Inclaud

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Inclaud

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

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 Inclaud

Property Description
Active Ingredient Cilostazol
Form Film-coated tablet
Pharmacological Class Selective PDE3 Inhibitor, Vasodilator, Antiplatelet agent
General Purpose Enhancing peripheral circulation
Origin Synthetic compound

Defining Inclaud: Identity, Form, and Origin

Inclaud is a synthetic, single-ingredient therapeutic agent designated as a prescription-only medicine intended for oral administration. The medication is supplied as a stable, film-coated tablet, which constitutes its specific oral dosage form. Its active component is the chemical substance, Cilostazol. Its status as a prescription-only medicine ensures that its potent effects are utilized under professional medical supervision, guaranteeing a precise, regulated approach to vascular support. This compound is clinically recognized for its therapeutic profile in peripheral vascular management.


What is the Active Ingredient in Inclaud and Its Pharmacological Class?

The active ingredient in Inclaud is Cilostazol, which belongs to the highly specific pharmacological class of Selective Phosphodiesterase Type 3 (PDE3) Inhibitors. This classification means the drug operates with a dual action, being simultaneously categorized as both a potent Platelet Aggregation Inhibitor (antiplatelet agent) and a Vasodilator. This confirms that Inclaud is designed to act both on the blood vessel walls and on the blood components themselves. Cilostazol is a quinolinone derivative, and its mechanism involves increasing levels of cyclic adenosine monophosphate (cAMP) within certain cells. Its dual role offers a distinctive approach compared to agents that focus on only one of these actions.


General Purpose: The Dual Action of Cilostazol

The general purpose of Inclaud is to enhance blood flow and improve circulation, particularly where arterial supply may be limited, through its two primary physiological effects. The medicine is designed to achieve dual circulatory improvement by promoting vascular relaxation (vasodilation) and preventing the excessive sticking of platelets (antithrombotic effect). For instance, a typical use scenario involves supporting patients experiencing reduced arterial perfusion in their limbs. By acting to both widen the channels and smooth the flow of blood, Inclaud supports the body’s ability to manage reduced arterial perfusion, offering a fundamental benefit in supporting peripheral vascular health.

Regulatory References

  1. according to MedlinePlus
  2. Cilostazol Legal Status and Prescribing Information (DailyMed)
  3. Cilostazol Administration and Dosage Forms (DailyMed)
  4. Cilostazol Dosage Form (DailyMed)
  5. Cilostazol Dosage and Administration (DailyMed)
  6. Cilostazol Active Ingredient Information (DailyMed)
  7. Cilostazol Clinical Efficacy and Recognition (NIH/NCBI)
  8. Cilostazol Drug Information (DailyMed)
  9. Cilostazol Mechanism of Action as PDE3 Inhibitor (DailyMed)
  10. Cilostazol Dual Action: Antiplatelet and Vasodilator (NIH/NCBI)
  11. Cilostazol: Platelet Aggregation Inhibition (DailyMed)
  12. Cilostazol: Vasodilator Mechanism (DailyMed)
  13. Cilostazol Dual Circulatory Improvement (NIH/NCBI)
  14. Cilostazol Mechanism: Vascular Relaxation (DailyMed)
  15. Cilostazol: Antithrombotic Effect (DailyMed)

What side effects are possible with Inclaud?

Possible Side Effects and Safety Information

The safety profile of Inclaud (Cilostazol) is defined by officially documented adverse reactions classified by frequency and body system, as documented in regulatory sources like the FDA and EMA.


Frequency-Classified Adverse Reactions

The most frequent effects are generally concentrated within the first month of treatment. Adverse reactions are categorized based on their expected occurrence rate:

  • Very Common (affecting ge 1 in 10 patients): Headache, Diarrhea, Abnormal stools, and Palpitation.
  • Common (affecting ge 1 in 100 to < 1 in 10 patients): Dizziness, Tachycardia, Nausea, Vomiting, Dyspepsia, and Edema.
  • Uncommon and Rare effects include more serious events affecting the Cardiac, Vascular, and Blood systems.

