Trombocil

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Trombocil

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 Trombocil

Quick Facts

Property Description
Active ingredient Cilostazol
Form Oral tablets
Pharmacological class Antiplatelet agent, Vasodilator, PDE3 Inhibitor
General purpose Improving blood circulation
Origin Synthetic compound (Quinolinone derivative)

Trombocil: Definition, Composition, and Pharmaceutical Form

Trombocil is a prescription medicine formulated as an oral tablet that contains the active ingredient Cilostazol. This synthetic compound is chemically classified as a quinolinone derivative and is the sole therapeutic component, establishing the product as a single-ingredient preparation intended for oral administration. Cilostazol is recognized in pharmacological studies for its distinctive capacity to moderate platelet function, confirming its role within the circulatory class of medicines. The product, marketed under the trade name Trombocil, is typically associated with the management of chronic conditions affecting peripheral circulation in adult patients.

What Type of Medicine is Cilostazol? (Pharmacological Class and Mechanism)

Cilostazol is officially categorized as a Platelet Aggregation Inhibitor and a Vasodilator. This critical dual classification is achieved by the drug’s primary function as a selective Phosphodiesterase Type 3 (PDE3) inhibitor. By inhibiting this enzyme, Cilostazol simultaneously reduces the clustering of platelets and promotes the expansion of arterial walls, a process known as vasodilation. The inhibitory effect of Cilostazol on the PDE3 enzyme plays a role in affecting vascular tone. This specific mechanism distinguishes Cilostazol from older antiplatelet agents and underscores its established role in circulation enhancement.

General Purpose and Therapeutic Function

To the patient, the overall function of Trombocil is to act as a circulatory enhancer. Its combined antiplatelet and vasodilating properties facilitate improved blood flow, especially in peripheral arteries. The general purpose of the medication is to ensure a more consistent and adequate blood supply to tissues, managing the overall health implications of restricted circulation.

What side effects are possible with Trombocil?

Possible side effects and safety information

The safety profile of Trombocil (Cilostazol) is officially categorized by the frequency and physiological systems affected, as documented in regulatory texts. The most frequent reactions are classified as Very Common, which includes Headache. Side effects classified as Common often involve the Gastrointestinal System, such as Diarrhoea and Abnormal stools, and Cardiac Disorders, where Palpitations and Tachycardia are noted. Official regulatory notes indicate that common effects, including headache and diarrhoea, may be more pronounced at the beginning of treatment.

Less frequent but more severe events are documented in the Uncommon category. These include serious Cardiac Disorders such as Myocardial infarction (heart attack) and significant vascular events like Cerebral haemorrhage (bleeding in the brain). Furthermore, rare to very rare but critical concerns include severe blood abnormalities, specifically Blood and Lymphatic System Disorders such as Agranulocytosis and Aplastic anaemia.

Safety Constraints and Restrictions

Official regulatory labeling includes explicit restrictions on the use of Trombocil due to its pharmacological mechanism. The medication is officially contraindicated in patients with any degree of Congestive Heart Failure (CHF). Use is also restricted in individuals with severe renal impairment or moderate to severe hepatic impairment. The combined antiplatelet effect means that use alongside two or more other antiplatelet or anticoagulant agents is officially contraindicated due to the increased risk of bleeding.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Trombocil (Cilostazol) describes overdose manifestations as an anticipated exaggeration of the drug's intended pharmacological effects.

Feature Description from Regulatory Sources
Documented Manifestations Symptoms include severe headache, diarrhea, hypotension (low blood pressure), and tachycardia (fast heart rate). Dizziness and fainting are also documented.
Severe Outcomes A severe outcome that may potentially occur is the presence of cardiac arrhythmias (irregular heartbeats).
Urgent Medical Help Required You must immediately contact emergency services if an individual has collapsed, had a seizure, has trouble breathing, or cannot be awakened. For any suspected overexposure, seek medical help right away.

Management and Constraints

Management focuses on supportive treatment and careful observation of the patient’s vital signs, which may involve measures such as gastric lavage. A primary constraint documented in the prescribing information is that no specific antidote is known. Furthermore, due to the drug's high protein binding and extensive metabolism, it is considered unlikely to be efficiently removed by hemodialysis in an overdose situation. No population-specific differences in overdose management are explicitly detailed in the official labeling.

Therapeutic Uses of Trombocil

What Trombocil Treats: Main Uses and Benefits

Trombocil (Cilostazol) is used in situations involving certain distressing symptoms due to insufficient blood flow in the peripheral arteries. The medication is applied across domains where additional symptomatic support is needed, focusing on mobility and specific symptom patterns. The medication may assist with reducing symptoms of intermittent claudication.

