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Cilostazol, Pletal

Description

Cilostazol (Pletal) is a drug for the treatment of intermittent claudication.

Cilostazol dilates the arteries supplying blood to the legs and decreasing platelet coagulation.

Action

inhibits platelet aggregration

Indications

Cilostazol (Pletal) is a drug for the treatment of intermittent claudication

Side Effects

Although side effects from cilostazol are not common, they can occur. Tell your doctor if any of these symptoms are severe or do not go away:

* headache
* fast or irregular heartbeats
* diarrhea
* dizziness
* upset stomach
* stomach pain
* abnormal stools
* runny nose
* sore throat
* flu-like symptoms

If you experience any of the following symptoms, call your doctor immediately:

* rash
* swelling of the hands, feet, ankles, or lower legs
* shortness of breath

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 (to the right).

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, hyperesthesia, 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 placebo, regardless of suspected drug relationship, are listed below.

Body as a whole: Chills, face edema, fever, generalized edema, malaise, neck rigidity, pelvic pain, retroperitoneal hemorrhage.

Cardiovascular: Atrial fibrillation, atrial flutter, cerebral infarct, cerebral ischemia, congestive heart failure, heart arrest, hemorrhage, 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 hemorrhage, esophagitis, GGT increased, gastritis, gastroenteritis, gum hemorrhage, hematemesis, melena, peptic ulcer, periodontal abscess, rectal hemorrhage, stomach ulcer, tongue edema.

Endocrine: Diabetes mellitus.

Hemic and Lymphatic: Anemia, ecchymosis, iron deficiency anemia, polycythemia, purpura.

Metabolic and Nutritional: Creatinine increased, gout, hyperlipemia, hyperuricemia.

Musculoskeletal: Arthralgia, bone pain, bursitis.

Nervous: Anxiety, insomnia, neuralgia.

Respiratory: Asthma, epistaxis, hemoptysis, pneumonia, sinusitis.

Skin and Appendages: Dr. skin, furunculosis, skin hypertrophy, urticaria.

Special Senses: Amblyopia, blindness, conjunctivitis, diplopia, ear pain, eye hemorrhage, retinal hemorrhage, tinnitus.

Urogenital: Albuminuria, cystitis, urinary frequency, vaginal hemorrhage, vaginitis.

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