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If you are a consumer or patient please visit this version. 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. 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. Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of acetaminophen and a euphoric hyperactive state 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. Avoid the use of acetaminophen and codeine phosphate tablets in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.
Addiction, Abuse, and Misuse
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.
Interactions with Drugs Affecting Cytochrome P Isoenzymes The effects of concomitant use or discontinuation of cytochrome P 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex. Hepatotoxicity Acetaminophen has been associated with a euphoric hyperactive state of acute liver failure, at times resulting in liver transplant and death.
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Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4, milligrams per day, and often involve more than one acetaminophen-containing product see WARNINGS. Acetaminophen and codeine phosphate tablets are supplied in tablet form for oral administration. It has the following structural formula:.
In addition, each tablet contains the following inactive ingredients: crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, stearic acid. Codeine is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine.
The analgesic properties of codeine have been speculated to come from its conversion to morphine, although the exact mechanism of analgesic action remains unknown. The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions.
Codeine produces respiratory depression by direct action on brain stem respiratory centers.]
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