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Hydrocodone/Paracetamol

    DEA Class;  Rx

    Common Brand Names; Vicodin, Lorcet, Hycet, Norco, Lortab Elixir, Anexsia, Vicodin ES, Vicodin HP, Xodol, Zamicet

    • Analgesics, Opioid Combos

    Combination product to treat moderate to severe pain. Acetaminophen is a non-salicylate analgesic; hydrocodone is a semisynthetic opiate agonist. The combination produces additive analgesia as compared to either agent alone.

    For the treatment of moderate pain to moderately severe pain.

    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

    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

    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

    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

    Lactation:

    Codeine and its active metabolite, morphine, are present in human milk; there are published studies and cases that have reported excessive sedation, respiratory depression, and death in infants exposed to codeine via breast milk; women who are ultra-rapid metabolizers of codeine achieve higher than expected serum levels of morphine, potentially leading to higher levels of morphine in breast milk that can be dangerous in their breastfed infants; in women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and dose-dependent

    There is no information on effects of codeine milk production; because of potential for serious adverse reactions, including excess sedation, respiratory depression, and death in a breastfed infant, breastfeeding is not recommended during treatment

    Withdrawal seizures in newborns whose mothers had taken butalbital-containing drug during pregnancy reported

    Adults

    The maximum dosage is dependent on the product. Do not exceed a total daily dose of 4 grams of acetaminophen from ALL sources.

    Geriatric

    The maximum dosage is dependent on the product. Do not exceed a total daily dose of 4 grams of acetaminophen from ALL sources.

    Adolescents

    >= 46 kg (101 pounds): acetaminophen 3 g/day PO; the maximum dose of the hydrocodone in the combination product is limited by the total daily limit of acetaminophen.
    32—45 kg (70—100 pounds): acetaminophen 2 g/day PO; the maximum dose of the hydrocodone in the combination product is limited by the total daily limit of acetaminophen.

    Children

    >= 2 years and 23—31 kg (51—69 pounds): acetaminophen 1.5 g/day PO; the maximum dose of the hydrocodone in the combination product is limited by the total daily limit of acetaminophen.
    >= 2 years and 16—22 kg (35—50 pounds): acetaminophen 1 g/day PO; the maximum dose of the hydrocodone in the combination product is limited by the total daily limit of acetaminophen.
    >= 2 years and 12—15 kg (27—34 pounds): acetaminophen 750 mg/day PO; the maximum dose of the hydrocodone in the combination product is limited by the total daily limit of acetaminophen.
    < 2 years or < 12 kg: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established

    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