AbbVie's Vicodin Is … Available in Three Formulations1

Each formulation:

  • Contains 300 mg of acetaminophen

  • Is a generic product with a generic co-pay

Vicodin Dosing and Strengths1

Vicodin contains 300 mg of acetaminophen per tablet, which is lower than the 325 mg amount mandated by the FDA.2 The amount of hydrocodone per dosage strength has not changed. See below for more information.

Appearance of AbbVie's Vicodin Tablets

AbbVie's Vicodin tablets are white, capsule-shaped, and have a scored line on one side, together with the appropriate strength. The other side of the tablet is printed with the product name.1

Not Actual Size
Vicodin 5 mg/300 mg
1–2 tablets every 4–6 hours
Not to exceed 8 tablets
Not Actual Size
Vicodin ES 7.5 mg/300 mg
1 tablet every 4–6 hours
Not to exceed 6 tablets
Not Actual Size
Vicodin HP 10 mg/300 mg
1 tablet every 4–6 hours
Not to exceed 6 tablets

Pain Management Discussion Guide for Patients

Have your patients use our Discussion Guide tool to record detailed information about their pain and pain management so you can make more informed decisions for their care.

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INDICATIONS AND IMPORTANT SAFETY INFORMATION1

INDICATIONS AND USAGE1

Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use:
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):

IMPORTANT SAFETY INFORMATION1

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse
Hydrocodone bitartrate and acetaminophen tablets expose 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 hydrocodone bitartrate and acetaminophen tablets, and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS].

Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate and acetaminophen tablets. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate and acetaminophen tablets or following a dose increase [see WARNINGS].

Accidental Ingestion
Accidental ingestion of hydrocodone bitartrate and acetaminophen tablets, especially by children, can result in a fatal overdose of hydrocodone bitartrate and acetaminophen tablets [see WARNINGS].

Neonatal Opioid Withdrawal Syndrome
Prolonged use of hydrocodone bitartrate and acetaminophen tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS].

Cytochrome P450 3A4 Interaction
The concomitant use of hydrocodone bitartrate and acetaminophen tablets with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentrations. Monitor patients receiving hydrocodone bitartrate and acetaminophen tablets and any cytochrome P450 3A4 inhibitor or inducer for signs of respiratory depression or sedation [see CLINICAL PHARMACOLOGY, WARNINGS, PRECAUTIONS; Drug Interactions].

Hepatotoxicity
Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product [see WARNINGS, OVERDOSAGE].

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see WARNINGS, PRECAUTIONS; Drug Interactions].

CONTRAINDICATIONS
VICODIN is contraindicated in patients with: • 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 • Hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis).

WARNINGS

Addiction, Abuse, and Misuse
VICODIN is a Schedule II controlled substance with the risks of opioid addiction, abuse, and misuse. The risk of addiction can occur in appropriately prescribed patients and at recommended dosages with misuse or abuse. Prescribe VICODIN in the smallest quantity and provide advice on the proper disposal of unused drug.

Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even if used as recommended. The risk is greatest during initiation of therapy or following a dose increase. Monitor for respiratory depression, especially during the first 24-72 hours.

Neonatal Opioid Withdrawal Syndrome
Prolonged VICODIN use during pregnancy can result in neonatal opioid withdrawal syndrome, and may be life-threatening. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly.

Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers
Concomitant VICODIN use with a CYP3A4 inhibitor (e.g., macrolide antibiotics, azole-antifungal agents, and protease inhibitors) or with the discontinuation of a CYP3A4 inducer (e.g., rifampin, carbamazepine, and phenytoin) may increase plasma concentrations of hydrocodone and prolong opioid adverse reactions, including fatal respiratory depression. Frequently monitor and adjust dose as needed.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
Concomitant VICODIN use with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol) can cause profound sedation, respiratory depression, coma, and death. Monitor and advise both patients and caregivers of the risks (including use with alcohol and illicit drugs). Inform patients not to drive or operate heavy machinery until the effects are known.

