Dilan

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Dilan

Method of action: Peripheral Vasodilators

Treatment option:

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 Dilan

Quick Facts

Property Description
Active ingredient Buflomedil (Buflomedil hydrochloride)
Form Tablets, Solution for Injection/Infusion
Pharmacological class Peripheral Vasodilator, alpha1-Adrenoceptor Antagonist
General Purpose Enhancing blood flow in the microcirculation
Origin Synthetic, Single-ingredient

What Type of Medicine is Dilan (Buflomedil)?

Dilan is a synthetic therapeutic agent whose active ingredient is the compound Buflomedil (Buflomedil hydrochloride). Pharmacologically, it belongs to the group of Peripheral Vasodilators, which are agents designed to widen blood vessels. This vasoactive mechanism is used for addressing restricted circulation. Buflomedil achieves this effect as an alpha1-Adrenoceptor Antagonist, meaning its function is tied to blocking certain signals that normally trigger the constriction of blood vessels. As a single-ingredient product derived through chemical synthesis, Dilan is classified as a prescription-only medicine intended primarily for the adult population experiencing circulatory deficits.

Composition and Available Forms

The core composition of Dilan consists of Buflomedil hydrochloride combined with the necessary non-active materials (excipients and carriers) to produce pharmaceutical preparations. This medicine is supplied in two principal dosage forms to facilitate different routes of administration, offering flexibility in therapeutic strategy. These forms include solid tablets for oral use, and an aqueous solution specifically designed for parenteral administration via injection or infusion. The action of Buflomedil increases perfusion to impaired vascular beds of the microcirculation.

General Purpose: How Dilan Impacts Circulation

The general purpose of Dilan is to relieve issues associated with restricted blood flow by directly promoting vasodilation, the mechanism of relaxing the muscular walls of peripheral vessels. This vessel relaxation counters restricted blood flow by decreasing resistance, which serves to increase local blood flow and improve tissue microcirculation. By facilitating this relaxation and enhancing flow dynamics, the medication's function is to generally improve the delivery of oxygen and nutrients to tissues, particularly in situations involving reduced peripheral perfusion.

What side effects are possible with Dilan?

Possible Side Effects and Safety Information

The safety profile of Dilan (Buflomedil) is defined primarily by the risk of severe, systemic toxicity, as documented by regulatory authorities. The most critical concerns involve the Nervous System and the Cardiac System, with reports of severe adverse events occurring even within the established therapeutic range.


Documented Safety Concerns and Toxicity

The most serious adverse reactions documented in regulatory sources include severe neurological events such as convulsions and status epilepticus, and severe cardiac issues including ventricular rhythm disorders and cardiac arrest. Other reactions reported in safety monitoring include tachycardia, hypotension, and flushing.


Safety Restrictions and Vulnerable Populations

Official regulatory assessments characterize Buflomedil as having a Narrow Therapeutic Index. This means there is a limited margin between a dose that provides a therapeutic effect and a dose that can cause serious, life-threatening toxicity. This fundamental restriction dictates the overall safety constraints for the medicine.

Population-specific safety considerations are necessary for patients with impaired drug clearance. Regulatory information specifies that elderly patients and individuals with renal impairment are at increased risk. The safety concern for renal impairment arises because the medicine can accumulate in the body, which can lead to life-threatening toxicity if the dose is not appropriately restricted. Consequently, the medicine is contraindicated in severe renal insufficiency (e.g., Creatinine Clearance less than 30 ml/min), as stated in official labeling.

Overdose and Emergency Response

Overdose and when to seek help

This information is derived strictly from official government regulatory documents detailing the documented manifestations and mandatory emergency actions related to Buflomedil overdose.


Overdose Scope

Domain Official Regulatory Statement
Documented overdose presentations Neurological disturbances, including convulsions and myoclonia; cardiac signs such as tachycardia (accelerated heart rate) and hypotension (low blood pressure).
Physiological systems affected (as stated in label) Central nervous system and cardiovascular system.
Dose-related or exposure-related factors Associated with accidental or intentional overdose where the narrow therapeutic index was exceeded.
Population-specific overdose notes Increased risk or severity is noted in patients with kidney problems (renal impairment), particularly when the dose was not appropriately adjusted.
Emergency-response statements Treatment is limited to symptomatic and supportive management as no specific antidote is known. Regulators advised prescribers to stop prescribing this medication due to associated risks.
When immediate medical help is required Immediate medical attention is required for the onset of life-threatening events such as cardiac arrest and status epilepticus (a persistent seizure state).

Overdose Classifications (High-Level)

Classification Official Regulatory Statement
Severity classification Associated with serious and sometimes fatal side effects.
Regulatory basis Based on reviews and pharmacovigilance reports by the European Medicines Agency (EMA) and national health authorities.
Overdose-context constraints No specific antidote is known.

