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Author: Admin | 2025-04-28
And antipyretic. It has the following structural formula:Each VICODIN® (Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/300 mg) contains:Hydrocodone Bitartrate…………5 mgAcetaminophen………………….300 mgEach VICODIN® ES (Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/300 mg) contains:Hydrocodone Bitartrate…………7.5 mgAcetaminophen…………………. 300 mgEach VICODIN HP® (Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/300 mg) contains:Hydrocodone Bitartrate………… 10 mgAcetaminophen…………………. 300 mgIn addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.This product complies with USP dissolution test 2. Uses for VicodinHydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severeenough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations Of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whomalternative 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 Dosage for VicodinImportant Dosage And Administration InstructionsUse the lowest effective dosage for the shortest duration consistent with individual patient treatmentgoals [see WARNINGS].Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain,patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse[see WARNINGS].Follow patients closely for respiratory depression, especially within the first 24-72 hours of initiatingtherapy and following dosage increases with hydrocodone bitartrate and acetaminophen tablets andadjust the dosage accordingly [see WARNINGS].Initial DosageInitiating Treatment With Hydrocodone Bitartrate And Acetaminophen Tablets VICODIN® 5 mg/300 mg The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets. VICODIN ES® 7.5 mg/300 mg The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets. VICODIN HP® 10 mg/300 mg The usual adult dosage is one tablet every four to six hours as needed for pain. The total daily dosage should not exceed 6 tablets. Conversion From Other Opioids To Hydrocodone Bitartrate And Acetaminophen TabletsThere is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, aconservative approach is advised when determining the total daily dosage of hydrocodone bitartrate andacetaminophen tablets. It is safer to underestimate a patient’s 24-hour hydrocodone bitartrate andacetaminophen tablets dosage than to overestimate the 24-hour hydrocodone bitartrate andacetaminophen tablets dosage and manage an adverse reaction due to overdose.Conversion From Hydrocodone Bitartrate And Acetaminophen Tablets To Extended-ReleaseHydrocodoneThe relative bioavailability of hydrocodone from hydrocodone bitartrate and acetaminophen tabletscompared to extended-release hydrocodone products is unknown, so conversion to extended-releaseproducts must be accompanied by close observation for signs of excessive sedation and respiratorydepression.Titration And Maintenance Of TherapyIndividually titrate hydrocodone bitartrate and acetaminophen tablets to a dose that provides adequateanalgesia and minimizes adverse reactions. Continually reevaluate patients receiving hydrocodonebitartrate and acetaminophen tablets to assess the maintenance of pain control and the relative incidenceof adverse reactions, as well
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