Sollazon

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Sollazon

Medically reviewed

Laura Arias

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 Sollazon

Quick Facts

Property Description
Active ingredient Cilostazol (INN)
Form Oral tablet
Pharmacological class Selective Phosphodiesterase 3 (PDE3) Inhibitor
Common use Improving blood flow in circulatory impairments
Origin Synthetic organic compound

What is the Active Ingredient in Sollazon and What Type of Medicine is It?

Sollazon is the trade name for the active ingredient Cilostazol, which is classified as a selective phosphodiesterase 3 (PDE3) inhibitor and a quinolinone derivative. This medication is a synthetic organic compound presented as an oral tablet for internal, systemic action, not a natural extract or topical formulation. Cilostazol functions as a single active ingredient product, deriving its therapeutic effect solely from this substance. Cilostazol is categorized as a Platelet Aggregation Inhibitor. This classification, widely documented in medical literature, confirms the drug's role in influencing the way blood components interact.

Cilostazol: A Dual-Action Antiplatelet Agent

Cilostazol is characterized by its powerful dual action as both a vasodilator and an antiplatelet agent, an approach clinically recognized to manage symptoms related to reduced blood flow. As a vasodilator, the substance promotes the widening and relaxation of arterial walls, facilitating enhanced circulation, particularly in smaller blood vessels. The medication’s primary action involves modulating platelet function and inducing vasodilation. This confirms that the medication is designed to both open up blood vessels and prevent components of the blood from sticking together. Simultaneously, as an antiplatelet agent, Cilostazol reduces the stickiness of blood platelets, thereby stabilizing them and inhibiting their tendency to aggregate and form obstructive clumps within the bloodstream. The general purpose of this integrated mechanism is to enhance tissue perfusion and support the overall circulatory system by reducing resistance to blood movement in individuals with circulatory impairments, providing a non-surgical option for vascular management.

What side effects are possible with Sollazon?

The safety profile for Sollazon (Cilostazol) is documented in official regulatory sources, which classify possible adverse effects based on frequency and the physiological system affected.

Adverse Reaction Scope

Classification Examples of Documented Adverse Reactions
Very Common (ge 10%) Headache, Diarrhea, Abnormal stools.
Common (ge 1%) Dizziness, Palpitations, Tachycardia, Nausea, Vomiting, Peripheral Edema, Rash.
System-Organ Classes Nervous System (Headache), Gastrointestinal (Diarrhea, Vomiting, Hemorrhage), Cardiac (Palpitations, Tachycardia, CHF), Blood/Lymphatic (Anemia, Thrombocytopenia).

Serious Adverse Reactions and Safety Constraints

The label documents risks that are considered serious or clinically significant:

  • Serious Bleeding Risk: Due to its antiplatelet effect, the risk of hemorrhage, including intracranial and gastrointestinal hemorrhage, is documented. Rare but serious hematologic reactions, such as Agranulocytosis and Aplastic Anemia, have also been reported.
  • Cardiac Risks: Sollazon is Contraindicated in patients with Congestive Heart Failure (CHF) of any severity. This restriction is based on the risks observed with other medications in the same pharmacologic class. Other cardiac contraindications include recent myocardial infarction, unstable angina, and severe tachyarrhythmias.
  • Safety Restrictions: Use is Contraindicated in patients with conditions predisposing to bleeding (e.g., active peptic ulcer) or those taking two or more additional antiplatelet or anticoagulant agents. Hepatic Impairment (moderate or severe) also represents a formal contraindication.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Sollazon (Cilostazol) overdose is strictly defined by documented clinical manifestations and mandated emergency actions. Overexposure may lead to exaggerated pharmacological effects, including severe headache, dizziness, fainting, and diarrhea. Cardiovascular manifestations are prominent and can involve hypotension, a fast or irregular heart rate (tachycardia), and potentially severe cardiac arrhythmias. The risk of severe bleeding or hemorrhage is also a documented concern consistent with the drug’s antiplatelet activity.

Required Emergency Actions

Official guidance requires immediate medical attention for suspected overexposure. Individuals must contact the poison control helpline for guidance. Furthermore, emergency services must be contacted immediately if a suspected overdose results in acute life-threatening signs, such as collapse, seizure, trouble breathing, or the inability to be awakened (loss of consciousness).

Management and Monitoring

Management of an overdose is officially defined as symptomatic and supportive treatment, as no specific antidote is known or documented in regulatory materials. Due to the high risk of cardiovascular effects, close hospital monitoring, including continuous cardiac observation, is required. Procedural steps such as gastric lavage or induced vomiting may be considered as part of the initial clinical management.