Resulting Overdose Structure

Official overdose statements:

  • Overdose may be associated with severe events affecting the central nervous system, including convulsions and status epilepticus.
  • Severe cardiac manifestations include ventricular rhythm disorders, cardiac arrest, tachycardia, and hypotension.
  • The risk of serious effects linked to overdose is explicitly noted as increased in patients with renal impairment who did not receive a dose adjustment.
  • In the event of suspected overdose, immediate medical attention is required due to the risk of life-threatening manifestations.
  • Treatment is limited to symptomatic and supportive management as no specific antidote is known.

Connection to the overall overdose profile (3 sentences):

Regulatory documents define the overdose profile for Dilan based on documented systemic toxicity, specifically severe adverse events in the nervous and cardiovascular systems. The documented potential for life-threatening outcomes, such as cardiac arrest and status epilepticus, establishes the condition for seeking urgent medical help. Official information also explicitly ties overdose risk to specific patient circumstances, noting that effects were observed when patients with kidney problems did not receive reduced doses.

Therapeutic Uses of Dilan

What Dilan Treats: Main Uses and Benefits

Dilan is commonly used to help with the symptomatic challenges associated with chronic peripheral vascular disorders. The medication is used to treat the symptoms of peripheral arterial occlusive disease (PAOD), particularly in Stage II PAOD patients who experience severe pain when walking. The role of the medication is often focused on assisting with functional stability and easing exertion-related symptoms.


The medication is relevant for easing symptoms that interfere with daily comfort, encompassing conditions such as Peripheral Arterial Occlusive Disease and Intermittent Claudication. It is generally applied in contexts where additional symptomatic support is needed to address the impaired functional stability caused by poor circulation. The treatment may assist with managing the symptom intensity.

“The medicine may provide support that assists with maintaining functional stability when symptoms become more noticeable.”

Quick Fact: Relief for Claudication

Property Description
Primary Symptom Pain or cramping in the lower limbs brought on by exertion.
Therapeutic Goal Assisting with the maintenance of day-to-day functional capacity.
Use Context Conservative management of chronic peripheral vascular disorders.
Patient Benefit Supports patients during difficult episodes by easing the overall symptom load.

Eligibility and Restrictions for Use

This section outlines the official eligibility and non-eligibility rules for Dilan as established in governmental regulatory documents (e.g., FDA Prescribing Information and EMA Summary of Product Characteristics).

Populations That Must Not Use Dilan (Contraindications)

Official labeling strictly contraindicates Dilan use for patients with a documented hypersensitivity or allergy to the active substance or any of its inactive components. Furthermore, the medicine is prohibited for use in patients with severe hepatic impairment or severe renal impairment, as these conditions pose a clear and documented risk that outweighs potential benefits.

Eligibility and Restrictions for Specific Groups

Population Group Regulatory Status Status Details
Pediatric Use Not Established Safety and effectiveness are formally not established in children and adolescents (e.g., under 18 years), limiting its approved use in this cohort.
Pregnancy/Lactation Not Recommended Use during pregnancy is generally not recommended. The label advises to discontinue the drug or discontinue nursing during lactation based on potential risks.
Older Adults Conditional Use Permitted, but official labeling mandates closer monitoring and careful dose selection due to increased susceptibility to adverse effects or reduced organ function.

These official statements define who is absolutely excluded and who requires special consideration. Use is strictly limited to patient populations where safety and efficacy are formally established and where no absolute contraindications are present.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section strictly outlines the official interaction profile of Dilan (Buflomedil) as documented in regulatory sources, such as reports from the European Medicines Agency.


Pharmacokinetic and Exposure Risk

The drug's clearance profile results in a significant Pharmacokinetic Impairment Risk in certain patient populations. The most notable formal restriction is the contraindication in severe renal impairment. This prohibition stems directly from the documented pattern of reduced drug clearance, which causes increased systemic exposure and accumulation of Buflomedil due to its narrow therapeutic index.

Pharmacodynamic Interactions

Interactions are also classified by Pharmacodynamic Reinforcement with specific medicinal product categories. Co-administration with Antihypertensive Agents or Vasodilators carries a risk of additive hypotensive effects. Furthermore, co-administration with Central Nervous System (CNS) Acting Agents may result in additive neurological adverse effects, including severe events such as convulsions. Formal use restrictions also applied to patients with a history of seizures or epilepsy.

Population Considerations

The clinical significance of these interactions is magnified in Elderly Patients, who are identified as a population facing a heightened risk of adverse events due to increased susceptibility to accumulation and other co-morbidities. No mandatory timing rules or interactions with food, alcohol, or specific supplements are explicitly documented in the official regulatory summaries.

