hydrocodone/acetaminophen (Rx)

Brand and Other Names:Vicodin, Lorcet, more...Hycet, Norco, Lortab Elixir, Anexsia, Vicodin ES, Vicodin HP, Xodol, Zamicet
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet: Schedule II

  • 2.5mg/325mg
  • 5mg/300mg, 5mg/325mg
  • 7.5mg/300mg, 7.5mg/325mg
  • 10mg/300mg, 10mg/325mg

oral solution/elixir: Schedule II

  • (7.5mg/325mg)/15mL
  • (10mg/300mg)/15mL, (10mg/325mg)/15mL
more...

Moderate to Severe Pain

1-2 tablets (2.5-10 mg hydrocodone; 300-325 mg acetaminophen) PO q4-6hr PRN

Acetaminophen: Not to exceed 1 g/dose or 4 g/24 hr

Hydrocodone: Maximum daily dose should not exceed 60 mg/24 hr

Dosing Modifications

Hepatic impairment: Avoid chronic use or high doses of acetaminophen (ie, >4 g/day) in hepatic impairment

Dosage Forms & Strengths

tablet: Schedule II

  • 2.5mg/325mg,
  • 5mg/300mg, 5mg/325mg
  • 7.5mg/300mg, 7.5mg/325mg
  • 10mg/300mg, 10mg/325mg

oral solution/elixir: Schedule II

  • (7.5mg/325mg)/15mL, (7.5mg/500mg)/15mL
  • (10mg/300mg)/15mL, (10mg/325mg)/15mL
more...

Moderate to Severe Pain

<2 years: Safety and efficacy not established

2-12 years: 0.135 mg/kg hydrocodone PO q4-6hr PRN 

>12 years: 1-2 tablets (2.5-10 mg hydrocodone; 300-325 mg acetaminophen) PO q4-6hr PRN

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Interactions

Interaction Checker

and hydrocodone/acetaminophen

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    Contraindicated

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            Adverse Effects

            Frequency Not Defined

            Biliary tract spasm

            Hallucinations

            Circulatory collapse

            Histamine release

            Physical and psychological dependence with prolonged use

            Urinary tract spasm

            Bradycardia

            Cardiac arrest

            Confusion

            Decreased urination

            Dizziness

            Drowsiness

            Dyspnea

            Fatigue

            Hypotension

            Coma

            Dysphoria

            Euphoria

            Lethargy

            Lightheadedness

            Mood changes

            Stupor

            Mental clouding

            Nausea

            Sedation

            Vomiting

            Weakness

            Peptic ulcer

            Agranulocytosis

            Hemolytic anemia

            Hepatic necrosis

            Respiratory depression

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            Warnings

            Black Box Warnings

            Addiction, abuse, and misuse

            • Long-acting hydrocodone exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death
            • Assess each patient’s risk prior to prescribing, and monitor all patients regularly for the development of these behaviors or conditions

            Life-threatening respiratory depression

            • Serious, life-threatening, or fatal respiratory depression may occur
            • Monitor for respiratory depression, especially during initiation or following a dose increase
            • Instruct patients to swallow capsules/tablets whole; crushing, chewing, or dissolving the extended-release dosage forms can cause rapid release and absorption of a potentially fatal dose of hydrocodone

            Accidental exposure

            • Accidental consumption of even 1 dose of hydrocodone, especially by children, can result in a fatal overdose of hydrocodone

            Neonatal opioid withdrawal syndrome

            • For patients who require opioid therapy while pregnant, be aware that infants may require treatment for neonatal opioid withdrawal syndrome
            • Prolonged maternal use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening and requires management according to protocols developed by neonatology experts

            Interaction with CNS depressants

            • Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death
            • 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
            • Coingestion with alcohol may increase hydrocodone plasma levels and result in a potentially fatal overdose (alters release of drug from capsule)

            Interaction with CYP3A4 inhibitors

            • Initiation of CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of hydrocodone from hydrocodone ER

            Contains acetaminophen

            Hepatotoxicity may occur with acetaminophen doses that exceed 4 g/day; take into account all acetaminophen-containing products the patient is taking, including PRN doses and OTC products

            Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplantation or death

            New dosage limit allows no more than 325 mg/dosage unit for prescription medications that contain acetaminophen

            Healthcare professionals can direct patients to take 1 or 2 tablets, capsules, or other dosage units of a prescription product containing 325 mg of acetaminophen up to 6 times daily (12 dosage units) and still not exceed the maximum daily dose of acetaminophen (ie, 4000 mg/day)

            Contraindications

            Hypersensitivity

            Significant respiratory depression

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

            Known or suspected gastrointestinal obstruction, including paralytic ileus

            Known hypersensitivity (e.g., anaphylactic reactions, serious skin reactions) to hydrocodone, ibuprofen, or any components of the drug product

            Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity

            Cautions

            Do not prescribe for acute pain or as needed (prn) pain relief; only for severe chronic pain requiring continuous, around-the-clock opioid analgesia

