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VICODIN, VICODIN ES, VICODIN HP (HYDROCODONE/ACETAMINOPHEN) TABLETS: WARNINGS
Addiction, Abuse, and Misuse
Vicodin, Vicodin ES and Vicodin HP tablets contain hydrocodone, a Schedule II controlled substance in the USA. As an opioid, Vicodin (Hydrocodone and Acetaminophen) tablets expose users to the risks of addiction, abuse, and misuse.
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Vicodin (Hydrocodone and Acetaminophen). Addiction can occur at recommended dosages and if the drug is misused or abused.
Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing Vicodin (Hydrocodone with Acetaminophen) tablets, and monitor all patients receiving Vicodin for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as Vicodin (Hydrocodone with Acetaminophen), but use in such patients necessitates intensive counseling about the risks and proper use of Vicodin along with intensive monitoring for signs of addiction, abuse, and misuse.
Opioids are sought by drug abusers and people with addiction disorders and are subject to criminal diversion. Consider these risks when prescribing or dispensing Vicodin (Hydrocodone, Acetaminophen) tablets. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity and advising the patient on the proper disposal of unused drug. Contact local state professional licensing board or state controlled substances authority for information on how to prevent and detect abuse or diversion of this product.
Life-Threatening Respiratory Depression
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 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 Vicodin (Hydrocodone, Acetaminophen), 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 Vicodin, Vicodin ES and Vicodin HP tablets.
To reduce the risk of respiratory depression, proper dosing and titration of Vicodin (Hydrocodone, Paracetamol) are essential. Overestimating this medication dosage when converting patients from another opioid product can result in a fatal overdose.
Accidental ingestion of Vicodin (Hydrocodone Bitartrate and Acetaminophen) tablets, especially by children, can result in respiratory depression and death due to an overdose of this medication.
Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients
The use of Vicodin, Vicodin ES, Vicodin HP tablets in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.
Patients with Chronic Pulmonary Disease
Vicodin treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory
depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of hydrocodone bitartrate and acetaminophen tablets.
Elderly, Cachectic, or Debilitated Patients
Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients.
Follow such patients closely, particularly when initiating and titrating Vicodin (Hydrocodone Bitartrate with Paracetamol) and when this medication is given concomitantly with other drugs that depress respiration. Alternatively, consider the use of non-opioid analgesics in these patients.
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