Mechanism of Action

How Dilan Works

Dilan (Buflomedil) functions through a composite mechanism that concurrently addresses both the resistance of blood vessels and the flow properties of the blood itself, contributing to enhanced blood distribution within the microcirculation.


alpha1-Adrenoceptor Antagonism and Vascular Relaxation

The primary action involves competitive antagonism at alpha1-Adrenoceptors on vascular smooth muscle, counteracting the constrictive signaling mediated by the sympathetic nervous system. By blocking these receptors, the drug induces the relaxation of peripheral blood vessels, which reduces mechanical resistance and supports an increase in blood flow.


Modification of Blood Component Dynamics (Hemorheology)

An additional mechanism involves the modification of blood fluidity. Dilan increases the deformability of red blood cells (RBCs), which supports passage through narrow capillaries, and simultaneously acts as an inhibitor of platelet aggregation, decreasing the aggregative tendency of blood components. This action on blood components is essential for optimizing flow dynamics in the small, fine vessels of the microcirculation.


Composite Action and Perfusion Enhancement

These two distinct mechanisms operate in tandem, resulting in a mechanistic cascade. The combination of reduced vascular resistance and modified blood fluidity results in an increase in local blood delivery (perfusion) to peripheral tissue.

Dosage and Administration Information

How Dilan is Used: Official Administration Guidelines

Dilan (Buflomedil) usage is defined by specific administration routes, dosing limits, and mandatory adjustments based on physiological status. This approach ensures consistent use within the established framework of the medicine's official instructions.


Administration Routes and Dosing Patterns

The medicine is available in two principal forms: a tablet for oral administration and a solution designed for parenteral administration via injection or infusion. The typical course of use involves starting therapy with the parenteral form to establish initial therapeutic levels, followed by a procedural switch to the oral tablets for continued maintenance.

Feature Official Usage Principle
Standard Daily Dose The usual maintenance dose for adults ranges between 300 mg and 600 mg daily.
Maximum Dose Limit The maximum recommended daily dose for adults with normal renal function is strictly 600 mg.
Dosing Frequency The total prescribed daily dose must be administered in at least two divided doses per day.

Mandatory Dose Adjustment

Official instructions mandate a specific dose adjustment requirement tied to a patient's kidney health. Dosing necessitates adaptation based on measured renal function (creatinine clearance). For patients with confirmed impaired renal function, the maximum daily intake must be reduced to 300 mg. This constraint is a critical procedural condition for correct use. The final usage protocol therefore combines form transition with mandatory dose limitation based on physiological status.

Recent Clinical Evidence

Research Evidence: Overview of Studies for Dilan (Buflomedil)

The clinical evaluation of Dilan, which contains the active ingredient Buflomedil, was conducted through formal clinical trials and systematic reviews, evaluating the medicine's potential application in managing symptoms related to restricted blood flow in the legs.


Evidence for Use in Peripheral Arterial Occlusive Disease (PAOD)

Clinical research primarily focused on Dilan in adults with Peripheral Arterial Occlusive Disease (PAOD), a condition marked by functional limitations and symptoms like pain or cramping when walking. The most important research design was observed in randomized controlled trials (RCTs), where patients either received Dilan or an inactive substance (placebo). These trials monitored outcomes related to physical discomfort and daily functioning or activity level, specifically measuring how far patients could walk before pain began (Pain-Free Walking Distance) and their total walking distance on a treadmill.

Studies explored short-term symptom changes over periods typically lasting 12 weeks. Findings contribute to understanding symptom patterns by describing measurements for walking distance that were observed during the study period. However, the reported measurements were noted to vary when reviewed by regulatory agencies. The measured differences in functional capacity were reported to be variable across the population that was observed in the studies.


Long-Term Research and Clinical Event Studies

A key part of the evidence landscape included a large, long-term RCT where Dilan was studied to monitor patient outcomes over a period of up to 2 to 4 years. This research examined long-term effects by monitoring critical outcomes related to systemic or functional imbalance that can occur in PAOD patients. The primary focus was observed in a composite outcome that tracked occurrences like symptomatic deterioration of PAOD, limb amputation, cardiovascular death, or stroke.

The data from this extended-duration study describe patterns in the frequency of the composite outcome as observed in the group receiving Dilan compared to the placebo group. This observation was primarily based on patterns in the outcome concerning symptomatic deterioration of PAOD.


Evidence Gaps and Areas of Uncertainty

Review of the body of evidence highlights several areas where certainty remains low and research is ongoing. A key limitation is that the evidence quality varies across studies, with many available reports excluded from systematic reviews due to methodological flaws. Furthermore, sample sizes were small in many of the key short-term efficacy studies. The available evidence provides limited insight into whether the measured differences correspond to changes in a patient's daily life.

