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.
Usage in Ambulatory Patients
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.
PRECAUTIONS
General
Propoxyphene should be administered with caution to patients with
hepatic or renal impairment since higher serum concentrations or delayed
elimination may occur.
Pregnancy
Safe use in pregnancy has not been established relative to possible adverse
effects on fetal development. Instances of withdrawal symptoms in the neonate
have been reported following usage during pregnancy. Therefore, propoxyphene
should not be used in pregnant women unless, in the judgment of the physician,
the potential benefits outweigh the possible hazards.
Nursing Mothers
Low levels of propoxyphene have been detected in human milk. In postpartum
studies involving nursing mothers who were given propoxyphene, no adverse
effects were noted in infants receiving mother’s milk.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
The rate of propoxyphene metabolism may be reduced in some patients. Increased
dosing interval should be considered.
|