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hydrocodone/acetaminophen (Rx)Brand and Other Names:Vicodin, Lorcet, more...Hycet, Norco, Lortab Elixir, Anexsia, Vicodin ES, Vicodin HP, Xodol, Zamicet

 
 
 

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

hydrocodone/acetaminophen and

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     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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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

            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

            CNS depression

            Severe respiratory depression

            Cautions

            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

            May cause CNS depression and impair ability to operate heavy machinery

            Use caution in patients with cardiovascular disease, hypovolemia, or drugs that may exacerbate hypotensive effects; may cause hypotension

            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 patients with adrenocortical insufficiency, including Addison's disease; long-term opioid use may cause secondary hypogonadism, which may lead to sexual dysfunction, infertility, mood disorders, and osteoporosis

            Use caution in patients with bliary tract dysfunction, including acute pancreatitis; may cause constriction of sphincter of Oddi

            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 category: C

            Lactation: Excreted in breast milk; breastfeeding not recommended

            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.

            more...
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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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            Images

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            Formulary

            FormularyPatient Discounts

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

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            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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