Serious Adverse Reactions and Safety Constraints

The regulatory safety profile highlights the potential for serious bleeding events, including Cerebral and Gastrointestinal hemorrhage, resulting from its antiplatelet activity. There is also a documented risk of severe hematological abnormalities, such as Aplastic Anaemia and Pancytopenia.

Safety is significantly constrained by absolute contraindications concerning pre-existing conditions. Inclaud is not used in patients with Congestive Heart Failure of any severity, a history of recent Myocardial Infarction or Coronary Intervention within the last six months, or severe Hepatic or Renal impairment. Use is also restricted in patients receiving two or more additional antiplatelet or anticoagulant agents. These constraints define the boundary of its safe administration.

Overdose and Emergency Response

Overdose and when to seek help

Overdose with Inclaud (Cilostazol) primarily involves an exacerbation of the drug’s pharmacological effects, leading to pronounced cardiovascular and systemic manifestations documented in regulatory labeling. Officially described overdose presentations include severe headache, diarrhea, dizziness, and fainting. More critically, over-ingestion is associated with significant cardiovascular instability, specifically hypotension (a substantial fall in blood pressure) and tachyarrhythmia, which are fast or irregular heart rhythms.

Severe outcomes officially documented in prescribing information include the risk of ventricular arrhythmias and a heightened risk of hemorrhage due to the antiplatelet properties. Because of these potentially life-threatening manifestations, regulatory authorities strictly mandate that individuals seek immediate medical attention following any suspected over-ingestion.

When overdose is suspected, the official guidance requires contacting a poison control center or emergency services at once. Clinical management is defined as symptomatic and supportive treatment. The official documentation states that the stomach should be emptied, possibly through procedures such as gastric lavage or induced vomiting, to limit further systemic exposure. Hospital monitoring is required for continuous observation of potential cardiovascular complications, as no specific antidote is known for Inclaud overdose.

Therapeutic Uses of Inclaud

Quick Facts: Inclaud

  • Primary Use: Supports the management of high blood pressure (hypertension).
  • Supports: Helps address specific types of irregular heart rhythms.
  • Also Used For: Contributes to the long-term management of stable chest discomfort.

Inclaud is a prescribed medication intended for use in managing specific cardiovascular conditions. Its main purpose is to assist healthcare providers in establishing effective control over high blood pressure, a condition that requires ongoing care. Through appropriate therapeutic regimens, Inclaud may contribute to maintaining blood pressure levels within a desirable range.

Furthermore, this medication is utilized as a part of a broader treatment plan to help regulate certain irregularities in the heart’s rhythm. It may also be administered for the long-term care of individuals experiencing stable, predictable chest discomfort, often in combination with other therapeutic options.

Patients should consistently consult with their healthcare professional to understand the intended purpose of this medication in their specific situation.

Eligibility and Restrictions for Use

Who Can and Cannot Use Inclaud?

The population eligibility for Inclaud (Cilostazol) is strictly defined by regulatory authorities and centers on two core factors: the absence of severe cardiovascular risk and the exclusion of certain health conditions.

Inclaud is generally allowed for adult patients diagnosed with intermittent claudication due to peripheral arterial disease ( PAD). However, use is prohibited in numerous populations:

Classification Exclusion Criteria (Official Labeling)
Absolute Contraindication Heart failure of any severity (due to the drug's pharmacological class).
Hypersensitivity to cilostazol or its components.
High-Risk Comorbidity Severe renal impairment ( CrCl le 25 mL/min) or moderate/severe hepatic impairment.
Recent (le 6 months) myocardial infarction (heart attack) or coronary intervention.
Active pathologic bleeding (e.g., active peptic ulceration) or hemostatic disorders.

Furthermore, the medicine is contraindicated in pregnant women by some authorities and not recommended for nursing mothers. Safety and efficacy have not been established in pediatric patients, making its use restricted to adults. Patients with a history of ischemic heart disease or those taking multiple antiplatelet/anticoagulant agents are subject to strict regulatory-mandated restrictions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Drug interactions can alter how Inclaud works in the body or increase the risk of side effects. It is important for patients to inform their healthcare providers about all medicines, over-the-counter products, and supplements they are taking, including herbal remedies.

