Darvon – N (Propoxyphene Napsylate)

DARVON-N®

Lilly

Propoxyphene Napsylate

Analgesic

Indications And Clinical Uses: For the relief of mild to moderate pain alone or when it is accompanied by fever.

Contra-Indications: Hypersensitivity to any of the components

Manufacturers’ Warnings In Clinical States: Do not prescribe propoxyphene for patients who are suicidal or addiction-prone.

Prescribe propoxyphene with caution for patients taking tranquilizers or antidepressant drugs and patients who use alcohol in excess.

Tell your patients not to exceed the recommended dose and to limit their intake of alcohol.

Propoxyphene products in excessive doses, either alone or in combination with other CNS depressants, including alcohol, are a major cause of drug-related deaths. Fatalities within the first hour of overdosage are not uncommon.

Propoxyphene should not be taken in doses higher than those recommended. The judicious prescribing of propoxyphene is essential to the safe use of this drug. With patients who are depressed or suicidal, consideration should be given to the use of non-narcotic analgesics. Patients should be cautioned about the concomitant use of propoxyphene products and alcohol because of potentially serious CNS-additive effects of these agents. Because of its added depressant effects, propoxyphene should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs. Patients should be advised of the additive depressant effects of these combinations.

Many of the propoxyphene-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation or attempts, as well as histories of misuse of tranquilizers, alcohol, and other CNS-active drugs. Some deaths have occurred as a consequence of the accidental ingestion of excessive quantities of propoxyphene alone or in combination with other drugs.

Drug dependence: Propoxyphene, when taken in higher-than- recommended doses over long periods of time, can produce drug dependence characterized by psychic dependence and, less frequently, physical dependence and tolerance. Propoxyphene will only partially suppress the withdrawal syndrome in individuals physically dependent on morphine or other narcotics. The abuse liability of propoxyphene is qualitatively similar to that of codeine although quantitatively less, and propoxyphene should be prescribed with the same degree of caution appropriate to the use of codeine.

Occupational Hazards: Ambulatory patients: Propoxyphene may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. The patient should be cautioned accordingly.

Precautions: Drug Interactions: The CNS-depressant effect of propoxyphene is additive with that of other CNS depressants, including alcohol.

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.

Lactation: 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.

Children: Propoxyphene is not recommended for use in children, because documented clinical experience has been insufficient to establish safety and a suitable dosage regimen in the pediatric age group.

Confusion, anxiety, and tremors have been reported in a few patients receiving propoxyphene concomitant with orphenadrine.

Adverse Reactions: Such adverse effects as dizziness, headache, sedation, somnolence, paradoxical excitement and insomnia, skin rash, and gastrointestinal disturbances (including nausea, vomiting, abdominal pain and constipation) may occur with the recommended doses of propoxyphene napsylate. Euphoria, dysphoria, and minor visual disturbance also have been reported.

The chronic ingestion of propoxyphene in doses exceeding 800 mg per day has caused toxic psychoses and convulsions. A single dose of 1 200 mg of propoxyphene napsylate has caused convulsions.

Symptoms And Treatment Of Overdose: Symptoms: The manifestations of serious overdosage with propoxyphene are similar to those of narcotic overdosage and include respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, initial pupillary constriction followed by dilation as hypoxia increases and circulatory collapse. In addition to these characteristics typical of narcotic poisoning, local and generalized convulsions constitute a prominent feature in most cases of severe propoxyphene poisoning, and cardiac arrhythmias and pulmonary edema have occasionally been reported. Apnea, cardiac arrest and death have occurred. tag_Treatment

Treatment: Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. The narcotic antagonist naloxone, is a specific antidote against the respiratory depression produced by propoxyphene.

An appropriate dose should be administered, preferably by the i.v. route, simultaneously with efforts at respiratory resuscitation, and should be repeated as necessary, at 20 to 30 minute intervals, until the patient’s condition remains satisfactory. 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. (Nalorphine and levallorphan may be used if naloxone is not available, but these agents are not as satisfactory as naloxone.)

Blood gases, pH, and electrolytes should be monitored in order that acidosis and any electrolytic disturbance present may be promptly corrected. 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 resuscitative (CPR) measures. Respiratory acidosis rapidly subsides as ventilation is restored and hypercapnea eliminated, but residual lactic acidosis may require i.v. bicarbonate for prompt correction.

Electrocardiographic monitoring is essential. Prompt correction of hypoxia, acidosis, and electrolytic 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 seizures. Analeptic drugs (e.g., caffeine or amphetamine) should not be used because of their tendency to precipitate convulsions.

General supportive measures, in addition to oxygen, include, when necessary, i.v. 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.

Dosage And Administration: Adults: 1 capsule 3 or 4 times daily. The maximum dose should not exceed 600 mg/day.

SuppliedSupplied: Each No. 3, pink capsule contains: propoxyphene napsylate 100 mg. Identi-Code: H64. Nonmedicinal ingredients: dimethicone and starch. Tartrazine-free. Bottles of 100.

DARVON-N® Lilly Propoxyphene Napsylate Analgesic

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