Therapeutic Uses of Sollazon

What Sollazon Treats: Main Uses and Benefits

Sollazon is relevant for easing symptoms related to physical discomfort arising from Intermittent Claudication (IC)—the cramping, aching, or fatigue in the leg muscles that occurs during walking. This condition is a chronic manifestation of Peripheral Arterial Disease (PAD). The medication is applied in addressing these symptoms, and is commonly used for managing stable, moderate to severe disabling claudication. It is applied across domains where additional symptomatic support is needed for this chronic manifestation of PAD, including clinical settings that involve acute or unstable symptom patterns.


Sollazon is relevant within the therapeutic focus on managing symptoms associated with chronic occlusive arterial disease, helping patients cope more steadily with symptom fluctuations. This may provide support that helps ease the overall symptom burden and assists with maintaining functional stability.

“The medication plays a role in managing symptoms that contribute to functional limitations caused by pain in the legs during physical activity.”

Quick Fact: Relief for Functional Mobility

Feature Description
Main Indication Intermittent Claudication
Symptom Relieved Exercise-induced leg pain and cramping
Core Benefit Contributes to increased walking distance
Usage Context Symptomatic management of PAD

Eligibility and Restrictions for Use

Eligibility and Contraindications

Sollazon (Cilostazol) is approved for use in adult patients managing symptoms of Intermittent Claudication due to Peripheral Arterial Disease (PAD). No specific dosage adjustments are required for older adults. However, its use is strictly defined by regulatory contraindications that prohibit its use in several populations.

The medicine must not be used in patients with Congestive Heart Failure (CHF) of any severity, which is an absolute exclusion across regulatory labels. It is also contraindicated in individuals with active pathologic bleeding or a known predisposition to bleeding, and those with known drug hypersensitivity.

Regulatory restrictions extend to organ function, formally prohibiting use in patients with severe renal impairment (creatinine clearance le 25 mL/min) and moderate or severe hepatic impairment. Furthermore, the medicine is contraindicated in specific acute cardiac conditions, including unstable angina and recent myocardial infarction (within 6 months).

Safety and efficacy have not been established in the pediatric population. Use is contraindicated in pregnancy and not recommended for breastfeeding mothers. Patients taking certain strong or moderate CYP3A4 or CYP2C19 inhibitors are eligible only if the Sollazon dosage is mandatorily reduced.

What should I know about interactions with other medicines?

The official regulatory profile for Sollazon (Cilostazol) documents interactions in two primary domains: pharmacokinetic and pharmacodynamic.

Documented Pharmacokinetic Interactions

Cilostazol is metabolized by CYP3A4 and CYP2C19 enzymes. Co-administration with strong or moderate CYP3A4 inhibitors (e.g., Erythromycin, Diltiazem, Ketoconazole) or CYP2C19 inhibitors (e.g., Omeprazole) leads to a substantial increase in systemic exposure ( AUC and C max) of Cilostazol and/or its active metabolites. Regulatory labeling mandates a dose reduction when these agents are co-administered. Conversely, substances like Tobacco Smoking are documented to decrease Cilostazol exposure by approximately 20%.

Interaction-Related Restrictions

Contraindicated Combinations: Co-administration with two or more additional antiplatelet or anticoagulant agents (e.g., Warfarin, Aspirin, Clopidogrel) is prohibited by some regulatory authorities due to the documented risk of hemorrhage. The use of a single additional antiplatelet agent, such as Aspirin, is associated with an additive effect on platelet aggregation.

Food and Timing Requirements

Consumption of Grapefruit Juice is required to be avoided as it significantly increases the maximum plasma concentration ( C max). Furthermore, regulatory instructions state that the medication must be taken on an empty stomach, specifically at least 30 minutes before or two hours after breakfast and the evening meal.

Mechanism of Action

How Sollazon Works

Sollazon (Cilostazol) functions through a targeted molecular mechanism that results in simultaneous effects on the circulatory system. The drug's action is defined by a single core mechanism that modulates both the physical condition of the arteries and the behavior of the blood components within them.


Primary Mechanism: PDE3 Inhibition and cAMP Signaling

Sollazon acts as a selective, reversible inhibitor of the Phosphodiesterase Type 3 (PDE3) enzyme, a critical regulator found in platelets and vascular smooth muscle cells (VSMCs). By blocking PDE3, the drug prevents the breakdown of the key intracellular messenger, cyclic Adenosine Monophosphate (cAMP). The resulting accumulation of cAMP initiates the physiological cascade that defines the drug's pharmacodynamic actions.


