国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7)
Sun Pharmaceutical Industries, Inc.
ACETAMINOPHEN
ACETAMINOPHEN 325 mg
ORAL
PRESCRIPTION DRUG
Hydrocodone Bitartrate and Acetaminophen Tablets, USP are indicated for the management of moderate to moderately severe 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 Hydrocodone Bitartrate and Acetaminophen Tablets, USP for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): Hydrocodone Bitartrate and Acetaminophen Tablets, USP are contraindicated in patients with:
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg are available as white to off-white round, uncoated tablets, debossed with “RX” above the bisect and “497” below the bisect on one side and plain on the other side. They are supplied as: Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured for Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA
Abbreviated New Drug Application
ACETAMINOPHEN TABLET Sun Pharmaceutical Industries, Inc. ---------- MEDICATION GUIDE Hydrocodone Bitartrate (hye” droe koe’ done bye tar’ trate) and Acetaminophen (a seet” a min’ oh fen) Tablets, USP 10 mg/325 mg, CII Hydrocodone Bitartrate and Acetaminophen Tablets, USP are: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine, 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 Hydrocodone Bitartrate and Acetaminophen Tablets, USP: • Get emergency help right away if you take too much Hydrocodone Bitartrate and Acetaminophen Tablets, USP (overdose). When you first start taking Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 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 Hydrocodone Bitartrate and Acetaminophen Tablets, USP 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 Hydrocodone Bitartrate and Acetaminophen Tablets, USP. They could die from taking it. Store Hydrocodone Bitartrate and Acetaminophen Tablets, USP away from children and in a safe place to prevent stealing or abuse. Selling or giving away Hydrocodone Bitartrate and Acetaminophen Tablets, USP is against the law. Do not take Hydrocodone Bitartrate and Acetaminophen Tablets, USP if you have: • severe asthma, trouble breathing, or other lung problems. • a bowel blockage or have narrowing of the stomach or intestines. • known hyp 阅读完整的文件
HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CII RX ONLY WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ADDICTION, ABUSE, AND MISUSE HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP, 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 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP, 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 • • • • LIFE-THREATENING RESPIRATORY DEPRESSION SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR WITH USE OF HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP OR FOLLOWING A DOSE INCREASE [SEE WARNINGS]. ACCIDENTAL INGESTION ACCIDENTAL INGESTION OF HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP [SEE WARNINGS]. NEONATAL OPIOID WITHDRAWAL SYNDROME PROLONGED 阅读完整的文件