Potential Drug-Drug Interactions

Combining Inclaud with certain medicinal products may require careful monitoring or dosage adjustment by a physician. Clinically significant interactions often fall into two categories:

  • Impact on Metabolism: Certain medicines can affect the liver enzymes (specifically cytochrome P450) responsible for processing Inclaud. If these enzymes are inhibited by a co-administered medicine, the level of Inclaud in the blood may increase, potentially leading to a higher risk of adverse effects. Conversely, if an enzyme inducer is used, Inclaud levels may decrease, reducing its effectiveness. Examples of substance classes that can cause this effect include strong inhibitors of the CYP3A4 or CYP2C19 enzyme pathways.
  • Increased Bleeding Risk: Because Inclaud may affect blood clotting properties, combining it with other medicines that also increase the risk of bleeding (antiplatelet agents or anticoagulants) can significantly raise the likelihood of hemorrhagic events. This requires close medical supervision and blood monitoring.

Interactions with Food and Beverages

Consumption of grapefruit or grapefruit juice may interfere with the metabolism of certain medications, potentially increasing their concentration in the bloodstream. Patients should discuss any dietary restrictions, including the use of grapefruit products or alcohol, with their healthcare professional to manage potential risks effectively.

Mechanism of Action

How Inclaud Works: The Core Mechanism of Cilostazol

Inclaud's mechanism is driven by highly selective action on key enzymatic pathways, resulting in a dual physiological effect on the vascular system.


Selective Inhibition of the PDE3A Enzyme

This domain outlines the drug's core molecular interaction by targeting the enzyme Phosphodiesterase Type 3 ( PDE3A) found in both vascular smooth muscle cells and platelets. By reversibly blocking PDE3A, the drug prevents the breakdown of the crucial signaling molecule, cyclic AMP ( cAMP), causing its intracellular concentration to rise significantly. This elevated cAMP level initiates all subsequent physiological changes and defines the mechanism as a cyclic nucleotide regulator.


Dual Modulation of Vascular Tone and Platelet Activity

The increased cAMP concentration translates into a combined action of arterial vasodilation and reduced platelet aggregation. In arterial walls, the cAMP cascade causes smooth muscle to relax, widening the vessels and lowering resistance. Concurrently, in platelets, the same signal suppresses the activation of aggregation receptors ( Glycoprotein IIb/ IIIa), limiting their ability to clump. This dual action enhances the fluidity and volume capacity of blood flow, resulting in altered peripheral circulation characteristics.


Mechanism Constraints in Non-Vascular Tissue

While primarily active in the periphery, PDE3 is also expressed in the myocardium (heart muscle), constraining the drug's selectivity. The same inhibitory mechanism that increases cAMP in blood vessels also operates in heart tissue, leading to a predictable, mechanism-dependent augmentation of myocardial contractility and heart rate. The intensity of this mechanism is also metabolically sensitive, relying heavily on the function of liver enzymes CYP3A4 and CYP2C19.

Dosage and Administration Information

How to Use Inclaud (Cilostazol) — Official Administration Guidelines

The use of Inclaud (Cilostazol) is strictly governed by official administration protocols. This section outlines the standardized instructions regarding the route, dose, frequency, and specific conditions for taking this medication.


Administration and Dosing Schedule

Instruction Detail
Route of Administration For oral use only. The medicine is supplied as a film-coated tablet.
Standard Dosing The recommended dose is 100 mg taken twice daily (b.i.d.).
Adjusted Dosing The dose must be reduced to 50 mg twice daily when co-administered with certain strong or moderate inhibitors of CYP3A4 or CYP2C19 enzymes.
Timing (Empty Stomach) Each dose must be taken on an empty stomach, specifically at least 30 minutes before or two hours after breakfast and the evening meal.

Use Protocol and Special Populations

This medication is not to be taken on an as-needed basis; it requires consistent, scheduled administration. If a dose is missed, it is generally advised to not take a double dose and instead take the next scheduled dose at the usual time.

Treatment must be assessed for continuation after an initial trial period. Protocol involves a formal assessment after 12 weeks (3 months) of treatment; if no improvement is observed, the therapy should be discontinued.