Frequently Asked Questions (FAQ)

Common questions about Dilan (FAQ)


Q: Does Dilan have a generic version available yet?

The active ingredient in Dilan is Buflomedil hydrochloride. Regulatory product information confirms that medicines containing this active substance may be available under different brand names or as a generic version.


Q: Will taking Dilan affect my ability to drive or operate machinery?

Official regulatory information documents the potential for severe neurological effects, such as convulsions. Official labels typically advise patients to exercise caution until they know how the medicine affects their personal functional ability, especially concerning driving or operating machinery.


Q: Are there specific symptoms that mean I should call my doctor immediately while on Dilan?

The official safety profile for Dilan details the risk of severe adverse events, including convulsions, ventricular rhythm disorders, and cardiac arrest. If symptoms related to these serious neurological or cardiac events are experienced, seeking immediate medical assistance is recommended by product labeling.


Q: Does Dilan treat the cause of the condition or just the symptoms?

The general purpose of the medicine is described as promoting vasodilation, which enhances blood flow to relieve issues related to restricted circulation. Clinical research focused on measuring changes in functional symptoms, such as the distance a patient can walk without pain.


Q: Is Dilan available over the counter in any country?

Dilan, which contains the active ingredient Buflomedil, is classified in regulatory documents as a prescription-only medicine. Its use is intended primarily for the adult population under medical supervision.


Q: Does Dilan interact with caffeine or coffee?

Official regulatory summaries do not explicitly document mandatory timing rules or specific interactions related to the consumption of caffeine or coffee.


Q: Is it safe to take Dilan while also taking a daily multivitamin?

The official regulatory summaries do not explicitly document mandatory timing rules or interactions specifically involving general multivitamins or common nutritional supplements.


Q: Is there a food or drink I should avoid completely when taking Dilan?

Official regulatory summaries do not explicitly document mandatory timing rules or interactions related to specific foods or drinks that must be avoided when taking Dilan.


Q: What are the signs that Dilan is starting to wear off?

Dilan is prescribed for repeated daily use, with the total dose typically divided into at least two daily administrations. The drug’s duration of effect is related to its plasma half-life, which one study described as being approximately 2 to 3 hours after oral administration.


Q: Is Dilan effective for [A related but specific symptom]? (e.g., nerve pain)

Clinical research evidence for Dilan primarily focused on managing symptoms related to restricted blood flow in the legs, a condition known as Peripheral Arterial Occlusive Disease (PAOD). Evidence summaries do not broadly address other specific symptoms, such as nerve pain.


Q: What is the official research summary on Dilan's use in younger adults?

Official regulatory and research summaries define the medicine’s use for the adult population. Safety and effectiveness are formally not established in children and adolescents, limiting its use to adults.


Q: Does the time of day I take Dilan matter?

Official regulatory summaries do not explicitly document mandatory timing rules related to the time of day for administration. However, official guidelines state that the total prescribed daily dose must be administered in at least two separate divided doses.


Q: What kind of condition is Dilan designed to help with?

Dilan has been clinically researched for its application in managing symptoms related to restricted blood flow in the legs, which is commonly referred to as Peripheral Arterial Occlusive Disease (PAOD).


Q: Can Dilan be taken on an empty stomach?

Official regulatory summaries do not explicitly document mandatory timing rules or interactions related to food intake, nor do they specify whether the medicine should be taken on an empty stomach.


Q: Can Dilan be taken alongside common supplements like Omega-3 or Vitamin D?

Official regulatory summaries do not explicitly document mandatory timing rules or interactions with specific supplements such as Omega-3 or Vitamin D.


Q: Can Dilan cause changes in mood or anxiety levels?

Official documentation details the potential for severe neurological effects, including convulsions and status epilepticus. These documented events are linked to the drug's activity on the Central Nervous System.

How should Dilan be stored and disposed of?

How to Store and Dispose of Dilan

Official Storage Requirements

Condition Requirement
Temperature Store at a controlled room temperature, typically between 15 C and 30 C (59 F and 86 F). Do not freeze or store near excess heat.
Protection Keep the medication in its original container, tightly closed, and protect it from both light and moisture. Do not store in the bathroom.
Safety Store strictly out of the reach of children and pets.

Disposal and Handling Rules

Unused or expired Dilan must be disposed of according to official regulatory guidelines. Do not flush the medication down the toilet or pour it into a drain, as environmental release is to be avoided. Consult with a pharmacist or local collection program for instruction on proper disposal. For opened injectable forms, any remaining portion must be discarded immediately.

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

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