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Author: Admin | 2025-04-28
Not expected to be tolerated have not provided adequate analgesia, or are not expected to provide adequate analgesia Contraindications Hydrocodone bitartrate and acetaminophen oral solution is contraindicated in patients with: Significant respiratory depression [see WARNINGS] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see WARNINGS] Known or suspected gastrointestinal obstruction, including paralytic ileus [see WARNINGS] Hypersensitivity to hydrocodone or acetaminophen (e.g., anaphylaxis) [see WARNINGS, ADVERSE REACTIONS] Warnings Risk of Accidental Overdose and Death due to Medication Errors Dosing errors can result in accidental overdose and death. Avoid dosing errors that may result from confusion between mg and mL and confusion with hydrocodone bitartrate and acetaminophen oral solutions of different concentrations, when prescribing, dispensing, and administering hydrocodone bitartrate and acetaminophen oral solution. Ensure that the dose is communicated clearly and dispensed accurately. Always use a calibrated measuring devise when administering hydrocodone bitartrate and acetaminophen oral solution to ensure the dose is measured and administered accurately. Addiction, Abuse, and Misuse Hydrocodone bitartrate and acetaminophen oral solution contains hydrocodone, a Schedule II controlled substance. As an opioid, hydrocodone bitartrate and acetaminophen oral solution exposes users to the risks of addiction, abuse, and misuse [see DRUG ABUSE AND DEPENDENCE]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed hydrocodone bitartrate and acetaminophen oral solution. 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 hydrocodone bitartrate and acetaminophen oral solution, and monitor all patients receiving hydrocodone bitartrate and acetaminophen oral solution 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 hydrocodone bitartrate and acetaminophen oral solution, but use in such patients necessitates intensive counseling about the risks and proper use of hydrocodone bitartrate and acetaminophen oral solution along with intensive monitoring for signs of addiction, abuse, and misuse. Consider prescribing naloxone for the emergency treatment of opioid overdose [see WARNINGS; Life-Threatening Respiratory Depression, DOSAGE AND ADMINISTRATRION; Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose].
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