Acetaminophen, 4′-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C8H9NO2 and the molecular weight is 151.17. It may be represented by the following structural formula:
Each tablet of Darvocet-N (propoxyphene napsylate and acetaminophen) 50 contains 50 mg (88.4 µmol) propoxyphene napsylate and 325 mg (2,150 µmol) acetaminophen.
Each tablet of Darvocet-N (propoxyphene napsylate and acetaminophen) 100 contains 100 mg (176.8 µmol) propoxyphene napsylate and 650 mg (4,300 µmol) acetaminophen.
Each tablet also contains amberlite, cellulose, F D & C Yellow No. 6, magnesium stearate, stearic acid, titanium dioxide, and other inactive ingredients.
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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 postmarketing 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 postmarketing surveillance include:
Cardiac disorders: arrhythmia, bradycardia, cardiac/respiratory arrest, congestive arrest, congestive heart failure (CHF), tachycardia, myocardial infarction (MI)
Eye disorder: eye swelling, vision blurred
General disorder and administration site conditions: drug ineffective, drug interaction, drug tolerance, influenza type illness, drug withdrawal syndrome
Gastrointestinal disorder: gastrointestinal bleed, acute pancreatitis
Hepatobiliary disorder: hepatic steatosis, hepatomegaly, hepatocellular injury
Immune system disorder: hypersensitivity
Injury poisoning and procedural complications: drug toxicity, hip fracture, multiple drug overdose, narcotic overdose
Investigations: blood pressure decreased, heart rate elevated/abnormal
Metabolism and nutrition disorder: metabolic acidosis
Nervous system disorder: ataxia, coma, dizziness, somnolence, syncope
Psychiatric: abnormal behavior, confusional state, hallucinations, mental status change
Respiratory, thoracic, and mediastinal disorders: respiratory depression, dyspnoea
Skin and subcutaneous tissue disorder: rash, itch
Darvocet-N (propoxyphene napsylate and acetaminophen) 100 (100 mg propoxyphene napsylate and 650 mg acetaminophen) The usual dosage is one tablet every 4 hours orally as needed for pain. The maximum dose of DARVOCET-N (propoxyphene napsylate and acetaminophen) 100 is 6 tablets per day. Do not exceed the maximum daily dose. Darvocet-N (propoxyphene napsylate and acetaminophen) 50 (50 mg propoxyphene napsylate and 325 mg acetaminophen) The usual dosage is two tablets every 4 hours orally as needed for pain. The maximum dose of DARVOCET-N (propoxyphene napsylate and acetaminophen) 50 is 12 tablets per day. Do not exceed the maximum daily dose.