Sedating chemical chloroform
• Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve hydrocodone bitartrate ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
• Hydrocodone bitartrate ER is not indicated as an as-needed analgesic.
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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 and Precautions (5.3)].
The concomitant use of hydrocodone bitartrate ER with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression.
Its structural formula is: Empirical formula: CO - Molecular weight: 494.50 g/mol Hydrocodone bitartrate exists as fine white crystals or a crystalline powder. It is soluble in water, slightly soluble in alcohol, and insoluble in ether and chloroform.
: The 20 mg, 30 mg, 40 mg, 60 mg, 80 mg, 100 mg and 120 mg tablets contain the following inactive ingredients: Butylated Hydroxytoluene (BHT, an additive in Polyethylene Oxide), Hydroxypropyl Cellulose, Macrogol/PEG 3350, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Oxide, Polysorbate 80, Polyvinyl Alcohol, Talc, Titanium Dioxide, and Black Ink.
Patients receiving other oral hydrocodone-containing formulations may be converted to hydrocodone bitartrate ER by administering the patient's total daily oral hydrocodone dose as hydrocodone bitartrate ER once daily.