Drug: Darvocet-N

Darvocet-N contains propoxyphene napsylate and acetaminophen. Propoxyphene Napsylate, USP is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water and soluble in methanol, ethanol, chloroform, and acetone. Chemically, it is (αS,1R)-α-[2-(Dimethylamino)-1-methylethyl]-α phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate, which can be represented by the accompanying structural formula. Its molecular weight is 565.72. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 µmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 µmol) of propoxyphene hydrochloride. 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 Liver dysfunction has been reported in association with both active components of Darvocet-N (propoxyphene napsylate and acetaminophen) 50 and Darvocet-N (propoxyphene napsylate and acetaminophen) 100. 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 OVERDOSAGE). 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. There have also been postmarketing 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. Drug Abuse And Dependence Controlled Substance Darvocet-N (propoxyphene napsylate and acetaminophen) is a Schedule IV narcotic under the U.S. Controlled Substances Act. Darvocet-N (propoxyphene napsylate and acetaminophen) can produce drug dependence of the morphine type, and therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration. Darvocet-N (propoxyphene napsylate and acetaminophen) should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic-containing medications. Abuse Since Darvocet-N (propoxyphene napsylate and acetaminophen) is a mu-opioid agonist, it may be subject to misuse, abuse, and addiction. Addiction to opioids prescribed for pain management has not been estimated. However, requests for opioids from opioid-addicted patients occur. As such, physicians should take appropriate care in prescribing Darvocet-N (propoxyphene napsylate and acetaminophen) . Dependence Opioid analgesics may cause psychological and physical dependence. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug after long term administration. Also, symptoms of withdrawal may be precipitated through the administration of drugs with mu-opioid antagonist activity, e.g., naloxone or mixed agonist/antagonist analgesics (pentazocine, butorphanol, nalbuphine, dezocine) (see OVERDOSAGE). Physical dependence usually does not occur to a clinically significant degree, until after several weeks of continued opioid usage. Tolerance, in which increasingly larger doses are required to produce the same degree of analgesia, is initially manifested by a shortened duration of an analgesic effect and subsequently, by decreases in the intensity of analgesia. In chronic pain patients, and in opioid-tolerant cancer patients, the administration of Darvocet-N (propoxyphene napsylate and acetaminophen) should be guided by the degree of tolerance manifested and the doses needed to adequately relieve pain. The severity of the Darvocet-N (propoxyphene napsylate and acetaminophen) abstinence syndrome may depend on the degree of physical dependence. Withdrawal is characterized by rhinitis, myalgia, abdominal cramping, and occasional diarrhea. Most observable symptoms disappear in 5 to 14 days without treatment; however, there may be a phase of secondary or chronic abstinence which may last for 2 to 6 months characterized by insomnia, irritability, and muscular aches. The patient may be detoxified by gradual reduction of the dose. Gastrointestinal disturbances or dehydration should be treated with supportive care. Read the Darvocet-N (propoxyphene napsylate and acetaminophen) Side Effects Center for a complete guide to possible side effectsLearn More »

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Darvocet-N (propoxyphene napsylate and acetaminophen) is intended for the management of mild to moderate pain. The dose should be individually adjusted according to severity of pain, patient response and patient size. 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. 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. Consideration should be given to a reduced total daily dosage in elderly patients and in patients with hepatic or renal impairment. Cessation of Therapy For patients who used Darvocet-N (propoxyphene napsylate and acetaminophen) on a regular basis for a period of time, when therapy with Darvocet-N (propoxyphene napsylate and acetaminophen) is no longer needed for the treatment of their pain, it may be useful to gradually discontinue the Darvocet-N (propoxyphene napsylate and acetaminophen) over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal). In general, therapy can be decreased by 25% to 50% per day with careful monitoring for signs and symptoms of withdrawal (see Drug Abuse And Dependence for description of the signs and symptoms of withdrawal). If the patient develops these signs or symptoms, the dose should be raised to the previous level and titrated down more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both.

