A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Darvon Warnings, Precautions, Pregnancy, Nursing, Abuse - Propoxyphene
Darvon Warnings, Precautions, Pregnancy, Nursing, Abuse - Propoxyphene
WARNINGS
SPECIAL 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
along 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 hours (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, considerations 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.
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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.
Usage in 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.
Usage in 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.
Usage in Children
Propoxyphene is not recommended for use in children, because documented
clinical experience
has been insufficient to establish safety and a suitable dosage
regimen in the pediatric
age group.
Geriatric Use
The rate of propoxyphene
metabolism may be reduced in some patients. Increased dosing interval
should be considered.
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