Aclusin

Quick links to important sections

Aclusin

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Aclusin

Property Description
Active ingredient Cilostazol
Form Oral Tablet
Pharmacological Class Antiplatelet Agent, Vasodilator
Origin Synthetic Compound (Quinolinone Derivative)

What is Aclusin and What Type of Drug is it?

Aclusin is the trade name for the prescription-only synthetic medication whose established active ingredient is Cilostazol. It is classified by its dual pharmacological actions, serving as both an antiplatelet agent and a vasodilator. This compound is a quinolinone derivative, available for oral administration in the form of a tablet.

The drug is distinguished as a selective phosphodiesterase type 3 (PDE3) inhibitor. This specific mechanism places it within the broader group of Antithrombotic agents. Pharmacological properties support the role of Cilostazol in systemic circulation challenges, establishing its clinical relevance.


Aclusin’s Composition and Origin

The foundation of Aclusin is the single active ingredient, Cilostazol, a chemically synthesized compound. It is a single-ingredient product, meaning its therapeutic effect is delivered solely by Cilostazol, combined with the solid pharmaceutical excipients required to create the stable oral dosage form.

As a synthetic compound, Cilostazol is manufactured through controlled laboratory processes. Its chemical structure confirms its origin as a derivative of the quinolinone family. The focused design of this medication targets specific biochemical pathways associated with platelet aggregation and vascular smooth muscle relaxation.


What is the General Therapeutic Purpose?

The general therapeutic purpose of Aclusin is to enhance and improve blood flow where circulation is restricted due to narrowed arteries, which is a key issue in peripheral vascular problems. This benefit is achieved through the combined physiological effects of Blood Vessel Widening (Vasodilation) and Preventing Clumping of Blood Cells (Antiplatelet Action).

The mechanism of action effectively helps maintain blood flow by relaxing the muscles around blood vessels and reducing platelet clumping. This action is utilized for improving circulation in the lower extremities, which is its typical use scenario. The physiological effect of the medication is associated with improving walking distance for patients with reduced blood flow in the limbs.

Regulatory References

  1. NIH (StatPearls) on Cilostazol Mechanism

What side effects are possible with Aclusin?

Possible Side Effects and Safety Information

The safety profile for Aclusin (Cilostazol) is defined by official government regulatory documents, focusing on categorized adverse reactions and mandatory safety restrictions. The frequency of side effects is classified according to regulatory standards (e.g., EMA/ICH frequency bands).


Official Adverse Reaction Frequencies

Classification Examples of Reactions
Very Common (ge 1 in 10) Headache, Diarrhea
Common (ge 1 in 100 to <1 in 10) Palpitations, Tachycardia, Dizziness, Peripheral Edema, Nausea, Vomiting
Uncommon (ge 1 in 1,000 to <1 in 100) Myocardial Infarction, Heart Failure, Anemia, Major Bleeding Events

Serious Safety Constraints

The regulatory safety profile highlights risks related to the drug's mechanism. Use is contraindicated in patients with Congestive Heart Failure (CHF) of any severity, which is associated with a specific regulatory warning. Serious risks also include major Hemorrhagic Events (such as cerebral or gastrointestinal bleeding) and serious Blood Dyscrasias (e.g., Agranulocytosis). The majority of adverse reactions are reported to be concentrated within the first four weeks of treatment.

Population-Specific Restrictions

Official labeling mandates specific safety constraints for certain patient groups. Aclusin is contraindicated in individuals with active bleeding, severe renal impairment (Creatinine Clearance le 25 mL/min), or moderate to severe hepatic impairment. Use is also restricted for patients with a history of recent serious cardiac events, such as myocardial infarction or coronary intervention within the last six months, and those with severe tachyarrhythmia.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information describes specific manifestations and necessary emergency actions following an overdose of Aclusin (Cilostazol).