The medicine is commonly used to help with conditions characterized by Peripheral Artery Disease (PAD), chronic arterial occlusive disease, and its primary manifestation: intermittent claudication. This is the characteristic cluster of cramping, aching, or pain in the leg muscles that occurs consistently during activity. Trombocil is considered relevant for patients whose circulation deficits have led to symptoms that interfere with daily functioning.

“The therapeutic benefit may include an increased distance a patient can walk before the onset of pain, and supports general well-being during symptomatic phases.”

The goal is relevant for easing these distressing manifestations. This supportive relief helps ease the overall symptom burden and assists with maintaining functional stability, particularly in clinical settings where supportive symptom management is appropriate.


Quick Fact: Relief for Vascular Claudication

Property Description
Primary Indication Intermittent claudication (symptom of PAD)
Symptom Focus Activity-induced leg pain, cramping, muscle aching
Core Patient Benefit Support for increased pain-free walking distance (functional benefit)
Typical Context Chronic management of peripheral circulation deficits

Regulatory References

  1. NIH MedlinePlus overview of Cilostazol

Eligibility and Restrictions for Use

The eligibility for Trombocil (Cilostazol) is strictly defined by regulatory authorities, focusing on specific health conditions and age groups. Trombocil is indicated for use only in adult patients with intermittent claudication.

Contraindications (Who Must Not Use)

Contraindicated Status Population or Condition
Absolute Prohibition Heart failure of any severity (Congestive Heart Failure).
Absolute Prohibition Active pathologic bleeding or hemostatic disorders (e.g., active peptic ulceration, recent hemorrhagic stroke).
Absolute Prohibition Severe renal impairment (Creatinine Clearance le 25 ml/min) or moderate/severe hepatic impairment (per some regulators).
Absolute Prohibition Pregnancy or concomitant use of two or more additional antiplatelet or anticoagulant medicines.

Restricted and Non-Established Use

  • Pediatric Use: Safety and effectiveness have not been established in the pediatric population.
  • Concomitant Medication: Use is restricted and requires a mandatory dose reduction when co-administered with strong inhibitors of the CYP3A4 or CYP2C19 enzymes, as specified in official labeling.
  • Nursing Mothers: Use is not recommended; women should not breastfeed during treatment and for five days after the final dose.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Trombocil (Cilostazol) has officially documented interactions that may alter its concentration in the body or enhance the effects of other substances, based on regulatory information.

Contraindicated Combinations

Classification Restricted Context
Disease Contraindication Co-use in patients with Congestive Heart Failure of any severity.
Product Contraindication Co-use with two or more additional antiplatelet or anticoagulant agents.

Pharmacokinetic Interactions

Cilostazol is metabolized by CYP3A4 and CYP2C19 enzymes, creating a potential for pharmacokinetic interaction when co-administered with inhibitors of these enzymes. These substances can increase the plasma concentration of Cilostazol or its active metabolites, requiring a change in the product's administration based on regulatory documentation. Interacting medicines explicitly listed include Ketoconazole, Clarithromycin, Erythromycin, Omeprazole, and Diltiazem.

Pharmacodynamic Interactions

Co-administration with other antiplatelet agents (e.g., Aspirin, Clopidogrel) or anticoagulants (e.g., Warfarin) may lead to an additive antiplatelet effect, resulting in an officially increased potential for hemorrhagic events. Caution is also advised when co-administering with hypotensive agents due to the potential for an additive reduction in blood pressure.

Food and Substance Restrictions

Food, especially high-fat meals, significantly increases Cilostazol's absorption. Regulatory labeling mandates administration on an empty stomach (at least mathbf30 minutes before or mathbf2 hours after meals). Consumption of Grapefruit Juice is restricted due to its documented ability to increase Cilostazol exposure.

Mechanism of Action

Trombocil (Cilostazol) works by engaging a complementary dual mechanism of action centered entirely on the inhibition of a key regulatory enzyme. Its effects are purely pharmacodynamic, focusing on two distinct cell populations within the circulatory system.

Targeted Inhibition of the PDE3 Enzyme

The drug initiates its action by acting as a selective inhibitor of the enzyme Phosphodiesterase Type 3 ( PDE3). This enzyme’s primary function is to break down the critical cellular messenger cyclic adenosine monophosphate ( cAMP). By blocking this breakdown, Trombocil causes cAMP levels to rise significantly inside both platelets and vascular smooth muscle cells (VSMCs). This mechanism is central because the increased cAMP is the molecular trigger for both of the drug's key physiological effects.

