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The following adverse reactions are discussed in greater detail inother sections of the labeling:
- Patients with Heart Failure [see BOX WARNING]
- Tachycardia [see WARNINGS AND PRECAUTIONS]
- Hematologic Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Hemostatic Disorders or Active Pathologic Bleeding [see WARNINGS AND PRECAUTIONS]
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 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 most frequent adverse reaction resulting in discontinuation of therapy in more than 3% of patients treated with PLETAL 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 PLETAL (all doses) versus 0.1% for placebo.
The most common adverse reactions, occurring in at least 2% of patients treated with PLETAL 50 or 100 mg twice daily, are shown in Table 1.
Table 1: Most Common Adverse Reactions in Patients on PLETAL
(PLT) 50 or 100 mg Twice Daily (Incidence at least 2% and Occurring
More Frequently (≥ 2%) in the 100 mg Twice Daily Group than on
|Adverse Reactions||Placebo (N=973)||PLT 50 mg twice daily (N=303)||PLT 100 mg twice daily (N=998)|
Less frequent clinical significant adverse reactions (less than 2%) that were experienced by patients treated with PLETAL 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
Hematologic and Lymphatic: anemia
Metabolic and Nutritional: increased creatinine, hyperuricemia
Skin and Appendages: urticaria
Urogenital: urinary frequency
The following adverse reactions have been identified during post-approval use of PLETAL. 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
General Disorders And Administration Site Conditions
Pain, chest pain, hot flushes
Hepatic dysfunction/abnormal liver function tests, jaundice
Immune System Disorders
Nervous System Disorders
Renal And Urinary Disorders
Respiratory, Thoracic And Mediastinal Disorders
Skin And Subcutaneous Tissue Disorders
Read the Pletal (cilostazol) Side Effects Center for a complete guide to possible side effects
Inhibitors Of CYP3A4 Or CYP2C19
Inhibitors Of CYP3A4
Coadministration of strong (e.g., ketoconazole) and moderate (e.g., erythromycin, diltiazem and grapefruit juice) CYP3A4 inhibitors can increase exposure to PLETAL. Reduce PLETAL dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP3A4 [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].
Inhibitors Of CYP2C19
Coadministration with CYP2C19 inhibitors (e.g., omeprazole) increases systemic exposure of PLETAL active metabolites. Reduce PLETAL dose to 50 mg twice daily when coadministered with strong or moderate inhibitors of CYP2C19 [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].
Read the Pletal Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 9/26/2016
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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