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VICODIN, VICODIN ES, VICODIN HP (HYDROCODONE/ACETAMINOPHEN) TABLETS: DOSAGE AND ADMINISTRATION

Important Dosage and Administration Instructions

Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.

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.

Follow patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy and following dosage increases with Vicodin (Hydrocodone, Acetaminophen) tablets and adjust the dosage accordingly.

Initial Dosage

Initiating Treatment with Vicodin, Vicodin ES, Vicodin HP

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 Vicodin (Hydrocodone, Acetaminophen)

There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of this medicine. It is safer to underestimate a patient's 24-hour Vicodin, Vicodin ES, Vicodin HP dosage than to overestimate the 24-hour Vicodin dosage and manage an adverse reaction due to overdose.

Conversion from Vicodin to Extended-Release Hydrocodone

The relative bioavailability of hydrocodone from Vicodin compared to extended-release hydrocodone products is unknown, so conversion to extended-release products must be accompanied by close observation for signs of excessive sedation and respiratory depression.

Titration and Maintenance of Therapy

Individually titrate Vicodin (Hydrocodone, Paracetamol) to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving this drug to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration.

If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the hydrocodone bitartrate and acetaminophen tablets dosage. If unacceptable opioidrelated adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

Discontinuation of Vicodin, Vicodin ES, Vicodin HP

When a patient who has been taking Vicodin (Hydrocodone Bitartrate and Acetaminophen) tablets regularly and may be physically dependent no longer requires therapy with this medicine, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue Vicodin, Vicodin ES, Vicodin HP in a physically-dependent patient.

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