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Basic Drug Info
Drug Name:Propoxyphene Hydrochloride and Acetaminophen
Manufacturer:Qualitest Pharmaceuticals
Other Info:Manufactured for:QUALITEST PHARMACEUTICALSHuntsville, AL 358118181577R11/07-R1Dispensing Pharmacy: Please call 800-444-4011 to request additional Patient Information Leaflets at no charge from the Regulatory Affairs Department.  



Clinical Trials:


Indications and Usage
Propoxyphene HCl and acetaminophen tablets are indicated for the relief of mild-to-moderate pain, either when pain is present alone or when it is accompanied by fever.
Pain -- An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.

Contraindications
Hypersensitivity to propoxyphene or to acetaminophen.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

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.

In a survey of deaths due to overdosage conducted in 1975, in approximately 20% of the fatal cases, death occurred within the first hour (5% occurred within 15 minutes).

Propoxyphene should not be taken in doses higher than those recommended by the physician.

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.

Patients taking propoxyphene should be warned not to exceed the dosage recommended by the physician.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.