Pletal: Restore Mobility with Improved Blood Flow
Pletal
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| Product dosage: 50mg | |||
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Synonyms
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Pletal (cilostazol) is a prescription medication specifically formulated to alleviate the symptoms of intermittent claudication, a condition characterized by pain, cramping, or weakness in the legs during physical activity due to reduced blood flow. As a quinolinone derivative, it functions as a selective phosphodiesterase III inhibitor, offering a targeted mechanism of action that distinguishes it from other therapies. This agent works by promoting vasodilation and inhibiting platelet aggregation, thereby increasing blood circulation to the extremities and enhancing functional capacity. It is indicated for the symptomatic management of patients to improve walking distance and overall quality of life, representing a critical option in the pharmacological management of peripheral arterial disease.
Features
- Active Ingredient: Cilostazol
- Pharmacological Class: Selective Phosphodiesterase III (PDE3) Inhibitor
- Available Formulations: 50 mg and 100 mg oral tablets
- Dual Mechanism of Action: Vasodilation and antiplatelet effects
- Prescription Status: Rx-only medication
- Manufacturer Standards: Produced under current Good Manufacturing Practices (cGMP)
Benefits
- Significantly increases pain-free and maximal walking distances in patients with intermittent claudication.
- Improves overall functional capacity and enables greater participation in daily activities and exercise.
- Enhances microcirculatory blood flow to ischemic extremities through vasodilation.
- Reduces platelet aggregation, potentially lowering the risk of thrombotic events in affected vasculature.
- Offers a non-surgical pharmacological option for symptomatic management of peripheral arterial disease.
- Provides a targeted therapeutic alternative for patients who cannot tolerate or have contraindications to other antiplatelet regimens.
Common use
Pletal is primarily prescribed for the symptomatic treatment of intermittent claudication, a manifestation of peripheral arterial disease (PAD). It is used in patients whose symptoms are not adequately managed through lifestyle modifications, such as smoking cessation and exercise programs, alone. The medication is intended to improve walking distance and reduce leg pain during ambulation, thereby enhancing mobility and quality of life. It is not indicated for the prevention of cardiovascular events or for use in critical limb ischemia. Treatment is typically considered after a thorough vascular assessment and a confirmed diagnosis of PAD.
Dosage and direction
The recommended dosage of Pletal is 100 mg taken orally twice daily, approximately 30 minutes before or 2 hours after breakfast and dinner. For patients who may not tolerate this dose, a reduction to 50 mg twice daily can be considered. Dosage adjustment is necessary in patients taking concomitant medications that inhibit CYP3A4 or CYP2C19 enzymes, such as certain antifungals or macrolide antibiotics. It should be taken on a consistent schedule to maintain stable plasma concentrations. Treatment response is typically evaluated over 3 to 6 months; discontinuation should be considered if no clinically meaningful improvement is observed. The medication is not recommended for use in patients with severe hepatic impairment, and caution is advised in those with moderate impairment.
Precautions
Pletal is contraindicated in patients with congestive heart failure (CHF) of any severity due to the potential for decreased survival observed with other PDE3 inhibitors in heart failure populations. It should be used with caution in patients with known or suspected hemostatic disorders or active pathological bleeding. Regular monitoring of cardiovascular status is advised, particularly in patients with a history of cardiac arrhythmias. Patients should be advised that dizziness may occur, potentially affecting the ability to operate machinery or drive. Caution is recommended when co-administering with other drugs affecting hemostasis (e.g., anticoagulants, antiplatelets). Use in pregnant women should be avoided unless the potential benefit justifies the potential risk to the fetus.
Contraindications
- Congestive heart failure of any severity
- Known hypersensitivity to cilostazol or any component of the formulation
- Co-administration with strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole) or CYP2C19 (e.g., omeprazole, esomeprazole)
- Active pathological bleeding such as peptic ulcer disease or intracranial hemorrhage
Possible side effect
The most common adverse reactions (>2%) include headache, diarrhea, abnormal stools, palpitations, dizziness, and pharyngitis. Less frequently reported effects include tachycardia, rhinitis, peripheral edema, nausea, dyspepsia, abdominal pain, infection, and back pain. Serious but rare adverse events may include thrombocytopenia, pancytopenia, agranulocytosis, and severe cardiovascular events including myocardial infarction and atrial fibrillation. Any signs of bleeding, such as unusual bruising or blood in stool, should be promptly reported to a healthcare provider.
Drug interaction
Pletal is primarily metabolized by CYP3A4 and CYP2C19 enzymes, leading to significant interactions with inhibitors of these pathways. Concomitant use with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) or strong CYP2C19 inhibitors (e.g., omeprazole) is contraindicated. Caution is advised with moderate inhibitors (e.g., diltiazem, fluconazole). Concurrent use with other antiplatelet agents (e.g., clopidogrel, aspirin) or anticoagulants (e.g., warfarin) may increase bleeding risk. Grapefruit juice may increase cilostazol concentrations and should be avoided. Drugs that induce these enzymes (e.g., rifampin) may decrease cilostazol efficacy.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next scheduled dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed. Doubling the dose to make up for a missed one is not recommended. Maintaining consistent timing helps optimize therapeutic plasma levels and clinical efficacy.
Overdose
Symptoms of overdose may include severe headache, diarrhea, hypotension, tachycardia, and cardiac arrhythmias. There is no specific antidote for cilostazol overdose. Management should consist of supportive measures, including monitoring of vital signs and ECG. Gastric lavage may be considered if ingestion was recent. Hemodialysis is unlikely to be effective due to high protein binding. Medical attention should be sought immediately in cases of suspected overdose.
Storage
Store at controlled room temperature, 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). Keep the container tightly closed and protect from moisture and light. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Dispose of unused medication properly according to local regulations, preferably through a drug take-back program.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional for diagnosis and treatment decisions. Do not initiate, discontinue, or alter the dosage of any medication without direct medical supervision. Individual patient responses may vary, and the full prescribing information should be reviewed for comprehensive details on use, warnings, and precautions.
Reviews
Clinical studies and post-marketing surveillance indicate that Pletal is generally well-tolerated and effective in improving walking distance in a significant proportion of patients with intermittent claudication. Many patients report meaningful improvements in daily functioning and quality of life. Some users note the occurrence of side effects like headache, which often diminish with continued use. Healthcare providers emphasize the importance of adherence to dosing instructions and regular follow-up to monitor efficacy and tolerability. Overall, it is regarded as a valuable option within a comprehensive management plan for symptomatic peripheral arterial disease.