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VICODIN (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.
Vicodin is a tablet containing a combination of (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. Acetaminophen, 4’-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a nonopiate, non-salicylate analgesic and antipyretic. It hasthe following structural formula: Each VICODIN tablet contains: Hydrocodone Bitartrate 5 mg and 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.
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DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals
VICODIN® 5 mg/300 mg: The usual adult dosage is one or two tablets every four to six hours as needed for pain. The total daily dosage should not exceed 8 tablets.
VICODIN® ES 7.5 mg/300 mg: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
VICODIN® HP 10 mg/300 mg: 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.
There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of hydrocodone bitartrate and acetaminophen tablets. It is safer to underestimate a patient’s 24-hour hydrocodone bitartrate and acetaminophen tablets dosage than to overestimate the 24-hour hydrocodone bitartrate and acetaminophen tablets dosage and manage an adverse reaction due to overdose.
Hydrocodone bitartrate and acetaminophen tablets are 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, includeusing paralytic il
Hypersensitivity to hydrocodone or acetaminophen.
Serious Vicodin side effects:
shallow breathing, slow heartbeat;
feeling light-headed, fainting;
confusion, fear, unusual thoughts or behavior;
problems with urination; or
nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice
(yellowing of the skin or eyes).
Less serious Vicodin side effects may include:
feeling anxious, dizzy, or drowsy;
mild nausea, vomiting, upset stomach, constipation;
headache, mood changes;
ringing in your ears; or
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.
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.
VICODIN tablets can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing VICODIN tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.
Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status .
Carbon dioxide (CO ) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of hydrocodone bitartrate and acetaminophen tablets, the risk is greatest during the initiation of therapy or following a dosage increase. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with and following dosage increases of hydrocodone bitartrate and acetaminophen tablets. WIKI