Drug: Darvon Compound

PROPOXYPHENE COMPOUND 65 mg CAPSULES (Propoxyphene Hydrochloride, Aspirin, and Caffeine Capsules,USP) Propoxyphene hydrochloride is an odorless, white crystalline powder with a bitter taste. It is freely soluble in water. Chemically, it is alpha (+)-4-(Dimethylamino)-3-methyl-1,2-diphenyl-2-butanol Propionate Hydrochloride. Each Pulvule¨ contains 65 mg (172.9 µmol) propoxyphene hydrochloride, 389 mg (2,159 µmol) aspirin, and 32.4 mg (166.8 µmol) caffeine. It also contains F D & C Red No. 3, F D & C Yellow No. 6, gelatin, glutamic acid hydrochloride, iron oxide, kaolin, silicone, titanium dioxide, and other inactive ingredients.

Source: http://www.rxlist.com

In a survey conducted in hospitalized patients less than 1% of patients taking propoxyphene hydrochloride at recommended doses experienced side effects. The most frequently reported were dizziness, sedation, nausea and vomiting. Some of these adverse reactions may be alleviated if the patient lies down. Other adverse reactions include constipation, abdominal pain, skin rashes, lightheadedness, headache, weakness, euphoria, dysphoria hallucinations, and minor visual disturbances. Propoxyphene therapy has been associated with abnormal liver function tests and more rarely with instances of reversible jaundice (including cholestatic jaundice). Renal papillary necrosis may result from chronic aspirin use, particularly when the dosage is greater than recommended and when combined with acetaminophen. Subacute painful myopathy has occurred following chronic propoxyphene overdosage. Read the Darvon Compound (propoxyphene, aspirin, and caffeine) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

This product is given orally. The usual dosage is 65 mg propoxyphene hydrochloride, 389 mg aspirin and 32.4 mg caffeine (one capsule) every 4 hours as needed for pain. The maximum recommended dose of propoxyphene hydrochloride is 390 mg per day. Consideration should be given to a reduced total daily dosage in patients with hepatic or renal impairment.

Source: http://www.rxlist.com

The CNS-depressant effect of propoxyphene is additive with that of other CNS depressants, including alcohol. Salicylates may enhance the effect of anticoagulants and inhibit the uric-casework effect of uricosuric agents. As is the case with many medicinal agents propoxyphene may slow the metabolism of a concomitantly administered drug. Should this occur the higher serum concentrations of that drug may result in increased pharmacologic or adverse effects of that drug. Such occurrences have been reported when propoxyphene was administered to patients on antidepressants, anticonvulsants, or warfarin-like drugs. Severe neurologic signs, including coma have occurred with concurrent use of carbamazepine.Last reviewed on RxList: 1/29/2005
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

This product is indicated for the relief of mild to moderate pain, either when pain is present alone or when it is accompanied by fever.

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Hypersensitivity to propoxyphene, aspirin, or caffeine.Last reviewed on RxList: 1/29/2005
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

