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
Trental Warnings, Precautions, Pregnancy, Nursing, Abuse - Pentoxifylline
Trental Warnings, Precautions, Pregnancy, Nursing, Abuse - Pentoxifylline
WARNINGS
TRENTAL should not be used in patients with recent cerebral and/or
retinal hemorrhage
or in patients who have previously exhibited intolerance to this
product or methylxanthines
such as caffeine, theophylline,
and theobromine.
PRECAUTIONS
General
Patients with chronic
occlusive arterial
disease of the limbs
frequently show other manifestations of arteriosclerotic disease.
TRENTAL has been used safely for treatment
of peripheral arterial
disease in patients
with concurrent coronary
artery and cerebrovascular
diseases, but there have been occasional reports of angina,
hypotension, and
arrhythmia. Controlled trials do not show
that TRENTAL causes such
adverse effects more often than placebo,
but, as it is a methylxanthine
derivative, it is possible some individuals will
experience such
responses. Patients on Warfarin should have more frequent monitoring
of prothrombin times,
while patients with other risk
factors complicated by hemorrhage
(e.g., recent surgery,
peptic ulceration, cerebral and/or retinal
bleeding) should have periodic
examinations for bleeding
including, hematocrit
and/or hemoglobin.
Drug Interactions
See DRUG INTERACTIONS section.
Carcinogenesis, Mutagenesis and Impairment of Fertility
Long-term studies of the carcinogenic
potential of pentoxifylline
were conducted in mice and rats by dietary
administration
of the drug at doses up
to 450 mg/kg (approximately 19 times the maximum
recommended human daily
dose (MRHD) in both species
when based on body weight;
1.5 times the MRHD in the mouse
and 3.3 times the MRHD in the rat
when based on body surface
area). In mice, the drug
was administered for 18 months, whereas in rats, the drug
was administered for 18 months followed by an additional 6 months
without drug exposure.
In the rat
study, there was a statistically significant increase in benign
mammary fibroadenomas
in females of the 450 mg/kg group. The relevance of this finding
to human use is uncertain.
Pentoxifylline was devoid of mutagenic activity
in various strains of Salmonella (Ames test) and in cultured
mammalian cells (unscheduled DNA
synthesis test) when tested in the presence and absence
of metabolic activation. It was also negative
in the in vivo mouse micronucleus
test.
Pregnancy
Category C. Teratogenicity studies have been performed
in rats and rabbits using oral
doses up to 576 and 264 mg/kg, respectively. On a weight
basis, these doses are 24 and 11 times the maximum
recommended human daily
dose (MRHD); on a body-surface-area basis, they are 4.2 and 3.5
times the MRHD. No evidence
of fetal malformation
was observed. Increased resorption
was seen in rats of the 576 mg/kg group. There are no
adequate and well controlled studies in pregnant
women. TRENTAL (pentoxifylline) should be used during pregnancy
only if the potential
benefit justifies the
potential risk
to the fetus.
Nursing Mothers
Pentoxifylline and its metabolites are excreted in human
milk. Because of the potential
for tumorigenicity shown for pentoxifylline
in rats, a decision should be made whether to discontinue nursing
or discontinue the drug, taking into account the importance of the
drug to the mother.
Pediatric Use
Safety and effectiveness
in pediatric patients
have not been established.
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