Modulating Platelet Activation Pathways

The rise in cAMP within platelets stabilizes them by activating Protein Kinase A ( PKA). PKA subsequently interferes with the molecular signals required for platelets to activate, specifically by reducing calcium release and inhibiting the function of the GPIIb/IIIa receptor complex. This pathway modulation results in reduced platelet aggregation, decreasing the propensity for cellular aggregation in blood vessels.

Direct Modulation of Arterial Smooth Muscle Tone

The same cAMP/ PKA cascade in the VSMCs of arterial walls leads to a different functional outcome: relaxation. Here, PKA inactivates the enzyme Myosin Light-Chain Kinase ( MLCK), which is essential for muscle contraction. The resulting smooth muscle relaxation causes arterial vasodilation (widening), which decreases vascular resistance and directly results in the physiological consequence of increased peripheral blood delivery.

Dosage and Administration Information

Trombocil (Cilostazol) is administered solely through the oral route as a tablet. The general principle of its use is a fixed frequency and timing pattern. The usual adult dose is 100 mg, which is taken twice daily to establish a consistent systemic presence. However, official guidelines require the dosage to be reduced to 50 mg twice daily when the medicine is co-administered with certain strong or moderate inhibitors of the CYP3A4 or CYP2C19 enzymes, a procedural rule based on managing drug exposure.

A critical administration constraint is the requirement for the tablets to be taken on an empty stomach. The medication must be administered at least 30 minutes before or two hours after both the morning and evening meals to ensure consistent systemic absorption. Following this specific timing is essential for proper administration.

The duration of use is procedural and time-bound. Official guidance indicates that patients should undergo a therapeutic trial for up to 3 months of continuous treatment before its continuation is determined. If no improvement is observed after this time period, the medication is typically discontinued. Administration rules for specific populations include advising caution for use in patients with severe renal or moderate-to-severe hepatic impairment, although no specific dose adjustment is mandated for older adults. If a dose is missed, patients should simply skip the missed dose and resume the regular twice-daily schedule with the next planned dose.

Recent Clinical Evidence

Trombocil: Recent Clinical Evidence

Phase III Trial Summary

Clinical research has explored Trombocil's potential role in managing symptoms related to chronic arterial occlusion and in the secondary prevention of cerebral infarction. Studies have investigated whether the drug may be associated with improved blood flow and reduced platelet aggregation. The primary Phase III trial for the initial indication was a randomized, controlled study that followed a substantial cohort of adult participants over a treatment period of several months.

  • Primary Endpoint: The study evaluated outcomes such as changes in maximum walking distance (MWD) in patients with intermittent claudication and the proportion of patients achieving specific symptomatic improvements.
  • Secondary Endpoint: Research also evaluated whether Trombocil might be associated with changes in the frequency of cerebrovascular events compared to placebo.

Long-Term Follow-up Data

Long-term data from open-label extension studies and meta-analyses were analyzed to gather information on durability of reported effects. Researchers investigated whether Trombocil may be associated with changes in long-term vascular outcomes, including recurrence rates after certain vascular procedures. The evidence remains limited regarding the long-term comparative effectiveness with all other treatment classes.

Safety and Tolerability Profiles

Study findings included data regarding safety and tolerability in participants, including those with pre-existing conditions. Trombocil was generally described as well-tolerated in many study cohorts, but the research protocol included analysis of potential adverse effects related to its mechanism of action.

  • Reported Adverse Events: The most frequently reported adverse events included mild to moderate headache, palpitations, and diarrhea. These events were generally described as mild to moderate and non-serious in the majority of reporting participants.
  • Onset of Action: Research has examined the onset of reported symptomatic effects, with some studies noting initial improvements within weeks of initiating treatment.

Key Studies & References Guideline for the Management of Peripheral Artery Disease (PAD): Evidence-Based Recommendations

Frequently Asked Questions (FAQ)

Common questions about Trombocil (FAQ)


Q: Why do doctors prescribe Trombocil instead of another blood thinner?

A: Trombocil is officially described in regulatory documents as a medicine with a dual mechanism of action. It functions as both a Platelet Aggregation Inhibitor and a Vasodilator (a medicine that widens blood vessels). This combination of actions, achieved by selectively inhibiting the PDE3 enzyme, distinguishes its mechanism from agents that only focus on platelet function or clotting factors.

Q: Is Trombocil the same kind of drug as Aspirin?

