País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
DIRECT RX
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 WARNI
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. Bottles of 30 NDC 13107-058-30 Bottles of 100 NDC 13107-058-01 Bottles of 500 NDC 13107-058-05 Bottles of 1000 NDC 13107-058-99 300 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. Bottles of 30 NDC 13107-059-30 Bottles of 100 NDC 13107-059-01 Bottles of 500 NDC 13107-059-05 Bottles of 1000 NDC 13107-059-99 300 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. Bottles of 30 NDC 13107-060-30 Bottles of 100 NDC 13107-060-01 Bottles of 500 NDC 13107-060-05 Bottles of 1000 NDC 13107-060-99 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
Abbreviated New Drug Application
ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET DIRECT RX ---------- APAP CODEINE C-III 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 Morphine Respiratory depression and death have occurred in children w Leia o documento completo