April 29, 2017
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Pletal

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Pletal




Side Effects
Interactions

SIDE EFFECTS

The following adverse reactions are discussed in greater detail inother sections of the labeling:

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 Placebo)

Adverse Reactions Placebo (N=973) PLT 50 mg twice daily (N=303) PLT 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 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

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

Postmarketing Experience

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

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.

Read the Pletal (cilostazol) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

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

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 9/26/2016

Side Effects
Interactions

Pletal - User Reviews

Pletal User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Pletal sorted by most helpful. Patient Discussions FAQs

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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