Documented Overdose Manifestations

Symptoms and signs documented in regulatory sources following an overdose primarily involve the cardiovascular and central nervous systems. These manifestations include severe headache, dizziness, fainting, and diarrhea. More critical signs involve the heart, such as tachyarrhythmia (fast or irregular heartbeat) and a significant fall in blood pressure (hypotension).

Required Emergency Actions

Urgent medical attention is mandated if an excess amount of Aclusin is taken. According to official guidance, immediate contact with emergency services is required if severe conditions occur, including collapse, seizure, trouble breathing, or if the individual cannot be awakened. When contacting a doctor or local hospital immediately after an overdose, the product packaging should be presented.

Supportive Management and Antidote Status

Management of an overdose consists of symptomatic and supportive treatment. No specific antidote is officially known or documented. Depending on the clinical assessment, procedures such as gastric lavage or induced vomiting may be considered. Due to the potential for severe cardiovascular effects, patients who have taken an overdose should receive close clinical monitoring.

Therapeutic Uses of Aclusin

Managing Activity-Limiting Discomfort in Peripheral Artery Disease

Aclusin is commonly used for managing the symptoms of intermittent claudication, which involves cramping muscle pain or aching in the legs that occurs consistently during walking. This condition is a key manifestation of Peripheral Artery Disease (PAD), a condition involving circulatory strain in the lower limbs. Aclusin is used for the management of these symptoms, which often create noticeable physiological strain and interfere with daily functioning. The medication is applied across domains relevant for easing symptoms related to chronic circulation challenges, exertional pain, and limitations in functional walking capacity.

Quick Fact: Supportive management for Exertional Leg Pain

Supporting Functional Mobility and Activity Tolerance

Aclusin is relevant for supporting the patient's functional capacity in situations where symptoms interfere with routine activities. By easing the symptoms related to claudication, the medication may assist with managing symptomatic limitations related to pain-free walking distance and maximal walking distance. This supportive relief helps patients cope more steadily with chronic circulation challenges and assists in easing the functional strain on daily routines, supporting general well-being and maintaining a sense of stability when symptoms are more noticeable.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Who Can and Cannot Use Aclusin?

The population eligibility for Aclusin (Cilostazol) is strictly defined by governmental regulatory documents, focusing primarily on absolute non-eligibility due to cardiac status, bleeding risk, and organ function.

Eligibility Status

Population Group Regulatory Status Status Detail
Adults Established Approved for use in adults with intermittent claudication.
Pediatric Population Use Not Established Safety and efficacy have not been established in children.
Geriatric Population Established No special dosage requirements are noted for the elderly.
Pregnancy Contraindicated Must not be used during pregnancy.
Lactation Not Recommended Use is advised against while breastfeeding.

Absolute Contraindications (Must Not Use)

Aclusin is absolutely contraindicated in patients with a history of heart failure of any severity. Use is also prohibited in individuals with severe renal impairment (Creatinine Clearance le 25 ml/min) or moderate to severe hepatic impairment. Further non-eligibility restrictions include patients with active pathologic bleeding or a known predisposition to bleeding, those who have suffered a myocardial infarction or undergone a coronary intervention within the last six months, and those receiving two or more additional antiplatelet or anticoagulant agents simultaneously.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents classify Aclusin's interaction profile primarily around its known metabolic pathway and the potential for additive effects with certain therapeutic classes.

Interaction Domain (Regulatory Basis) Interacting Product Categories
Pharmacokinetic (CYP3A4) Strong CYP3A4 Inducers, Strong CYP3A4 Inhibitors
Pharmacodynamic (Additive Effect) Other Serotonergic Agents, CNS Depressants

