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 Side Effects, and Drug Interactions - Pentoxifylline
Trental Side Effects, and Drug Interactions - Pentoxifylline
SIDE EFFECTS
Clinical trials were conducted using either controlled-release
TRENTAL tablets for up to 60 weeks or immediate-release TRENTAL
capsules for up to 24 weeks. Dosage ranges in the tablet
studies were 400 mg bid to
tid and in the capsule
studies, 200-400 mg tid.
The table summarizes the
incidence (in percent)
of adverse reactions considered drug
related, as well as the numbers of patients who received controlled-release
TRENTAL tablets, immediate-release TRENTAL capsules, or the corresponding
placebos. The incidence
of adverse reactions was higher in the capsule
studies (where dose related increases were seen in digestive
and nervous system
side effects) than in the
tablet studies. Studies
with the capsule include
domestic experience, whereas studies with the controlled-release
tablets were conducted outside the U.S.
The table indicates that
in the tablet studies
few patients discontinued because of adverse effects.
INCIDENCE (%) OF SIDE EFFECTS
| |
Controlled-Release
Tablets
Commercially
Available
|
Immediate-Release
Capsules
Used only for
Controlled Clinical
Trials
|
|
TRENTAL
|
Placebo
|
TRENTAL
|
Placebo
|
| (Numbers of Patients at Risk) |
(321)
|
(128)
|
(177)
|
(138)
|
| Discontinued for Side Effect |
3.1
|
0
|
9.6
|
7.2
|
| CARDIOVASCULAR
SYSTEM |
| Angina/Chest Pain |
0.3
|
-
|
1.1
|
2.2
|
| Arrhythmia/Palpitation |
-
|
-
|
1.7
|
0.7
|
| Flushing |
-
|
-
|
2.3
|
0.7
|
| DIGESTIVE
SYSTEM |
| Abdominal Discomfort |
-
|
-
|
4.0
|
1.4
|
| Belching/Flatus/Bloating |
0.6
|
-
|
9.0
|
3.6
|
| Diarrhea |
-
|
-
|
3.4
|
2.9
|
| Dyspepsia |
2.8
|
4.7
|
9.6
|
2.9
|
| Nausea |
2.2
|
0.8
|
28.8
|
8.7
|
| Vomiting |
1.2
|
-
|
4.5
|
0.7
|
| NERVOUS
SYSTEM |
| Agitation/Nervousness |
-
|
-
|
1.7
|
0.7
|
| Dizziness |
1.9
|
3.1
|
11.9
|
4.3
|
| Drowsiness |
-
|
-
|
1.1
|
5.8
|
| Headache |
1.2
|
1.6
|
6.2
|
5.8
|
| Insomnia |
-
|
-
|
2.3
|
2.2
|
| Tremor |
0.3
|
0.8
|
-
|
-
|
| Blurred Vision |
-
|
-
|
2.3
|
1.4
|
TRENTAL has been marketed in Europe and elsewhere since 1972. In
addition to the above
symptoms, the following have been reported spontaneously since marketing
or occurred in other clinical
trials with an incidence
of less than 1%; the causal relationship was uncertain:
Cardiovascular - dyspnea,
edema, hypotension.
Digestive - anorexia,
cholecystitis, constipation,
dry mouth/thirst.
Nervous - anxiety,
confusion, depression,
seizures.
Respiratory - epistaxis,
flu-like symptoms, laryngitis,
nasal congestion.
Skin and Appendages - brittle fingernails, pruritus,
rash, urticaria,
angioedema.
Special Senses - blurred vision, conjunctivitis,
earache, scotoma.
Miscellaneous - bad taste, excessive salivation,
leukopenia, malaise,
sore throat/swollen neck
glands, weight change.
A few rare events have been reported spontaneously worldwide since
marketing in 1972. Although they occurred under circumstances in
which a causal relationship with pentoxifylline
could not be established, they are listed to serve as information
for physicians. "Cardiovascular?angina, arrhythmia, tachycardia,
anaphylactoid reactions." Digestive?hepatitis, jaundice, increased
liver enzymes; and Hemic
and Lymphatic?decreased serum fibrinogen, pancytopenia,
aplastic anemia, leukemia,
purpura, thrombocytopenia.
DRUG INTERACTIONS
Although a causal relationship has not been established, there
have been reports of bleeding
and/or prolonged prothrombin
time in patients treated
with TRENTAL with and without anticoagulants or platelet aggregation
inhibitors. 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) should
have periodic examinations
for bleeding including
hematocrit and/or
hemoglobin. Concomitant administration
of TRENTAL and theophylline-containing drugs leads to increased
theophylline levels
and theophylline
toxicity in some individuals.
Such patients should be closely monitored for signs of toxicity
and have their theophylline
dosage adjusted as necessary.
TRENTAL has been used concurrently with antihypertensive
drugs, beta blockers, digitalis,
diuretics, antidiabetic
agents, and antiarrhythmics, without observed problems. Small decreases
in blood pressure
have been observed in some patients treated with TRENTAL; periodic
systemic blood
pressure monitoring
is recommended for patients receiving concomitant
antihypertensive
therapy. If indicated, dosage of the antihypertensive
agents should be reduced.
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