Cilostazol
Generic: CILOSTAZOL
Basic Information
Manufacturer
Chartwell RX, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
77e77eaf-5556-43ac-844e-c0e29f02fe07
Indications & Usage
1 INDICATIONS AND USAGE Cilostazol tablets are indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance.
Cilostazol tablets are a phosphodiesterase III inhibitor (PDE III inhibitor) indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance ( 1 )
Cilostazol tablets are a phosphodiesterase III inhibitor (PDE III inhibitor) indicated for the reduction of symptoms of intermittent claudication, as demonstrated by an increased walking distance ( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Patients with Heart Failure [see Boxed Warning ] Tachycardia [see Warnings and Precautions (5.1) ] Left Ventricular Outflow Tract Obstruction [see Warnings and Precautions (5.2) ] Hematologic Adverse Reactions [see Warnings and Precautions (5.3) ] Hemostatic Disorders or Active Pathologic Bleeding [see Warnings and Precautions (5.4) ] Most common adverse reactions greater than or equal to 2% and at least twice that for placebo in patients on 100 mg twice daily are headache, diarrhea, abnormal stools, and palpitation ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chartwell RX, LLC.
at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions were assessed in eight placebo-controlled clinical trials involving patients exposed to either 50 or 100 mg twice daily cilostazol (n=1,301) or placebo (n=973), with a median treatment duration of 127 days for patients on cilostazol and 134 days for patients on placebo.
The most frequent adverse reaction resulting in discontinuation of therapy in more than 3% of patients treated with cilostazol was headache [50 mg twice daily (1.3%), 100 mg twice daily (3.5%) and placebo (0.3%)].
Other frequent causes of discontinuation included palpitation and diarrhea, both 1.1% for cilostazol (all doses) versus 0.1% for placebo.
The most common adverse reactions, occurring in at least 2% of patients treated with cilostazol 50 or 100 mg twice daily, are shown in Table 1.
Table 1: Most Common Adverse Reactions in Patients on Cilostazol 50 or 100 mg Twice Daily (Incidence at least 2% and Occurring More Frequently (greater than or equal to 2%) in the 100 mg Twice Daily Group than on Placebo) Adverse Reactions Placebo (N=973) Cilostazol 50 mg twice daily (N=303) Cilostazol 100 mg twice daily (N=998) Headache 14% 27% 34% Diarrhea 7% 12% 19% Abnormal stools 4% 12% 15% Palpitation 1% 5% 10% Dizziness 6% 9% 10% Pharyngitis 7% 7% 10% Infection 8% 14% 10% Peripheral edema 4% 9% 7% Rhinitis 5% 12% 7% Dyspepsia 4% 6% 6% Abdominal pain 3% 4% 5% Tachycardia 1% 4% 4% Less frequent clinical significant adverse reactions (less than 2%) that were experienced by patients treated with cilostazol 50 mg twice daily or 100 mg twice daily in the eight controlled clinical trials and that occurred at a frequency in the 100 mg twice daily group greater than in the placebo group are listed below.
Body as a whole: fever, generalized edema, malaise Cardiovascular: atrial fibrillation, heart failure, myocardial infarction, nodal arrhythmia, supraventricular tachycardia, ventricular extrasystoles, ventricular tachycardia Digestive: anorexia, melena Hematologic and Lymphatic: anemia Metabolic and Nutritional: increased creatinine, hyperuricemia Nervous: insomnia Respiratory: epistaxis Skin and Appendages: urticaria Special Senses: conjunctivitis, retinal hemorrhage, tinnitus Urogenital: urinary frequency 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of cilostazol.
Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and lymphatic system disorders: Aplastic anemia, granulocytopenia, pancytopenia, bleeding tendency Cardiac disorders: Torsade de pointes and QTc prolongation in patients with cardiac disorders (e.g.
complete atrioventricular block, heart failure; and bradyarrythmia), angina pectoris.
