País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
PAI Holdings, LLC
ORAL
PRESCRIPTION DRUG
Acetaminophen and codeine phosphate oral solution is indicated for the management of mild to moderate pain where treatment with an opioid is appropriate and for which alternative treatments are inadequate. Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS ], reserve acetaminophen and codeine phosphate oral solution 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 Acetaminophen and codeine phosphate oral solution is contraindicated for: - all children younger than 12 years of age [see WARNINGS ]. - post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see WARNINGS ]. Acetaminophen and codeine phosphate oral solution is contraindicated in patients with: -
Acetaminophen and Codeine Phosphate Oral Solution USP (orange-yellow color, cherry flavor) is supplied in the following oral dosage forms: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.
Abbreviated New Drug Application
PAI Holdings, LLC ---------- Medication Guide Acetaminophen and Codeine Phosphate (a seet' a min' oh fen and koe' deen fos'fate) Oral Solution, CV Acetaminophen and Codeine Phosphate Oral Solution is: • 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 Codeine Phosphate Oral Solution: • Get emergency help right away if you take too much acetaminophen and codeine phosphate oral solution (overdose). When you first start taking acetaminophen and codeine phosphate oral solution, 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 acetaminophen and codeine phosphate oral solution 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 acetaminophen and codeine phosphate oral solution. They could die from taking it. Store acetaminophen and codeine phosphate oral solution away from children and in a safe place to prevent stealing or abuse. Selling or giving away acetaminophen and codeine phosphate oral solution is against the law. Important Information Guiding Use in Pediatric Patients: • Do not give acetaminophen and codeine phosphate oral solution to a child younger than 12 years of age. • Do not give acetaminophen and codeine phosphate oral solution to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids. • Avoid giving acetaminophen and codeine phosp Llegiu el document complet
ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE PHOSPHATE SOLUTION PAI HOLDINGS, LLC ---------- ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION USP CV WARNING: RISK OF MEDICATION ERRORS; ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE- THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; NEONATAL OPIOID WITHDRAWAL SYNDROME; DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES; HEPATOTOXICITY; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS RISK OF MEDICATION ERRORS ENSURE ACCURACY WHEN PRESCRIBING, DISPENSING, AND ADMINISTERING ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION. DOSING ERRORS DUE TO CONFUSION BETWEEN MG AND ML, AND OTHER CODEINE CONTAINING ORAL PRODUCTS OF DIFFERENT CONCENTRATIONS CAN RESULT IN ACCIDENTAL OVERDOSE AND DEATH [SEE WARNINGS, DOSAGE AND ADMINISTRATION]. ADDICTION, ABUSE, AND MISUSE ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION 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 ACETAMINOPHEN AND CODEINE PHOSPHATE ORAL SOLUTION, 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 EVER Llegiu el document complet