Official Interaction Statements

  • Strong CYP3A4 Inhibitors (e.g., ketoconazole, clarithromycin): Co-administration is predicted to significantly increase Aclusin systemic exposure (AUC and Cmax). This is a clinically significant interaction. A use-with-caution classification mandates close monitoring and consideration of alternative therapies, as regulatory data do not support a universal dose adjustment rule for all patients.
  • Strong CYP3A4 Inducers (e.g., rifampin, carbamazepine): Concomitant use is expected to substantially decrease Aclusin plasma concentrations, potentially leading to a loss of the compound’s intended effect. Regulatory documents advise against co-administration due to the risk of inadequate therapeutic benefit.
  • Other Serotonergic Agents (e.g., SSRIs, triptans): The regulatory classification for this group notes a potential for additive pharmacodynamic effects. This necessitates specific patient monitoring for signs of excessive serotonergic activity, establishing a key interaction-context constraint.
  • Alcohol and CNS Depressants: These substances are noted in official labeling due to the risk of enhanced central nervous system effects when co-administered. The specific constraint is to advise against concomitant use with alcohol.

Interaction Classifications and Structure

The most critical interaction-related restriction is the recommendation to avoid co-administration with strong CYP3A4 inducers. Clinically significant interactions are based on Aclusin being a sensitive substrate for CYP3A4. This regulatory structure defines the product’s safety constraints, requiring practitioners to identify and manage these pharmacokinetic and pharmacodynamic risks before and during use.

Mechanism of Action

Aclusin (Cilostazol) exerts its action through a precise, dual mechanism of action involving the Phosphodiesterase type 3 (PDE3) enzyme. This action simultaneously produces two primary physiological consequences: vasodilation and inhibition of platelet aggregation.


The Molecular Cascade: Inhibiting PDE3 and Raising cAMP

The drug's primary action is the selective, reversible inhibition of PDE3, an enzyme that breaks down the cellular signaling molecule, cyclic AMP ( cAMP). By blocking this breakdown, Cilostazol causes cAMP levels to rise inside target cells, including those in the vascular walls and circulating blood platelets . This accumulation activates Protein Kinase A ( PKA), which initiates the cascade leading to the drug's physiological consequences.


Dual Physiological Effect: Vasodilation and Reduced Platelet Aggregation

The elevated cAMP/ PKA pathway activates distinct but related mechanisms: in the vascular smooth muscle cells, it inactivates the enzyme responsible for contraction, causing the vessels to relax, resulting in vasodilation. Simultaneously, in the platelets, it suppresses the release of calcium ions and limits the function of the Glycoprotein IIb/ IIIa receptor, thereby reducing platelet aggregation. These two core physiological changes together improve the flow of blood through arteries.

Dosage and Administration Information

How to Use Aclusin: Administration Guidelines

Aclusin is a prescription medication whose usage is defined by guidelines concerning its administration route, dosage, and relationship to mealtimes. The medicine is supplied as an oral tablet and is available in strengths of 50 mg and 100 mg.


Standard Dosing and Frequency

The standard protocol for administration involves taking the medicine twice daily (every 12 hours). The typical standard dose for adults is 100 mg per dose. This regimen is established to maintain consistent therapeutic levels over a 24-hour period.

Feature Guideline
Route of Administration Oral administration
Standard Daily Frequency Twice daily (bid)

Contextual Use Instructions

Proper administration is dependent on the timing relative to food intake. Guidelines specify that Aclusin tablets must be taken on an empty stomach. This means the dose should be administered 30 minutes before or 2 hours after both the morning and evening meals.

Treatment with Aclusin follows a structured duration pattern. The therapeutic effect should be formally reassessed after 3 months (12 weeks) of continuous treatment. Continuation of the medication is evaluated based on the symptomatic response observed during this period.


Required Dose Modification

The standard dose requires modification when Aclusin is used alongside specific concurrent medications. If a patient is taking strong inhibitors of certain cytochrome P450 enzymes (such as CYP3A4 or CYP2C19 inhibitors), the dose must be reduced to 50 mg twice daily. No specific dose adjustment is required for older adults, and its use is not established in the pediatric population.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Aclusin

Evidence for use in Managing Symptoms of Intermittent Claudication

Aclusin was studied in research exploring its use in patients experiencing intermittent claudication, which is leg pain during walking often linked to narrowed arteries. The evidence base primarily consists of many Randomized Controlled Trials (RCTs) and subsequent Systematic Reviews that consolidate the findings from these individual studies. Research explored functional limitations associated with leg pain during walking (intermittent claudication).