No special dosage adjustments are required for older adults or for patients with mild renal impairment (creatinine clearance >25 ml/min). The safety and efficacy of Inclaud have not been established in the pediatric population. The tablet should be swallowed whole and not chewed or crushed.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Inclaud (Cilostazol)

Evidence for Intermittent Claudication in Peripheral Arterial Disease (PAD)

Inclaud was studied for use in patients with symptoms related to Intermittent Claudication (IC), a condition where leg muscle pain occurs with activity due to reduced blood flow. The core research supporting evaluation comes from large, multi-center Randomized Controlled Trials (RCTs). These short-term studies compared Inclaud to a placebo, focusing on objective measures like the Pain-Free Walking Distance (PFWD) and Maximum Walking Distance (MWD) on a treadmill. Findings described patterns where measured walking distances in the compound group were associated with different outcomes compared to the placebo group, contributing to understanding short-term functional measures.

Evidence for Secondary Prevention of Ischemic Stroke

Inclaud was evaluated in long-term, large-scale clinical trials involving patients with a history of non-cardioembolic ischemic stroke or transient ischemic attack (TIA). These studies monitored event-based outcomes, tracking the frequency of recurrent stroke events over several years. Long-term follow-up findings described patterns related to a difference in the frequency of recurrent stroke events between groups in the specific research settings studied. This evidence largely emerged from studies conducted in Asian populations.

Key Research Gaps and Uncertainties

While short-term RCTs provide data on functional outcomes, long-term outcomes on major cardiovascular events or mortality are not fully established through controlled trials. The body of research highlights several areas where the evidence remains incomplete. For instance, the main efficacy trials generally excluded patients with specific, severe co-existing heart conditions. Consequently, data for certain groups remain insufficient, and the generalizability of the observed patterns to diverse global populations remains a key topic of discussion.

Key Studies & References Efficacy of Cilostazol in reducing restenosis in patients undergoing contemporary stent based PCI: a meta-analysis of randomised controlled trials | EuroIntervention

Frequently Asked Questions (FAQ)

Common questions about Inclaud (FAQ)


Q: How quickly does Inclaud typically start to show its effects?

A: A measurable response is described in regulatory documents as sometimes being observed as early as 2 to 4 weeks after treatment starts. However, the official guidance requires therapy to be assessed after up to 12 weeks (3 months) of use.


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

A: Official documentation specifies that Inclaud is taken twice daily. The timing is linked to the empty stomach requirement, meaning it should be taken a specific time interval before or after breakfast and the evening meal.


Q: What should I know about taking Inclaud with food?

A: Regulatory information indicates that taking the medicine with food can increase the amount of the drug absorbed into the bloodstream. This higher level of the drug in the bloodstream may lead to a greater potential for adverse reactions.


Q: Are headaches a commonly reported side effect of Inclaud?

A: Yes, regulatory safety data classifies headache as a Very Common adverse reaction to Inclaud. This means it is reported to affect 1 in 10 patients or more.


Q: Is it normal to feel a mild stomach upset when first starting Inclaud?

A: Regulatory documents indicate that common gastrointestinal effects like diarrhea, nausea, and indigestion are often reported within the first month of starting treatment. These symptoms are listed among the Common adverse reactions.


Q: Does Inclaud affect energy levels?

A: Adverse reactions reported in regulatory documents include a generalized feeling of tiredness or weakness (fatigue). Swelling, known as peripheral edema, is also listed as a Common side effect.


Q: What is the maximum duration Inclaud has been studied for continuous use?

A: Studies on Inclaud have involved both short-term assessments and long-term research. Long-term, large-scale clinical trials have been conducted for secondary prevention of ischemic stroke, tracking event-based outcomes over several years.


Q: What is the typical time frame for clinical trials of Inclaud?

A: The core efficacy research supporting the evaluation for intermittent claudication came from short-term trials. Separately, studies focusing on secondary stroke prevention tracked outcomes and safety over several years.


Q: What is the difference between Inclaud and other medicines used for similar purposes?

A: Official sources describe Inclaud as belonging to a specific pharmacological class known as a Selective Phosphodiesterase Type 3 ( PDE3) Inhibitor. This classification provides the drug a dual action, functioning as both an antiplatelet agent and a vasodilator, meaning it helps prevent blood cells from clumping while also widening blood vessels.