            Hydrocodone is an opioid agonist and a Schedule II controlled substance with a high potential for abuse similar to fentanyl, methadone, morphine, oxycodone, and oxymorphone

            Coadministration with other CNS depressants may cause profound sedation, respiratory depression, and death; if coadministration is required, consider dose reduction of 1 or both drugs

            Monitor carefully in elderly, cachectic, debilitated patients, and those with chronic pulmonary disease because of increased risk for life-threatening respiratory depression

            Monitor patients with head injury or increased ICP for sedation and respiratory depression; avoid use in patients with impaired consciousness or coma susceptible to intracranial effects of CO2 retention

            May cause severe hypotension, including orthostatic hypotension and syncope; added risk to individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone

            Coadministration with CYP3A4 inhibitors may increase hydrocodone systemic exposure and result in toxicity; if co-administration with CYP3A4 necessary, monitor patients closely who are currently taking, or discontinuing, CYP3A4 inhibitors or inducers; evaluate these patients at frequent intervals and consider dose adjustments until stable drug effects are achieved

            Caution must be used with potentially hazardous activities

            Avoid use of mixed agonist/antagonist analgesics (ie, pentazocine, nalbuphine, butorphanol) when taking full opioid agonist analgesics

            Profound sedation, respiratory depression, coma, and death may result from concomitant administration with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol); because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate

            Cases of adrenal insufficiency reported with opioid use, more often following greater than one month of use; symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure; if adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids; wean patient off of opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers; other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency

            May cause spasm of sphincter of Oddi; opioids may cause increases in serum amylase; monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms

            Cases of serotonin syndrome, a potentially life-threatening condition, reported with concomitant use of serotonergic drugs; this may occur within the recommended dosage range; the onset of symptoms generally occur within several hours to a few days of concomitant use, but may occur later than that; discontinue therapy immediately if serotonin syndrome is suspected

            Use caution in debilitated patients, drug abuse history, elderly patients, G6PD deficiency, head injury, hepatic dysfunction, hypothyroidism, impaired pulmonary function, increased intracranial pressure, toxic psychosis, renal dysfunction

            Hydrocodone may obscure diagnosis or clinical symptoms of acute abdominal conditions

            Acetaminophen associated with cases of acute liver failure, at times resulting in liver transplantation or death; risk increases in individuals with underlying liver disease, alcohol ingestion, and/or use of more than 1 acetaminophen-containing product (see Black Box Warnings)

            Acetaminophen associated with rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash

            Caution and awareness are necessary regarding misuse, abuse, or diversion

            Constipation may occur; take measures to prevent constipation, such as, administering stool softener and increasing fiber

            Chronic alcoholics should limit acetaminophen intake to <2 g/day

            Use caution in morbidly obese patients

            Use hydrocodone with caution in patients with prostatic hyperplasia and/or urinary stricture

            Use caution in patients with seizure disorders

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            Pregnancy & Lactation

            Pregnancy

            Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome; there are no available data in pregnant women to inform a drug associated risk for major birth defects and miscarriage; published studies with morphine use during pregnancy have not reported a clear association with opioids and major birth defects

            Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth; the onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of drug by newborn; observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly

            Lactation

            Drug is present in breast milk; published lactation studies report variable concentrations of drug in breast milk with administration of immediate-release formulation to nursing mothers in early postpartum period

            The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy; capsules and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

            Monitor infants exposed to drug through breast milk for excess sedation and respiratory depression; withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast- feeding is stopped

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

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

            Hydrocodone: 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

            Metabolism

            Acetaminophen: Primarily undergoes glucuronidation and sulfate conjugation; however, a small percentage is metabolized via CYP2E1 and CYP1A2 to a hepatotoxic metabolite

            Hydrocodone: Metabolized in the liver to the active opioid hydromorphone via CYP2D6; also by O-demethylation, N-demethylation, and 6 ketosteroid reduction

            CYP2D6 poor metabolizers may not achieve adequate analgesia

            Ultrarapid metabolizers (up to 7% of whites and up to 30% of Asian and African populations) may have increased toxicity due to rapid conversion

            Metabolites (acetaminophen): N-acetyl-p-benzoquinoneimine, N-acetylimidoquinone, NAPQI; further metabolized via conjugation with glutathione

            Elimination

            Half-life

            • Hydrocodone: 3.3-4.4 hr
            • Acetaminophen: 2-4 hr

            Onset of action

            • Hydrocodone: 10-20 min (analgesic effects)
            • Acetaminophen: <1 hr (PO); 5-10 min (IV; analgesia)

            Duration

            • Hydrocodone: 4-8 hr
            • Acetaminophen: 4-6 hr (analgesia); > 6hr (antipyretic)

            Excretion

            • Hydrocodone: Urine (26% of single dose)
            • Acetaminophen: Urine (90-100%; principally as acetaminophen glucuronide with acetaminophen sulfate/mercaptate)
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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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