국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), DIHYDROCODEINE BITARTRATE (UNII: 8LXS95BSA9) (DIHYDROCODEINE - UNII:N9I9HDB855)
Xspire Pharma, Llc
ACETAMINOPHEN
ACETAMINOPHEN 320.5 mg
ORAL
PRESCRIPTION DRUG
Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules 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 Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate 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, Caffeine, and Dihydrocodeine Bitartrate is contraindicated for: - All children younger than 12 years of age [see WARNINGS and PRECAUTIONS] - Post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see WARNINGS and PRECAUTIONS]. Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate is also contraindicated in pati
Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules, containing Acetaminophen 320.5 mg, caffeine 30 mg and dihydrocodeine bitartrate 16 mg, are supplied in bottles of 100 capsules (NDC # 42195-840-10) and 30 capsules (NDC # 42195-840-30). Capsules are imprinted “TREZIX” on the red cap in white ink. Store at 20°C to 25°C (68°F to 77°F). [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Protect from moisture. Rx Only Manufactured for: Xspire Pharma LLC Ridgeland, MS 39157 13001 Rev. 7/2017 Physician’s Desk Reference® is the registered trademark of Thomson Healthcare, Inc.
Abbreviated New Drug Application
ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE- ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE XSPIRE PHARMA, LLC ---------- ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE CIII 320.5 MG / 30 MG / 16 MG CAPSULES RX ONLY WARNING: ADDICTION, ABUSE, AND MISUSE; 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; INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYME; HEPATOTOXICITY AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ADDICTION, ABUSE AND MISUSE ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE 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, CAFFEINE, AND DIHYDROCODEINE BITARTRATE 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, CAFFEINE, AND DIHYDROCODEINE BITARTRATE MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE OR FOLLOWING A DOSE INCREASE [SEE WARNINGS]. ACCIDENTAL INGESTION ACCIDENTAL INGESTION OF ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE [SEE WARNINGS]. ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN LIFE-THREATENING RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN CHILDREN WHO RECEIVED CODEINE. MOST OF THE REPORTED CASES OCCURRED FOLLOWING TONSILLECTOMY AND/OR ADENOIDECTOMY, AND MANY OF THE CHILDREN HAD EVIDENCE OF BEING AN ULTRA-RAPID METABOLIZER OF CODEINE DUE TO CYP2D6 POLYMORPHISM [SEE 전체 문서 읽기