INDICATION AND IMPORTANT SAFETY INFORMATION1-4

INDICATION

VICODIN® 5 mg/300 mg, VICODIN ES® 7.5 mg/300 mg, VICODIN HP® 10 mg/300 mg, VICODIN® 5 mg/500 mg, VICODIN ES® 7.5 mg/750 mg, and VICODIN HP® 10 mg/660 mg (hydrocodone bitartrate and acetaminophen tablets, USP) tablets are indicated for the relief of moderate to moderately severe pain.

IMPORTANT SAFETY INFORMATION

BOXED WARNING

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 4000 MILLIGRAMS PER DAY, AND OFTEN INVOLVE MORE THAN ONE ACETAMINOPHEN-CONTAINING PRODUCT.

CONTRAINDICATIONS

VICODIN, VICODIN ES, and VICODIN HP tablets are contraindicated in patients previously exhibiting hypersensitivity to hydrocodone or acetaminophen, and also in patients known to be hypersensitive to other opioids, as they may exhibit cross-sensitivity to hydrocodone.

WARNINGS

Controlled Substance: VICODIN, VICODIN ES, and VICODIN HP contain hydrocodone, which is an opioid agonist and a Schedule III controlled substance with an abuse liability.

Abuse and Dependence: VICODIN, VICODIN ES, and VICODIN HP can be abused in a manner similar to other opioid agonists, legal or illicit. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, these products should be prescribed and administered with caution.

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

Hypersensitivity/Anaphylaxis: There have been postmarketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen.

Respiratory Depression: At high doses or in sensitive patients, hydrocodone may produce dose-related respiratory depression.

Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury or other intracranial pressure.

Acute Abdominal Conditions: The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

PRECAUTIONS

As with any narcotic, special caution should be used when prescribing hydrocodone to elderly or debilitated patients and those with severe impairment of hepatic or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy, or urethral stricture. Caution should also be exercised with patients who are likely to take other acetaminophen-containing medications, antihistamines, antipsychotics, antianxiety agents, other narcotic analgesics, or other central nervous system (CNS) depressants (including alcohol) concomitantly. When combined therapy is contemplated, the dose of one or both agents should be reduced. Hydrocodone, like all narcotics, may impair mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery.

The use of monoamine oxidase (MAO) inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

VICODIN, VICODIN ES, and VICODIN HP tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. Administration to the mother during labor or shortly before delivery may result in some degree of respiratory depression in the newborn.

ADVERSE REACTIONS

The most frequently reported adverse reactions include lightheadedness, dizziness, sedation, nausea, and vomiting. Prolonged administration may produce constipation.

DOSAGE AND ADMINISTRATION