Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
HYDROCODONE BITARTRATE (UNII: NO70W886KK) (HYDROCODONE - UNII:6YKS4Y3WQ7), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Quality Care Products, LLC
ORAL
PRESCRIPTION DRUG
Hydrocodone bitartrate 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 hydrocodone bitartrate 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 been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia have not provided adequate analgesia, or are not expected to provide adequate analgesia Hydrocodone bitartrate and acetaminophen tablets are contraindicated in patients with: - Significant respiratory depression (see WARNINGS ) Significant respiratory depression (see WARNINGS ) - Acute or severe bronchial asthma in an unmonitor
Hydrocodone Bitartrate and Acetaminophen Tablets USP are supplied as follows: Strength How Supplied Each tablet contains: Description of tablet Hydrocodone Bitartrate Acetaminophen 5 mg/325 mg 5 mg 325 mg It is available as a capsule-shaped white tablet debossed with M365 on one side and bisected on the other side. 7.5 mg/325 mg 7.5 mg 325 mg It is available as an unscored oval-shaped white tablet debossed with M366 on one side. 10 mg/325 mg Bottles of 30 …………..… NDC 55700-991-30 Bottles of 60 …………..… NDC 55700-991-60 Bottles of 90 …………..… NDC 55700-991-90 10 mg 325 mg It is available as a capsule-shaped white tablet debossed with M367 on one side and bisected on the other side. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container (as defined in USP) with a child-resistant closure. Store hydrocodone bitartrate and acetaminophen tablets securely and dispose of properly (see PRECAUTIONS, Information for Patients ). Mallinckrodt, the “M” brand mark and the Mallinckrodt Pharmaceuticals logo are trademarks of a Mallinckrodt company. © 2020 Mallinckrodt. SpecGx LLC Webster Groves, MO 63119 USA Rev 08/2020 Mallinckrodt™ Pharmaceuticals An electronic copy of this medication guide can be obtained from www.mallinckrodt.com/Medguide/MG20H32.pdf or by calling 1-800-778-7898 for alternate delivery options.
Abbreviated New Drug Application
ACETAMINOPHEN TABLET Quality Care Products, LLC ---------- Medication Guide Hydrocodone Bitartrate (hye” droe koe’ done bye tar’ trate) and Acetaminophen (a seet” a min’ oh fen) Tablets CII Hydrocodone bitartrate 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 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: • Get emergency help or call 911 right away if you take too many hydrocodone bitartrate and acetaminophen tablets (overdose). When you first start taking hydrocodone bitartrate and acetaminophen tablets, when your dose is changed, or if you take too many (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 hydrocodone bitartrate 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 hydrocodone bitartrate and acetaminophen tablets. They could die from taking it. Selling or giving away hydrocodone bitartrate and acetaminophen tablets is against the law. • Store hydrocodone bitartrate 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 hydrocodone bitartrate and acetaminophen tablets if you have: • severe asthma, trouble breathing, Lestu allt skjalið
HYDROCODONE BITARTRATE AND ACETAMINOPHEN- HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET QUALITY CARE PRODUCTS, LLC ---------- HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS USP CII 5 MG/325 MG, 7.5 MG/325 MG AND 10 MG/325 MG 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 HYDROCODONE BITARTRATE 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 HYDROCODONE BITARTRATE 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 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS. MONITOR FOR RESPIRATORY DEPRES Lestu allt skjalið