FDA label 4fa80ba3-bcc2-4fb2-82a9-44c04c227d71

WARNINGS There have been numerous cases of accidental and intentional overdose with propoxyphene products either alone or in combination with other CNS depressants, including alcohol. Fatalities within the first hour of overdosage are not uncommon. Many of the propoxyphene-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation/attempts and/or concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants or other CNS-depressant drugs. Do not prescribe propoxyphene for patients who are suicidal or have a history of suicidal ideation. The metabolism of propoxyphene may be altered by strong CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazadone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice and verapamil) leading to enhanced propoxyphene plasma levels. Patients receiving propoxyphene and any CYP3A4 inhibitor should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted (see and , and for further information). CLINICAL PHARMACOLOGY: Drug Interactions WARNINGS PRECAUTIONS DOSAGE AND ADMINISTRATION

Propoxyphene napsylate and acetaminophen tablets are a federally controlled substance (C-IV) because it is a strong opioid pain medicine that can be abused by people who abuse prescription medicines or street drugs. Prevent theft, misuse or abuse. Keep propoxyphene napsylate and acetaminophen tablets in a safe place to protect it from being stolen. Propoxyphene napsylate and acetaminophen tablets can be a target for people who misuse or abuse prescription medicines or street drugs. Never give propoxyphene napsylate and acetaminophen tablets to anyone else, even if they have the same symptoms that you have. It may harm them or even cause death. Selling or giving away this medicine is against the law.

WARNINGS

ADVERSE REACTIONS During clinical trials, the most frequently reported adverse reactions were dizziness, sedation, nausea and vomiting. Other adverse reactions include constipation, abdominal pain, skin rashes, lightheadedness, headache, weakness, euphoria, dysphoria, hallucinations and minor visual disturbances. The most frequently reported post-marketing adverse events have included completed suicide, accidental and intentional overdose, drug dependence, cardiac arrest, coma, drug ineffective, drug toxicity, nausea, respiratory arrest, cardio-respiratory arrest, death, vomiting, dizziness, convulsion, confusional state and diarrhea. Additional adverse experiences reported through post-marketing surveillance include: arrhythmia, bradycardia, cardiac/respiratory arrest, congestive arrest, congestive heart failure (CHF), tachycardia, myocardial infarction (MI) Cardiac Disorders: eye swelling, vision blurred Eye Disorder: drug ineffective, drug interaction, drug tolerance, influenza type illness, drug withdrawal syndrome General Disorder and Administration Site Conditions: gastrointestinal bleed, acute pancreatitis Gastrointestinal Disorder: hepatic steatosis, hepatomegaly, hepatocellular injury Hepatobiliary Disorder: hypersensitivity Immune System Disorder: drug toxicity, hip fracture, multiple drug overdose, narcotic overdose Injury Poisoning and Procedural Complications: blood pressure decreased, heart rate elevated/abnormal Investigations: metabolic acidosis Metabolism and Nutrition Disorder: ataxia, coma, dizziness, somnolence, syncope Nervous System Disorder: abnormal behavior, confusional state, hallucinations, mental status change Psychiatric: respiratory depression, dyspnoea Respiratory, Thoracic and Mediastinal Disorders: rash, itch Skin and Subcutaneous Tissue Disorder: Liver dysfunction has been reported in association with both active components of propoxyphene napsylate and acetaminophen tablets. Propoxyphene therapy has been associated with abnormal liver function tests and, more rarely, with instances of reversible jaundice (including cholestatic jaundice). Hepatic necrosis may result from acute overdose of acetaminophen (see ). In chronic ethanol abusers, this has been reported rarely with short-term use of acetaminophen dosages of 2.5 to 10 g/day. Fatalities have occurred. OVERDOSAGE There have also been post-marketing reports of renal papillary necrosis associated with chronic acetaminophen use, particularly when the dosage is greater than recommended and when combined with aspirin. Subacute painful myopathy has been reported following chronic propoxyphene overdosage.