The studies monitored participants over defined time intervals, typically ranging from a few months up to six months. In these research contexts, outcomes related to physical discomfort were measured. Studies report how symptoms evolved in the observed populations, focusing on objective measures of physical activity. Studies monitored measured changes in the distance participants could walk in the group receiving the medication compared to the group receiving an inactive placebo.

Examining Trial Outcomes: Functional Capacity and Quality of Life

In the clinical trials, researchers mainly focused on two specific functional measurements: the Pain-free Walking Distance and the Maximal Walking Distance. These are outcomes reflecting daily functioning or activity level, assessed using standardized treadmill tests. Researchers used these objective measures to document how walking capacity was observed to change during the study period.

Beyond objective measurements, studies also monitored patient-reported experiences. Researchers used standardized questionnaires to assess perceived physical functioning, general well-being, and outcomes related to systemic or functional imbalance. This research provides insight into short-term changes and describes how patients reported their experience when symptoms were more noticeable.

What is Still Uncertain About Aclusin

Evidence highlights what is known, but there are areas where research is ongoing and more data are still emerging. The research focusing on functional endpoints, like walking distance, contributes to the broader evidence landscape but does not provide individual predictions regarding long-term cardiovascular health. Specifically, there is limited information for long-term outcomes regarding major adverse cardiovascular events (e.g., heart attack or stroke) or all-cause mortality. The primary trials were not designed to collect data on these outcomes over many years. Findings describe group patterns, not personal outcomes.

Frequently Asked Questions (FAQ)

Common questions about Aclusin (FAQ)

Q: Is Aclusin considered a common or specialized type of drug?

Official classification documents describe the active ingredient, Cilostazol, as a PDE3 inhibitor and a miscellaneous cardiovascular agent. This classification indicates it has a focused, therapeutic purpose based on its effects on blood vessels and platelets.


Q: How long does it usually take for Aclusin's effects to become noticeable?

Regulatory guidelines indicate that some individuals may begin to observe a response as early as 2 to 4 weeks after starting therapy. However, up to 12 weeks of treatment may be needed before the full beneficial effect is experienced. The official regulatory guidelines state that formal assessment of the drug's effectiveness is recommended after 12 weeks of continuous treatment.


Q: What happens if I stop using Aclusin suddenly?

The drug is eliminated from the body within approximately three days after discontinuation. Regulatory information does not define specific stopping protocols, but all decisions regarding discontinuation are typically managed by a healthcare provider.


Q: Do I need to take Aclusin at a specific time of day?

Official administration guidelines state the medicine is for twice-daily use and must be timed specifically around meals. The regulatory documents specify taking the medication on an empty stomach, meaning its administration must be separated from meal times.


Q: Are there any known long-term side effects associated with Aclusin use?

Official product information describes side effects that have been reported over the course of treatment, including severe cardiac and hematologic (blood-related) reactions. While the majority of reported events occur within the first few weeks, some adverse events have also been noted after long-term use.


Q: Is Aclusin available without a prescription in some countries?

In the United States, the active ingredient, Cilostazol, is classified as a Prescription Only (Rx) medication, meaning it is not available over the counter.


Q: Does Aclusin affect my ability to drive or operate machinery?

Dizziness is a side effect that is commonly reported in official documents. Regulatory information notes that if this symptom occurs, activities requiring concentration, such as driving or operating machinery, may be affected.


Q: Are there any specific foods or drinks that should be avoided while using Aclusin?

Yes, regulatory labeling advises against co-administration with grapefruit or grapefruit juice. This is because grapefruit can increase the amount of the drug circulating in the blood, potentially increasing the risk of side effects.


Q: Can Aclusin be taken with vitamin supplements?

Regulatory labeling cautions that many over-the-counter medicines, vitamins, and herbal products can interact with prescription drugs. These combinations may affect the levels of the drug in the blood, potentially making the medicine less effective or increasing side effects. The potential for these combinations to affect drug levels should be reviewed by a healthcare provider.


