দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
Proficient Rx LP
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] Acetaminophen and codeine phosphate tablets are contraindicated for: Acetaminophen and codeine phosphate tablets are contraindicated in patients with: Acetaminophen and codeine phosphate tablets contain codeine. Codeine in combination with acetaminophen, a Schedule III controlled substance. Acetaminophen and codeine phosphate tablets contain codeine, a substance with a high potential for abuse similar to other opioids, including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. Acetaminophen and c
Acetaminophen and codeine phosphate tablets USP (white, round, unscored): List No. 0150, acetaminophen 300 mg and codeine phosphate 30 mg, debossed “3” on one side and “TV”-“150” on the other side of tablet. Bottles of 15…………………………………NDC 71205-001-15 Bottles of 20…………………………………NDC 71205-001-20 Bottles of 30…………………………………NDC 71205-001-30 Bottles of 60…………………………………NDC 71205-001-60 Bottles of 90…………………………………NDC 71205-001-90 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Distributed By: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Repackaged By: Proficient Rx LP Thousand Oaks, CA 91320 Rev. AN 7/2017
Abbreviated New Drug Application
ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET Proficient Rx LP ---------- Medication Guide Acetaminophen and Codeine Phosphate (a seet' a min' oh fen and koe' deen fos' fate) Tablets USP, CIII Acetaminophen and Codeine Phosphate Tablets 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 Codeine Phosphate Tablets: • Get emergency help right away if you take too many acetaminophen and codeine phosphate tablets (overdose). When you first start taking acetaminophen and codeine 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. • Taking acetaminophen and codeine 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 acetaminophen and codeine phosphate tablets. They could die from taking them. Store acetaminophen and codeine tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away acetaminophen and codeine phosphate tablets is against the law. Important Information Guiding Use in Pediatric Patients: • Do not give acetaminophen and codeine phosphate tablets to a child younger than 12 years of age. • Do not give acetaminophen and codeine phosphate tablets to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids. • Avoid giving acetaminophen and codeine phosphate সম্পূর্ণ নথি পড়ুন
ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET PROFICIENT RX LP ---------- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP CIII 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 ISOENZYMES; HEPATOTOXICITY; 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 ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, ESPECIALLY BY CHILDREN, CAN RESULT IN A FATAL OVERDOSE OF ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS [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 ULTRA-RAPID METABOLIZERS OF CODEINE DUE TO A CYP2D6 POLYMORPHISM [SEE WARNINGS, PRECAUTIONS; INFORMATION FOR PATIENTS/CAREGIVERS, NURSING MOTHERS]. ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS ARE CONTRAIND সম্পূর্ণ নথি পড়ুন