Brand Names

COMPOUND 65
DARVOCET
DARVON
DARVON COMPOUND
DARVON COMPOUND-65
DARVON W/ ASA
DOLENE
DOLENE AP-65
KESSO-GESIC
PROPHENE 65
PROPOXYPHENE COMPOUND 65
PROPOXYPHENE COMPOUND-65
PROPOXYPHENE HYDROCHLORIDE
PROPOXYPHENE HYDROCHLORIDE 65
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
PROPOXYPHENE HYDROCHLORIDE W/ ASPIRIN AND CAFFEINE
WYGESIC

Boxed Warning

WARNINGS There have been numerous cases of accidental and intentional overdose with propoxyphene products either alone or in combination with other CNS depressants, including alcohol. Fatalities within the first hour of overdosage are not uncommon. Many of the propoxyphene-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation/attempts and/or concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants or other CNS-depressant drugs. Do not prescribe propoxyphene for patients who are suicidal or have a history of suicidal ideation. 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. 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 (see CLINICAL PHARMACOLOGY: Drug Interactions and WARNINGS, PRECAUTIONS and DOSAGE AND ADMINISTRATION for further information).

Indications and Usage

INDICATIONPropoxyphene hydrochloride capsules are indicated for the relief of mild to moderate pain.

Dosage and Administration

DOSAGE AND ADMINISTRATIONPropoxyphene hydrochloride capsules are 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. Propoxyphene hydrochloride capsules are given orally. The usual dosage is one 65 mg propoxyphene hydrochloride capsule every 4 hours as needed for pain. The maximum dose of propoxyphene hydrochloride capsules is 6 capsules 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 TherapyFor patients who used propoxyphene hydrochloride capsules on a regular basis for a period of time, when therapy with propoxyphene hydrochloride capsules is no longer needed for the treatment of their pain, it may be useful to gradually discontinue the propoxyphene hydrochloride capsules 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.

Contraindications

CONTRAINDICATIONSPropoxyphene hydrochloride capsules are contraindicated in patients with known hypersensitivity to propoxyphene. Propoxyphene hydrochloride capsules are 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. Propoxyphene hydrochloride capsules are contraindicated in any patient who has or is suspected of having paralytic ileus.

Adverse Reactions

ADVERSE REACTIONSIn hospitalized patients, the most frequently reported 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 post-marketing 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 post-marketing 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 interaction, drug tolerance, 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 propoxyphene. Propoxyphene therapy has been associated with abnormal liver function tests and, more rarely, with instances of reversible jaundice (including cholestatic jaundice). Subacute pa

Overdosage

OVERDOSAGEOverdose of propoxyphene may present with the signs and symptoms of propoxyphene overdose. 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. Symptoms of Propoxyphene OverdosageThe 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 (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 OverdosageAttention 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

⚠ Caution

Medical Disclaimer: This information is for educational purposes only. Always consult a healthcare professional before taking any medication.