Gastrointestinal disorders: Gastrointestinal hemorrhage, vomiting, flatulence, nausea General disorders and administration site conditions: Pain, chest pain, hot flushes Hepatobiliary disorders: Hepatic dysfunction/abnormal liver function tests, jaundice Immune system disorders: Anaphylaxis, angioedema, and hypersensitivity Investigations: Blood glucose increased, blood uric acid increased, increase in BUN (blood urea increased), blood pressure increase Nervous system disorders: Intracranial hemorrhage, cerebral hemorrhage, cerebrovascular accident, extradural hematoma and subdural hematoma Renal and urinary disorders: Hematuria Respiratory, thoracic and mediastinal disorders: Pulmonary hemorrhage, interstitial pneumonia Skin and subcutaneous tissue disorders: Hemorrhage subcutaneous, pruritus, skin eruptions including Stevens-Johnson syndrome, skin drug eruption (dermatitis medicamentosa), rash Vascular disorders: Subacute stent thrombosis, hypertension.
at 1-845-232-1683 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse reactions were assessed in eight placebo-controlled clinical trials involving patients exposed to either 50 or 100 mg twice daily cilostazol (n=1,301) or placebo (n=973), with a median treatment duration of 127 days for patients on cilostazol and 134 days for patients on placebo.
The most frequent adverse reaction resulting in discontinuation of therapy in more than 3% of patients treated with cilostazol was headache [50 mg twice daily (1.3%), 100 mg twice daily (3.5%) and placebo (0.3%)].
Other frequent causes of discontinuation included palpitation and diarrhea, both 1.1% for cilostazol (all doses) versus 0.1% for placebo.
The most common adverse reactions, occurring in at least 2% of patients treated with cilostazol 50 or 100 mg twice daily, are shown in Table 1.
Table 1: Most Common Adverse Reactions in Patients on Cilostazol 50 or 100 mg Twice Daily (Incidence at least 2% and Occurring More Frequently (greater than or equal to 2%) in the 100 mg Twice Daily Group than on Placebo) Adverse Reactions Placebo (N=973) Cilostazol 50 mg twice daily (N=303) Cilostazol 100 mg twice daily (N=998) Headache 14% 27% 34% Diarrhea 7% 12% 19% Abnormal stools 4% 12% 15% Palpitation 1% 5% 10% Dizziness 6% 9% 10% Pharyngitis 7% 7% 10% Infection 8% 14% 10% Peripheral edema 4% 9% 7% Rhinitis 5% 12% 7% Dyspepsia 4% 6% 6% Abdominal pain 3% 4% 5% Tachycardia 1% 4% 4% Less frequent clinical significant adverse reactions (less than 2%) that were experienced by patients treated with cilostazol 50 mg twice daily or 100 mg twice daily in the eight controlled clinical trials and that occurred at a frequency in the 100 mg twice daily group greater than in the placebo group are listed below.
Body as a whole: fever, generalized edema, malaise Cardiovascular: atrial fibrillation, heart failure, myocardial infarction, nodal arrhythmia, supraventricular tachycardia, ventricular extrasystoles, ventricular tachycardia Digestive: anorexia, melena Hematologic and Lymphatic: anemia Metabolic and Nutritional: increased creatinine, hyperuricemia Nervous: insomnia Respiratory: epistaxis Skin and Appendages: urticaria Special Senses: conjunctivitis, retinal hemorrhage, tinnitus Urogenital: urinary frequency 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of cilostazol.
Because these reactions are reported voluntarily from a population of an unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and lymphatic system disorders: Aplastic anemia, granulocytopenia, pancytopenia, bleeding tendency Cardiac disorders: Torsade de pointes and QTc prolongation in patients with cardiac disorders (e.g.
complete atrioventricular block, heart failure; and bradyarrythmia), angina pectoris.
Gastrointestinal disorders: Gastrointestinal hemorrhage, vomiting, flatulence, nausea General disorders and administration site conditions: Pain, chest pain, hot flushes Hepatobiliary disorders: Hepatic dysfunction/abnormal liver function tests, jaundice Immune system disorders: Anaphylaxis, angioedema, and hypersensitivity Investigations: Blood glucose increased, blood uric acid increased, increase in BUN (blood urea increased), blood pressure increase Nervous system disorders: Intracranial hemorrhage, cerebral hemorrhage, cerebrovascular accident, extradural hematoma and subdural hematoma Renal and urinary disorders: Hematuria Respiratory, thoracic and mediastinal disorders: Pulmonary hemorrhage, interstitial pneumonia Skin and subcutaneous tissue disorders: Hemorrhage subcutaneous, pruritus, skin eruptions including Stevens-Johnson syndrome, skin drug eruption (dermatitis medicamentosa), rash Vascular disorders: Subacute stent thrombosis, hypertension.