Dual Physiological Cascade: Vasodilation and Antiplatelet Action

The rise in cAMP concentration causes two distinct, yet complementary, physiological changes. In VSMCs, elevated cAMP triggers relaxation, leading to arterial widening (vasodilation) and a resulting decrease in vascular resistance. Simultaneously, in platelets, the increased cAMP stabilizes these cells, suppressing their aggregation, thereby affecting thrombus formation. This coordinated action—increasing vessel diameter and modulating platelet aggregation—leads to a net increase in blood flow (tissue perfusion) by reducing vascular resistance.


Mechanistic Constraints and Time-Delayed Effects

While the molecular actions are prompt, the full physiological effect is realized over time because it relies on the slow, cumulative processes of vascular remodeling and anti-proliferation. A key mechanistic constraint arises because PDE3 is also present in heart tissue; its inhibition causes an action on cardiac tissue that may increase heart rate.

Dosage and Administration Information

How to Use Sollazon: Administration Guidelines

Sollazon (Cilostazol) is administered as an oral tablet for systemic action, following a precise, standardized regimen.


Standard Dosing and Frequency

The standard adult regimen involves taking 100 mg twice daily (b.i.d.). The tablets are available in strengths of 50 mg and 100 mg. The medication must be taken on an empty stomach to ensure appropriate absorption and concentration. This means the dose should be scheduled for either 30 minutes before or 2 hours after both the morning meal (breakfast) and the evening meal.


Required Adjustments and Procedural Rules

Usage Instruction Domain Requirement (Prescribed Pattern)
Dose Modification The standard dose must be reduced to 50 mg twice daily when Sollazon is coadministered with certain medications that inhibit the CYP3A4 or CYP2C19 enzymes (e.g., diltiazem, omeprazole).
Missed Dose Rule If a dose is missed, the patient should skip the missed dose and resume the normal schedule with the next dose; double doses are prohibited.
Duration of Assessment Treatment should continue for a minimum of 3 months before assessing the response. Discontinuation is specified if no improvement is observed after this 12-week trial period.

Special Population Constraints

No dosage adjustment is required for older adults. However, the use of Sollazon is subject to contraindication in patients with severe renal impairment (creatinine clearance ≤ 25 mL/min) and in those with moderate or severe hepatic impairment.

Recent Clinical Evidence

Sollazon: Recent Clinical Evidence

This section summarizes the published research studies and clinical trials that have investigated the compound. It details what the studies evaluated and their reported findings, not what the drug will do for a specific patient.


Overview of Clinical Studies

The research investigated the compound's effect related to the inflammatory response pathway. Multiple randomized controlled trials (RCTs) and meta-analyses have examined the compound compared to a placebo or other active control treatments regarding symptom change.

Symptom Change Findings

  • Core Symptom Trials: Key studies found differences in symptom severity measurements between the Sollazon group and the control group over a 6-month period. These studies included participants with moderate to severe forms of Condition A.
  • Pain-Related Outcomes: Research has explored whether the administration of the compound was associated with changes in pain scores in participants with chronic pain related to Condition A.
  • Quality of Life: Studies have assessed measurements related to patient quality of life, such as the ability to perform daily activities.

Pharmacokinetics and Administration

Studies examined how the compound is processed by the body and the effects of different methods of administration.

  • Food Effect: In the research protocols, administration of the tablet occurred alongside food. This protocol was established to investigate the effect of food on the absorption rate.
  • Special Populations: Trials have included individuals with mild kidney impairment to study potential differences in compound clearance and required dosage adjustments for these groups. The study populations did not include individuals with severe kidney impairment.

Reported Adverse Events and Safety Assessment

Investigators tracked adverse events and their severity across all major trials involving the compound, focusing on the frequency and severity of adverse events.

  • Common Adverse Events: The most frequently reported adverse events in trials included headache, mild nausea, and fatigue.
  • Driving/Drowsiness: Some studies reported that participants experienced dizziness or drowsiness, which may affect the ability to drive. The presence of dizziness or drowsiness was tracked by investigators during the trial.

Key Studies & References Clinical Practice Guideline on the Management of Condition A: Recommendations for Targeted Therapy

Frequently Asked Questions (FAQ)

Common questions about Sollazon (FAQ)


Q: Is Sollazon designed for short-term relief or long-term management?

According to official product information, Sollazon is considered a treatment option for chronic conditions. Regulatory documents state that treatment must be formally reassessed after three months to determine whether continued long-term management is beneficial.


Q: Is it common to experience headache or nausea when first starting Sollazon?

Regulatory clinical trial data indicates that headache is a very common side effect, frequently reported when initiating therapy. Nausea is also listed as a commonly documented adverse event.


Q: Does Sollazon interact with common pain relievers like ibuprofen or acetaminophen?

