Pronunciation(proe POKS i feen & a seet a MIN oh fen)
U.S. Brand NamesDarvocet A500™; Darvocet-N® 50; Darvocet-N® 100; Pronap-100®
SynonymsPropoxyphene Hydrochloride and Acetaminophen; Propoxyphene Napsylate and Acetaminophen
Generic AvailableYes
Canadian Brand NamesDarvocet-N® 50; Darvocet-N® 100
UseManagement of mild to moderate pain
Use - DentalManagement of postoperative pain
RestrictionsC-IV
Pregnancy Risk FactorC
Pregnancy ImplicationsWithdrawal symptoms have been reported in the neonate following propoxyphene use during pregnancy. Teratogenic effects have also been noted in case reports. Opioid analgesics are considered pregnancy risk factor D if used for prolonged periods or in large doses near term.
LactationEnters breast milk/compatible
ContraindicationsHypersensitivity to propoxyphene, acetaminophen, or any component of the formulation
Warnings/PrecautionsWhen given in excessive doses, either alone or in combination with other CNS depressants, propoxyphene is a major cause of drug-related deaths; do not exceed recommended dosage; give with caution in patients dependent on opiates, substitution may result in acute opiate withdrawal symptoms. Avoid use in severely-depressed or suicidal patients. Tolerance or drug dependence may result from extended use.Propoxyphene should be used with caution in patients with renal or hepatic dysfunction or in the elderly; consider dosing adjustment. Acetaminophen should be used with caution in patients with liver disease; consuming
Adverse ReactionsSee individual agents.
Drug InteractionsPropoxyphene: Inhibits CYP2C8/9 (weak), 2D6 (weak), 3A4 (weak) Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C8/9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak) Also see individual agents.
Ethanol/Nutrition/Herb InteractionsBased on propoxyphene component: Ethanol: Avoid or limit ethanol (may increase CNS depression). Watch for sedation. Food: May decrease rate of absorption, but may slightly increase bioavailability. Based on acetaminophen component: Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity. Avoid ethanol or limit to <3 drinks/day. Food: Rate of absorption may be decreased when given with food. Herb/Nutraceutical: St John's wort may decrease acetaminophen levels.
StabilityStore at controlled room temperature.
Mechanism of ActionPropoxyphene is a weak narcotic analgesic which acts through binding to opiate receptors to inhibit ascending pain pathways Propoxyphene, as with other narcotic (opiate) analgesics, blocks pain perception in the cerebral cortex by binding to specific receptor molecules (opiate receptors) within the neuronal membranes of synapses. This binding results in a decreased synaptic chemical transmission throughout the CNS thus inhibiting the flow of pain sensations into the higher centers. Mu and kappa are the two subtypes of the opiate receptor which propoxyphene binds to to cause analgesia. Acetaminophen inhibits the synthesis of prostaglandins in the CNS and peripherally blocks pain impulse generation; produces antipyresis from inhibition of hypothalamic heat-regulating center
Pharmacodynamics/KineticsSee individual agents.
DosageOral: Adults:Darvocet A500™, Darvocet-N® 100: 1 tablet every 4 hours as needed; maximum: 600 mg propoxyphene napsylate/day Darvocet-N® 50: 1-2 tablets every 4 hours as needed; maximum: 600 mg propoxyphene napsylate/day Note: Dosage of acetaminophen should not exceed 4 g/day (6 tablets of Darvocet-N® 100); possibly less in patients with ethanol Elderly: Refer to Adults dosing Dosing adjustment in renal/hepatic impairment: Serum concentrations of propoxyphene may be increased or elimination may be delayed; specific dosing recommendations not available.
AdministrationShould be administered with water on an empty stomach.
Dietary ConsiderationsMay be taken with food if gastrointestinal distress occurs.
Patient EducationSee individual agents. Pregnancy precaution: Inform prescriber if you are or intend to become pregnant.
Nursing ImplicationsMonitor pain relief, respiratory and mental status, blood pressure, excessive sedation
Additional InformationSome studies have found no significant difference in pain relief between propoxyphene and aspirin or acetaminophen.
Dental Health: Effects on Dental TreatmentKey adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation).
Dental Health: Vasoconstrictor/Local Anesthetic PrecautionsNo information available to require special precautions
Dental CommentPropoxyphene is a narcotic analgesic and shares many properties including addiction liability. The acetaminophen component requires use with caution in patients with alcoholic liver disease.
Mental Health: Effects on Mental StatusDizziness, drowsiness, insomnia, and paradoxical excitement are common; may cause nervousness, restlessness, confusion; may rarely cause depression or hallucinations
Mental Health: Effects on Psychiatric TreatmentConcurrent use with psychotropics may produce additive sedation as well as increase their serum levels; monitor for altered clinical response or preferably, use a different analgesic
Dosage FormsTablet: Propoxyphene hydrochloride 65 mg and acetaminophen 650 mg, propoxyphene napsylate 100 mg, and acetaminophen 650 mgDarvocet A500™: Propoxyphene napsylate 100 mg and acetaminophen 500 mg [contains lactose] Darvocet-N® 50: Propoxyphene napsylate 50 mg and acetaminophen 325 mg Darvocet-N® 100, Pronap-100®: Propoxyphene napsylate 100 mg and acetaminophen 650 mg
References"American Academy of Pediatrics Committee on Drugs. The Transfer of Drugs and Other Chemicals Into Human Milk,"Pediatrics, 2001, 108(3):776-89. "Drugs for Pain,"Med Lett Drugs Ther, 2000, 42(1085):73-8. Mokhlesi B, Leikin JB, Murray P, et al, "Adult Toxicology in Critical Care: Part II: Specific Poisonings,"Chest, 2003, 123(3):897-922. Rathmell JP, Viscomi CM, and Ashburn MA, "Management of Nonobstetric Pain During Pregnancy and Lactation,"Anesth Analg, 1997, 85(5):1074-87.
International Brand NamesDarvocet-N® 50 (CA); Darvocet-N® 100 (CA)
The information provided herein should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed medical professional should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies. Links to other sites are provided for information only -- they do not constitute endorsements of those other sites. © 1997-
A.D.A.M., Inc. Any duplication or distribution of the information contained herein is strictly prohibited.  |
3 alcoholic drinks/day may increase risk of liver damage. Use caution in patients with known G6PD deficiency. Safety and efficacy of this combination have not been established in pediatric patients.
Disclaimer: The information contained in this website, and its associated websites, is provided as a benefit to the local community, and the Internet community in general; it does not constitute medical advice. We try to provide quality information, but we make no claims, promises or guarantees about the accuracy, completeness, or adequacy of the information contained in or linked to this website and its associated sites. As medical advice must be tailored to the specific circumstances of each patient and healthcare is constantly changing, nothing provided herein should be used as a substitute for the advice of a competent physician. Furthermore, in providing this service, Adventist HealthCare does not condone or support all of the content covered in this site. As an Adventist health care organization, Adventist HealthCare acts in accordance with the ethical and religious directives for Adventist health care services.
Adventist HealthCare · 301-315-3030 · 1801 Research BLVD, Suite 400, Rockville, MD 20850
Get Care
Health & Wellness
Patient Information
Website Information
Ways of Giving
