Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), DIHYDROCODEINE BITARTRATE (UNII: 8LXS95BSA9) (DIHYDROCODEINE - UNII:N9I9HDB855)
Bryant Ranch Prepack
ACETAMINOPHEN
ACETAMINOPHEN 320.5 mg
ORAL
PRESCRIPTION DRUG
TREZIX™ (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 TREZIX™ 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 TREZIX™ 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]. - TREZIXTM is also contraindicated in patients with: - Significant respiratory depression [see WARNINGS] - Acute or severe bronchial asthma in an unmonitored setting
NDC: 63629-5637-1: 30 Capsules in a BOTTLE NDC: 63629-5637-2: 60 Capsules in a BOTTLE NDC: 63629-5637-3: 90 Capsules in a BOTTLE NDC: 63629-5637-4: 120 Capsules in a BOTTLE
Abbreviated New Drug Application
TREZIX- acetaminophen, caffeine, dihydrocodeine bitartrate capsule Bryant Ranch Prepack ---------- Medication Guide Trezix (Tre~zix) Capsules, CIII Trezix is: • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage moderate to moderately severe pain, when otherpain 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 Trezix: • Get emergency help right away if you take too much Trezix (overdose). When you first start taking Trezix, 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 Trezix with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decrease awareness, breathing problems, coma and death. • Never give anyone else your Trezix. They could die from taking it. Store Trezix away from children and in a safe place to prevent stealing or abuse. Selling or giving away Trezix is against the law. Important Information Guiding Use in Pediatric Patients: • Do not give Trezix to a child younger than 12 years of age. • Do not give Trezix to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids. • Avoid giving Trezix to children between 12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems Do not take Trezix if you have: • severe asthma, trouble breathing, or other lung problems. • a bowel blockage or have narrowing of the stomach or intestines. • previously had an allergic reaction to dihydrocodeine or acetaminophen. Before taking Trezix, tell your healthcare pro Soma hati kamili
TREZIX- ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE BRYANT RANCH PREPACK ---------- TREZIX™ CAPSULES ACETAMINOPHEN, CAFFEINE AND DIHYDROCODEINE BITARTRATE 320.5 MG / 30 MG / 16 MG RX ONLY CIII 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 ISOENYME; HEPTATOTOXICITY; AND RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS ADDICTION, ABUSE AND MISUSE TREZIX™ 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 TREZIX™, 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 TREZIX™. MONITOR FOR RESPIRATORY DEPRESSION, ESPECIALLY DURING INITIATION OF TREZIX™ OR FOLLOWING A DOSE INCREASE [SEE WARNINGS]. ACCIDENTAL INGESTION ACCIDENTAL INGESTION OF TREZIX™, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF TREZIX™ [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 WARNINGS AND PRECAUTIONS]. TREZIX IS CONTRAINDICATED IN CHILDREN YOUNGER THAN 12 YEARS OF AGE AND IN CHILDREN YOUNGER THAN 18 YEARS OF AGE FOLLOWING TONSILLECTOMY AND/OR ADENOIDECTOMY [SEE CONTRAINDICATIONS]. AVOID THE USE OF TREZIX™ IN ADOLESCENTS 12 TO 18 YEARS OF AGE WHO HAVE OTHER RISK FACTO Soma hati kamili