Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2484
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VICODIN HP (Tablet)
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dailymed-instance:dosage |
Dosage should be adjusted
according to severity of pain and the response of the patient. However,
it should be kept in mind that tolerance to hydrocodone can develop
with continued use and that the incidence of untoward effects is dose
related. The usual
adult dosage is one tablet every four to six hours as needed for pain.
The total daily dosage should not exceed 6 tablets.
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dailymed-instance:descripti... |
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��-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate
(1:1) hydrate (2:5). It has the following structural formula: CHNO��CHO��2��HO M.W. = 494.50 Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white,
odorless, crystalline powder, is a non-opiate, non-salicylate analgesic
and antipyretic. It has the following structural formula: CHNOM.W. = 151.17 Each VICODIN HP Tablet contains:Hydrocodone Bitartrate 10 mgAcetaminophen 660 mg In addition each tablet contains the following inactive ingredients:
colloidal silicon dioxide, croscarmellose sodium, magnesium stearate,
microcrystalline cellulose, povidone, pregelatinized starch, and stearic
acid. Meets USP Dissolution
Test 2.
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dailymed-instance:clinicalP... |
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 mechanism 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 hypothalamic 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.<br/>Pharmacokinetics: The behavior of
the individual components is described below.<br/>Hydrocodone: Following
a 10 mg oral dose of hydrocodone administered to five adult male subjects,
the mean peak concentration was 23.6��5.2 ng/mL. Maximum serum
levels were achieved at 1.3��0.3 hours and the half-life was
determined to be 3.8��0.3 hours. Hydrocodone
exhibits a complex pattern of metabolism including O-demethylation,
N-demethylation and 6-keto reduction to the corresponding 6-��-
and 6-��-hydroxy- metabolites. See OVERDOSAGE for toxicity information.<br/>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 conjugatesand unchanged drug. See OVERDOSAGE for toxicity information.
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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.
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dailymed-instance:supply |
VICODIN HP (hydrocodone
bitartrate and acetaminophen, 10 mg/660 mg) is supplied as a white,
oval-shaped, tablet bisected on one side and debossed with "VICODIN
HP" on the other side.Bottles of 100-NDC #0074-2274-14Bottles
of 500-NDC #0074-2274-54<br/>Storage: Store at 25��C (77��F); excursions permitted to 15��-30��C
(59��-86��F). [see USP Controlled Room Temperature]. Dispense
in a tight, light-resistant container as defined in the USP. A Schedule CS-III Controlled Drug Substance. ��Abbott Abbott Laboratories North Chicago, IL 60064, U.S.A.
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dailymed-instance:overdosag... |
Following an acute overdosage,
toxicity may result from hydrocodone or acetaminophen.<br/>Signs and Symptoms:<br/>Hydrocodone: Serious
overdose with hydrocodone is characterized by respiratory depression
(a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes
respiration, cyanosis), extreme somnolence progressing to stupor or
coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes
bradycardia and hypotension. In severe overdosage, apnea, circulatory
collapse, cardiac arrest and death may occur.<br/>Acetaminophen: In acetaminophen
overdosage: dose-dependent, potentially fatal hepatic necrosis is
the most serious adverse effect. Renal tubular necrosis, hypoglycemic
coma, and thrombocytopenia may also occur. Early symptoms following a potentially hepatotoxic overdose may include:
nausea, vomiting, diaphoresis and general malaise. Clinical and
laboratory evidence of hepatic toxicity may not be apparent until
48 to 72 hours post-ingestion. In adults, hepatic toxicity has rarely been reported with acute overdoses
of less than 10 grams, or fatalities with less than 15 grams.<br/>Treatment: A single or multiple
overdose with hydrocodone and acetaminophen is a potentially lethal
polydrug overdose, and consultation with a regional poison control
center is recommended. Immediate treatment includes support of cardiorespiratory function
and measures to reduce drug absorption. Vomiting should be induced
mechanically, or with syrup of ipecac, if the patient is alert (adequate
pharyngeal and laryngeal reflexes). Oral activated charcoal (1 g/kg)
should follow gastric emptying. The first dose should be accompanied
by an appropriate cathartic. If repeated doses are used, the cathartic
might be included with alternate doses as required. Hypotension is
usually hypovolemic and should respond to fluids. Vasopressors and
other supportive measures should be employed as indicated. A cuffed
endo-tracheal tube should be inserted before gastric lavage of the
unconscious patient and, when necessary, to provide assisted respiration. Meticulous attention
should be given to maintaining adequate pulmonary ventilation. In
severe cases of intoxication, peritoneal dialysis, or preferably hemodialysis
may be considered. If hypoprothrombinemia occurs due to acetaminophen
overdose, vitamin K should be administered intravenously. Naloxone, an opioid antagonist,
can reverse respiratory depression and coma associated with opioid
overdose. Naloxone hydrochloride 0.4 mg to 2 mg is given parenterally.
