"The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternat"...
(Generic versions may still be available.)
DOSAGE AND ADMINISTRATION
Darvon (propoxyphene) is 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.
Darvon is given orally. The usual dosage is one 65 mg propoxyphene hydrochloride capsule every 4 hours as needed for pain. The maximum dose of Darvon (propoxyphene) is 6 tablets 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.
Cessation of Therapy
For patients who used Darvon (propoxyphene) on a regular basis for a period of time, when therapy with Darvon (propoxyphene) is no longer needed for the treatment of their pain, it may be useful to gradually discontinue the Darvon (propoxyphene) 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.
Darvon (propoxyphene) Pulvules are available in:
65 mg capsules with opaque pink body and cap, imprinted with the script "Darvon (propoxyphene) " on the body, in edible black ink.
They are available as follows:
Bottles of 100........................NDC 66479-510-10
Storage: Store at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature].
Inform patients of the availability of a Medication Guide for Darvon (propoxyphene) /Darvon (propoxyphene) -N that accompanies each prescription dispensed. Instruct patients to read the Darvon (propoxyphene) /Darvon (propoxyphene) -N Medication Guide prior to using Darvon (propoxyphene) .
Marketed by: X-nodyne pharmaceuticals, inc. Newport, KY 41071. REV. 09-2009.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/12/2009
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