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Drug Interactions with Propoxyphene Propoxyphene is metabolized mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when propoxyphene is administered concurrently with agents that affect CYP3A4 activity. 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. Coadministration with agents that induce CYP3A4 activity may reduce the efficacy of propoxyphene. Strong CYP3A4 inducers such as rifampin may lead to enhanced metabolite (norpropoxyphene) levels. Propoxyphene is also thought to possess CYP3A4 and CYP2D6 enzyme inhibiting properties and coadministration with drugs that rely on either of these enzymes for metabolism may result in increased pharmacologic or adverse effects of that drug. Severe neurologic signs, including coma, have occurred with concurrent use of carbamazepine (metabolized by CYP3A4). Increased risk of bleeding has been observed with warfarin-like agents when given along with propoxyphene; however, the mechanistic basis of this interaction is unknown. CNS Depressants Patients receiving narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with Darvocet-N (propoxyphene napsylate and acetaminophen) may exhibit an additive CNS depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, or coma may result if these drugs are taken in combination with the usual dosage of Darvocet-N (propoxyphene napsylate and acetaminophen) . When such combined therapy is contemplated, the dose of one or both agents should be reduced. Mixed Agonist/Antagonist Opioid Analgesics Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol and buprenorphine) should be administered with caution to patients who have received or are receiving a course of therapy with a pure opioid agonist analgesic such as Darvocet-N (propoxyphene napsylate and acetaminophen) . In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of Darvocet-N (propoxyphene napsylate and acetaminophen) and/or may precipitate withdrawal symptoms in these patients. Monoamine Oxidase Inhibitors (MAOIs) MAOIs have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant depression of respiration or coma. The use of Darvocet-N (propoxyphene napsylate and acetaminophen) is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. Drug Interactions with Acetaminophen Alcohol: Hepatotoxicity has occurred in chronic alcoholics following various dose levels (moderate to excessive) of acetaminophen. Anticholinergics: The onset of acetaminophen effect may be delayed or decreased slightly, but the ultimate pharmacological effect is not significantly affected by anticholinergics. Oral Contraceptives: Increase in glucuronidation resulting in increased plasma clearance and a decreased half-life of acetaminophen. Beta Blockers (Propranolol): Propranolol appears to inhibit the enzyme systems responsible for the glucuronidation and oxidation of acetaminophen. Therefore, the pharmacologic effects of acetaminophen may be increased. Loop Diuretics: The effects of the loop diuretic may be decreased because acetaminophen may decrease renal prostaglandin excretion and decrease plasma renin activity. Lamotrigine: Serum lamotrigine concentrations may be reduced, producing a decrease in therapeutic effects. Probenecid: Probenecid may increase the therapeutic effectiveness of acetaminophen slightly. Zidovudine: The pharmacologic effects of zidovudine may be decreased because of enhanced nonhepatic or renal clearance of zidovudine. Last reviewed on RxList: 12/20/2010
This monograph has been modified to include the generic and brand name in many instances.

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Darvocet-N (propoxyphene napsylate and acetaminophen) is indicated for the relief of mild to moderate pain.

