Individualize dosing based on severity of pain, patient response, prior analgesic experience, and risk factors for addiction, abuse, and misuse.Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.Daily doses of Hydrocodone Bitartrate Extended-Release Capsules, a single dose greater than 40 mg, or a total daily dose greater than 80 mg are only for use in patients in whom tolerance to an opioid of comparable potency has been established.To be prescribed only by healthcare providers knowledgeable in use of potent opioids for management of chronic pain.Instruct patients not to consume alcohol or any products containing alcohol while taking Hydrocodone Bitartrate Extended-Release Capsules because co-ingestion can result in fatal plasma hydrocodone levels.Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation. Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of hydrocodone.If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
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