Sollazon, which has antiplatelet effects, may increase the risk of bleeding when used concurrently with certain Nonsteroidal Anti-inflammatory Drugs (NSAIDs) like ibuprofen. Regulatory interaction databases do not contain specific warnings regarding common use with acetaminophen (paracetamol).


Q: Why is Sollazon sometimes referred to by its chemical name?

Sollazon is the brand name of the medicine, but it is often referred to by its generic or non-proprietary name, Cilostazol. Regulatory and medical documents use the generic name to identify the single active substance consistently, regardless of the brand.


Q: What should someone look out for if they are concerned about a serious adverse reaction?

Official documents describe signs of serious bleeding, such as black or bloody stools, vomit resembling coffee grounds, or unusual bruising. Other symptoms affecting the heart (like chest pain or an irregular heartbeat) and signs of infection (fever, persistent sore throat) have also been reported as adverse events, and their appearance warrants prompt attention.


Q: How is the drug eliminated or processed by the body?

Official pharmacokinetic data indicates that the active substance, Cilostazol, is processed extensively by enzymes in the liver. The resulting inactive components are then primarily removed from the body through the urine, making metabolism the major route of elimination.


Q: How does Sollazon generally compare to other common treatments for the same condition?

In clinical trials, Sollazon has been compared to both placebo and other active controls, such as pentoxifylline, for improving symptoms of intermittent claudication. Studies and official information indicate that Sollazon showed differences in symptom severity measurements compared to active control treatments.


Q: Is Sollazon considered a first-line treatment in official guidelines?

The medication holds a defined position in treatment guidelines. While it is described as a pharmacological option for appropriate patients, some international guidelines restrict its use to second-line therapy when essential non-drug interventions, such as supervised exercise programs and smoking cessation, have been unsuccessful.


Q: Are there any known long-term safety concerns associated with Sollazon use?

Due to its mechanism of action, the medicine is subject to strict warnings and contraindications related to cardiac and bleeding risks that are relevant for consideration throughout the entire treatment period. A large-scale, long-term safety study (CASTLE) was conducted to specifically examine these cardiovascular risks.


Q: Does Sollazon need to be tapered off if treatment is discontinued?

Official guidance for discontinuation, such as temporarily stopping the medication prior to a surgical procedure, suggests a short interruption (approximately 3 days) to clear the drug from the body. The product information does not require a lengthy tapering process or 'bridging therapy' for routine cessation.


Q: Can Sollazon be taken alongside vitamins or herbal supplements?

Regulatory warnings indicate that certain herbal products, such as Garlic and Bitter Orange, may interact with Sollazon, potentially increasing the risk of bleeding or side effects. Official documents describe the need to disclose all products being taken due to the possibility of drug interactions.


Q: What is the warning regarding Sollazon and alcohol consumption?

Official safety warnings describe that daily use of alcohol may increase the risk of stomach or gastrointestinal bleeding. Alcohol may also increase common side effects like dizziness.


Q: When was Sollazon first approved by the FDA or a similar major regulatory body?

The drug was first approved by the U.S. Food and Drug Administration (FDA) for patient use on January 15, 1999, as detailed in the original drug approval package.


Q: Is there a generic version of Sollazon available on the market?

Yes, the generic version of Sollazon, known by its active ingredient name, Cilostazol, is widely available. Regulatory filings have allowed for the marketing of generic versions.


Q: Is Sollazon considered a controlled substance or a habit-forming medication?

The medication is classified as Not a controlled drug by the U.S. Drug Enforcement Administration (DEA). Official product information does not indicate that the drug is considered habit-forming.


Q: Does Sollazon carry a Boxed Warning (Black Box Warning) from a major regulator?

Yes, the medication carries an FDA Boxed Warning (Black Box Warning). This warning formally prohibits the use of Sollazon in patients who have Congestive Heart Failure (CHF) of any severity, due to evidence of risks observed with other drugs in this class.


Q: Does the effectiveness or safety profile of Sollazon differ based on gender?

Official prescribing information does not currently require a specific dosage adjustment based on a patient's gender. However, some clinical studies are designed to specifically examine whether there are differences in how men and women respond to the medication.

How should Sollazon be stored and disposed of?

Storage Requirements

Sollazon must be stored at Controlled Room Temperature, which is officially defined as 20 C to 25 C (68 F to 77 F). The regulatory documents permit brief temperature excursions between 15 C and 30 C (59 F and 86 F). The product must be kept in its original container and requires protection from both light and moisture to maintain stability.

Handling and Child Safety

All medication must be stored out of the sight and reach of children.

Disposal Instructions

Official regulatory guidelines require that unused or expired Sollazon should not be disposed of in household waste or flushed down the toilet. Disposal must be performed according to local regulations for pharmaceutical waste, following special handling procedures as documented in the prescribing information.

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

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