Since the duration of action of hydrocodone may exceed that of the
naloxone, the patient should be kept under continuous surveillance
and repeated doses of the antagonist should be administered as needed
to maintain adequate respiration. An opioid antagonist should not
be administered in the absence of clinically significant respiratory
or cardiovascular depression. If the dose of acetaminophen may have exceeded 140 mg/kg, acetylcysteine
should be administered as early as possible. Serum acetaminophen
levels should be obtained, since levels four or more hours following
ingestion help predict acetaminophen toxicity. Do not await acetaminophen
assay results before initiating treatment. Hepatic enzymes should
be obtained initially, and repeated at 24-hour intervals. Methemoglobinemia over
30% should be treated with methylene blue by slow intravenous administration. The toxic dose for adults
for acetaminophen is 10 g.
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dailymed-instance:genericMe... |
hydrocodone bitartrate and acetaminophen
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dailymed-instance:fullName |
VICODIN HP (Tablet)
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dailymed-instance:adverseRe... |
The most frequently reported
adverse reactions are lightheadedness, dizziness, sedation, nausea
and vomiting. These effects seem to be more prominent in ambulatory
than in nonambulatory patients, and some of these adverse reactions
may be alleviated if the patient lies down. Other adverse reactions include:<br/>Central Nervous System: Drowsiness, mental
clouding, lethargy, impairment of mental and physical performance,
anxiety, fear, dysphoria, psychic dependence, mood changes.<br/>Gastrointestinal System: Prolonged administration
of VICODIN HP Tablets may produce constipation.<br/>Genitourinary System: Ureteral spasm,
spasm of vesical sphincters and urinary retention have been reported
with opiates.<br/>Respiratory Depression: Hydrocodone bitartrate
may produce dose-related respiratory depression by acting directly
on the brain stem respiratory centers (see OVERDOSAGE).<br/>Special Senses: Cases of hearing
impairment or permanent loss have been reported predominantly in patients
with chronic overdose.<br/>Dermatological: Skin rash, pruritus. The following adverse drug events may be borne in
mind as potential effects of acetaminophen: allergic reactions, rash,
thrombocytopenia, agranulocytosis. Potential effects of high dosage are listed in the OVERDOSAGE section.
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dailymed-instance:warning |
Respiratory Depression: At high doses or
in sensitive patients, hydrocodone may produce dose-related 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.<br/>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.<br/>Acute Abdominal Conditions: The administration
of narcotics may obscure the diagnosis or clinical course of patients
with acute abdominal conditions.<br/>Misuse Abuse and Diversion of Opioids: VICODIN HP contains hydrocodone an opioid agonist,
and is a Schedule III controlled substance. Opioid agonists have
the potential for being abused and are sought by abusers and people
with addiction disorders, and are subject to diversion. VICODIN HP can be abused in a manner similar to other
opioid agonists, legal or illicit. This should be considered when
prescribing or dispensing VICODIN HP in situations where the physician
or pharmacist is concerned about an increased risk of misuse, abuse
or diversion (see DRUG ABUSE AND DEPENDENCE).
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dailymed-instance:indicatio... |
VICODIN HP Tablets are indicated
for the relief of moderate to moderately severe pain.
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dailymed-instance:name |
VICODIN HP
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