Elderly, Cachectic, or Debilitated Patients
Significant chronic obstructive pulmonary disease or cor pulmonale; substantial decreased respiratory reserve, hypoxia, hypercapnia; or pre-existing respiratory depression increases the risk of decreased respiratory drive, even at recommended dosages. Elderly, cachectic, or debilitated patients are at greater risk for life-threatening respiratory depression than younger, healthier patients. Monitor patients, particularly when initiating and titrating. Consider non-opioid analgesics.

Adrenal Insufficiency
Adrenal insufficiency, usually with more than one month of opioid use, has been reported. Non-specific symptoms and signs include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Confirm suspected adrenal insufficiency and treat with corticosteroids, as needed. Wean patient off the opioid and continue corticosteroid treatment until adrenal function recovers.

Severe Hypotension
VICODIN may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. Inability to maintain blood pressure due to reduced blood volume or concurrent use of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics) increases this risk. Monitor for signs of hypotension after initiating or titrating the dose. Avoid the use of VICODIN with circulatory shock.

Hepatotoxicity
Acetaminophen has been associated with acute liver failure, sometimes resulting in liver transplant and death. Underlying liver disease and alcohol ingestion while taking acetaminophen increase the risk of acute liver failure. Instruct patients to look for acetaminophen or APAP on package labels, not to use more than one product that contains acetaminophen, and to seek medical attention immediately upon ingestion of more than 4,000 milligrams of acetaminophen per day, even if they feel well.

Serious Skin Reactions
Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Inform patients of the signs of serious skin reactions, and discontinue drug at the first appearance of skin rash or any other sign of hypersensitivity.

Hypersensitivity/Anaphylaxis
Post-marketing reports of acetaminophen hypersensitivity and anaphylaxis have occurred, some life-threatening and requiring emergency medical attention. Clinical signs included swelling of the face, mouth, and throat; respiratory distress; uticaria; rash; pruritus; and vomiting. Instruct patients to discontinue VICODIN immediately and seek medical care if they experience these symptoms. Do not prescribe VICODIN for patients with acetaminophen allergy.

Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness
VICODIN may reduce respiratory drive and further increase intracranial pressure in patients at risk of effects of CO2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors). Monitor for sedation and respiratory depression, particularly when initiating VICODIN therapy. Opioids may obscure the clinical course in a patient with a head injury. Avoid VICODIN use in patients with impaired consciousness or coma.

Risks of Use in Patients with Gastrointestinal Conditions
Use of VICODIN or other opioids in patients with acute abdominal conditions may obscure the diagnosis or clinical course. Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms.

Increased Risk of Seizures in Patients with Seizure Disorders
VICODIN may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor loss of seizure control or worsening during VICODIN therapy.

Withdrawal
Avoid using mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics with full opioid agonist analgesics, including VICODIN, as it may reduce the analgesic effect and/or precipitate withdrawal symptoms. To discontinue VICODIN, gradually taper the dose. Do not discontinue VICODIN abruptly if used around the clock for more than 5 days.

PRECAUTIONS

Risks of Driving and Operating Machinery
VICODIN may impair the mental or physical abilities needed to perform potentially hazardous activities (e.g., driving a car or operating machinery). Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of VICODIN and know how they will react to the medication.

ADVERSE REACTIONS
The most frequently reported adverse reactions are light-headedness, dizziness, sedation, nausea, and vomiting.

Please see Full Prescribing Information, including Boxed WARNING, for Vicodin formulations.

References: 1. VICODIN, VICODIN ES, VICODIN HP 5, 7.5, 10 mg (hydrocodone)/300 mg (acetaminophen) [package insert]. North Chicago, IL: AbbVie Inc. 2. US Department of Health and Human Services. FDA drug safety communication. US Food and Drug Administration website. http://www.fda.gov/Drugs/DrugSafety/
ucm239821.htm
. Accessed June 7, 2017.