Q: Are there any long-term effects associated with using Inclaud?

A: While the frequency of some adverse reactions is concentrated within the first month of use, post-marketing surveillance has reported a certain proportion of adverse reactions occurring after long-term use, defined as exceeding 360 days.


Q: Why do some people experience initial sleepiness when starting Inclaud?

A: Regulatory documents list drowsiness (somnolence) and dizziness as potential adverse reactions associated with Inclaud. These central nervous system effects may be experienced by some patients.


Q: Does Inclaud cause changes in weight?

A: Weight gain is listed as a reported symptom. Patients experiencing this, or any new symptom, should discuss it with their healthcare provider. Swelling, or peripheral edema, is also a Common side effect that can contribute to changes in body mass.


Q: Is there any risk of interaction between Inclaud and common pain relievers?

A: Regulatory warnings describe a possible increased risk of bleeding when Inclaud is taken with Nonsteroidal Anti-inflammatory Drugs (NSAIDs), which includes several common pain relievers. This is due to the way both medicines may affect blood clotting.


Q: What if I'm taking multiple other medications—is Inclaud still an option?

A: Official documents place strict restrictions on concurrent medicine use. For instance, Inclaud is contraindicated (prohibited) for patients receiving two or more additional antiplatelet or anticoagulant agents. Regulatory restrictions exist regarding the co-administration of Inclaud with medicines that are strong inhibitors of certain liver enzyme pathways.


Q: What should I do if I suspect an interaction between Inclaud and another medicine?

A: Official health guidance advises that patients should tell their healthcare provider about all medicines, over-the-counter products, and supplements they are currently taking. This allows a professional to manage potential interaction risks.


Q: Is Inclaud a type of antibiotic or a different class of medicine?

A: Inclaud is classified as a Phosphodiesterase Type 3 ( PDE3) Inhibitor. It is a class of medicine designed for enhancing circulation and is not categorized as an antibiotic.


Q: Does Inclaud affect liver function?

A: Official prescribing information states that severe hepatic (liver) impairment is an absolute contraindication for use. Post-marketing experience has also included reports of serum enzyme elevations and hepatitis (liver inflammation).


Q: Are allergic reactions to Inclaud common?

A: Official labeling states that known hypersensitivity (an allergic reaction) to Inclaud or its components is an absolute contraindication for use. Reported adverse reactions also include skin rash and hives (urticaria).


Q: What should be in a medical history discussion before starting Inclaud?

A: The medical history discussion should cover absolute contraindications to the drug. This includes any history of heart failure, recent heart attack or coronary intervention, active bleeding, and severe hepatic (liver) or renal (kidney) impairment.


Q: How is the research on Inclaud typically conducted?

A: Research primarily relies on large, multi-center Randomized Controlled Trials ( RCTs) compared to a placebo. These trials use objective measures, such as the distance a patient can walk, and long-term studies track event-based outcomes.


Q: Are there restrictions on taking Inclaud with herbal supplements?

A: Official guidance advises patients to inform their healthcare providers about all supplements, including herbal remedies, that they are taking. This is because co-administration may affect the drug's metabolism and its levels in the body.


Q: Does Inclaud need to be refrigerated?

A: No. Official storage requirements state that the medicine must be stored at Controlled Room Temperature (20 C to 25 C) and must be kept from freezing.

How should Inclaud be stored and disposed of?

How to Store and Dispose of Inclaud?

Inclaud (Cilostazol) must be stored and disposed of according to official regulatory labeling to ensure product stability and safety.


Storage Requirements

  • Temperature: Store at Controlled Room Temperature (20 C to 25 C). The medicine must be kept from freezing.
  • Protection: Keep the tablets in the original, tightly closed container and store them away from excess heat and moisture.
  • Child Safety: The medication must be kept out of the reach and sight of children.

Disposal Instructions

  • Unused Product: The preferred method is to use a drug take-back program or authorized collection site.
  • Household Disposal: If a take-back option is unavailable, unused medication must be mixed with an undesirable substance (e.g., used coffee grounds) and placed in a sealed container for household trash disposal.
  • Restriction: Do not flush the medication down a toilet or pour it into a drain.

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

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