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
Pletal Side Effects, and Drug Interactions - Cilostazol
Pletal Side Effects, and Drug Interactions - Cilostazol
SIDE EFFECTS
Adverse events were assessed in eight placebo-controlled clinical trials involving
2274 patients exposed to either 50 or 100 mg b.i.d. PLETAL (n=1301) or placebo (n=973), with a median
treatment duration of 127 days for patients on PLETAL and 134 days for patients on placebo.
The only adverse event resulting in discontinuation of therapy in = 3% of patients treated with PLETAL
50 or 100 mg b.i.d. was headache, which occurred with an incidence of 1.3%, 3.5%, and 0.3% in
patients treated with PLETAL 50 mg b.i.d., 100 mg b.i.d, or placebo, respectively. Other frequent causes
of discontinuation included palpitation and diarrhea, both 1.1% for cilostazol (all doses) versus 0.1%
for placebo.
The most commonly reported adverse events, occurring in = 2% of patients treated with PLETAL 50
or 100 mg b.i.d., are shown in the table (shown below).
Other events seen with an incidence of = 2%, but occurring in the placebo group at least as frequently
as in the 100 mg b.i.d. group were: asthenia, hypertension, vomiting, leg cramps, hypesthesia,
paresthesia, dyspnea, rash, hematuria, urinary tract infection, flu syndrome, angina pectoris, arthritis,
and bronchitis.
Less frequent adverse events (< 2%) that were experienced by patients exposed to
PLETAL 50 mg b.i.d. or 100 mg b.i.d. in the eight controlled clinical trials and that occurred at a
frequency in the 100 mg b.i.d. group greater than in the placebo group, regardless of suspected drug
relationship, are listed below.
Body as a whole: Chills, face edema, fever, generalized edema, malaise, neck rigidity, pelvic pain,
retroperitoneal haemorrhage.
Cardiovascular: Atrial fibrillation, atrial flutter, cerebral infarct, cerebral ischemia, congestive heart failure,
heart arrest, haemorrhage, hypotension, myocardial infarction, myocardial ischemia, nodal arrhythmia,
postural hypotension, supraventricular tachycardia, syncope, varicose vein, vasodilation, ventricular
extrasystoles, ventricular tachycardia.
Digestive: Anorexia, cholelithiasis, colitis, duodenal ulcer, duodenitis, esophageal haemorrhage, esophagitis,
increased GGT, gastritis, gastroenteritis, gum haemorrhage, hematemesis, melena, peptic ulcer, periodontal
abscess, rectal haemorrhage, stomach ulcer, tongue edema.
Endocrine: Diabetes mellitus.
Hemic and Lymphatic: Anemia, ecchymosis, iron deficiency anemia, polycythemia, purpura.
Metabolic and Nutritional: Increased creatinine, gout, hyperlipemia, hyperuricemia.
Musculoskeletal: AArthralgia, bone pain, bursitis.
Nervous: Anxiety, insomnia, neuralgia.
Respiratory: Asthma, epistaxis, hemoptysis, pneumonia, sinusitis.
Skin and Appendages: Dry skin, furunculosis, skin hypertrophy, urticaria.
Special Senses: Amblyopia, blindness, conjunctivitis, diplopia, ear pain, eye haemorrhage, retinal
haemorrhage, tinnitus.
Urogenital: Albuminuria, cystitis, urinary frequency, vaginal haemorrhage, vaginitis.
|
Adverse Events (AEs) by Body
System
|
Most Commonly Reported AEs
(Incidence ³ 2%) in Patients on
PLETAL (PLT) 50 mg b.i.d.
or 100 mg b.i.d.
and Occurring at a Rate in the 100 mg
b.i.d. Group Higher
Than in Patients on Placebo
|
|
PLT 50 mg
b.i.d.
(N=303)
|
PLT 100 mg
b.i.d.
(N=998)
|
Placebo
(N=973)
|
|
%
|
%
|
%
|
BODY AS A WHOLE
|
| Abdominal pain |
4
|
5
|
3
|
| Back pain |
6
|
7
|
6
|
| Headache |
27
|
34
|
14
|
| Infection |
14
|
10
|
8
|
CARDIOVASCULAR
|
| Palpitation |
5
|
10
|
1
|
| Tachycardia |
4
|
4
|
1
|
DIGESTIVE
|
| Abnormal stools |
12
|
15
|
4
|
| Diarrhea |
12
|
19
|
7
|
| Dyspepsia |
6
|
6
|
4
|
| Flatulence |
2
|
3
|
2
|
| Nausea |
6
|
7
|
6
|
METABOLIC & NUTRITIONAL
|
| Peripheral edema |
9
|
7
|
4
|
MUSCULO-SKELETAL
|
| Myalgia |
2
|
3
|
2
|
NERVOUS
|
| Dizziness |
9
|
10
|
6
|
| Vertigo 3 1 1 |
RESPIRATORY
|
| Cough increased |
3
|
4
|
3
|
| Pharyngitis |
7
|
10
|
7
|
| Rhinitis |
12
|
7
|
5
|
DRUG INTERACTIONS
Since PLETAL is extensively metabolized by cytochrome
P-450 isoenzymes, caution should be exercised when PLETAL is coadministered
with inhibitors of C.P.A. such
as ketoconazole and erythromycin
or inhibitors of CYP2C19 such as omeprazole. Pharmacokinetic studies have
demonstrated that omeprazole and erythromycin
significantly increased the systemic
exposure of cilostazol and/or
its major metabolites. Population pharmacokinetic studies showed higher
concentrations of cilostazol among patients concurrently treated with
diltiazem, an inhibitor
of C.P.A. (see CLINICAL
PHARMACOLOGY: Pharmacokinetic and Pharmacodynamic Drug-Drug
Interactions). Pletal does not, however, appear to cause
increased blood levels of drugs metabolized by CYP3A4, as it had no
effect on lovastatin, a drug
with metabolism very sensitive
to C.P.A. inhibition.
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