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Darvocet-N (propoxyphene napsylate and acetaminophen) is contraindicated in patients with known hypersensitivity to propoxyphene or acetaminophen. Darvocet-N (propoxyphene napsylate and acetaminophen) is contraindicated in patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe asthma or hypercarbia. Darvocet-N (propoxyphene napsylate and acetaminophen) is contraindicated in any patient who has or is suspected of having paralytic ileus. Last reviewed on RxList: 12/20/2010
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Darvocet-N (propoxyphene napsylate and acetaminophen) is a combination product containing propoxyphene and acetaminophen. Overdose of Darvocet-N (propoxyphene napsylate and acetaminophen) may present with the signs and symptoms of propoxyphene overdose, acetaminophen overdose or both. Fatalities within the first hour of overdosage are not uncommon. In all cases of suspected overdosage, call your regional Poison Control Center to obtain the most up-to-date information about the treatment of overdose. This recommendation is made because, in general, information regarding the treatment of overdosage may change more rapidly than do package inserts. Initial consideration should be given to the management of the CNS effects of propoxyphene overdosage. Resuscitative measures should be initiated promptly. Propoxyphene Overdosage Symptoms of Propoxyphene Overdosage The manifestations of acute overdosage with propoxyphene are those of opioid overdosage. The patient is usually somnolent but may be stuporous or comatose and convulsing. Respiratory depression is characteristic. The ventilatory rate and/or tidal volume is decreased, which results in cyanosis and hypoxia. Pupils, initially pinpoint, may become dilated as hypoxia increases. Cheyne-Stokes respiration and apnea may occur. Blood pressure and heart rate are usually normal initially, but blood pressure falls and cardiac performance deteriorates, which ultimately results in pulmonary edema and circulatory collapse, unless the respiratory depression is corrected and adequate ventilation is restored promptly. Cardiac arrhythmias and conduction delay may be present. A combined respiratory-metabolic acidosis occurs owing to retained CO2 (hypercapnia) and to lactic acid formed during anaerobic glycolysis. Acidosis may be severe if large amounts of salicylates have also been ingested. Death may occur. Treatment of Propoxyphene Overdosage Attention should be directed first to establishing a patent airway and to restoring ventilation. Mechanically assisted ventilation, with or without oxygen, may be required, and positive pressure respiration may be desirable if pulmonary edema is present. The opioid antagonist naloxone will markedly reduce the degree of respiratory depression, and should be administered promptly, preferably intravenously. The duration of action of the antagonist may be brief. If no response is observed after 10 mg of naloxone have been administered, the diagnosis of propoxyphene toxicity should be questioned. In addition to the use of an opioid antagonist, the patient may require careful titration with an anticonvulsant to control convulsions. Activated charcoal can adsorb a significant amount of ingested propoxyphene. Dialysis is of little value in poisoning due to propoxyphene. Efforts should be made to determine whether other agents, such as alcohol, barbiturates, tranquilizers, or other CNS depressants, were also ingested, since these increase CNS depression as well as cause specific toxic effects or death. Acetaminophen Overdosage Symptoms of Acetaminophen Overdosage Overdose of acetaminophen may cause dose-dependent potentially fatal hepatic toxicity. Early symptoms within 24 hours after the overdose may include anorexia, nausea, vomiting, diaphoresis, general malaise, and abdominal pain. The patient may then present no symptoms, but evidence of liver dysfunction may become apparent up to 72 hours after ingestion, with elevated serum transaminase and lactic dehydrogenase levels, an increase in serum bilirubin concentrations, and a prolonged prothrombin time. Death from hepatic failure may result 3 to 7 days after overdosage. Because clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion, liver function studies should be obtained initially and repeated at 24-hour intervals. Acute renal failure may accompany the hepatic dysfunction and has been noted in patients who do not exhibit signs of fulminant hepatic failure. Typically, renal impairment is more apparent 6 to 9 days after ingestion of the overdose. Treatment of Acetaminophen Overdosage In all cases of suspected overdose, immediately call the Rocky Mountain Poison Center's toll-free number (800-525-6115) for assistance in diagnosis and for directions in the use of N-acetylcysteine as an antidote. Patients' estimates of the quantity of a drug ingested are notoriously unreliable. Therefore, if an acetaminophen overdose is suspected, a serum acetaminophen assay should be obtained as early as possible, but no sooner than 4 hours following ingestion. The antidote, N-acetylcysteine, should be administered as early as possible, and within 16 hours of the overdose ingestion for optimal results.

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Darvocet-N (propoxyphene napsylate and acetaminophen) Tablets are available in: The 50 mg tablets are dark orange, capsule shaped, film-coated and imprinted with the script "DARVOCET-N (propoxyphene napsylate and acetaminophen) 50" on one side of the tablet, using edible black ink. They are available as follows: Bottles of 100.........................NDC 66479-514-10 The 100 mg tablets are dark orange, capsule shaped, film-coated, and imprinted with the script "DARVOCET-N (propoxyphene napsylate and acetaminophen) 100" on one side of the tablet, using edible black ink. They are available as follows: Bottles of 100.........................NDC 66479-515-10
Bottles of 500.........................NDC 66479-515-50 Store at 25°C (77°F); excursions are permitted to 15°- 30°C (59°- 86°F) [see USP Controlled Room Temperature]. Inform patients of the availability of a Medication Guide for Darvocet-N (propoxyphene napsylate and acetaminophen) that accompanies each prescription dispensed. Instruct patients to read the Darvocet-N (propoxyphene napsylate and acetaminophen) Medication Guide prior to using Darvocet-N (propoxyphene napsylate and acetaminophen) . Marketed by: Xanodyne pharmaceuticals, inc. Newport, KY 41071. REV. 09/2009 Last reviewed on RxList: 12/20/2010
This monograph has been modified to include the generic and brand name in many instances.

