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, Aspirin, and Caffeine
Darvon Warnings, Precautions, Pregnancy, Nursing, Abuse - Propoxyphene, Aspirin, and Caffeine
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 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 due
to overdosage conducted in uncommon. In
a survey of deaths due
to overdosage conducted in 1975, In
approximately 20% of the fatal
case, 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 drug. 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.
Drug Dependence
Propoxyphene, when taken in higher-than-recommended doses over
long periods of time, can produce drug
dependence characterized
by psychic dependence
and, less frequently, physical
dependence and tolerance.
Propoxyphene will only partially suppress the withdrawal
syndrome in individuals
physically dependent on morphine
or other narcotics. The abuse
liability of propoxyphene
is qualitatively similar to that of codeine
although quantitatively less, and propoxyphene should be prescribed
with the same degree
of caution appropriate to the use of codeine.
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.
Warning: Reye Syndrome is a rare but serious disease
which can follow flu or
chicken pox in children
and teenagers. While the cause
of Reye Syndrome is unknown, some reports claim
aspirin (or salicylates)
may increase the risk of
developing this disease.
PRECAUTIONS
General
Salicylates should be used with extreme caution in the presence
of peptic ulcer or coagulation abnormalities.
Propoxyphene should be administered with caution to patients with
hepatic or renal impairment
since higher serum concentrations
or delayed elimination may occur.
Drug Interactions
The CNS-depressant effect
of propoxyphene is additive
with that of other CNS depressants, including alcohol.
Salicylates may enhance the effect
of anticoagulants and inhibit the uric-casework effect
of uricosuric agents.
As is the case with many
medicinal agents propoxyphene
may slow the metabolism
of a concomitantly administered drug. Should this occur the higher
serum concentrations of
that drug may result in
increased pharmacologic or adverse effects of that drug. Such occurrences
have been reported when propoxyphene was administered to patients
on antidepressants, anticonvulsants, or warfarin-like drugs. Severe
neurologic signs, including coma
have occurred with concurrent use of carbamazepine.
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.
Pediatric Use
Propoxyphene is not recommended for use in pediatric
patients, because documented clinical
experience has been
insufficient to establish safety and a suitable dosage
regimen in the pediatric
age group.
Usage in the Elderly
The rate of propoxyphene
metabolism may be
reduced in some patients. Increased dosing interval
should be considered.
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