Darvon (Propoxyphene) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 21, 2012

Darvon

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Sleep disorder drugs (hypnotic and sedative drugs) overview

Insomnia, a disorder of sleep, occurs occasionally in most people but usually lasts only a few days. The body then "corrects" itself naturally, and people return to a normal pattern of sleep. Insomnia may be short-term (less than three weeks) or chronic, lasting longer than three weeks. Contributing factors include, but are not limited to, poor sleeping habits, stress, jet lag, medications, disease, and depression. Chronic insomnia may warrant the use of sedative/hypnotics medications; however, it is important that the treating physician perform a complete diagnostic evaluation as well as take medication and substance abuse histories, to exclude secondary insomnia due to other conditions.

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Darvon

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DARVON®
(propoxyphene hydrochloride) Capsules, USP Pulvules®

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).

DRUG DESCRIPTION

Darvon contains propoxyphene hydrochloride, USP which is an odorless, white crystalline powder with a bitter taste. It is freely soluble in water. Chemically, it is (2S,3R)-(+)-4-(Dimethylamino)-3-methyl-1,2-diphenyl-2-butanol propionate (ester) hydrochloride, which can be represented by the accompanying structural formula. Its molecular weight is 375.94.

DARVON (propoxyphene hydrochloride) Structural Formula Illustration

Each pulvule contains 65 mg (172.9 µmol) propoxyphene hydrochloride. It also contains D & C Red No. 33, F D & C Yellow No. 6, gelatin, magnesium stearate, silicone, starch, titanium dioxide, and other inactive ingredients.

What are the possible side effects of propoxyphene (Darvon, Darvon-N)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

shallow breathing, slow heartbeat;
feeling light-headed, fainting;
confusion, hallucinations, unusual thoughts or behavior;
seizure (convulsions); or
jaundice (yellowing of the skin or eyes).

Less serious side effects...

Read All Potential Side Effects and See Pictures of Darvon »

What are the precautions when taking propoxyphene (Darvon)?

Before taking propoxyphene, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty...

Read All Potential Precautions of Darvon »

Last reviewed on RxList: 10/12/2009
This monograph has been modified to include the generic and brand name in many instances.