In all cases of suspected over-dosage, 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. Symptoms of Propoxyphene OVERDOSE The manifestations of acute overdosage with propoxyphene are those of narcotic 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 (hypercapnea) 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 at Propoxyphene OVERDOSE 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 narcotic antagonist naloxone will markedly reduce the degree of respiratory depression, and 0.4 mg to 2 mg should be administered promptly, preferably intravenously. If the desired degree of counteraction with improvement in respiratory functions is not obtained, naloxone should be repeated at 2 to 3-minute intervals. 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. Naloxone may also be administered by continuous intravenous infusion. Treatment of Propoxyphene Overdosage in Pediatric Patients The usual initial dose of naloxone in children is 0.01 mg/kg body weight given intravenously. If this dose does not result in the desired degree of clinical improvement, a subsequent increased dose of 0.1 mg/kg body weight may be administered. If an IV route of administration is not available naloxone may be administered IM or subcutaneously in divided doses. If necessary, naloxone can be diluted with sterile water for injection. Blood gases, pH, and electrolytes should be monitored in order that acidosis and any electrolyte disturbance present may be corrected promptly. Acidosis, hypoxia, and generalized CNS depression predispose to the development of cardiac arrhythmias. Ventricular fibrillation or cardiac arrest may occur and necessitate the full complement of cardiopulmonary resuscitation (CPR) measures. Respiratory acidosis rapidly subsides as ventilation is restored and hypercapnea eliminated, but lactic acidosis may require intravenous bicarbonate for prompt correction. Electrocardiographic monitoring is essential. Prompt correction of hypoxia, acidosis and electrolyte disturbance (when present) will help prevent these cardiac complications and will increase the effectiveness of agents administered to restore normal cardiac function. In addition to the use of a narcotic antagonist the patient may require careful titration with an anticonvulsant to control convulsions. Analeptic drugs (for example, caffeine or amphetamine) should not be used because of their tendency to precipitate convulsions. General supportive measures in addition to oxygen include, when necessary, intravenous fluids, vasopressor-inotropic compounds and when infection is likely anti-infective agents. Gastric lavage may be useful and 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. Symptoms of Salicylate OVERDOSE Such symptoms include central nausea and vomiting tinnitus and deafness, vertigo and headaches, mental dullness and confusion, diaphoresis, rapid pulse and increased respiration and respiratory alkalosis. Treatment of Salicylate OVERDOSE When propoxyphene with aspirin and caffeine has been ingested the clinical picture may be complicated by salicylism. The treatment of acute salicylate intoxication includes minimizing drug absorption, promoting elimination through the kidneys, and correcting metabolic derangements affecting body temperature, hydration, acid-base balance, and electrolyte balance. The technique to be employed for eliminating salicylate from the bloodstream depends on the degree of drug intoxication. If the patient is seen within 4 hours of ingestion the stomach should be emptied by inducing vomiting or by gastric lavage as soon as possible. The nomogram of Done is a useful prognostic guide in which the expected severity of salicylate intoxication is based on serum salicylate levels and the time interval between ingestion and taking the blood sample. Exchange transfusion is most feasible for a small infant. Intermittent peritoneal dialysis is useful for cases of moderate severity in adults. Intravenous fluids alkalinized by the addition of sodium bicarbonate or potassium citrate are helpful. Hemodialysis with the artificial kidney is the most effective means of removing salicylate and is indicated for the very severe cases of salicylate intoxication.

Source: http://www.rxlist.com

Darvon® Compound 65 Pulvules® are available in:
The 65 mg parabolic-shaped capsules are imprinted with the script "Darvon Comp 65" on the opaque red body in axial print, using edible black ink. There are available as follows:
Bottles of 100     NDC 66591-612-41
Bottles of 500     NDC 66591-612-51 Store at controlled room temperature 15°-30°C (59°-86°F). Dispense with child-resistant closure (as required) and in a tight, light-resistant container as defined in the USP CAUTION: Federal law prohibits dispensing without prescription.
Darvon, Darvon-N, Darvocet-N are registered trademarks of aaiPharma LLC.
Darvocet is a trademark of aaiPharma Inc.
© 2003 aaiPharma LLC

Manufactured by:
AAI Development Services
An aaiPharma¨ Company
1726 North 23rd St.
Wilmington, NC 28405

Manufactured for:
aaiPharama®
Wilmington, NC 28405Last reviewed on RxList: 1/29/2005
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

General Salicylates should be used with extreme caution in the presence of peptic ulcer or coagulation abnormalities. Propoxyphene should be administered with caution to patients with hepatic or renal impairment since higher serum concentrations or delayed elimination may occur. Usage In Pregnancy Safe use in pregnancy has not been established relative to possible adverse effects on fetal development. Instances of withdrawal symptoms in the neonate have been reported following usage during pregnancy. Therefore, propoxyphene should not be used in pregnant women unless in the judgment of the physician the potential benefits outweigh the possible hazards. Aspirin does not appear to have teratogenic effects. However, prolonged pregnancy and labor with increased bleeding before and after delivery, decreased birth weight, and increased rate of stillbirth were reported with high blood salicylate levels. Because of possible adverse effects on the neonate and the potential for increased maternal blood loss, aspirin should be avoided during the last 3 months of pregnancy. Usage In Nursing Mothers Low levels of propoxyphene have been detected in human milk. In postpartum studies involving nursing mothers who were given propoxyphene no adverse effects were noted in infants receiving mother's milk. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Usage in the Elderly The rate of propoxyphene metabolism may be reduced in some patients. Increased dosing interval should be considered.Last reviewed on RxList: 1/29/2005
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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