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. 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 propoxyphene napsylate and acetaminophen may cause increases in the serum amylase level. 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.
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. Propoxyphene is metabolized mainly via the human cytochrome P 3A4 isoenzyme system CYP3A4 , therefore potential interactions may occur when propoxyphene is administered concurrently with agents that affect CYP3A4 activity. 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 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 propoxyphene napsylate and acetaminophen.
When such combined therapy is contemplated, the dose of one or both agents should be reduced. 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 propoxyphene napsylate and acetaminophen is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
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. 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. 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.
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. 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 propoxyphene napsylate and acetaminophen is administered to a nursing woman. Clinical studies of 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.
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. General disorder and administration site conditions: drug ineffective, drug interaction, drug tolerance, influenza type illness, drug withdrawal syndrome.
Hepatobiliary disorder: hepatic steatosis, hepatomegaly, hepatocellular injury. Injury poisoning and procedural complications: drug toxicity, hip fracture, multiple drug overdose, narcotic overdose. Psychiatric: abnormal behavior, confusional state, hallucinations, mental status change. Respiratory, thoracic, and mediastinal disorders: respiratory depression, dyspnoea. 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. In chronic ethanol abusers, this has been reported rarely with short-term use of acetaminophen dosages of 2. 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. Propoxyphene napsylate and acetaminophen is a Schedule IV narcotic under the U. Controlled Substances Act. 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. Propoxyphene napsylate and acetaminophen should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic-containing medications.
Since 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 propoxyphene napsylate and acetaminophen. 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. 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 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 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. Propoxyphene napsylate and acetaminophen is a combination product containing propoxyphene and acetaminophen.
Overdose of propoxyphene napsylate and acetaminophen may present with the signs and symptoms of propoxyphene overdose, acetaminophen overdose or both. 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. 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. 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 CO 2 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. 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.
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.
Both were manufactured by Vintage pharmaceuticals and are discontinued as of writing this. I found a pill in my 14 year old's pocket. It is white oval and V on the front and blank on the back.
Please help me, I'm very worried. This is a moderate pain reliever, generic for Darvocet. A picture can be seen HERE. V and V tablets What are the milligrams of active ingredients in these tablets?
Dispose of unused propoxyphene in your household trash by following the recommendations outlined in the Federal Drug Disposal Guidelines: Take your propoxyphene out of its original container and mix it with an undesirable substance, such as used coffee grounds or kitty litter.
The medication will be less appealing to children and pets, and unrecognizable to people who may intentionally go through your trash.
Put the medication in a sealable bag, empty can, or other container to prevent it from breaking out of a garbage bag. Additional Information for Healthcare Professionals FDA recommends that healthcare professionals: Stop prescribing and dispensing propoxyphene-containing products to patients.
Contact patients currently taking propoxyphene-containing products and ask them to discontinue the drug. Inform patients of the risks associated with propoxyphene. Discuss alternative pain management strategies other than propoxyphene with your patients. Be aware of the possible risk of cardiac conduction abnormalities prolonged QT, PR, and QRS intervals in patients taking propoxyphene and assess patients for these events if they present with any signs or symptoms of arrhythmia.
October Beaver WT. Mild analgesics. A review of their clinical pharmacology. Am J Med Sci. Lasagna L. The clinical evaluation of morphine and its substitutes as analgesics. Pharmacol Rev.
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