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Addiction, Abuse, and Misuse: This drug exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.US BOXED WARNINGS: ADDICTION, ABUSE AND MISUSE LIFE-THREATENING RESPIRATORY DEPRESSION ACCIDENTAL INGESTION ULTRA-RAPID METABOLISM OF CODEINE AND LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN NEONATAL OPIOID WITHDRAWAL SYNDROME HEPATOTOXICITY INTERACTIONS WITH DRUGS AFFECTING CYP450 ISOENZYMES and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS: Do not abruptly discontinue in the physically dependent patient.Monitor for signs and symptoms of withdrawal if they occur, raise the dose to the previous level and taper more slowly.Taper gradually, by 25% to 50% every 2 to 4 days.If it is necessary to switch from another opioid to codeine, a conservative approach is recommended as it is safest to underestimate the codeine dose than to overestimate and manage an adverse reaction due to overdose.ĭiscontinuation of Therapy in the Physically Dependent Patient:.Severe hepatic impairment: Use with caution monitor therapy with liver function tests Dose AdjustmentsĮlderly: Use caution, usually starting at the low end of the dosing range Severe renal impairment: Use with caution monitor therapy with renal function tests Liver Dose Adjustments Use: For the management of mild to moderate pain where treatment with an opioid is appropriate and from which alternative treatments are inadequate. Codeine doses higher than 60 mg have not been shown to improve pain relief and are associated with an increased incidence of adverse effects.Risk factors that increase sensitivity to the respiratory depressant effects of codeine include postoperative status, obstructive sleep apnea, obesity, and other conditions associated with hypoventilation syndromes (e.g., neuromuscular disease), concomitant use of other mediations that cause respiratory depression, and severe pulmonary disease.Initial dose: Acetaminophen (300 to 600 mg) and codeine (15 to 60 mg) orally every 4 hours as needed for pain.Usual Pediatric Dose for Painġ2 to 18 years (postoperatively following a tonsillectomy and/or adenoidectomy): Contraindicatedġ2 to 18 years (with risk factors for respiratory depression): Avoid useġ2 to 18 years: Use only if benefits outweigh potential risks Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.Codeine doses higher than 60 mg have not been shown to improve pain relief and are associated with an increased incidence of adverse effects tolerance to codeine can develop with continued use.Initial doses should be individualized taking into account severity of pain, response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse.Maximum doses: Acetaminophen 4000 mg/24 hours Codeine: 360 mg/24 hours Titrate to a dose that provides adequate analgesia and minimizes adverse reactions. Initial dose: Acetaminophen (300 to 600 mg) and codeine (15 to 60 mg) orally every 4 hours as needed for pain
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