国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
NCS HealthCare of KY, LLC dba Vangard Labs
ACETAMINOPHEN
ACETAMINOPHEN 300 mg
ORAL
PRESCRIPTION DRUG
Acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain,where treatment with an opioid is appropriate 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 acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - Have not provided adequate analgesia, or are not expected to provide adequate analgesia - Have not been tolerated, or are not expected to be tolerated Acetaminophen and codeine phosphate tablets are contraindicated in patients with: - Patients with significant respiratory depression [see WARNINGS]. - Patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS]. - Postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy [see WARNINGS]
Acetaminophen and codeine phosphate tablets, USP are supplied as follows: 300 mg/15 mg White to off-white, round, flat-faced, beveled-edged tablets, debossed with “U35” on one side and plain on the other side. 300 mg/30 mg White to off-white, round, flat-faced, beveled-edged tablets, debossed with “U36” on one side and plain on the other side. Blistercards of 30 NDC 0615-8102-39 300 mg/60 mg White to off-white, round, flat-faced, beveled-edged tablets, debossed with “U37” on one side and plain on the other side. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep this and all medication out of the reach of children. Protect from moisture. Dispense in a tight, light-resistant container as described in the USP. PROTECT FROM LIGHT Dispense with Medication Guide availableat www.aurobindousa.com/product-medication-guides Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 Revised: 12/2016 LM 2126
Abbreviated New Drug Application
ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET NCS HealthCare of KY, Inc dba Vangard Labs ---------- MEDICATION GUIDE MEDICATION GUIDE Acetaminophenand Codeine Phosphate Tablets, USP CIII ass-cet-ah-MEE-noe-fenwith KOE-deen FOSS-fate Acetaminophen and Codeine PhosphateTablets are: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage mild to moderate pain, 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 acetaminophen and codeinephosphate tablets: • Get emergency help right away if you take too much acetaminophen and codeine phosphate tablets (overdose). When you first start taking acetaminophen and codeine phosphate 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. • Acetaminophen and Codeine Phosphate Tablets can cause severe drowsiness, breathing problems (respiratory depression), coma and death when taken with benzodiazepines or other medicines that depress consciousness. • Never give anyone else your acetaminophen and codeine phosphate tablets. They could die from taking it. Store acetaminophen and codeine phosphate tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away acetaminophen and codeine phosphate tablets are against the law. Do not take Acetaminophen and Codeine Phosphate Tablets ifyou have: •severe asthma, trouble breathing, or other lung problems. •a bowel blockage or narrowing of the stomach or intestines. •previously had an allergic reaction to codeine or acetaminophen. Before taking acetaminophen and codeine phosphatetablets, tell your healthcare provideri 完全なドキュメントを読む
ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP CIII BOXED WARNING WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE; HEPATOTOXICITY; CYTOCHROME P450 2D6 INTERACTION; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ADDICTION, ABUSE, AND MISUSE ACETAMINOPHEN AND CODEINE PHOSPHATE 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 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, AND MONITOR ALL PATIENTS REGULARLY FOR THE DEVELOPMENT OF THESE BEHAVIORS AND CONDITIONS [SEE WARNINGS]. LIFE-THREATENING RESPIRATORY DEPRESSION SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR WITH USE OF ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS OR FOLLOWING A DOSE INCREASE [SEE WARNINGS]. ACCIDENTAL INGESTION ACCIDENTAL INGESTION OF EVEN ONE DOSE OF ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS [SEE WARNINGS]. NEONATAL OPIOID WITHDRAWAL SYNDROME PROLONGED USE OF ACETAMINOPHEN AND CODEINE PHOSPHATE 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]. DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO M 完全なドキュメントを読む