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Tolerance and Physical Dependence Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy. The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. In general, opioids should not be abruptly discontinued (see DOSAGE AND ADMINISTRATION: Cessation of Therapy). If Darvocet-N (propoxyphene napsylate and acetaminophen) is abruptly discontinued in a physically dependent patient, an abstinence syndrome may occur (see Drug Abuse And Dependence). If signs and symptoms of withdrawal occur, patients should be treated by reinstitution of opioid therapy followed by gradual tapered dose reduction of Darvocet-N (propoxyphene napsylate and acetaminophen) combined with symptomatic support (see DOSAGE AND ADMINISTRATION: Cessation of Therapy). Use in Pancreatic/Biliary Tract Disease Darvocet-N (propoxyphene napsylate and acetaminophen) may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids like Darvocet-N (propoxyphene napsylate and acetaminophen) may cause increases in the serum amylase level. Hepatic or Renal Impairment Insufficient information exists to make appropriate dosing recommendations regarding the use of either propoxyphene alone or in combination with acetaminophen in patients with hepatic or renal impairment as a function of degree of impairment. Higher plasma concentrations and/or delayed elimination may occur in case of impaired hepatic function and/or impaired renal function (see CLINICAL PHARMACOLOGY). If the drug is used in these patients, it should be used with caution because of the hepatic metabolism of propoxyphene and acetaminophen and renal excretion of their metabolites. Information for Patients/Caregivers
  • Patients should be advised to report pain and adverse experiences occurring during therapy. Individualization of dosage is essential to make optimal use of this medication.
  • Patients should be advised not to adjust the dose of Darvocet-N (propoxyphene napsylate and acetaminophen) without consulting the prescribing professional.
  • Patients should be advised that Darvocet-N (propoxyphene napsylate and acetaminophen) may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).
  • Patients should not combine Darvocet-N (propoxyphene napsylate and acetaminophen) with central nervous system (CNS) depressants (e.g., sleep aids, tranquilizers) except by the orders of the prescribing physician, because additive effects may occur.
  • Patients should be instructed not to consume alcoholic beverages, including prescription and over-the-counter medications that contain alcohol, while using Darvocet-N (propoxyphene napsylate and acetaminophen) because of risk of serious adverse events including death.
  • Women of childbearing potential who become, or are planning to become, pregnant should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.
  • Patients should be advised that Darvocet-N (propoxyphene napsylate and acetaminophen) is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
  • Patients should be advised that if they have been receiving treatment with Darvocet-N (propoxyphene napsylate and acetaminophen) for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the Darvocet-N (propoxyphene napsylate and acetaminophen) dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.
  • Instruct patients not to consume any other medication that contain acetaminophen, including acetaminophen-based over-the-counter medications, while taking Darvocet-N (propoxyphene napsylate and acetaminophen) .
Carcinogenesis, Mutagenesis, Impairment of Fertility The mutagenic and carcinogenic potential of propoxyphene and acetaminophen alone and in combination have not been evaluated. In animal studies there was no effect of propoxyphene on mating behavior, fertility, duration of gestation, or parturition when rats were fed propoxyphene as a component of their daily diet at estimated daily propoxyphene intake up to 8-fold greater than the maximum human equivalent dose (HED) based on body surface area comparison. At this highest dose, fetal weight and survival on postnatal day 4 was reduced. Acetaminophen has not been studied in animals for effects on fertility and the effects on human fertility are unknown. Pregnancy Risk summary Pregnancy category C. There are no adequate and well-controlled studies of propoxyphene with acetaminophen in pregnant women. While there are limited data in the published literature, adequate animal reproduction studies have not been conducted with propoxyphene or acetaminophen. Therefore, it is not known whether propoxyphene or acetaminophen can affect reproduction or cause fetal harm when administered to a pregnant woman. Propoxyphene with acetaminophen should be given to a pregnant woman only if clearly needed. Clinical considerations Acetaminophen, propoxyphene and its major metabolite, norpropoxyphene, cross the human placenta. Neonates whose mothers have taken opiates chronically may exhibit respiratory depression or withdrawal symptoms. Data In published animal reproduction studies, no teratogenic effects occurred in offspring born to pregnant rats or rabbits that received propoxyphene during organogenesis. Pregnant animals received propoxyphene doses approximately 10-fold (rats) and 4-fold (rabbits) the maximum recommended human dose (based on mg/m2 body surface area comparison). Nursing Mothers Propoxyphene, norpropoxyphene (major metabolite), and acetaminophen are excreted in human milk. Published studies of nursing mothers using propoxyphene detected no adverse effects in nursing infants. Based on a study of six mother-infant pairs, an exclusively breastfed infant receives approximately 2% of the maternal weight-adjusted dose. Norpropoxyphene is renally excreted and renal clearance is lower in neonates than in adults. Therefore, it is possible that prolonged maternal propoxyphene use could result in norpropoxyphene accumulation in a breastfed infant. Watch breastfeeding infants for signs of sedation including poor feeding, somnolence, or respiratory depression. Caution should be exercised when Darvocet-N (propoxyphene napsylate and acetaminophen) is administered to a nursing woman. Pediatric Patients Safety and effectiveness in pediatric patients have not been established. Elderly Patients Clinical studies of Darvocet-N (propoxyphene napsylate and acetaminophen) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, postmarketing reports suggest that patients over the age of 65 may be more susceptible to CNS-related side effects. Therefore, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Decreased total daily dosage should be considered (see DOSAGE AND ADMINISTRATION). Last reviewed on RxList: 12/20/2010
This monograph has been modified to include the generic and brand name in many instances.

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