Form Required. Dispense with Medication Guide available atwww.aurobindousa.com/product-medication-guides Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 Repackaged by: Proficient Rx LP. Thousand Oaks, CA 91320 Revised: 12/2016
Abbreviated New Drug Application
OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET Proficient Rx LP ---------- SPL MEDGUIDE 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 for the management of relief of moderate to moderately severe pain, pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate or when 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 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. • 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. Store oxycodone and acetaminophen tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away oxycodone and acetaminophen tablets is against the law. Do not take oxycodone 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 hypersensitivity to oxycodone, acetaminophen, or any ingredient in Oxycodone Hydrochloride and Acetaminop Lire le document complet
OXYCODONE AND ACETAMINOPHEN- OXYCODONE AND ACETAMINOPHEN TABLET PROFICIENT RX LP ---------- OXYCODONE AND ACETAMINOPHEN TABLETS, USP CII BOXED WARNING WARNING: ADDICTION, ABUSE, AND MISUSE; 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[SEEWARNINGS]. 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 [S EEWARNINGS]. ACCIDENTAL INGESTION ACCIDENTAL INGESTION OF OXYCODONE AND ACETAMINOPHEN TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF OXYCODONE AND ACETAMINOPHEN TABLETS [SEEWARNINGS]. NEONATAL OPIOID WITHDRAWAL SYNDROME PROLONGED USE OF OXYCODONE AND ACETAMINOPHEN TABLETS DURING PREGNANCY CAN RESULT IN NEONATAL OPIOID WITHDRAWAL SYNDROME, WHICH MAY BE LIFE-THREATENING IF NOT RECOGNIZED AND TREATED, AND REQUIRES MANAGEMENT ACCORDING TO PROTOCOLS DEVELOPED BY NEONATOLOGY EXPERTS. IF OPIOID USE IS REQUIRED FOR A PROLONGED PERIOD IN A PREGNANT WOMAN, ADVISE THE PATIENT OF THE RISK OF NEONATAL OPIOID WITHDRAWAL SYNDROME AND ENSURE THAT APPROPRIATE TREATMENT WILL BE AVAILABLE [SEE WARNINGS]. CYTOCHROME P450 3A4 INTERACTION THE CONCOMITANT USE OF OXYCODONE TABLETS WITH ALL CYTOCHROME P450 3A4 INHIBITORS MAY RESULT IN AN INCREASE IN OXYCODONE PLASMA CONCENTRATIONS, WHICH COULD INCREASE OR PROLONG ADVERSE REACTIONS AND MAY CAUSE POT Lire le document complet