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VICODIN, VICODIN ES, VICODIN HP (HYDROCODONE/ACETAMINOPHEN) TABLETS: RISKS

Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers

Concomitant use of Vicodin (Hydrocodone Bitartrate and Acetaminophen) tablets with a CYP3A4 inhibitor, such as azole-antifungal agents (e.g., ketoconazole), macrolide antibiotics (e.g., erythromycin), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of hydrocodone and acetaminophen and prolong opioid adverse reactions, and which may cause potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of Vicodin, Vicodin ES, Vicodin HP tablets is achieved. Similarly, discontinuation of a CYP3A4 inducer, such as carbamazepine, rifampin, and phenytoin, in Vicodin treated patients may increase hydrocodone plasma concentrations and prolong opoid adverse reactions. When adding CYP3A4 inhibitors or discontinuing CYP3A4 inducers in Vicodin treated patients, follow patients at frequent intervals and consider dosage reduction of hydrocodone bitartrate and acetaminophen tablets until stable drug effects are achieved.

Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants

Profound sedation, respiratory depression, coma, and death may result from the concomitant use of hydrocodone Vicodin (Hydrocodone Bitartrate and Paracetamol) with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, tranquilizers, anxiolytics, muscle relaxants, antipsychotics, general anesthetics, alcohol, other opioids). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.

Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics.

If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Follow patients closely for signs and symptoms of respiratory depression and sedation.

Advise both patients and caregivers about the risks of respiratory depression and sedation when Vicodin (Hydrocodone Bitartrate with Acetaminophen) tablets are used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs.

Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness

In patients who may be susceptible to the intracranial effects of CO retention (e.g., those with evidence of increased intracranial pressure or brain tumors), Vicodin, Vicodin ES, Vicodin HP may reduce respiratory drive, and the resultant CO retention can further increase intracranial pressure.

Follow such patients for signs of sedation and respiratory depression, particularly when initiating therapy with Vicodin (Hydrocodone and Acetaminophen).

Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of Vicodin (Hydrocodone with Acetaminophen) tablets in patients with impaired consciousness or coma.

Risks of Use in Patients with Gastrointestinal Conditions

Vicodin, Vicodin ES, Vicodin HP is contraindicated in patients with gastrointestinal obstruction, including paralytic ileus.

The administration of this medicine or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

Hydrocodone may cause spasm of the sphincter of Oddi. 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 (Hydrocodone, Acetaminophen) tablets 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. Follow patients with a history of seizure disorders for worsened seizure control during Vicodin, Vicodin ES, Vicodin HP therapy.

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