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Benzhydrocodone/Paracetamol

    DEA Class;  Rx

    Common Brand Names; Apadaz

    •  Analgesics, Opioid Combos

    Benzhydrocodone: Prodrug of hydrocodone, which is an opioid analgesic agonist; blocks pain perception in the cerebral cortex; decreases synaptic chemical transmission throughout the CNS, which in turn inhibits pain sensation into higher centers; when ingested, enzymes in the GI tract cleave the ligand from the prodrug (benzhydrocodone) and release the parent drug (hydrocodone)

    Acetaminophen: Acts on the hypothalamus to produce antipyresis; inhibits prostaglandin synthetase

    Indicated for short-term (ie, not to exceed 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate

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

    Total dosage of benzhydrocodone/acetaminophen and any concomitant acetaminophen-containing products should not exceed 4000 mg/day of acetaminophen

    Initiate dosing regimen for each patient individually, taking into account the severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse

    Significant respiratory depression

    Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment

    Known or suspected gastrointestinal obstruction, including paralytic ileus

    Hypersensitivity to hydrocodone or acetaminophen

    >10%

    Nausea (21.5%)

    Somnolence (18.5%)

    Vomiting (13%)

    Constipation (12%)

    Pruritus (11.5%)

    1-10%

    Dizziness (7.5%)

    Headache (6%)

    1-5%

    Gastrointestinal disorder: Abdominal distension, abdominal pain, flatulence

    General disorders and administration site conditions: Asthenia

    Nervous system disorders: Presyncope, tremor

    Respiratory, thoracic and mediastinal disorders: Dyspnea

    Vascular disorders: Hot flush, hypotension

    <1%

    Eye disorders: Eye pruritus

    Gastrointestinal disorders: Diarrhea, gastroesophageal reflux disease, hematemesis

    General disorders and administration site conditions: Chest discomfort

    Infections and infestations: Rhinitis

    Nervous system disorders: Hypoesthesia, syncope

    Psychiatric disorders: Agitation, euphoric mood, nightmare

    Contains benzhydrocodone, a Schedule II controlled substance; as an opioid, benzhydrocodone exposes users to the risks of addiction, abuse, and misuse (see Black Box Warnings)

    Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended (see Black Box Warnings)

    Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia; opioid use increases risk of CSA in a dose-dependent fashion; in patients who present with CSA, consider decreasing opioid dosage using best practices for opioid taper

    Use in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated; life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance

    Do not abruptly discontinue buprenorphine in a patient physically dependent on opioids; when discontinuing therapy, in a physically dependent patient, gradually taper the dosage; rapid tapering in a patient physically dependent on opioids may lead to a withdrawal syndrome and return of pain

    Pregnancy

    Prolonged use of opioid analgesics during pregnancy can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth (see Black Box Warnings)

    Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea and failure to gain weight

    Onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing, amount of last maternal use, and rate of elimination of the drug by the newborn

    Published studies with oral acetaminophen use during pregnancy have not reported an association with major congenital malformations

    Lactation

    Hydrocodone

    Present in human milk

    Variable concentrations of hydrocodone and hydromorphone (active metabolite) reported in breast milk when administered to nursing mothers in the early postpartum period

    Potential for sedation and respiratory depression in the breastfed infant

    Acetaminophen

    Present in human milk in small quantities after PO administration

    Adults

    Total dosage of benzhydrocodone/acetaminophen and any concomitant acetaminophen-containing products should not exceed 4000 mg/day of acetaminophen

    Use as first opioid analgesic (ie, opioid-naïve): 1-2 tablets PO q4-6hr prn pain

    Not to exceed 12 tablets/24 hr

    Pediatric

    <18 years: Safety and efficacy not established

    benzhydrocodone/acetaminophen

    tablet, immediate-release (IR): Schedule II

    • 4.08mg/325mg
    • 6.12mg/325mg
    • 8.16mg/325mg