Classes
DEA Class; Rx
Common Brand Names; Vicodin, Lorcet, Hycet, Norco, Lortab Elixir, Anexsia, Vicodin ES, Vicodin HP, Xodol, Zamicet
- Analgesics, Opioid Combos
Description
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.
Indications
For the treatment of moderate pain to moderately severe pain.
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
Adverse Effects
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
Warnings
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 and 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
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
Maximum Dosage
The maximum dosage is dependent on the product. Do not exceed a total daily dose of 4 grams of acetaminophen from ALL sources.
The maximum dosage is dependent on the product. Do not exceed a total daily dose of 4 grams of acetaminophen from ALL sources.
>= 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.
>= 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.
Safety and efficacy have not been established.
Safety and efficacy have not been established