Hepatotoxicity: Acetaminophen has been as s ociated with cas es of acute liver failure, at times res ulting in liver trans plant and death. Mos t of the cas es of liver injury are as s ociated with the us e of acetaminophen at dos es that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product.
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Hepatotoxicity: Acetaminophen has been as s ociated with cas es of acute liver failure, at times res ulting in liver trans plant and death. Mos t of the cas es of liver injury are as s ociated with the us e of acetaminophen at dos es that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. The exces s ive intake of acetaminophen may be intentional to caus e s elf-harm or unintentional as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing products . The ris k of acute liver failure is higher in individuals with underlying liver dis eas e and in individuals who inges t alcohol while taking acetaminophen. Ins truct patients to look for acetaminophen or APAP on package labels and not to us e more than one product that contains acetaminophen. Ins truct patients to s eek medical attention immediately upon inges tion of more than 4000 milligrams of acetaminophen per day, even if they feel well. Serious s kin reactions : Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity. Hypers ens itivity/anaphylaxis : There have been pos t-marketing reports of hypers ens itivity and anaphylaxis as s ociated with us e of acetaminophen. Clinical s igns included s welling of the face, mouth, and throat, res piratory dis tres s , urticaria, ras h, pruritus , and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Ins truct patients to dis continue Hydrocodone Bitartrate and Acetaminophen Tablets , USP immediately and s eek medical care if they experience thes e s ymptoms . Do not pres cribe Hydrocodone Bitartrate and Acetaminophen Tablets , USP for patients with acetaminophen allergy. Res piratory Depres s ion: 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. Head Injury and Increas ed Intracranial Pres s ure: 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. Acute Abdominal Conditions : The administration of narcotics may obscure the diagnosis or clinical course of patients with acute abdominal conditions. Mis us e, Abus e, and Divers ion of Opioids : Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a Schedule II 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. Hydrocodone bitartrate and acetaminophen tablets can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing hydrocodone bitartrate and acetaminophen tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see DRUG ABUSE AND DEPENDENCE).
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: Central Nervous Sys tem: Drowsiness, mental clouding, lethargy, impairment of mental and physical performance, anxiety, fear, dysphoria, psychic dependence, mood changes. Gas trointes tinal Sys tem: Prolonged administration of hydrocodone bitartrate and acetaminophen tablets may produce constipation. Genitourinary Sys tem: Ureteral spasm, spasm of vesical sphincters and urinary retention have been reported with opiates. Res piratory Depres s ion: Hydrocodone bitartrate may produce dose-related respiratory depression by acting directly on the brain stem respiratory centers (see OVERDOSAGE). Special Sens es : Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose. 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. DRUG ABUSE AND DEPENDENCE Mis us e, Abus e, and Divers ion of Opioids : Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a Schedule II controlled substance. Hydrocodone bitartrate and acetaminophen tablets, and other opioids, used in analgesia can be abused and are subject to criminal diversion. Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease utilizing a multidisciplinary approach, but relapse is common. "Drug seeking" behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated "loss" of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). "Doctor shopping" to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction. Abuse and addiction are separate and distinct from physical dependence and tolerance. Physical dependence usually assumes clinically significant dimensions only after several weeks of continued opioid use, although a mild degree of physical dependence may develop after a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Physicians should be aware that abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. Hydrocodone bitartrate and acetaminophen tablets, like other opioids, may be diverted for non-medical use. Record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised. Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.