A: No, while both Trombocil and Aspirin are classified as antiplatelet agents, they work via different mechanisms. Trombocil selectively inhibits the PDE3 enzyme and also results in vasodilation. Aspirin works through a separate mechanism and belongs to a different pharmacological class. Therefore, they are not the same kind of drug.

Q: I'm feeling lightheaded, is that a Trombocil side effect?

A: Official regulatory labeling lists dizziness as a common side effect of Trombocil. Because the drug may affect blood pressure, a feeling of lightheadedness or dizziness can occur, particularly when a person stands up quickly. This effect is noted in the drug’s official product information.

Q: Can Trombocil affect my stomach?

A: Yes, regulatory documents indicate that Trombocil can affect the gastrointestinal system. Side effects noted include diarrhea, abdominal pain, and abnormal stools. Official product information notes that these effects may be more pronounced at the beginning of treatment.

Q: How long does it take for Trombocil to start working?

A: Clinical studies show that initial symptomatic improvement may be observed as early as two to four weeks after starting Trombocil. However, to observe the full intended effects, official guidance specifies that patients should undergo a therapeutic trial of up to 12 weeks, after which the decision to continue treatment may be reviewed.

Q: How long do the effects of Trombocil last after I take a dose?

A: According to pharmacokinetic data, the elimination half-life of the active ingredient is approximately 11 hours. This means the drug remains active in the body for an extended period after each intake. This supports the general schedule of taking the medicine twice daily to maintain a consistent presence in the system.

Q: Can someone with kidney problems use Trombocil?

A: Trombocil is contraindicated (use is prohibited) in people who have severe renal impairment (a specific, advanced kidney condition). For individuals with mild to moderate kidney impairment, official labeling generally does not mandate a dose change, but monitoring may be advised.

Q: Is it okay to take Trombocil with vitamins or supplements?

A: Trombocil is metabolized by specific liver enzymes, which creates a potential for drug-substance interactions. While specific supplements are not listed, the labeling advises caution with any substance that may affect the drug's metabolism or increase the potential for bleeding. Therefore, co-administration with supplements and vitamins should be discussed with a healthcare provider.

Q: Are there any specific lifestyle changes recommended when taking Trombocil?

A: Official information emphasizes that the management program for this condition includes non-pharmacological interventions. This means the continuation of lifestyle modifications, such as smoking cessation and a structured exercise program, is important. It is also a mandatory administration condition that the drug must be taken on an empty stomach.

Q: Has Trombocil been studied in children?

A: According to official regulatory labeling, the safety and effectiveness of Trombocil have not been established for use in the pediatric population. The medication is currently indicated only for use in adult patients.

Q: Can Trombocil affect my sleep?

A: Official post-marketing experience reports have noted insomnia (difficulty falling or staying asleep) as a potential adverse reaction associated with Trombocil. This indicates that the medication may affect the sleep cycle in some individuals.

Q: Can Trombocil interfere with other chronic medications?

A: Yes, Trombocil can potentially interfere with other long-term medicines. Regulatory documents state it is metabolized by the CYP3A4 and CYP2C19 liver enzymes, and many chronic medicines may influence these enzymes, potentially increasing Trombocil's concentration. It is also documented to have an additive antiplatelet effect when combined with other agents that affect clotting.

Q: Are there special warnings for people with liver disease using Trombocil?

A: Trombocil is contraindicated (must not be used) in patients with moderate or severe hepatic impairment (liver disease). Since the drug is metabolized by the liver, those with mild impairment require observation, as noted in official regulatory guidance.

Q: Can Trombocil affect fertility?

A: Regulatory documents include findings from animal studies that indicate a potential for reproductive toxicity. While human fertility data is absent in standard labeling, this information is cited in official warnings about potential effects on the reproductive system and the unborn child.

How should Trombocil be stored and disposed of?

How to Store and Dispose of Trombocil

The storage and disposal of Trombocil (Cilostazol) tablets must strictly follow official regulatory guidelines to maintain potency and ensure safety.


Storage Requirements

Condition Requirement
Temperature Store at Controlled Room Temperature, 25 C (77 F), with excursions permitted between 15 C and 30 C (59 F and 86 F).
Protection Keep from freezing, excess heat, and moisture (e.g., do not store in the bathroom).
Container Keep in the original container and ensure the container is tightly closed.

Safety and Disposal

Trombocil must be stored out of the sight and reach of children.

Unused or expired tablets should be disposed of by utilizing a drug take-back program whenever available. If no program is accessible, mix the tablets with an undesirable substance (such as dirt or coffee grounds) and place the mixture in a sealed container before discarding in the household trash. The medication must not be flushed down the toilet and must be kept from entering sewers or ground water.

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

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