VICODINB (Abbott)
(hydrocodone bitartrate and acetaminophen tablets, USP)
5 mg/500 mg
Rx only
DESCRIPTION
Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration.
Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as fine, white crystals or
as a crystalline powder. It is affected by light. The chemical name is: 4,5(alpha)epoxy-3-
methoxy-17-methy1morphinan-6-oneta rtrate (1 :1 ) hydrate (25).
Each VICODIN tablet contains:
Hydrocodone Bitartrate 5 mg
Acetaminophen 500 mg
In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide,
starch, croscarmellose sodium, dibasic calcium phosphate, magnesium stearate, microcrystalline
cellulose, povidone, and stearic acid.
CLINICAL PHARMACOLOGY
Hydrocodone is a semisynthetic narcotic analgesic and antitussive with multiple actions
qualitatively similar to those of codeine. Most of these involve the central nervous system and
smooth muscle. The precise mechamism of action of hydrocodone and other opiates is not
known, although it is believed to relate to the existence of opiate receptors in the central nervous
system. In addition to analgesia, narcotics may produce drowsiness, changes in mood and mental
clouding.
The analgesic action of acetaminophen involves peripheral influences, but the specific
mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalmic heat
regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of
acetaminophen have negligible effects on the cardiovascular or respiratory systems; however,
toxic doses may cause circulatory failure and rapid, shallow breathing.
Pharmacokinetics:
The behavior of the individual components is described below.
Hydrocodone: Following a 1 Omg oral dose of hydrocodone administered to five adult male
subjects, the mean peak concentration was 23.6 f 5.2ng/mL. Maximum serum levels were
achieved at 1.3 f 0.3 hours and the half-life was determined to be 3.8 f 0.3 hours. Hydrocodone
exhibits a complex pattern of metabolism including 0-demethylation, N-demethylation and 6-
keto reduction to the corresponding 6-(alpha)- and 6-(beta)-hydroxymetabolites. See
OVERDOSAGE for toxicity information.
Acetaminophen: Acetaminophen is rapidly absorbed from the gastrointestinal tract and is
distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be
increased by liver damage and following overdosage. Elimination of acetaminophen is
principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites.
Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most
as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. See
OVERDOSAGE for toxicity information.
INDICATIONS AND USAGE
VICODIN tablets are indicated for the relief of moderate to moderately severe pain.
CONTRAINDICATIONS
This product should not be administered to patients who have previously exhibited
hypersensitivity to hydrocodone or acetaminophen.
Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to
hydrocodone.
WARNINGS
Respiratory Depression: At high doses or in sensitive patients, hydrocodone may produce doserelated
respiratory depression by acting directly on the brain stem respiratory center.
Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular
and periodic breathing.
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, other intracranial lesions or a preexisting increase in intracranial
pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical
course of patients with head injuries.
Acute Abdominal Conditions: The administration of narcotics may obscure the diagnosis or
clinical course of patients with acute abdominal conditions.
PRECAUTIONS
General:
Special Risk Patients: As with any narcotic analgesic agent, VICODIN Tablets should be used
with caution in elderly or debilitated patients and those with severe impairment of hepatic or
renal function, hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture.
The usual precautions should be observed and the possibility of respiratory depression should be
kept in mind.
Cough Reflex: Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be
exercised when VICODIN Tablets are used postoperatively and in patients with pulmonary
disease.
Information for Patients: Hydrocodone, like all narcotics, may impair the mental and/or
physical abilities required for the performance of potentially hazardous tasks such as driving a
car or operating machinery; patients should be cautioned accordingly.
Alcohol and other CNS depressants may produce an additive CNS depression, when taken with
this combination product, and should be avoided.
Hydrocodone may be habit forming. Patients should take the drug only for as long as it is
prescribed, in the amounts prescribed, and no more frequently than prescribed.
