Propoxyphene Hydrochloride
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Questions & Answers
Side Effects & Adverse Reactions
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.
Respiratory depression is the chief hazard from all opioid agonist preparations. Respiratory depression occurs most frequently in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration. Propoxyphene hydrochloride capsule should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of propoxyphene hydrochloride capsule may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.
Propoxyphene hydrochloride capsule, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone. Propoxyphene hydrochloride capsule may produce orthostatic hypotension in ambulatory patients. Propoxyphene hydrochloride capsule, like all opioid analgesics, should be administered with caution to patients in circulatory shock, since vasodilatation produced by the drug may further reduce cardiac output and blood pressure.
The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.
The concomitant use of propoxyphene and CNS depressants, including alcohol, can result in potentially serious adverse events including death. 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.
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.
Patients should be cautioned about the concomitant use of propoxyphene products and alcohol because of potentially serious CNS-additive effects of these agents that can lead to death.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Propoxyphene hydrochloride capsule is indicated for the relief of mild to moderate pain.
History
There is currently no drug history available for this drug.
Other Information
Propoxyphene Hydrochloride, USP 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.
Each capsule contains 65 mg (172.9 µmol) propoxyphene hydrochloride. It also contains starch NF, magnesium stearate NF, gelatin, titanium dioxide, FD & C Red #40, D & C Red #28 and FD & C Blue #1.
Sources
Propoxyphene Hydrochloride Manufacturers
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Heritage Pharmaceuticals Inc
![Propoxyphene Hydrochloride Capsule [Heritage Pharmaceuticals Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Propoxyphene Hydrochloride | Heritage Pharmaceuticals Inc
Propoxyphene hydrochloride capsule 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.
Propoxyphene hydrochloride capsule is 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 capsule 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.
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 capsule on a regular basis for a period of time, when therapy with propoxyphene hydrochloride capsule is no longer needed for the treatment of their pain, it may be useful to gradually discontinue the propoxyphene hydrochloride capsule 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.
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Bryant Ranch Prepack
Propoxyphene Hydrochloride | Bryant Ranch Prepack
Propoxyphene hydrochloride capsules, USP 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, USP are given orally. The usual dosage is one 65 mg propoxyphene hydrochloride capsule, USP every 4 hours as needed for pain. The maximum dose of propoxyphene hydrochloride capsules, USP 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.
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, USP on a regular basis for a period of time, when therapy with propoxyphene hydrochloride capsules, USP is no longer needed for the treatment of their pain, it may be useful to gradually discontinue the propoxyphene hydrochloride capsules, USP 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.
![Propoxyphene Hydrochloride Capsule [Bryant Ranch Prepack]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=49c4f24c-648b-2db2-5c00-2835d14b1275&name=label1datamaxfda620.jpg)
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