Q: Is it okay to drink alcohol in moderation while using Aclusin?

Regulatory labeling restricts the concomitant use of alcohol with the medication. The reason for this restriction is the potential risk for enhanced central nervous system effects, such as increased dizziness or drowsiness, when alcohol is combined with the medication.


Q: Are the reported side effects common, or do they happen rarely?

Regulatory documents classify side effects by their frequency in clinical trials. They are placed into categories like 'Very Common' (e.g., Headache, Diarrhea, occurring in ge 1 in 10 people) and 'Common' (e.g., Dizziness, Nausea, occurring in ge 1 in 100 to <1 in 10 people).


Q: Can Aclusin cause changes in weight?

Changes in weight are not listed among the commonly reported side effects in official documents. However, edema (swelling) is classified as a Common side effect, which may sometimes be mistaken for weight gain.


Q: Can Aclusin be crushed or split if the tablet is too large?

Regulatory administration instructions state that Aclusin tablets must be swallowed whole. They should not be crushed, chewed, or broken. This instruction is provided in the administration guidelines.


Q: Does Aclusin affect laboratory test results?

Official postmarketing experience sections have noted changes in some laboratory values. These include reported increases in blood creatinine and blood uric acid levels.


Q: Does Aclusin affect blood sugar levels?

Official postmarketing reports have included instances of increased blood glucose (sugar) levels. However, regulatory labeling does not establish a direct link between the drug and these changes.


Q: Is the long-term safety profile of Aclusin well-established by research?

Regulatory data notes that the initial clinical trials were primarily designed to assess improvements in walking distance. These trials were not specifically structured to evaluate long-term outcomes, such as major adverse cardiovascular events.


Q: Are there any lifestyle changes recommended when using Aclusin?

Official information advises patients against smoking or using tobacco products while taking the medication. This advice is provided because tobacco smoking has been observed in studies to decrease the amount of the drug in the blood.


Q: Are there specific storage instructions for Aclusin that I need to know?

Official instructions for the oral tablets require storing the medicine at controlled room temperature, typically between 20 C to 25 C. It is important to keep the medicine out of direct heat and away from excess moisture.


Q: Does Aclusin contain any ingredients that might cause an allergic reaction?

Regulatory information indicates that the drug is contraindicated in anyone who has had a history of hypersensitivity (allergic reaction) to the active ingredient, Cilostazol, or any of the inactive components (excipients) used to form the tablets.


Q: Is Aclusin a controlled substance?

The active ingredient, Cilostazol, is confirmed by regulatory schedules in the United States as not being classified as a controlled substance under the Drug Enforcement Administration (DEA) scheduling system.


Q: Is it normal to feel slightly tired when first starting Aclusin?

Tiredness or fatigue is not listed among the very common or common side effects. However, dizziness is classified as common, and malaise (a general feeling of discomfort or unease) is also listed as a potential adverse reaction.


Q: Are there any specific genetic factors that affect how Aclusin works?

The drug's metabolism is influenced by certain liver enzymes, specifically CYP3A4 and CYP2C19. Regulatory information notes that individual genetic variations can affect how these enzymes function, which in turn may influence the concentration and effect of the drug in the body.

How should Aclusin be stored and disposed of?

How to Store and Dispose of Aclusin: Official Requirements

Regulatory information defines strict storage and handling requirements for this product, which is often labeled as a pressurized container. These instructions must be followed to maintain safety and product integrity.

Mandatory Storage Conditions

The product must be stored in a cool location and protected from direct sunlight. It is officially prohibited to expose the container to temperatures exceeding 50 C (122 F). The container must be kept away from all heat sources, sparks, open flames, or hot surfaces.

Handling and Disposal Instructions

Official labeling requires specific care when handling the pressurized container. Do not pierce or burn the container, even after use. Disposal must align with official regulations and should not include flushing with water or discarding with common household waste, due to the nature of the contents and container.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Aclusin found in:

A-Z Index: